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Emend (aprepitant) – Package leaflet - A04AD12

Updated on site: 06-Oct-2017

Medication nameEmend
ATC CodeA04AD12
Substanceaprepitant
ManufacturerMerck Sharp

Package leaflet: Information for the user

EMEND 40 mg hard capsules aprepitant

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

-Keep this leaflet. You may need to read it again.

-If you have any further questions, ask your doctor, pharmacist, or nurse.

-This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.

-If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet

1.What EMEND is and what it is used for

2.What you need to know before you take EMEND

3.How to take EMEND

4.Possible side effects

5.How to store EMEND

6.Contents of the pack and other information

1.What EMEND is and what it is used for

EMEND contains the active substance aprepitant and belongs to a group of medicines called "neurokinin 1 (NK1) receptor antagonists" (antiemetics and antinauseants). The brain has a specific area that controls nausea and vomiting. EMEND works by blocking signals to that area and is used to prevent nausea and vomiting after surgery in adults.

2. What you need to know before you take EMEND

Do not take EMEND:

-if you are allergic to aprepitant or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Talk to your doctor, pharmacist, or nurse before taking EMEND.

Before treatment with this medicine, tell your doctor if you have liver disease because your liver is important in breaking down the medicine in your body. Your doctor may therefore have to monitor the condition of your liver.

Children and adolescents

Do not give EMEND 40 mg to children and adolescents under 18 years of age, because the 40 mg capsules have not been studied in this population.

Other medicines and EMEND

This medicine can affect other medicines.

The effects of EMEND or other medicines might be influenced if you take EMEND together with other medicines including those listed below. Please talk to your doctor or pharmacist if you are taking any of the following medicines:

-birth control medicines which can include birth control pills, skin patches, implants, and certain Intrauterine devices (IUDs) that release hormones may not work adequately when taken

together with EMEND. Another or additional non-hormonal form of birth control should be used during treatment with EMEND and for up to 2 months after using EMEND,

-pimozide (used to treat psychiatric illnesses),

-terfenadine; astemizole (used for hay fever and other allergic conditions),

-cisapride (used for treating digestive problems),

-medicines containing ergot alkaloid derivatives (used for treating migraines),

-rifampicin, clarithromycin, telithromycin (antibiotics used to treat infections),

-phenytoin (a medicine used to treat seizures),

-carbamazepine (used to treat depression and epilepsy),

-midazolam, phenobarbital (medicines used to produce calmness or help you sleep),

-St. John’s Wort (an herbal preparation used to treat depression),

-protease inhibitors (used to treat HIV infections),

-nefazodone (used to treat depression),

-ketoconazole except shampoo (used to treat Cushing’s syndrome - when the body produces an excess of cortisol),

-itraconazole, voriconazole, posaconazole (antifungals),

-corticosteroids (such as dexamethasone)

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

Pregnancy and breast-feeding

You should not use this medicine during pregnancy unless clearly necessary. If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.

For information regarding birth control, see ‘Other medicines and EMEND.

It is not known whether EMEND is excreted in human milk; therefore, breast-feeding is not recommended during treatment with this medicine. It is important that you tell your doctor if you are breast-feeding or are planning to breast-feed before taking this medicine.

Driving and using machines

It should be taken into account that some people feel dizzy and sleepy after taking EMEND. If you feel dizzy or sleepy, you should avoid driving or using machines after taking this medicine (see Possible side effects).

EMEND contains sucrose

EMEND capsules contain sucrose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

3.How to take EMEND

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

The recommended oral dose of EMEND is one 40 mg capsule within 3 hours prior to the start of anaesthesia.

Swallow the capsule whole with some liquid.

4.Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Stop taking EMEND and see a doctor immediately if you notice any of the following side effects, which may be serious, and for which you may need urgent medical treatment:

-Hives, rash, itching, difficulty breathing or swallowing (frequency not known, cannot be estimated from the available data); these are signs of an allergic reaction.

Other side effects that have been reported are listed below.

Common side effects (may affect up to 1 in 10 people) are:

-increased amount of liver enzymes in your blood.

Uncommon side effects (may affect up to 1 in 100 people) are:

-upper stomach pain, bowel sounds abnormal, dry mouth, nausea, stomach discomfort, serious constipation, small bowel not working properly (sub-ileus),

-decreased feeling or sensitivity (especially in skin), sensory disturbance, difficulty in speaking,

-decrease in pupil size, decrease in sharpness of vision (vision loss),

-inability to sleep,

-slow heartbeat,

-whistling sound while breathing, shortness of breath.

Side effects for which the frequency is not known:

-Stevens-Johnson syndrome/toxic epidermal necrolysis (rare severe skin reaction).

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.

5.How to store EMEND

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiry date refers to the last day of that month.

Store in the original package in order to protect from moisture.

Do not remove the capsule from its blister until you are ready to take it.

Do not throw away any medicines via wastewater or house hold waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

What EMEND contains

-The active substance is aprepitant. Each capsule contains 40 mg of aprepitant.

-The other ingredients are: sucrose, microcrystalline cellulose (E 460), hydroxypropylcellulose (E 463), sodium laurilsulfate, gelatin, titanium dioxide (E 171), shellac, potassium hydroxide, black iron oxide (E 172), and yellow iron oxide (E 172).

What EMEND looks like and contents of the pack

The 40 mg hard capsule is opaque with a white body and mustard yellow cap with “464” and “40 mg” printed radially in black ink on the body.

EMEND 40 mg hard capsules are supplied in the following pack sizes:

-Aluminium blister containing one 40 mg capsule

-5 Aluminium blisters each containing one 40 mg capsule

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Manufacturer

Merck Sharp & Dohme Ltd.

Merck Sharp & Dohme B. V.

Hertford Road, Hoddesdon

Waarderweg 39

Hertfordshire EN11 9BU

2031 BN Haarlem

United Kingdom

The Netherlands

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder.

Belgique/België/Belgien

Lietuva

MSD Belgium BVBA/SPRL

UAB Merck Sharp & Dohme

Tél/Tel: 0800 38 693 (+32(0)27766211)

Tel. + 370 5278 02 47

dpoc_belux@merck.com

msd_lietuva@merck.com

България

Luxembourg/Luxemburg

Мерк Шарп и Доум България ЕООД

MSD Belgium BVBA/SPRL

Тел.: +359 2 819 3737

Tél/Tel: +32(0)27766211

info-msdbg@merck.com

dpoc_belux@merck.com

Česká republika

Magyarország

Merck Sharp & Dohme s.r.o.

MSD Pharma Hungary Kft.

Tel: +420 233 010 111

Tel.: +36 1 888 5300

dpoc_czechslovak@merck.com

hungary_msd@merck.com

Danmark

Malta

MSD Danmark ApS

Merck Sharp & Dohme Cyprus Limited

Tlf: + 45 4482 4000

Tel: 8007 4433 (+356 99917558)

dkmail@merck.com

malta_info@merck.com

Deutschland

Nederland

MSD SHARP & DOHME GMBH

Merck Sharp & Dohme BV

Tel: 0800 673 673 673 (+49 (0) 89 4561 2612)

Tel: 0800 9999000

e-mail@msd.de

(+31 23 5153153)

 

medicalinfo.nl@merck.com

Eesti

Norge

Merck Sharp & Dohme OÜ

MSD (Norge) AS

Tel.: +372 6144 200

Tlf: +47 32 20 73 00

msdeesti@merck.com

msdnorge@msd.no

Eλλάδα

Österreich

MSD Α.Φ.Β.Ε.Ε.

Merck Sharp & Dohme Ges.m.b.H.

Τηλ: +30 210 98 97 300

Tel: +43 (0) 1 26 044

dpoc_greece@merck.com

msd-medizin@merck.com

España

Merck Sharp & Dohme de España, S.A. Tel: +34 91 321 06 00 msd_info@merck.com

France

MSD France

Tél: +33 (0) 1 80 46 40 40

Hrvatska

Merck Sharp & Dohme d.o.o. Tel: + 385 1 6611 333 croatia_info@merck.com

Ireland

Merck Sharp & Dohme Ireland (Human Health) Limited

Tel: +353 (0)1 2998700 medinfo_ireland@merck.com

Ísland

Vistor hf.

Simi: +354 535 7000

Ιtalia

MSD Italia S.r.l. Tel: +39 06 361911

medicalinformation.it@merck.com

Κύπρος

Merck Sharp & Dohme Cyprus Limited Τηλ.: 800 00 673 (+357 22866700) cyprus_info@merck.com

Latvija

SIA Merck Sharp & Dohme Latvija Tel: +371 67364224 msd_lv@merck.com

This leaflet was last revised in

Polska

MSD Polska Sp. z o.o. Tel: +48 22 549 51 00 msdpolska@merck.com

Portugal

Merck Sharp & Dohme, Lda Tel: +351 21 4465700 clic@merck.com

România

Merck Sharp & Dohme Romania S.R.L. Tel: +40 21 529 29 00 msdromania@merck.com

Slovenija

Merck Sharp & Dohme, inovativna zdravila d.o.o.

Tel: +386 1 5204 201 msd_slovenia@merck.com

Slovenská republika

Merck Sharp & Dohme, s. r. o. Tel: +421 2 58282010 dpoc_czechslovak@merck.com

Suomi/Finland

MSD Finland Oy

Puh/Tel: +358 (0)9 804 650 info@msd.fi

Sverige

Merck Sharp & Dohme (Sweden) AB Tel: +46 77 5700488 medicinskinfo@merck.com

United Kingdom

Merck Sharp & Dohme Limited Tel: +44 (0) 1992 467272 medicalinformationuk@merck.com

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu.

Package leaflet: Information for the user

EMEND 80 mg hard capsules aprepitant

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you. If you are the parent of a child taking EMEND, please read this information carefully.

-Keep this leaflet. You may need to read it again.

-If you have any further questions, ask the doctor, pharmacist, or nurse.

