English
A B C D E F G H I J K L M N O P Q R S T U V W X Y Z

Aerius (desloratadine) – Package leaflet - R06AX27

Updated on site: 05-Oct-2017

Package leaflet: Information for the patient

Aerius 5 mg film-coated tablets desloratadine

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 Aerius is and what it is used for

2.What you need to know before you take Aerius

3.How to take Aerius

4.Possible side effects

5.How to store Aerius

6.Contents of the pack and other information

1.What Aerius is and what it is used for

What Aerius is

Aerius contains desloratadine which is an antihistamine.

How Aerius works

Aerius is an antiallergy medicine that does not make you drowsy. It helps control your allergic reaction and its symptoms.

When Aerius should be used

Aerius relieves symptoms associated with allergic rhinitis (inflammation of the nasal passages caused by an allergy, for example, hay fever or allergy to dust mites) in adults and adolescents 12 years of age and older. These symptoms include sneezing, runny or itchy nose, itchy palate, and itchy, red or watery eyes.

Aerius is also used to relieve the symptoms associated with urticaria (a skin condition caused by an allergy). These symptoms include itching and hives.

Relief of these symptoms lasts a full day and helps you to resume your normal daily activities and sleep.

2. What you need to know before you take Aerius

Do not take Aerius

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

Warnings and precautions

Talk to your doctor, pharmacist or nurse before taking Aerius:

-if you have poor kidney function.

-if you have medical or familial history of seizures.

Use in children and adolescents

Do not give this medicine to children less than 12 years of age.

Other medicines and Aerius

There are no known interactions of Aerius with other medicines.

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

Aerius with food, drink and alcohol

Aerius may be taken with or without a meal.

Use caution when taking Aerius with alcohol.

Pregnancy, breast-feeding and fertility

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Taking Aerius is not recommended if you are pregnant or nursing a baby.

Fertility

There is no data available on male/female fertility.

Driving and using machines

At the recommended dose, this medicine is not expected to affect your ability to drive or use machines. Although most people do not experience drowsiness, it is recommended not to engage in activities requiring mental alertness, such as driving a car or operating machinery until you have established your own response to the medicinal product.

Aerius contains lactose

Aerius tablets contain lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

3.How to take Aerius

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

Adults and adolescents 12 years of age and over

The recommended dose is one tablet once a day with water, with or without food.

This medicine is for oral use.

Swallow the tablet whole.

Regarding the duration of treatment, your physician will determine the type of allergic rhinitis you are suffering from and will determine for how long you should take Aerius.

If your allergic rhinitis is intermittent (presence of symptoms for less than 4 days per week or for less than 4 weeks), your physician will recommend you a treatment schedule that will depend on the evaluation of the history of your disease.

If your allergic rhinitis is persistent (presence of symptoms for 4 days or more per week and for more than 4 weeks), your physician may recommend you a longer term treatment.

For urticaria, the duration of treatment may be variable from patient to patient and therefore you should follow the instructions of your physician.

If you take more Aerius than you should

Take Aerius only as it is prescribed for you. No serious problems are expected with accidental overdose. However, if you take more Aerius than you were told to, tell your doctor, pharmacist or nurse immediately.

If you forget to take Aerius

If you forget to take your dose on time, take it as soon as possible and then go back to your regular dosing schedule. Do not take a double dose to make up for a forgotten dose.

If you stop taking Aerius

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

4.Possible side effects

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

During the marketing of Aerius, cases of severe allergic reactions (difficulty in breathing, wheezing, itching, hives and swelling) have been reported very rarely. If you notice any of these serious side effects, stop taking the medicine and seek urgent medical advice straight away.

In clinical studies in adults, side effects were about the same as with a dummy tablet. However, fatigue, dry mouth and headache were reported more often than with a dummy tablet. In adolescents, headache was the most commonly reported side effect.