-This medicine has been prescribed for you or the child only. Do not pass it on to others. It may harm them, even if their signs of illness are the same.

-If you or the child gets any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet

1.What EMEND is and what it is used for

2.What you need to know before you take or give EMEND

3.How to take EMEND

4.Possible side effects

5.How to store EMEND

6.Contents of the pack and other information

1. What EMEND is and what it is used for

EMEND contains the active substance aprepitant and belongs to a group of medicines called "neurokinin 1 (NK1) receptor antagonists". The brain has a specific area that controls nausea and vomiting. EMEND works by blocking signals to that area, thereby reducing nausea and vomiting. EMEND capsules are used in adults and adolescents from the age of 12 years in combination with other medicines to prevent nausea and vomiting caused by chemotherapy (cancer treatment) that are strong and moderate triggers of nausea and vomiting (such as cisplatin, cyclophosphamide, doxorubicin or epirubicin).

2. What you need to know before you take or give EMEND

Do not take EMEND:

-if you or the child is allergic to aprepitant or any of the other ingredients of this medicine (listed in section 6).

-with medicines containing pimozide (used to treat psychiatric illnesses), terfenadine and astemizole (used for hay fever and other allergic conditions), cisapride (used for treating digestive problems). Tell the doctor if you or the child is taking these medicines since the treatment must be modified before you or the child start taking EMEND.

Warnings and precautions

Talk to the doctor, pharmacist, or nurse before you take EMEND or give this medicine to the child.

Before treatment with this medicine, tell the doctor if you or the child have liver disease because the liver is important in breaking down the medicine in the body. The doctor may therefore have to monitor the condition of your or the child’s liver.

Children and adolescents

Do not give EMEND 80 mg capsules to children under 12 years of age, because the 80 mg capsules have not been studied in this population.

Other medicines and EMEND

EMEND can affect other medicines both during and after treatment with EMEND. There are some medicines that should not be taken with EMEND (such as pimozide, terfenadine, astemizole, and cisapride) or that require a dose adjustment (see also Do not take EMEND).

The effects of EMEND or other medicines might be influenced if you or the child take EMEND together with other medicines including those listed below. Please talk to the doctor or pharmacist if you or the child is taking any of the following medicines:

-birth control medicines which can include birth control pills, skin patches, implants, and certain Intrauterine devices (IUDs) that release hormones may not work adequately when taken together with EMEND. Another or additional non-hormonal form of birth control should be used during treatment with EMEND and for up to 2 months after using EMEND,

-cyclosporine, tacrolimus, sirolimus, everolimus (immunosuppressants),

-alfentanil, fentanyl (used to treat pain),

-quinidine (used to treat an irregular heart beat),

-irinotecan, etoposide, vinorelbine, ifosfamide (medicines used to treat cancer),

-medicines containing ergot alkaloid derivatives such as ergotamine and diergotamine (used for treating migraines),

-warfarin, acenocoumarol (blood thinners; blood tests may be required),

-rifampicin, clarithromycin, telithromycin (antibiotics used to treat infections),

-phenytoin (a medicine used to treat seizures),

-carbamazepine (used to treat depression and epilepsy),

-midazolam, triazolam, phenobarbital (medicines used to produce calmness or help you sleep),

-St. John’s Wort (an herbal preparation used to treat depression),

-protease inhibitors (used to treat HIV infections),

-ketoconazole except shampoo (used to treat Cushing’s syndrome - when the body produces an excess of cortisol),

-itraconazole, voriconazole, posaconazole (antifungals),

-nefazodone (used to treat depression),

-corticosteroids (such as dexamethasone and methylprednisolone),

-anti-anxiety medicines (such as alprazolam),

-tolbutamide (a medicine used to treat diabetes)

Tell the doctor or pharmacist if you or the child are taking, have recently taken, or might take any other medicines.

Pregnancy and breast-feeding

This medicine should not be used during pregnancy unless clearly necessary. If you or the child are pregnant or breast-feeding, may be pregnant or are planning to have a baby, ask the doctor for advice before taking this medicine.

For information regarding birth control, see ‘Other medicines and EMEND.

It is not known whether EMEND is excreted in human milk; therefore, breast-feeding is not recommended during treatment with this medicine. It is important to tell the doctor if you or the child are breast-feeding or are planning to breast-feed before taking this medicine.

Driving and using machines

It should be taken into account that some people feel dizzy and sleepy after taking EMEND. If you or the child feels dizzy or sleepy, avoid driving, riding a bicycle or using machines or tools after taking this medicine (see Possible side effects).

EMEND contains sucrose

EMEND capsules contain sucrose. If you or the child have been told by your doctor that you or the child have an intolerance to some sugars, contact the doctor before taking this medicine.

3. How to take EMEND

Always take this medicine or give this medicine to the child exactly as the doctor, pharmacist or nurse has told you. You should check with the doctor, pharmacist or nurse if you are not sure. Always take EMEND together with other medicines, to prevent nausea and vomiting. After treatment with EMEND, the doctor may ask you or the child to continue taking other medicines including a corticosteroid (such as dexamethasone) and a ‘5HT3 antagonist’ (such as ondansetron) for preventing nausea and vomiting. Check with the doctor, pharmacist or nurse if you are not sure.

The recommended oral dose of EMEND is

Day 1:

-one 125 mg capsule 1 hour before you start your chemotherapy session

and

Days 2 and 3:

-one 80 mg capsule each day

-If no chemotherapy is given, take EMEND in the morning.

-If chemotherapy is given, take EMEND 1 hour before you start your chemotherapy session.

EMEND can be taken with or without food.

Swallow the capsule whole with some liquid.

If you take more EMEND than you should

Do not take more capsules than the doctor recommends. If you or the child has taken too many capsules, contact your doctor immediately.

If you forget to take EMEND

If you or the child has missed a dose, contact your doctor for advice.

If you have any further questions on the use of this medicine, ask the doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Stop taking EMEND and see a doctor immediately if you or the child notice any of the following side effects, which may be serious, and for which you or the child may need urgent medical treatment:

-Hives, rash, itching, difficulty breathing or swallowing (frequency not known, cannot be estimated from the available data); these are signs of an allergic reaction.

Other side effects that have been reported are listed below.

Common side effects (may affect up to 1 in 10 people) are:

-constipation, indigestion,

-headache,

-tiredness,

-loss of appetite,

-hiccups,

-increased amount of liver enzymes in your blood.

Uncommon side effects (may affect up to 1 in 100 people) are:

-dizziness, sleepiness,

-acne, rash,

-anxiousness,

-burping, nausea, vomiting, heartburn, stomach pain, dry mouth, passing wind,

-increased painful or burning urination,

-weakness, generally feeling unwell,

-hot flush/reddening of the face or skin,

-fast or irregular heartbeats,

-fever with increased risk of infection, lowering of red blood cells.

Rare side effects (may affect up to1 in 1,000 people) are:

-difficulty thinking, lack of energy, taste disturbance,

-sensitivity of the skin to sun, excessive sweating, oily skin, sores on skin, itching rash, Stevens-Johnson syndrome/toxic epidermal necrolysis (rare severe skin reaction),

-euphoria (feeling of extreme happiness), disorientation,

-bacterial infection, fungal infection,

-severe constipation, stomach ulcer, inflammation of the small intestine and colon, sores in mouth, bloating,

-frequent urination, passing more urine than normal, presence of sugar or blood in urine,

-chest discomfort, swelling, change in the manner of walking,

-cough, mucus in back of throat, throat irritation, sneezing, sore throat,

-eye discharge and itching,

-ringing in the ear,

-muscle spasms, muscle weakness,

-excessive thirst,

-slow heartbeat, heart and blood vessel disease,

-lowering of white blood cells, low sodium levels in the blood, weight loss.

Reporting of side effects

If you or the child gets any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store EMEND

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiry date refers to the last day of that month.

Store in the original package in order to protect from moisture.

Do not remove the capsule from its blister until you are ready to take it.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

What EMEND contains

-The active substance is aprepitant. Each capsule contains 80 mg of aprepitant.

-The other ingredients are: sucrose, microcrystalline cellulose (E 460), hydroxypropylcellulose (E 463), sodium laurilsulfate, gelatin, titanium dioxide (E 171), shellac, potassium hydroxide, and black iron oxide (E 172).

What EMEND looks like and contents of the pack

The 80 mg hard capsule is opaque with a white cap and body with “461” and “80 mg” printed radially in black ink on the body.

EMEND 80 mg hard capsules are supplied in the following pack sizes:

Aluminium blister containing one 80 mg capsule

2-day treatment pack containing two 80 mg capsules

5 Aluminium blisters each containing one 80 mg capsule

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Manufacturer

Merck Sharp & Dohme Ltd.

Merck Sharp & Dohme B. V.

Hertford Road, Hoddesdon

Waarderweg 39

Hertfordshire EN11 9BU

2031 BN Haarlem

United Kingdom

The Netherlands

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder.

Belgique/België/Belgien

Lietuva

MSD Belgium BVBA/SPRL

UAB Merck Sharp & Dohme

Tél/Tel: 0800 38 693 (+32(0)27766211)

Tel. + 370 5278 02 47

dpoc_belux@merck.com

msd_lietuva@merck.com

България

Luxembourg/Luxemburg

Мерк Шарп и Доум България ЕООД

MSD Belgium BVBA/SPRL

Тел.: +359 2 819 3737

Tél/Tel: +32(0)27766211

info-msdbg@merck.com

dpoc_belux@merck.com

Česká republika

Magyarország

Merck Sharp & Dohme s.r.o.

MSD Pharma Hungary Kft.

Tel: +420 233 010 111

Tel.: +36 1 888 5300

dpoc_czechslovak@merck.com

hungary_msd@merck.com

Danmark

Malta

MSD Danmark ApS

Merck Sharp & Dohme Cyprus Limited

Tlf: + 45 4482 4000

Tel: 8007 4433 (+356 99917558)

dkmail@merck.com

malta_info@merck.com

Deutschland

Nederland

MSD SHARP & DOHME GMBH

Merck Sharp & Dohme BV

Tel: 0800 673 673 673 (+49 (0) 89 4561 2612)

Tel: 0800 9999000

e-mail@msd.de

(+31 23 5153153)

 

medicalinfo.nl@merck.com

Eesti

Norge

Merck Sharp & Dohme OÜ

MSD (Norge) AS

Tel.: +372 6144 200

Tlf: +47 32 20 73 00

msdeesti@merck.com

msdnorge@msd.no

Eλλάδα

MSD Α.Φ.Β.Ε.Ε.

Τηλ: +30 210 98 97 300 dpoc_greece@merck.com

España

Merck Sharp & Dohme de España, S.A. Tel: +34 91 321 06 00 msd_info@merck.com

France

MSD France

Tél: +33 (0) 1 80 46 40 40

Hrvatska

Merck Sharp & Dohme d.o.o. Tel: + 385 1 6611 333 croatia_info@merck.com

Ireland

Merck Sharp & Dohme Ireland (Human Health) Limited

Tel: +353 (0)1 2998700 medinfo_ireland@merck.com

Ísland

Vistor hf.

Simi: +354 535 7000

Ιtalia

MSD Italia S.r.l. Tel: +39 06 361911

medicalinformation.it@merck.com

Κύπρος

Merck Sharp & Dohme Cyprus Limited Τηλ.: 800 00 673 (+357 22866700) cyprus_info@merck.com

Latvija

SIA Merck Sharp & Dohme Latvija Tel: +371 67364224 msd_lv@merck.com

This leaflet was last revised in

Österreich

Merck Sharp & Dohme Ges.m.b.H. Tel: +43 (0) 1 26 044 msd-medizin@merck.com

Polska

MSD Polska Sp. z o.o. Tel: +48 22 549 51 00 msdpolska@merck.com

Portugal

Merck Sharp & Dohme, Lda Tel: +351 21 4465700 clic@merck.com

România

Merck Sharp & Dohme Romania S.R.L. Tel: +40 21 529 29 00 msdromania@merck.com

Slovenija

Merck Sharp & Dohme, inovativna zdravila d.o.o.

Tel: +386 1 5204 201 msd_slovenia@merck.com

Slovenská republika

Merck Sharp & Dohme, s. r. o. Tel: +421 2 58282010 dpoc_czechslovak@merck.com

Suomi/Finland

MSD Finland Oy

Puh/Tel: +358 (0)9 804 650 info@msd.fi

Sverige

Merck Sharp & Dohme (Sweden) AB Tel: +46 77 5700488 medicinskinfo@merck.com

United Kingdom

Merck Sharp & Dohme Limited Tel: +44 (0) 1992 467272 medicalinformationuk@merck.com

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu.

Package leaflet: Information for the user

EMEND 125 mg hard capsules aprepitant

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you. If you are the parent of a child taking EMEND, please read this information carefully.

-Keep this leaflet. You may need to read it again.

-If you have any further questions, ask the doctor, pharmacist, or nurse.

-This medicine has been prescribed for you or the child only. Do not pass it on to others. It may harm them, even if their signs of illness are the same.

-If you or the child gets any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet

1.What EMEND is and what it is used for

2.What you need to know before you take or give EMEND

3.How to take EMEND

4.Possible side effects

5.How to store EMEND

6.Contents of the pack and other information

1. What EMEND is and what it is used for

EMEND contains the active substance aprepitant and belongs to a group of medicines called "neurokinin 1 (NK1) receptor antagonists". The brain has a specific area that controls nausea and vomiting. EMEND works by blocking signals to that area, thereby reducing nausea and vomiting. EMEND capsules are used in adults and adolescents from the age of 12 years in combination with other medicines to prevent nausea and vomiting caused by chemotherapy (cancer treatment) that are strong and moderate triggers of nausea and vomiting (such as cisplatin, cyclophosphamide, doxorubicin or epirubicin).

2. What you need to know before you take or give EMEND

Do not take EMEND:

-if you or the child is allergic to aprepitant or any of the other ingredients of this medicine (listed in section 6).

-with medicines containing pimozide (used to treat psychiatric illnesses), terfenadine and astemizole (used for hay fever and other allergic conditions), cisapride (used for treating digestive problems). Tell the doctor if you or the child is taking these medicines since the treatment must be modified before you or the child start taking EMEND.

Warnings and precautions

Talk to the doctor, pharmacist, or nurse before you take EMEND or give this medicine to the child.

Before treatment with EMEND, tell the doctor if you or the child have liver disease because the liver is important in breaking down the medicine in the body. The doctor may therefore have to monitor the condition of your or the child’s liver.

Children and adolescents

Do not give EMEND 125 mg capsules to children under 12 years of age, because the 125 mg capsules have not been studied in this population.

Other medicines and EMEND

EMEND can affect other medicines both during and after treatment with EMEND. There are some medicines that should not be taken with EMEND (such as pimozide, terfenadine, astemizole, and cisapride) or that require a dose adjustment (see also Do not take EMEND).

The effects of EMEND or other medicines might be influenced if you or the child take EMEND together with other medicines including those listed below. Please talk to the doctor or pharmacist if you or the child is taking any of the following medicines:

-birth control medicines which can include birth control pills, skin patches, implants, and certain Intrauterine devices (IUDs) that release hormones may not work adequately when taken together with EMEND. Another or additional non-hormonal form of birth control should be used during treatment with EMEND and for up to 2 months after using EMEND,

-cyclosporine, tacrolimus, sirolimus, everolimus (immunosuppressants),

-alfentanil, fentanyl (used to treat pain),

-quinidine (used to treat an irregular heart beat),

-irinotecan, etoposide, vinorelbine, ifosfamide (medicines used to treat cancer),

-medicines containing ergot alkaloid derivatives such as ergotamine and diergotamine (used for treating migraines),

-warfarin, acenocoumarol (blood thinners; blood tests may be required),

-rifampicin, clarithromycin, telithromycin (antibiotics used to treat infections),

-phenytoin (a medicine used to treat seizures),

-carbamazepine (used to treat depression and epilepsy),

-midazolam, triazolam, phenobarbital (medicines used to produce calmness or help you sleep),

-St. John’s Wort (an herbal preparation used to treat depression),

-protease inhibitors (used to treat HIV infections)

-ketoconazole except shampoo (used to treat Cushing’s syndrome - when the body produces an excess of cortisol),

-itraconazole, voriconazole, posaconazole (antifungals),

-nefazodone (used to treat depression),

-corticosteroids (such as dexamethasone and methylprednisolone),

-anti-anxiety medicines (such as alprazolam),

-tolbutamide (a medicine used to treat diabetes)

Tell the doctor or pharmacist if you or the child are taking, have recently taken, or might take any other medicines.

Pregnancy and breast-feeding

This medicine should not be used during pregnancy unless clearly necessary. If you or the child are pregnant or breast-feeding, may be pregnant or are planning to have a baby, ask the doctor for advice before taking this medicine.

For information regarding birth control, see ‘Other medicines and EMEND.

It is not known whether EMEND is excreted in human milk; therefore, breast-feeding is not recommended during treatment with this medicine. It is important to tell the doctor if you or the child are breast-feeding or are planning to breast-feed before taking this medicine.

Driving and using machines

It should be taken into account that some people feel dizzy and sleepy after taking EMEND. If you or the child feels dizzy or sleepy, avoid driving, riding a bicycle or using machines or tools after taking this medicine (see Possible side effects).

EMEND contains sucrose

EMEND capsules contain sucrose. If you or the child have been told by your doctor that you or the child have an intolerance to some sugars, contact the doctor before taking this medicine.

3. How to take EMEND

Always take this medicine or give this medicine to the child exactly as the doctor, pharmacist or nurse has told you. You should check with the doctor, pharmacist or nurse if you are not sure. Always take EMEND together with other medicines, to prevent nausea and vomiting. After treatment with EMEND, the doctor may ask you or the child to continue taking other medicines including a corticosteroid (such as dexamethasone) and a ‘5HT3 antagonist’ (such as ondansetron) for preventing nausea and vomiting. Check with the doctor, pharmacist or nurse if you are not sure.

The recommended oral dose of EMEND is

Day 1:

-one 125 mg capsule 1 hour before you start your chemotherapy session

and

Days 2 and 3:

-one 80 mg capsule each day

-If no chemotherapy is given, take EMEND in the morning.

-If chemotherapy is given, take EMEND 1 hour before you start your chemotherapy session.

EMEND can be taken with or without food.

Swallow the capsule whole with some liquid.

If you take more EMEND than you should

Do not take more capsules than the doctor recommends. If you or the child has taken too many capsules, contact your doctor immediately.

If you forget to take EMEND

If you or the child has missed a dose, contact your doctor for advice.

If you have any further questions on the use of this medicine, ask the doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Stop taking EMEND and see a doctor immediately if you or the child notice any of the following side effects, which may be serious, and for which you or the child may need urgent medical treatment:

-Hives, rash, itching, difficulty breathing or swallowing (frequency not known, cannot be estimated from the available data); these are signs of an allergic reaction.

Other side effects that have been reported are listed below.

Common side effects (may affect up to 1 in 10 people) are:

-constipation, indigestion,

-headache,

-tiredness,

-loss of appetite,

-hiccups,

-increased amount of liver enzymes in your blood.

Uncommon side effects (may affect up to 1 in 100 people) are:

-dizziness, sleepiness,

-acne, rash,

-anxiousness,

-burping, nausea, vomiting, heartburn, stomach pain, dry mouth, passing wind,

-increased painful or burning urination,

-weakness, generally feeling unwell,

-hot flush/reddening of the face or skin,

-fast or irregular heartbeats,

-fever with increased risk of infection, lowering of red blood cells.