In clinical studies with Aerius, the following side effects were reported as:

Common: the following may affect up to 1 in 10 people

fatigue

dry mouth

headache

Adults

During the marketing of Aerius, the following side effects were reported as:

Very rare: the following may affect up to 1 in 10,000 people

 

● severe allergic reactions

● rash

● pounding or irregular heartbeat

● fast heartbeat

● stomach ache

● feeling sick (nausea)

● vomiting

● upset stomach

● diarrhoea

● dizziness

● drowsiness

● inability to sleep

● muscle pain

● hallucinations

● seizures

● restlessness with increased

● liver inflammation

● abnormal liver function tests

body movement

 

 

Not known: frequency cannot be estimated from the available data

● unusual weakness

● yellowing of the skin and/or eyes

increased sensitivity of the skin to the sun, even in case of hazy sun, and to UV light, for instance to UV lights of a solarium

changes in the way the heart beats

abnormal behaviour

aggression

Children

Not known: frequency cannot be estimated from the available data

● slow heartbeat

● change in the way the heart beats

● abnormal behaviour

● aggression

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 Aerius

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 and blister after EXP. The expiry date refers to the last day of that month.

Do not store above 30°C. Store in the original package.

Do not use this medicine if you notice any change in the appearance of the tablets.

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 to protect the environment.

6. Contents of the pack and other information

What Aerius contains

-The active substance is desloratadine 5 mg

-The other ingredients of the tablet are calcium hydrogen phosphate dihydrate, microcrystalline cellulose, maize starch, talc. Tablet coating contains film coat (containing lactose monohydrate, hypromellose, titanium dioxide, macrogol 400, indigotin (E132)), clear coat (containing hypromellose, macrogol 400), carnauba wax, white wax.

What Aerius looks like and contents of the pack

Aerius 5 mg film-coated tablets are packed in blisters in packs of 1, 2, 3, 5, 7, 10, 14, 15, 20, 21, 30, 50, 90 or 100 tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder: Merck Sharp & Dohme Ltd, Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom.

Manufacturer: SP Labo N.V., Industriepark 30, B-2220 Heist-op-den-Berg, Belgium.

For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:

België/Belgique/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

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

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

Ελλάδα

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

Luxembourg/Luxemburg

MSD Belgium BVBA/SPRL

Tél/Tel: 0800 38 693 (+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

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

Ísland

Vistor hf.

Sími: + 354 535 70 00

Italia

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

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

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

Package leaflet: Information for the patient

Aerius 2.5 mg orodispersible tablets desloratadine

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 Aerius orodispersible tablet is and what it is used for

2.What you need to know before you take Aerius orodispersible tablet

3.How to take Aerius orodispersible tablet

4.Possible side effects

5.How to store Aerius orodispersible tablet

6.Contents of the pack and other information

1.What Aerius orodispersible tablet is and what it is used for

What Aerius is

Aerius contains desloratadine which is an antihistamine.

How Aerius works

Aerius orodispersible tablet is an antiallergy medicine that does not make you drowsy. It helps control your allergic reaction and its symptoms.

When Aerius should be used

Aerius orodispersible tablet relieves symptoms associated with allergic rhinitis (inflammation of the nasal passages caused by an allergy, for example, hay fever or allergy to dust mites) in adults, adolescents and children 6 years of age and older. These symptoms include sneezing, runny or itchy nose, itchy palate, and itchy, red or watery eyes.

Aerius orodispersible tablet is also used to relieve the symptoms associated with urticaria (a skin condition caused by an allergy). These symptoms include itching and hives.

Relief of these symptoms lasts a full day and helps you to resume your normal daily activities and sleep.

2. What you need to know before you take Aerius orodispersible tablet

Do not take Aerius orodispersible tablet

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

Warnings and precautions

Talk to your doctor, pharmacist or nurse before taking Aerius:

-if you have poor kidney function.

-if you have medical or familial history of seizures.

Use in children and adolescents

Do not give this medicine to children less than 6 years of age.

Other medicines and Aerius

There are no known interactions of Aerius with other medicines.

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

Aerius orodispersible tablet with food, drink and alcohol

Aerius orodispersible tablet does not need to be taken with water or liquid. Additionally, Aerius orodispersible tablet may be taken with or without a meal. Use caution when taking Aerius with alcohol.