Rare side effects (may affect up to1 in 1,000 people) are:

-difficulty thinking, lack of energy, taste disturbance,

-sensitivity of the skin to sun, excessive sweating, oily skin, sores on skin, itching rash, Stevens-Johnson syndrome/toxic epidermal necrolysis (rare severe skin reaction),

-euphoria (feeling of extreme happiness), disorientation,

-bacterial infection, fungal infection,

-severe constipation, stomach ulcer, inflammation of the small intestine and colon, sores in mouth, bloating,

-frequent urination, passing more urine than normal, presence of sugar or blood in urine,

-chest discomfort, swelling, change in the manner of walking,

-cough, mucus in back of throat, throat irritation, sneezing, sore throat,

-eye discharge and itching,

-ringing in the ear,

-muscle spasms, muscle weakness,

-excessive thirst,

-slow heartbeat, heart and blood vessel disease,

-lowering of white blood cells, low sodium levels in the blood, weight loss.

Reporting of side effects

If you or the child gets any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store EMEND

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiry date refers to the last day of that month.

Store in the original package in order to protect from moisture.

Do not remove the capsule from its blister until you are ready to take it.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

What EMEND contains

-The active substance is aprepitant. Each 125 mg hard capsule contains 125 mg of aprepitant.

-The other ingredients are: sucrose, microcrystalline cellulose (E 460), hydroxypropylcellulose (E 463), sodium laurilsulfate, gelatin, titanium dioxide (E 171), shellac, potassium hydroxide, black iron oxide (E 172), red iron oxide (E 172) and yellow iron oxide (E 172).

What EMEND looks like and contents of the pack

The 125 mg hard capsule is opaque with a white body and pink cap with “462” and “125 mg” printed radially in black ink on the body.

EMEND 125 mg hard capsules are supplied in the following pack sizes:

-Aluminium blister containing one 125 mg capsule

-5 Aluminium blisters each containing one 125 mg capsule

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Manufacturer

Merck Sharp & Dohme Ltd.

Merck Sharp & Dohme B. V.

Hertford Road, Hoddesdon

Waarderweg 39

Hertfordshire EN11 9BU

2031 BN Haarlem

United Kingdom

The Netherlands

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder.

Belgique/België/Belgien

Lietuva

MSD Belgium BVBA/SPRL

UAB Merck Sharp & Dohme

Tél/Tel: 0800 38 693 (+32(0)27766211)

Tel. + 370 5278 02 47

dpoc_belux@merck.com

msd_lietuva@merck.com

България

Luxembourg/Luxemburg

Мерк Шарп и Доум България ЕООД

MSD Belgium BVBA/SPRL

Тел.: +359 2 819 3737

Tél/Tel: +32(0)27766211

info-msdbg@merck.com

dpoc_belux@merck.com

Česká republika

Magyarország

Merck Sharp & Dohme s.r.o.

MSD Pharma Hungary Kft.

Tel: +420 233 010 111

Tel.: +36 1 888 5300

dpoc_czechslovak@merck.com

hungary_msd@merck.com

Danmark

Malta

MSD Danmark ApS

Merck Sharp & Dohme Cyprus Limited

Tlf: + 45 4482 4000

Tel: 8007 4433 (+356 99917558)

dkmail@merck.com

malta_info@merck.com

Deutschland

Nederland

MSD SHARP & DOHME GMBH

Merck Sharp & Dohme BV

Tel: 0800 673 673 673 (+49 (0) 89 4561 2612)

Tel: 0800 9999000

e-mail@msd.de

(+31 23 5153153)

 

medicalinfo.nl@merck.com

Eesti

Norge

Merck Sharp & Dohme OÜ

MSD (Norge) AS

Tel.: +372 6144 200

Tlf: +47 32 20 73 00

msdeesti@merck.com

msdnorge@msd.no

Eλλάδα

MSD Α.Φ.Β.Ε.Ε.

Τηλ: +30 210 98 97 300 dpoc_greece@merck.com

España

Merck Sharp & Dohme de España, S.A. Tel: +34 91 321 06 00 msd_info@merck.com

France

MSD France

Tél: +33 (0) 1 80 46 40 40

Hrvatska

Merck Sharp & Dohme d.o.o. Tel: + 385 1 6611 333 croatia_info@merck.com

Ireland

Merck Sharp & Dohme Ireland (Human Health) Limited

Tel: +353 (0)1 2998700 medinfo_ireland@merck.com

Ísland

Vistor hf.

Simi: +354 535 7000

Ιtalia

MSD Italia S.r.l. Tel: +39 06 361911

medicalinformation.it@merck.com

Κύπρος

Merck Sharp & Dohme Cyprus Limited Τηλ.: 800 00 673 (+357 22866700) cyprus_info@merck.com

Latvija

SIA Merck Sharp & Dohme Latvija Tel: +371 67364224 msd_lv@merck.com

This leaflet was last revised in

Österreich

Merck Sharp & Dohme Ges.m.b.H. Tel: +43 (0) 1 26 044 msd-medizin@merck.com

Polska

MSD Polska Sp. z o.o. Tel: +48 22 549 51 00 msdpolska@merck.com

Portugal

Merck Sharp & Dohme, Lda Tel: +351 21 4465700 clic@merck.com

România

Merck Sharp & Dohme Romania S.R.L. Tel: +40 21 529 29 00 msdromania@merck.com

Slovenija

Merck Sharp & Dohme, inovativna zdravila d.o.o.

Tel: +386 1 5204 201 msd_slovenia@merck.com

Slovenská republika

Merck Sharp & Dohme, s. r. o. Tel: +421 2 58282010 dpoc_czechslovak@merck.com

Suomi/Finland

MSD Finland Oy

Puh/Tel: +358 (0)9 804 650 info@msd.fi

Sverige

Merck Sharp & Dohme (Sweden) AB Tel: +46 77 5700488 medicinskinfo@merck.com

United Kingdom

Merck Sharp & Dohme Limited Tel: +44 (0) 1992 467272 medicalinformationuk@merck.com

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu.

Package leaflet: Information for the user

EMEND 165 mg hard capsules aprepitant

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

-Keep this leaflet. You may need to read it again.

-If you have any further questions, ask your doctor, pharmacist, or nurse.

-This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.

-If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet

1.What EMEND is and what it is used for

2.What you need to know before you take EMEND

3.How to take EMEND

4.Possible side effects

5.How to store EMEND

6.Contents of the pack and other information

1.What EMEND is and what it is used for

EMEND contains the active substance aprepitant and belongs to a group of medicines called "neurokinin 1 (NK1) receptor antagonists". The brain has a specific area that controls nausea and vomiting. EMEND works by blocking signals to that area, thereby reducing nausea and vomiting. EMEND is used in adults in combination with other medicines to prevent nausea and vomiting caused by chemotherapy (cancer treatment) containing cisplatin (a strong trigger of nausea and vomiting) and with chemotherapy that is a moderate trigger of nausea and vomiting (such as cyclophosphamide, doxorubicin or epirubicin).

2. What you need to know before you take EMEND

Do not take EMEND:

-if you are allergic to aprepitant or any of the other ingredients of this medicine (listed in section 6).

-with medicines containing pimozide (used to treat psychiatric illnesses), terfenadine and astemizole (used for hay fever and other allergic conditions), cisapride (used for treating digestive problems). Tell your doctor if you are taking these medicines since your treatment must be modified before you start taking EMEND.

Warnings and precautions

Talk to your doctor, pharmacist, or nurse before taking this medicine.

Before treatment with EMEND, tell your doctor if you have liver disease because your liver is important in breaking down the medicine in your body. Your doctor may therefore have to monitor the condition of your liver.

Children and adolescents

Do not give EMEND 165 mg to children and adolescents under 18 years of age, because the 165 mg capsules have not been studied in this population.

Other medicines and EMEND

EMEND can affect other medicines both during and after treatment with EMEND. There are some medicines that should not be taken with EMEND (such as pimozide, terfenadine, astemizole, and cisapride) or that require a dose adjustment (see also Do not take EMEND).

The effects of EMEND or other medicines might be influenced if you take EMEND together with other medicines including those listed below. Please talk to your doctor or pharmacist if you are taking any of the following medicines:

-birth control medicines which can include birth control pills, skin patches, implants, and certain Intrauterine devices (IUDs) that release hormones may not work adequately when taken together with EMEND. Another or additional non-hormonal form of birth control should be used during treatment with EMEND and for up to 2 months after using EMEND,

-cyclosporine, tacrolimus, sirolimus, everolimus (immunosuppressants),

-alfentanil, fentanyl (used to treat pain),

-quinidine (used to treat an irregular heart beat),

-irinotecan, etoposide, vinorelbine, ifosfamide (medicines used to treat cancer),

-medicines containing ergot alkaloid derivatives such as ergotamine and diergotamine (used for treating migraines),

-warfarin, acenocoumarol (blood thinners; blood tests may be required),

-rifampicin, clarithromycin, telithromycin (antibiotics used to treat infections),

-phenytoin (a medicine used to treat seizures),

-carbamazepine (used to treat depression and epilepsy),

-midazolam, triazolam, phenobarbital (medicines used to produce calmness or help you sleep),

-St. John’s Wort (an herbal preparation used to treat depression),

-protease inhibitors (used to treat HIV infections),

-ketoconazole except shampoo (used to treat Cushing’s syndrome - when the body produces an excess of cortisol),

-itraconazole, voriconazole, posaconazole (antifungals),

-nefazodone (used to treat depression),

-corticosteroids (such as dexamethasone and methylprednisolone),

-anti-anxiety medicines (such as alprazolam),

-tolbutamide (a medicine used to treat diabetes)

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

Pregnancy and breast-feeding

You should not use this medicine during pregnancy unless clearly necessary. If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.

For information regarding birth control, see 'Other medicines and EMEND'.

It is not known whether EMEND is excreted in human milk; therefore, breast-feeding is not recommended during treatment with this medicine. It is important that you tell your doctor if you are breast-feeding or are planning to breast-feed before taking this medicine.