Pregnancy, breast-feeding and fertility

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Taking Aerius is not recommended if you are pregnant or nursing a baby.

Fertility

There is no data available on male/female fertility.

Driving and using machines

At the recommended dose, this medicine is not expected to affect your ability to drive or use machines. Although most people do not experience drowsiness, it is recommended not to engage in activities requiring mental alertness, such as driving a car or operating machinery until you have established your own response to the medicinal product.

Aerius orodispersible tablet contains aspartame

This product contains aspartame. Aspartame is a source of phenylalanine, which may be harmful for people with phenylketonuria.

3. How to take Aerius orodispersible tablet

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

Adults and adolescents 12 years of age and over

The recommended dose is two tablets once a day with or without food.

This medicine is for oral use.

Before using, carefully peel open the blister and remove the dose of orodispersible tablet without crushing it. Place it in your mouth and it will disperse immediately. Water or other liquid is not needed to swallow the dose. Take the dose immediately after removal from the blister.

Children from 6 to 11 years of age

The recommended dose is one tablet once a day with or without food.

Regarding the duration of treatment, your physician will determine the type of allergic rhinitis you are suffering from and will determine for how long you should take Aerius orodispersible tablets.

If your allergic rhinitis is intermittent (presence of symptoms for less than 4 days per week or for less than 4 weeks), your physician will recommend you a treatment schedule that will depend on the evaluation of the history of your disease.

If your allergic rhinitis is persistent (presence of symptoms for 4 days or more per week and for more than 4 weeks), your physician may recommend you a longer term treatment.

For urticaria, the duration of treatment may be variable from patient to patient and therefore you should follow the instructions of your physician.

If you take more Aerius orodispersible tablet than you should

Take Aerius orodispersible tablet only as prescribed for you. No serious problems are expected with accidental overdose. However, if you take more Aerius orodispersible tablet than you were told to, tell your doctor, pharmacist or nurse immediately.

If you forget to take Aerius orodispersible tablet

If you forget to take your dose on time, take it as soon as possible and then go back to your regular dosing schedule. Do not take a double dose to make up for forgotten individual doses.

If you stop taking Aerius orodispersible tablet

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

4. Possible side effects

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

During the marketing of Aerius, cases of severe allergic reactions (difficulty in breathing, wheezing, itching, hives and swelling) have been reported very rarely. If you notice any of these serious side effects, stop taking the medicine and seek urgent medical advice straight away.

In clinical studies in adults, side effects were about the same as with a dummy tablet. However, fatigue, dry mouth and headache were reported more often than with a dummy tablet. In adolescents, headache was the most commonly reported side effect.

In clinical studies with Aerius, the following side effects were reported as:

Common: the following may affect up to 1 in 10 people

fatigue

dry mouth

headache

Adults

During the marketing of Aerius, the following side effects were reported as:

Very rare: the following may affect up to 1 in 10,000 people

 

● severe allergic reactions

● rash

● pounding or irregular heartbeat

● fast heartbeat

● stomach ache

● feeling sick (nausea)

● vomiting

● upset stomach

● diarrhoea

● dizziness

● drowsiness

● inability to sleep

● muscle pain

● hallucinations

● seizures

● restlessness with increased

● liver inflammation

● abnormal liver function tests

body movement

 

 

Not known: frequency cannot be estimated from the available data

● unusual weakness

● yellowing of the skin and/or eyes

increased sensitivity of the skin to the sun, even in case of hazy sun, and to UV light, for instance to UV lights of a solarium

changes in the way the heart beats

abnormal behaviour

aggression

Children

Not known: frequency cannot be estimated from the available data

● slow heartbeat

● change in the way the heart beats

● abnormal behaviour

● aggression

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 Aerius orodispersible tablet

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 and blister after EXP. The expiry date refers to the last day of that month.

Store in the original package.

Do not use this medicine if you notice any change in the appearance of Aerius orodispersible tablet.

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 to protect the environment.

6. Contents of the pack and other information

What Aerius orodispersible tablet contains

-The active substance is desloratadine 2.5 mg

-The other ingredients are microcrystalline cellulose, pregelatinized starch, sodium starch glycolate, magnesium stearate, butylated methacrylate copolymer, crospovidone, sodium hydrogen carbonate, citric acid, colloidal silicon dioxide, ferric oxide, mannitol, aspartame (E951) and flavour Tutti-Frutti.

What Aerius orodispersible tablet looks like and contents of the pack

Aerius 2.5 mg orodispersible tablet is light red, speckled, and round with “K” branded on one side. Aerius orodispersible tablet is packed in unit dose blisters in packs of

5, 6, 10, 12, 15, 18, 20, 30, 50, 60, 90 and 100 doses of orodispersible tablet. Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder: Merck Sharp & Dohme Ltd, Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom.

Manufacturer: SP Labo N.V., Industriepark 30, B-2220 Heist-op-den-Berg, Belgium.

For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:

België/Belgique/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

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

Ελλάδα

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

Lietuva

UAB Merck Sharp & Dohme Tel. + 370 5 278 02 47 msd_lietuva@merck.com

Luxembourg/Luxemburg

MSD Belgium BVBA/SPRL

Tél/Tel: 0800 38 693 (+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

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 2900 msdromania@merck.com

Ireland

Merck Sharp & Dohme Ireland (Human Health) Limited

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

Ísland

Vistor hf.

Sími: + 354 535 70 00

Italia

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

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

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

Package leaflet: Information for the patient

Aerius 5 mg orodispersible tablets desloratadine

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 Aerius orodispersible tablet is and what it is used for

2.What you need to know before you take Aerius orodispersible tablet

3.How to take Aerius orodispersible tablet

4.Possible side effects

5.How to store Aerius orodispersible tablet

6.Contents of the pack and other information

1. What Aerius orodispersible tablet is and what it is used for

What Aerius is

Aerius contains desloratadine which is an antihistamine.

How Aerius works

Aerius orodispersible tablet is an antiallergy medicine that does not make you drowsy. It helps control your allergic reaction and its symptoms.

When Aerius should be used

Aerius orodispersible tablet relieves symptoms associated with allergic rhinitis (inflammation of the nasal passages caused by an allergy, for example, hay fever or allergy to dust mites) in adults and adolescents 12 years of age and older. These symptoms include sneezing, runny or itchy nose, itchy palate, and itchy, red or watery eyes.

Aerius orodispersible tablet is also used to relieve the symptoms associated with urticaria (a skin condition caused by an allergy). These symptoms include itching and hives.

Relief of these symptoms lasts a full day and helps you to resume your normal daily activities and sleep.

2. What you need to know before you take Aerius orodispersible tablet

Do not take Aerius orodispersible tablet

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

Warnings and precautions

Talk to your doctor, pharmacist or nurse before taking Aerius:

-if you have poor kidney function.

-if you have medical or familial history of seizures.

Use in children and adolescents

Do not give this medicine to children less than 12 years of age.

Other medicines and Aerius

There are no known interactions of Aerius with other medicines.

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

Aerius orodispersible tablet with food, drink and alcohol

Aerius orodispersible tablet does not need to be taken with water or liquid. Additionally, Aerius orodispersible tablet may be taken with or without a meal. Use caution when taking Aerius with alcohol.

Pregnancy, breast-feeding and fertility

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Taking Aerius is not recommended if you are pregnant or nursing a baby.

Fertility

There is no data available on male/female fertility.

Driving and using machines

At the recommended dose, this medicine is not expected to affect your ability to drive or use machines. Although most people do not experience drowsiness, it is recommended not to engage in activities requiring mental alertness, such as driving a car or operating machinery until you have established your own response to the medicinal product.

Aerius orodispersible tablet contains aspartame

This product contains aspartame. Aspartame is a source of phenylalanine, which may be harmful for people with phenylketonuria.

3. How to take Aerius orodispersible tablet

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

Adults and adolescents 12 years of age and over

The recommended dose is one tablet once a day with or without food.

This medicine is for oral use.

Before using, carefully peel open the blister and remove the dose of orodispersible tablet without crushing it. Place it in your mouth and it will disperse immediately. Water or other liquid is not needed to swallow the dose. Take the dose immediately after removal from the blister.