Driving and using machines

It should be taken into account that some people feel dizzy and sleepy after taking EMEND. If you feel dizzy or sleepy, you should avoid driving or using machines after taking this medicine (see Possible side effects).

EMEND contains sucrose

EMEND capsules contain sucrose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

3. How to take EMEND

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. Take the EMEND capsule on the first day of your chemotherapy cycle, together with other medicines, to prevent nausea and vomiting. Your doctor will ask you to continue taking other medicines including a corticosteroid (such as dexamethasone) and a ‘5HT3 antagonist’ (such as ondansetron) for preventing nausea and vomiting the following three days.

The recommended oral dose of EMEND is one 165 mg capsule on the first day of your chemotherapy treatment cycle. Take the capsule 1 hour before you start your chemotherapy session.

EMEND can be taken with or without food.

Swallow the capsule whole with some liquid.

If you take more EMEND than you should

Do not take more capsules than the doctor recommends. If you have taken too many capsules, contact your doctor immediately.

If you forget to take EMEND

If you have missed a dose, contact your doctor for advice.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Stop taking EMEND and see a doctor immediately if you notice any of the following side effects, which may be serious, and for which you may need urgent medical treatment:

-Hives, rash, itching, difficulty breathing or swallowing (frequency not known, cannot be estimated from the available data); these are signs of an allergic reaction.

Other side effects that have been reported are listed below.

Common side effects (may affect up to 1 in 10 people) are:

-constipation, indigestion,

-headache,

-tiredness,

-loss of appetite,

-hiccups,

-increased amount of liver enzymes in your blood.

Uncommon side effects (may affect up to 1 in 100 people) are:

-dizziness, sleepiness,

-acne, rash,

-anxiousness,

-burping, nausea, vomiting, heartburn, stomach pain, dry mouth, passing wind,

-increased painful or burning urination,

-weakness, generally feeling unwell,

-hot flush,

-fast or irregular heartbeats,

-fever with increased risk of infection, lowering of red blood cells.

Rare side effects (may affect up to 1 in 1,000 people) are:

-difficulty thinking, lack of energy, taste disturbance,

-sensitivity of the skin to sun, excessive sweating, oily skin, sores on skin, itching rash, Stevens-Johnson syndrome/toxic epidermal necrolysis (rare severe skin reaction),

-euphoria (feeling of extreme happiness), disorientation,

-bacterial infection, fungal infection,

-severe constipation, stomach ulcer, inflammation of the small intestine and colon, sores in mouth, bloating,

-frequent urination, passing more urine than normal, presence of sugar or blood in urine,

-chest discomfort, swelling, change in the manner of walking,

-cough, mucus in back of throat, throat irritation, sneezing, sore throat,

-eye discharge and itching,

-ringing in the ear,

-muscle spasms, muscle weakness,

-excessive thirst,

-slow heartbeat, heart and blood vessel disease,

-lowering of white blood cells, low sodium levels in the blood, weight loss.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store EMEND

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the blister and carton after EXP. The expiry date refers to the last day of that month.

Store in the original package in order to protect from moisture.

Do not remove the capsule from its blister until you are ready to take it.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

What EMEND contains

The active substance is aprepitant. Each capsule contains 165 mg of aprepitant.

The other ingredients are: sucrose, microcrystalline cellulose (E 460), hydroxypropylcellulose (E 463), sodium laurilsulfate, gelatin, titanium dioxide (E 171), Indigo carmine (E 132), shellac, potassium hydroxide, and black iron oxide (E 172).

What EMEND looks like and contents of the pack

The 165 mg hard capsule is opaque with a light blue cap and a white body with “466” and “165 mg” printed radially in black ink on one side of the body and the Merck logo on the other side.

EMEND 165 mg hard capsules are supplied in cartons in the following pack sizes:

-Aluminium blister containing one 165 mg capsule

-6 Aluminium blisters each containing one 165 mg capsule

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Manufacturer

Merck Sharp & Dohme Ltd.

Merck Sharp & Dohme B. V.

Hertford Road, Hoddesdon

Waarderweg 39

Hertfordshire EN11 9BU

2031 BN Haarlem

United Kingdom

The Netherlands

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder.

Belgique/België/Belgien

Lietuva

MSD Belgium BVBA/SPRL

UAB Merck Sharp & Dohme

Tél/Tel: 0800 38 693 (+32(0)27766211)

Tel. + 370 5278 02 47

dpoc_belux@merck.com

msd_lietuva@merck.com

България

Luxembourg/Luxemburg

Мерк Шарп и Доум България ЕООД

MSD Belgium BVBA/SPRL

Тел.: +359 2 819 3737

Tél/Tel: +32(0)27766211

info-msdbg@merck.com

dpoc_belux@merck.com

Česká republika

Magyarország

Merck Sharp & Dohme s.r.o.

MSD Pharma Hungary Kft.

Tel: +420 233 010 111

Tel.: +36 1 888 5300

dpoc_czechslovak@merck.com

hungary_msd@merck.com

Danmark

Malta

MSD Danmark ApS

Merck Sharp & Dohme Cyprus Limited

Tlf: + 45 4482 4000

Tel: 8007 4433 (+356 99917558)

dkmail@merck.com

malta_info@merck.com

Deutschland

Nederland

MSD SHARP & DOHME GMBH

Merck Sharp & Dohme BV

Tel: 0800 673 673 673 (+49 (0) 89 4561 2612)

Tel: 0800 9999000

e-mail@msd.de

(+31 23 5153153)

 

medicalinfo.nl@merck.com

Eesti

Norge

Merck Sharp & Dohme OÜ

MSD (Norge) AS

Tel.: +372 6144 200

Tlf: +47 32 20 73 00

msdeesti@merck.com

msdnorge@msd.no

Eλλάδα

Österreich

MSD Α.Φ.Β.Ε.Ε.

Merck Sharp & Dohme Ges.m.b.H.

Τηλ: +30 210 98 97 300

Tel: +43 (0) 1 26 044

dpoc_greece@merck.com

msd-medizin@merck.com

España

Polska

Merck Sharp & Dohme de España, S.A.

MSD Polska Sp. z o.o.

Tel: +34 91 321 06 00

Tel: +48 22 549 51 00

msd_info@merck.com

msdpolska@merck.com

France

MSD France

Tél: +33 (0) 1 80 46 40 40

Hrvatska

Merck Sharp & Dohme d.o.o. Tel: + 385 1 6611 333 croatia_info@merck.com

Ireland

Merck Sharp & Dohme Ireland (Human Health) Limited

Tel: +353 (0)1 2998700 medinfo_ireland@merck.com

Ísland

Vistor hf.

Simi: +354 535 7000

Ιtalia

MSD Italia S.r.l. Tel: +39 06 361911

medicalinformation.it@merck.com

Κύπρος

Merck Sharp & Dohme Cyprus Limited Τηλ.: 800 00 673 (+357 22866700) cyprus_info@merck.com

Latvija

SIA Merck Sharp & Dohme Latvija Tel: +371 67364224 msd_lv@merck.com

This leaflet was last revised in

Portugal

Merck Sharp & Dohme, Lda Tel: +351 21 4465700 clic@merck.com

România

Merck Sharp & Dohme Romania S.R.L. Tel: +40 21 529 29 00 msdromania@merck.com

Slovenija

Merck Sharp & Dohme, inovativna zdravila d.o.o.

Tel: +386 1 5204 201 msd_slovenia@merck.com

Slovenská republika

Merck Sharp & Dohme, s. r. o. Tel: +421 2 58282010 dpoc_czechslovak@merck.com

Suomi/Finland

MSD Finland Oy

Puh/Tel: +358 (0)9 804 650 info@msd.fi

Sverige

Merck Sharp & Dohme (Sweden) AB Tel: +46 77 5700488 medicinskinfo@merck.com

United Kingdom

Merck Sharp & Dohme Limited Tel: +44 (0) 1992 467272 medicalinformationuk@merck.com

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu.

Package leaflet: Information for the user

EMEND 125 mg hard capsules EMEND 80 mg hard capsules aprepitant

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you. If you are the parent of a child taking EMEND, please read this information carefully.

-Keep this leaflet. You may need to read it again.

-If you have any further questions, ask the doctor, pharmacist, or nurse.

-This medicine has been prescribed for you or the child only. Do not pass it on to others. It may harm them, even if their signs of illness are the same.

-If you or the child gets any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet

1.What EMEND is and what it is used for

2.What you need to know before you take or give EMEND

3.How to take EMEND

4.Possible side effects

5.How to store EMEND

6.Contents of the pack and other information

1. What EMEND is and what it is used for

EMEND contains the active substance aprepitant and belongs to a group of medicines called "neurokinin 1 (NK1) receptor antagonists". The brain has a specific area that controls nausea and vomiting. EMEND works by blocking signals to that area, thereby reducing nausea and vomiting. EMEND capsules are used in adults and adolescents from the age of 12 years in combination with other medicines to prevent nausea and vomiting caused by chemotherapy (cancer treatment) that are strong and moderate triggers of nausea and vomiting (such as cisplatin, cyclophosphamide, doxorubicin or epirubicin).

2. What you need to know before you take or give EMEND

Do not take EMEND:

-if you or the child is allergic to aprepitant or any of the other ingredients of this medicine (listed in section 6).

-with medicines containing pimozide (used to treat psychiatric illnesses), terfenadine and astemizole (used for hay fever and other allergic conditions), cisapride (used for treating digestive problems). Tell the doctor if you or the child is taking these medicines since the treatment must be modified before you or the child start taking EMEND.

Warnings and precautions

Talk to the doctor, pharmacist, or nurse before you take EMEND or give this medicine to the child.

Before treatment with EMEND, tell the doctor if you or the child have liver disease because the liver is important in breaking down the medicine in the body. The doctor may therefore have to monitor the condition of your or the child’s liver.

Children and adolescents

Do not give EMEND 80 mg and 125 mg capsules to children under 12 years of age, because the 80 mg and 125 mg capsules have not been studied in this population.