Regarding the duration of treatment, your physician will determine the type of allergic rhinitis you are suffering from and will determine for how long you should take Aerius orodispersible tablets.

If your allergic rhinitis is intermittent (presence of symptoms for less than 4 days per week or for less than 4 weeks), your physician will recommend you a treatment schedule that will depend on the evaluation of the history of your disease.

If your allergic rhinitis is persistent (presence of symptoms for 4 days or more per week and for more than 4 weeks), your physician may recommend you a longer term treatment.

For urticaria, the duration of treatment may be variable from patient to patient and therefore you should follow the instructions of your physician.

If you take more Aerius orodispersible tablet than you should

Take Aerius orodispersible tablet only as prescribed for you. No serious problems are expected with accidental overdose. However, if you take more Aerius orodispersible tablet than you were told to, tell your doctor, pharmacist or nurse immediately.

If you forget to take Aerius orodispersible tablet

If you forget to take your dose on time, take it as soon as possible and then go back to your regular dosing schedule. Do not take a double dose to make up for forgotten individual doses.

If you stop taking Aerius orodispersible tablet

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

4. Possible side effects

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

During the marketing of Aerius, cases of severe allergic reactions (difficulty in breathing, wheezing, itching, hives and swelling) have been reported very rarely. If you notice any of these serious side effects, stop taking the medicine and seek urgent medical advice straight away.

In clinical studies in adults, side effects were about the same as with a dummy tablet. However, fatigue, dry mouth and headache were reported more often than with a dummy tablet. In adolescents, headache was the most commonly reported side effect.

In clinical studies with Aerius, the following side effects were reported as:

Common: the following may affect up to 1 in 10 people

fatigue

dry mouth

headache

Adults

During the marketing of Aerius, the following side effects were reported as:

Very rare: the following may affect up to 1 in 10,000 people

 

● severe allergic reactions

● rash

● pounding or irregular heartbeat

● fast heartbeat

● stomach ache

● feeling sick (nausea)

● vomiting

● upset stomach

● diarrhoea

● dizziness

● drowsiness

● inability to sleep

● muscle pain

● hallucinations

● seizures

● restlessness with increased

● liver inflammation

● abnormal liver function tests

body movement

 

 

Not known: frequency cannot be estimated from the available data

● unusual weakness

● yellowing of the skin and/or eyes

increased sensitivity of the skin to the sun, even in case of hazy sun, and to UV light, for instance to UV lights of a solarium

changes in the way the heart beats

abnormal behaviour

aggression

Children

Not known: frequency cannot be estimated from the available data

● slow heartbeat

● change in the way the heart beats

● abnormal behaviour

● aggression

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 Aerius orodispersible tablet

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 and blister after EXP. The expiry date refers to the last day of that month.

Store in the original package.

Do not use this medicine if you notice any change in the appearance of Aerius orodispersible tablet.

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 to protect the environment.

6. Contents of the pack and other information

What Aerius orodispersible tablet contains

-The active substance is desloratadine 5 mg

-The other ingredients are microcrystalline cellulose, pregelatinized starch, sodium starch glycolate, magnesium stearate, butylated methacrylate copolymer, crospovidone, sodium hydrogen carbonate, citric acid, colloidal silicon dioxide, ferric oxide, mannitol, aspartame (E951) and flavour Tutti-Frutti.

What Aerius orodispersible tablet looks like and contents of the pack

Aerius 5 mg orodispersible tablet is light red, speckled, and round with “A” branded on one side. Aerius orodispersible tablet is packed in unit dose blisters in packs of

5, 6, 10, 12, 15, 18, 20, 30, 50, 60, 90 and 100 doses of orodispersible tablet. Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder: Merck Sharp & Dohme Ltd, Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom.

Manufacturer: SP Labo N.V., Industriepark 30, B-2220 Heist-op-den-Berg, Belgium.

For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:

België/Belgique/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

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

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

Ελλάδα

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

Luxembourg/Luxemburg

MSD Belgium BVBA/SPRL

Tél/Tel: 0800 38 693 (+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

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

Ísland

Vistor hf.