Other medicines and EMEND

EMEND can affect other medicines both during and after treatment with EMEND. There are some medicines that should not be taken with EMEND (such as pimozide, terfenadine, astemizole, and cisapride) or that require a dose adjustment (see also Do not take EMEND).

The effects of EMEND or other medicines might be influenced if you or the child take EMEND together with other medicines including those listed below. Please talk to the doctor or pharmacist if you or the child is taking any of the following medicines:

-birth control medicines which can include birth control pills, skin patches, implants, and certain Intrauterine devices (IUDs) that release hormones may not work adequately when taken together with EMEND. Another or additional non-hormonal form of birth control should be used during treatment with EMEND and for up to 2 months after using EMEND,

-cyclosporine, tacrolimus, sirolimus, everolimus (immunosuppressants),

-alfentanil, fentanyl (used to treat pain),

-quinidine (used to treat an irregular heart beat),

-irinotecan, etoposide, vinorelbine, ifosfamide (medicines used to treat cancer),

-medicines containing ergot alkaloid derivatives such as ergotamine and diergotamine (used for treating migraines),

-warfarin, acenocoumarol (blood thinners; blood tests may be required),

-rifampicin, clarithromycin, telithromycin (antibiotics used to treat infections),

-phenytoin (a medicine used to treat seizures),

-carbamazepine (used to treat depression and epilepsy),

-midazolam, triazolam, phenobarbital (medicines used to produce calmness or help you sleep),

-St. John’s Wort (an herbal preparation used to treat depression),

-protease inhibitors (used to treat HIV infections)

-ketoconazole except shampoo (used to treat Cushing’s syndrome - when the body produces an excess of cortisol),

-itraconazole, voriconazole, posaconazole (antifungals),

-nefazodone (used to treat depression),

-corticosteroids (such as dexamethasone and methylprednisolone),

-anti-anxiety medicines (such as alprazolam),

-tolbutamide (a medicine used to treat diabetes)

Tell the doctor or pharmacist if you or the child are taking, have recently taken, or might take any other medicines.

Pregnancy and breast-feeding

This medicine should not be used during pregnancy unless clearly necessary. If you or the child are pregnant or breast-feeding, may be pregnant or are planning to have a baby, ask the doctor for advice before taking this medicine.

For information regarding birth control, see ‘Other medicines and EMEND.

It is not known whether EMEND is excreted in human milk; therefore, breast-feeding is not recommended during treatment with this medicine. It is important to tell the doctor if you or the child are breast-feeding or are planning to breast-feed before taking this medicine.

Driving and using machines

It should be taken into account that some people feel dizzy and sleepy after taking EMEND. If you or the child feels dizzy or sleepy, avoid driving, riding a bicycle or using machines or tools after taking this medicine (see Possible side effects).

EMEND contains sucrose

EMEND capsules contain sucrose. If you or the child have been told by your doctor that you or the child have an intolerance to some sugars, contact the doctor before taking this medicine.

3. How to take EMEND

Always take this medicine or give this medicine to the child exactly as the doctor, pharmacist or nurse has told you. You should check with the doctor, pharmacist or nurse if you are not sure. Always take EMEND together with other medicines, to prevent nausea and vomiting. After treatment with EMEND, the doctor may ask you or the child to continue taking other medicines including a corticosteroid (such as dexamethasone) and a ‘5HT3 antagonist’ (such as ondansetron) for preventing nausea and vomiting. Check with the doctor, pharmacist or nurse if you are not sure.

The recommended oral dose of EMEND is

Day 1:

-one 125 mg capsule 1 hour before you start your chemotherapy session

and

Days 2 and 3:

-one 80 mg capsule each day

-If no chemotherapy is given, take EMEND in the morning.

-If chemotherapy is given, take EMEND 1 hour before you start your chemotherapy session.

EMEND can be taken with or without food.

Swallow the capsule whole with some liquid.

If you take more EMEND than you should

Do not take more capsules than the doctor recommends. If you or the child has taken too many capsules, contact your doctor immediately.

If you forget to take EMEND

If you or the child has missed a dose, contact your doctor for advice.

If you have any further questions on the use of this medicine, ask the doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Stop taking EMEND and see a doctor immediately if you or the child notice any of the following side effects, which may be serious, and for which you or the child may need urgent medical treatment:

-Hives, rash, itching, difficulty breathing or swallowing (frequency not known, cannot be estimated from the available data); these are signs of an allergic reaction.

Other side effects that have been reported are listed below.

Common side effects (may affect up to 1 in 10 people) are:

-constipation, indigestion,

-headache,

-tiredness,

-loss of appetite,

-hiccups,

-increased amount of liver enzymes in your blood.

Uncommon side effects (may affect up to 1 in 100 people) are:

-dizziness, sleepiness,

-acne, rash,

-anxiousness,

-burping, nausea, vomiting, heartburn, stomach pain, dry mouth, passing wind,

-increased painful or burning urination,

-weakness, generally feeling unwell,

-hot flush/reddening of the face or skin,

-fast or irregular heartbeats,

-fever with increased risk of infection, lowering of red blood cells.

Rare side effects (may affect up to1 in 1,000 people) are:

-difficulty thinking, lack of energy, taste disturbance,

-sensitivity of the skin to sun, excessive sweating, oily skin, sores on skin, itching rash, Stevens-Johnson syndrome/toxic epidermal necrolysis (rare severe skin reaction),

-euphoria (feeling of extreme happiness), disorientation,

-bacterial infection, fungal infection,

-severe constipation, stomach ulcer, inflammation of the small intestine and colon, sores in mouth, bloating,

-frequent urination, passing more urine than normal, presence of sugar or blood in urine,

-chest discomfort, swelling, change in the manner of walking,

-cough, mucus in back of throat, throat irritation, sneezing, sore throat,

-eye discharge and itching,

-ringing in the ear,

-muscle spasms, muscle weakness,

-excessive thirst,

-slow heartbeat, heart and blood vessel disease,

-lowering of white blood cells, low sodium levels in the blood, weight loss.

Reporting of side effects

If you or the child gets any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store EMEND

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiry date refers to the last day of that month.

Store in the original package in order to protect from moisture.

Do not remove the capsule from its blister until you are ready to take it.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

What EMEND contains

-The active substance is aprepitant. Each 125 mg hard capsule contains 125 mg of aprepitant. Each 80 mg hard capsule contains 80 mg of aprepitant.

-The other ingredients are: sucrose, microcrystalline cellulose (E 460), hydroxypropylcellulose (E 463), sodium laurilsulfate, gelatin, titanium dioxide (E 171), shellac, potassium hydroxide, and black iron oxide (E 172); the 125 mg hard capsule also contains red iron oxide (E 172) and yellow iron oxide (E 172).

What EMEND looks like and contents of the pack

The 125 mg hard capsule is opaque with a white body and pink cap with “462” and “125 mg” printed radially in black ink on the body.

The 80 mg hard capsule is opaque with a white cap and body with “461” and “80 mg” printed radially in black ink on the body.

EMEND 125 mg and 80 mg hard capsules are supplied in the following pack size: - 3-day treatment pack containing one 125 mg capsule and two 80 mg capsules

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Manufacturer

Merck Sharp & Dohme Ltd.

Merck Sharp & Dohme B. V.

Hertford Road, Hoddesdon

Waarderweg 39

Hertfordshire EN11 9BU

2031 BN Haarlem

United Kingdom

The Netherlands

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder.

Belgique/België/Belgien

MSD Belgium BVBA/SPRL

Tél/Tel: 0800 38 693 (+32(0)27766211) dpoc_belux@merck.com

България

Мерк Шарп и Доум България ЕООД Тел.: +359 2 819 3737 info-msdbg@merck.com

Česká republika

Merck Sharp & Dohme s.r.o. Tel: +420 233 010 111 dpoc_czechslovak@merck.com

Danmark

MSD Danmark ApS Tlf: + 45 4482 4000 dkmail@merck.com

Lietuva

UAB Merck Sharp & Dohme Tel. + 370 5278 02 47 msd_lietuva@merck.com

Luxembourg/Luxemburg

MSD Belgium BVBA/SPRL Tél/Tel: +32(0)27766211 dpoc_belux@merck.com

Magyarország

MSD Pharma Hungary Kft. Tel.: +36 1 888 5300 hungary_msd@merck.com

Malta

Merck Sharp & Dohme Cyprus Limited Tel: 8007 4433 (+356 99917558) malta_info@merck.com

Deutschland

MSD SHARP & DOHME GMBH

Tel: 0800 673 673 673 (+49 (0) 89 4561 2612) e-mail@msd.de

Eesti

Merck Sharp & Dohme OÜ Tel.: +372 6144 200 msdeesti@merck.com

Eλλάδα

MSD Α.Φ.Β.Ε.Ε.

Τηλ: +30 210 98 97 300 dpoc_greece@merck.com

España

Merck Sharp & Dohme de España, S.A. Tel: +34 91 321 06 00 msd_info@merck.com

France

MSD France

Tél: +33 (0) 1 80 46 40 40

Hrvatska

Merck Sharp & Dohme d.o.o. Tel: + 385 1 6611 333 croatia_info@merck.com

Ireland

Merck Sharp & Dohme Ireland (Human Health) Limited

Tel: +353 (0)1 2998700 medinfo_ireland@merck.com

Ísland

Vistor hf.

Simi: +354 535 7000

Ιtalia

MSD Italia S.r.l. Tel: +39 06 361911

medicalinformation.it@merck.com

Κύπρος

Merck Sharp & Dohme Cyprus Limited Τηλ.: 800 00 673 (+357 22866700) cyprus_info@merck.com

Latvija

SIA Merck Sharp & Dohme Latvija Tel: +371 67364224 msd_lv@merck.com

Nederland

Merck Sharp & Dohme BV Tel: 0800 9999000

(+31 23 5153153) medicalinfo.nl@merck.com

Norge

MSD (Norge) AS Tlf: +47 32 20 73 00 msdnorge@msd.no

Österreich

Merck Sharp & Dohme Ges.m.b.H. Tel: +43 (0) 1 26 044 msd-medizin@merck.com

Polska

MSD Polska Sp. z o.o. Tel: +48 22 549 51 00 msdpolska@merck.com

Portugal

Merck Sharp & Dohme, Lda Tel: +351 21 4465700 clic@merck.com

România

Merck Sharp & Dohme Romania S.R.L. Tel: +40 21 529 29 00 msdromania@merck.com

Slovenija

Merck Sharp & Dohme, inovativna zdravila d.o.o.

Tel: +386 1 5204 201 msd_slovenia@merck.com

Slovenská republika

Merck Sharp & Dohme, s. r. o. Tel: +421 2 58282010 dpoc_czechslovak@merck.com

Suomi/Finland

MSD Finland Oy

Puh/Tel: +358 (0)9 804 650 info@msd.fi

Sverige

Merck Sharp & Dohme (Sweden) AB Tel: +46 77 5700488 medicinskinfo@merck.com

United Kingdom

Merck Sharp & Dohme Limited Tel: +44 (0) 1992 467272 medicalinformationuk@merck.com

This leaflet was last revised in

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu.

Package leaflet: Information for the user

EMEND 125 mg powder for oral suspension aprepitant

Read all of this leaflet carefully before you start using this medicine because it contains important information. This leaflet has been written for the parent or carer who will give this medicine to the child- please read this information carefully.

-Keep this leaflet. You may need to read it again.

-If you have any further questions, ask the doctor, pharmacist, or nurse.

-This medicine has been prescribed for the child only. Do not pass it on to others. It may harm them, even if their signs of illness are the same.

-If the child gets any side effects, talk to the doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet

1.What EMEND is and what it is used for

2.What you need to know before you give EMEND

3.How to give EMEND

4.Possible side effects

5.How to store EMEND

6.Contents of the pack and other information

1. What EMEND is and what it is used for

EMEND contains the active substance ‘aprepitant.’ It belongs to a group of medicines called ‘neurokinin 1 (NK1) receptor antagonists’.

The brain has a specific area that controls nausea and vomiting. EMEND works by blocking signals to that area, thereby reducing nausea and vomiting.

The powder for oral suspension is used in children aged 6 months to less than 12 years in combination with other medicines to prevent nausea and vomiting caused by chemotherapy (cancer treatment) that are strong and moderate triggers of nausea and vomiting (such as cisplatin, cyclophosphamide, doxorubicin or epirubicin).

2. What you need to know before you give EMEND

Do not give EMEND:

-if the child is allergic to aprepitant or any of the other ingredients of this medicine (listed in section 6).

-if the child is using medicines that contain ‘pimozide’ (for mental health problems).

-if the child is using ‘terfenadine’ or ‘astemizole’ (for hay fever and other allergies).

-if the child is using ‘cisapride’ - (for problems with digestion).

Do not give this medicine if any of the above applies to the child and tell the child’s doctor if they are using any of the medicines above. This is because their treatment will need to be changed before starting this medicine. If you are not sure, talk to the doctor, pharmacist or nurse before giving this medicine.

Warnings and precautions

Talk to the doctor, pharmacist, or nurse before giving this medicine to the child.

Liver problems

Tell the doctor before treatment with EMEND starts, if the child has liver problems. This is because the liver is important in breaking down the medicine in the body. The doctor may have to check the condition of the child’s liver during treatment.

Children and adolescents

Do not give EMEND powder for oral suspension to children under 6 months of age or who weigh less than 6 kg, or to adolescents between 12 and 18 years, because the powder for oral suspension has not been studied in this population.

Other medicines and EMEND

Tell the doctor, pharmacist or nurse if the child is using, has recently used or might use any other medicines. This is because EMEND can affect how other medicines work, during and after treatment with EMEND. Also, some other medicines can affect the way this medicine works.

Do not give EMEND and tell the doctor or pharmacist if the child is using any of the following medicines (see also under ‘Do not give EMEND’). This is because their treatment will need to be changed before starting EMEND:

-pimozide - for mental health problems

-terfenadine and astemizole - for hay fever and other allergies

-cisapride - for problems with digestion

Do not give this medicine and tell the doctor or pharmacist if any of the above apply to the child.

Talk to the doctor, pharmacist or nurse if the child is taking any of the following medicines:

-medicines that affect the immune system – such as cyclosporine, tacrolimus, sirolimus, everolimus

-alfentanil, fentanyl – for pain

-quinidine – for irregular heart beat

-medicines for cancer – such as irinotecan, etoposide, vinorelbine, ifosfamide

-medicines containing ‘ergot alkaloid derivatives’ - such as ergotamine and diergotamine - for migraines

-medicines that thin the blood – such as warfarin, acenocoumarol. Your child may need blood tests during treatment with EMEND

-antibiotics to treat infections – such as rifampicin, clarithromycin, telithromycin

-phenytoin - for fits (seizures)

-carbamazepine - for depression and epilepsy

-midazolam, triazolam, phenobarbital - to produce calmness or help you sleep

-St. John’s Wort - a herbal medicine for depression

-protease inhibitors - for HIV infections

-ketoconazole except shampoo (used to treat Cushing’s syndrome - when the body produces an excess of cortisol)

-antifungal medicines such as itraconazole, voriconazole, posaconazole

-nefazodone - for depression

-corticosteroids - such as dexamethasone and methylprednisolone

-medicines for anxiety such as alprazolam

-tolbutamide - for diabetes

-contraceptive medicines including pills, patches, implants, and some Intrauterine devices (IUDs) that release hormones. These may not work properly when taken with this medicine. You may need to use a different or an extra non-hormonal contraceptive during treatment with

this medicine and for up to 2 months after treatment has finished.

If any of the above apply to the child (or you are not sure), talk to the doctor, pharmacist or nurse before giving this medicine.

Pregnancy and breast-feeding

This medicine should not be used during pregnancy and breastfeeding unless clearly necessary.

For information regarding pregnancy, breast-feeding and contraception, ask your doctor for advice.

Driving and using machines

It should be taken into account that some people may feel dizzy and sleepy after taking EMEND. If the child feels dizzy or sleepy, they should not ride a bicycle or use any tools or machines.

EMEND contains sucrose and lactose

The powder for oral suspension contains sucrose and lactose. If a doctor has told you that the child has an intolerance to some sugars, contact the doctor before giving this medicine to the child.

3.How to give EMEND

Healthcare professionals: See the instructions for preparation of the oral suspension for healthcare professionals at the end of this package leaflet. This tells you how to prepare a dose of EMEND as an oral suspension.

Parents and caregivers: Always give this medicine to the child exactly as the doctor, pharmacist or nurse has told you. Check with the child’s doctor, pharmacist or nurse if you are not sure.

It is very important that this medicine is given exactly as directed below.

For each dose of EMEND, you will get a pre-filled oral dispenser that contains the child’s prescribed dose.

Keep the oral dispenser in the refrigerator (between 2oC and 8oC) until you give the medicine to the child

Use this medicine within 2 days of getting the medicine from the healthcare provider.

The medicine can be kept at room temperature (not above 30oC) for up to 3 hours, prior to administration.

The color of the medicine in the oral dispenser may be different shades of pink (light pink to dark pink). This is normal and the medicine is okay to use.

-Take the cap off the oral dispenser.

-Place the tip of the oral dispenser in the child’s mouth along in the inner cheek on either the right or left side.

-Slowly push the plunger all the way down to give all the medicine in the oral dispenser.

If the child could not take the whole dose, call the child’s healthcare provider.

When you have finished do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

How much to take

-The doctor will work out the right dose of powder for oral suspension based on the weight of the child.

-Do not change the dose or stop treatment without first talking to the doctor, pharmacist or nurse.

When to take

Day 1:

-Give this medicine one hour before the start of the chemotherapy session. Day 2 and Day 3:

-If the child will not have chemotherapy - give this medicine in the morning.

-If the child will have chemotherapy - give this medicine one hour before the start of the chemotherapy session.

EMEND can be taken with or without food.

Always give this medicine together with other medicines, to prevent nausea and vomiting. After treatment with EMEND, the doctor may ask the child to continue taking other medicines for preventing nausea and vomiting which may include:

-a corticosteroid - such as dexamethasone and

-a ‘5-HT3 antagonist’ - such as ondansetron

Check with the doctor, pharmacist or nurse if you are not sure.

If you give more EMEND than you should

Do not give the child more of this medicine than the doctor recommends. If you give the child more than you should, contact the doctor straight away.

If you forget to give EMEND

If the child misses a dose of this medicine, talk to the doctor.

If you have any further questions on the use of this medicine, ask the doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Serious side effects

Stop giving this medicine and see a doctor straight away if you or the child notice any of the following serious side effects – the child may need urgent medical treatment:

-allergic reaction – the signs may include hives, rash, itching, difficulty breathing or swallowing (it is not known how often this happens).

Stop giving this medicine and see a doctor straight away if you notice any of the serious side effects above.

Other side effects

Tell the doctor, pharmacist or nurse if you or the child notice any of the following side effects:

Common: may affect up to 1 in 10 people

-constipation or indigestion

-headache

-feeling tired

-loss of appetite

-hiccups

-increased amount of liver enzymes in the blood (shown in tests).

Uncommon: may affect up to 1 in 100 people

-feeling dizzy or sleepy

-acne, rash

-feeling anxious

-burping, nausea, vomiting, heartburn, stomach pain, dry mouth, passing wind

-pain or burning when urinating

-feeling weak, generally feeling unwell

-hot flushes/reddening of the face or skin

-fast or irregular heart beat

-fever with increased risk of infection, low number of red blood cells (shown in tests).