Sími: + 354 535 7000

Italia

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

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

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

Package leaflet: Information for the patient

Aerius 0.5 mg/ml oral solution desloratadine

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 Aerius oral solution is and what it is used for

2.What you need to know before you take Aerius oral solution

3.How to take Aerius oral solution

4.Possible side effects

5.How to store Aerius oral solution

6.Contents of the pack and other information

1.What Aerius oral solution is and what it is used for

What Aerius is

Aerius contains desloratadine which is an antihistamine.

How Aerius works

Aerius oral solution is an antiallergy medicine that does not make you drowsy. It helps control your allergic reaction and its symptoms.

When Aerius should be used

Aerius oral solution relieves symptoms associated with allergic rhinitis (inflammation of the nasal passages caused by an allergy, for example, hay fever or allergy to dust mites) in adults, adolescents and children 1 year of age and older. These symptoms include sneezing, runny or itchy nose, itchy palate, and itchy, red or watery eyes.

Aerius oral solution is also used to relieve the symptoms associated with urticaria (a skin condition caused by an allergy). These symptoms include itching and hives.

Relief of these symptoms lasts a full day and helps you to resume your normal daily activities and sleep.

2. What you need to know before you take Aerius oral solution

Do not take Aerius oral solution

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

Warnings and precautions

Talk to your doctor, pharmacist or nurse before taking Aerius:

-if you have poor kidney function.

-if you have medical or familial history of seizures.

Use in children and adolescents

Do not give this medicine to children less than 1 year of age.

Other medicines and Aerius

There are no known interactions of Aerius with other medicines.

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

Aerius oral solution with food, drink and alcohol

Aerius may be taken with or without a meal.

Use caution when taking Aerius with alcohol.

Pregnancy, breast-feeding and fertility

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Taking Aerius oral solution is not recommended if you are pregnant or nursing a baby.

Fertility

There is no data available on male/female fertility.

Driving and using machines

At the recommended dose, this medicine is not expected to affect your ability to drive or use machines. Although most people do not experience drowsiness, it is recommended not to engage in activities requiring mental alertness, such as driving a car or operating machinery until you have established your own response to the medicinal product.

Aerius oral solution contains sorbitol

Aerius oral solution contains sorbitol. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

3. How to take Aerius oral solution

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

Children

Children 1 through 5 years of age:

The recommended dose is 2.5 ml (½ of a 5 ml spoonful) of oral solution once a day.

Children 6 through 11 years of age:

The recommended dose is 5 ml (one 5 ml spoonful) of oral solution once a day.

Adults and adolescents 12 years of age and over

The recommended dose is 10 ml (two 5 ml spoonfuls) of oral solution once a day.

In case an oral measuring syringe is provided with the bottle of oral solution, you can alternatively use it to take the appropriate amount of oral solution.

This medicine is for oral use.

Swallow the dose of oral solution and then drink some water. You can take this medicine with or without food.

Regarding the duration of treatment, your physician will determine the type of allergic rhinitis you are suffering from and will determine for how long you should take Aerius oral solution.

If your allergic rhinitis is intermittent (presence of symptoms for less than 4 days per week or for less than 4 weeks), your physician will recommend you a treatment schedule that will depend on the evaluation of the history of your disease.

If your allergic rhinitis is persistent (presence of symptoms for 4 days or more per week and for more than 4 weeks), your physician may recommend you a longer term treatment.

For urticaria, the duration of treatment may be variable from patient to patient and therefore you should follow the instructions of your physician.

If you take more Aerius oral solution than you should

Take Aerius oral solution only as it is prescribed for you. No serious problems are expected with accidental overdose. However, if you take more Aerius oral solution than you were told to, tell your doctor, pharmacist or nurse immediately.

If you forget to take Aerius oral solution

If you forget to take your dose on time, take it as soon as possible and then go back to your regular dosing schedule. Do not take a double dose to make up for a forgotten dose.