Rare: may affect up to1 in 1,000 people

-difficulty thinking, lack of energy, changes in taste

-sensitivity of the skin to sun, excessive sweating, oily skin, sores on the skin, itchy rash, Stevens-Johnson syndrome or toxic epidermal necrolysis (rare severe skin reactions)

-euphoria (feeling of extreme happiness), feeling confused

-bacterial infection, fungal infection

-severe constipation, stomach ulcer, inflamed small intestine and colon, sores in the mouth, bloating

-urinating more often or passing more urine than normal, sugar or blood in urine

-chest discomfort, swelling, change in the manner of walking

-cough, mucus in the back of the throat, throat irritation, sneezing, sore throat

-eye discharge and itching

-ringing in the ears

-muscle spasms, muscle weakness

-feeling very thirsty

-slow heartbeat, heart and blood vessel disease

-low number of white blood cells, low sodium levels in the blood, weight loss.

Reporting of side effects

If the child gets any side effects, talk to the doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store EMEND

Keep this medicine out of the sight and reach of children.

Before reconstitution:

Emend will generally be stored by healthcare professionals. The storage details, should you need them, are as follows:

Do not give this medicine to the child after the expiry date which is stated on the carton and sachet after EXP. The expiry date refers to the last day of that month.

This medicine does not require any special temperature storage conditions.

Store in the original package in order to protect from moisture.

After reconstitution:

The oral suspension can be kept at room temperature (not above 30oC) for up to 3 hours, prior to administration. It can also be stored refrigerated (between 2oC and 8oC) for up to 72 hours.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

What EMEND contains

-The active substance is aprepitant. Each sachet contains 125 mg of aprepitant. After reconstitution, 1 mL oral suspension contains 25 mg of aprepitant

-The other ingredients are: hydroxypropyl-cellulose (E 463), sodium laurilsulfate (E 487), sucrose and lactose (see section 2 under ‘EMEND contains sucrose and lactose’), red iron oxide (E 172) and sodium stearyl fumarate (E 485).

What EMEND looks like and contents of the pack

The powder for oral suspension is a pink to light pink powder in a single-use sachet.

Single-use carton

Pack size of one carton contains one sachet, one 1 mL and one 5 mL oral dispenser (polypropylene with silicone o-ring), one cap and one mixing cup (polypropylene).

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Manufacturer

Merck Sharp & Dohme Ltd.

Merck Sharp & Dohme B. V.

Hertford Road, Hoddesdon

Waarderweg 39

Hertfordshire EN11 9BU

2031 BN Haarlem

United Kingdom

The Netherlands

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder.

Belgique/België/Belgien

Lietuva

MSD Belgium BVBA/SPRL

UAB Merck Sharp & Dohme

Tél/Tel: 0800 38 693 (+32(0)27766211)

Tel.: +370 5 278 02 47

dpoc_belux@merck.com

msd_lietuva@merck.com

България

Luxembourg/Luxemburg

Мерк Шарп и Доум България ЕООД

MSD Belgium BVBA/SPRL

Тел.: +359 2 819 3737

Tél/Tel: +32(0)27766211

info-msdbg@merck.com

dpoc_belux@merck.com

Česká republika

Magyarország

Merck Sharp & Dohme s.r.o.

MSD Pharma Hungary Kft.

Tel.: +420 233 010 111

Tel.: +36 1 888 53 00

dpoc_czechslovak@merck.com

hungary_msd@merck.com

Danmark

Malta

MSD Danmark ApS

Merck Sharp & Dohme Cyprus Limited

Tlf: +45 44824000

Tel: 8007 4433 (+356 99917558)

dkmail@merck.com

malta_info@merck.com

Deutschland

Nederland

MSD SHARP & DOHME GMBH

Merck Sharp & Dohme BV

Tel: 0800 673 673 673 (+49 (0) 89 4561 2612)

Tel: 0800 9999000 (+31 23 5153153)

e-mail@msd.de

medicalinfo.nl@merck.com

Eesti

Merck Sharp & Dohme OÜ Tel.: +372 6144 200 msdeesti@merck.com

Eλλάδα

MSD Α.Φ.Β.Ε.Ε.

Τηλ: + 30 210 98 97 300 dpoc_greece@merck.com

España

Merck Sharp & Dohme de España, S.A. Tel: +34 91 321 06 00 msd_info@merck.com

France

MSD France

Tél: +33 (0) 1 80 46 40 40

Hrvatska

Merck Sharp & Dohme d.o.o. Tel: + 385 1 6611 333 croatia_info@merck.com

Ireland

Merck Sharp & Dohme Ireland (Human Health) Limited

Tel: +353 (0)1 2998700 medinfo_ireland@merck.com

Ísland

Vistor hf.

Simi: +354 535 7000

Ιtalia

MSD Italia S.r.l. Tel: +39 06 361911

medicalinformation.it@merck.com

Κύπρος

Merck Sharp & Dohme Cyprus Limited Τηλ: 80000 673 (+357 22866700) cyprus_info@merck.com

Latvija

SIA Merck Sharp & Dohme Latvija Tel: +371 67364 224 msd_lv@merck.com

This leaflet was last revised in

Norge

MSD (Norge) AS Tlf: +47 32 20 73 00 msdnorge@msd.no

Österreich

Merck Sharp & Dohme Ges.m.b.H. Tel: +43 (0) 1 26 044 msd-medizin@merck.com

Polska

MSD Polska Sp.z o.o. Tel: +48 22 549 51 00 msdpolska@merck.com

Portugal

Merck Sharp & Dohme, Lda Tel: +351 21 4465700 clic@merck.com

România

Merck Sharp & Dohme Romania S.R.L. Tel: + 4021 529 29 00 msdromania@merck.com

Slovenija

Merck Sharp & Dohme, inovativna zdravila d.o.o.

Tel: + 386 1 5204201 msd_slovenia@merck.com

Slovenská republika

Merck Sharp & Dohme, s. r. o. Tel.: +421 2 58282010 dpoc_czechslovak@merck.com

Suomi/Finland

MSD Finland Oy

Puh/Tel: +358 (0)9 804650 info@msd.fi

Sverige

Merck Sharp & Dohme (Sweden) AB Tel: +46 (0) 77 5700488 medicinskinfo@merck.com

United Kingdom

Merck Sharp & Dohme Limited Tel: +44 (0) 1992 467272 medicalinformationuk@merck.com

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu.

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The following information is intended for healthcare professionals only:

Instructions for healthcare professionals on the preparation of the oral suspension

Each pack of EMEND contains a sachet with the powder for oral suspension, a 1 ml and a 5 ml oral dispenser, one cap and one mixing cup.

1.Fill the mixing cup with room temperature drinking water.

2.Fill the 5 mL oral dispenser with 4.6 mL of water from the mixing cup.

Make sure no air is in the oral dispenser (if air is present, remove).

3.Discard all the unused water remaining in the mixing cup.

4.Add the 4.6 mL of water from the oral dispenser back into the mixing cup.

5.Each sachet of EMEND for oral suspension contains 125 mg of aprepitant which is to be suspended in 4.6 mL of water giving a final concentration of 25 mg/mL.

Hold the EMEND powder for oral suspension sachet upright and shake the contents to the bottom before opening the sachet.

6.Pour the entire contents of the sachet into the 4.6 mL of water in the mixing cup and snap the lid shut.

7.Mix the EMEND suspension gently by swirling 20 times; then gently invert the mixing cup 5 times.

To prevent foaming, do not shake the mixing cup. The mixture will be cloudy pink to light pink.

8.Check the EMEND mixture for any clumps or foaming:

-If any clumps are present, repeat Step 7 until there are no clumps.

-If there is any foam, wait for the foam to disappear before going on to Step 9.

Body weight

 

Dose volume of suspension to be administered orally

 

Day 1

 

Day 2

 

Day 3

less than 6 kg

 

 

Not recommended

 

 

6 kg to less than 8 kg

1 mL

(25 mg)

0.6 mL

(15 mg)

0.6 mL

(15 mg)

8 kg to less than 10 kg

1.2 mL

(30 mg)

0.8 mL

(20 mg)

0.8 mL

(20 mg)

10 kg to less than 12 kg

1.4 mL

(35 mg)

1 mL

(25 mg)

1 mL

(25 mg)

12 kg to less than 15 kg

1.8 mL

(45 mg)

1.2 mL

(30 mg)

1.2 mL

(30 mg)

15 kg to less than 20 kg

2.4 mL

(60 mg)

1.6 mL

(40 mg)

1.6 mL

(40 mg)

20 kg to less than 25 kg

3 mL

(75 mg)

2 mL

(50 mg)

2 mL

(50 mg)

25 kg to less than 30 kg

3.6 mL

(90 mg)

2.4 mL

(60 mg)

2.4 mL

(60 mg)

30 kg and above

Withdraw

(125 mg)

3.2 mL

(80 mg)

3.2 mL

(80 mg)

 

all of the

 

 

 

 

 

 

contents

 

 

 

 

 

 

from the

 

 

 

 

 

 

mixing

 

 

 

 

 

 

cup into

 

 

 

 

 

 

the oral

 

 

 

 

 

 

dispenser

 

 

 

 

 

 

(~5 mL)

 

 

 

 

 

9.Fill the oral dispenser with the prescribed dose from the mixing cup according to the table above.

-Choose the oral dispenser based on dose:

-Use 1 mL oral dispenser if dose is 1 mL or less.

-Use 5 mL oral dispenser if dose is more than 1 mL.

-It is common to have medicine leftover in the cup.

Make sure no air is in the oral dispenser (if air is present, remove).

Make sure the oral dispenser contains the prescribed dose.

10.Place the cap on the oral dispenser until it clicks.

11.If the dose is not administered immediately after measuring, store filled oral dispenser(s) in the refrigerator between 2°C-8°C for up to 72 hours prior to use. When dispensing dose(s) to the caregiver, instruct them to refrigerate the oral dispenser(s) until they are ready to administer the dose.

12.The oral suspension can be kept at room temperature (not above 30oC) for up to 3 hours, prior to administration.

Discard any remaining suspension and waste material. Any unused medicinal product or waste material should be disposed of in accordance with local regulations.

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