If you stop taking Aerius oral solution

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

4. Possible side effects

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

During the marketing of Aerius, cases of severe allergic reactions (difficulty in breathing, wheezing, itching, hives and swelling) have been reported very rarely. If you notice any of these serious side effects, stop taking the medicine and seek urgent medical advice straight away.

In clinical studies in most children and adults, side effects with Aerius were about the same as with a dummy solution or tablet. However, common side effects in children less than 2 years of age were diarrhoea, fever and insomnia while in adults, fatigue, dry mouth and headache were reported more often than with a dummy tablet.

In clinical studies with Aerius, the following side effects were reported as:

Children

Common in children less than 2 years of age: the following may affect up to 1 in 10 children

diarrhoea

fever

insomnia

Adults

Common: the following may affect up to 1 in 10 people

fatigue

dry mouth

headache

During the marketing of Aerius, the following side effects were reported as:

Adults

Very rare: the following may affect up to 1 in 10,000 people

● severe allergic reactions

● rash

● fast heartbeat

● stomach ache

● vomiting

● upset stomach

pounding or irregular heartbeat

feeling sick (nausea)

diarrhoea

● dizziness

● drowsiness

● inability to sleep

● muscle pain

● hallucinations

● seizures

● restlessness with increased

● liver inflammation

● abnormal liver function tests

body movement

 

 

Not known: frequency cannot be estimated from the available data

● unusual weakness

● yellowing of the skin and/or eyes

increased sensitivity of the skin to the sun, even in case of hazy sun, and to UV light, for instance to UV lights of a solarium

changes in the way the heart beats

abnormal behaviour

aggression

Children

Not known: frequency cannot be estimated from the available data

● slow heartbeat

● change in the way the heart beats

● abnormal behaviour

● aggression

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 Aerius oral solution

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 bottle after EXP. The expiry date refers to the last day of that month.

Do not freeze. Store in the original package.

Do not use this medicine if you notice any change in the appearance of the oral solution.

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 to protect the environment.

6. Contents of the pack and other information

What Aerius oral solution contains

-The active substance is desloratadine 0.5 mg/ml

-The other ingredients of the oral solution are sorbitol, propylene glycol, sucralose E 955, hypromellose 2910, sodium citrate dihydrate, natural and artificial flavour (bubblegum), citric acid anhydrous, disodium edetate and purified water.

What Aerius oral solution looks like and contents of the pack

Aerius oral solution is available in bottles of 30, 50, 60, 100, 120, 150, 225 and 300 ml, with a childproof cap. For all packages except the 150 ml bottle, a measuring spoon is provided, marked for doses of 2.5 ml and 5 ml. For the 150 ml package, a measuring spoon or an oral measuring syringe is provided, marked for doses of 2.5 ml and 5 ml.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder: Merck Sharp & Dohme Ltd, Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom.

Manufacturer: SP Labo N.V., Industriepark 30, B-2220 Heist-op-den-Berg, Belgium.

For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:

België/Belgique/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

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

Ελλάδα

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

Lietuva

UAB Merck Sharp & Dohme Tel. + 370 5 278 02 47 msd_lietuva@merck.com

Luxembourg/Luxemburg

MSD Belgium BVBA/SPRL

Tél/Tel: 0800 38 693 (+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

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

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.

Sími: + 354 535 7000

Italia

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

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

ANNEX IV

SCIENTIFIC CONCLUSIONS AND GROUNDS FOR THE VARIATION TO THE TERMS

OF THE MARKETING AUTHORISATION(S)

Scientific conclusions

Taking into account the PRAC Assessment Report on the PSUR(s) for desloratadine, the scientific conclusions of CHMP are as follows:

Two literature reports identified a possible relationship between aggressive reaction/abnormal behaviour and desloratadine use with supportive temporal relationships, positive dechallenges and some with positive rechallenges. Similar cases were reported in Eudravigilance for the reference period. Considering the potential seriousness of these events in children, and the number of reported cases with positive dechallenge and rechallenge, the ‘abnormal behaviour’ and ‘aggression’ should be added to the list of adverse drug reactions (ADRs) of desloratadine.

A literature article published during the reference period describes 4 cases of epilepsy in children with a family history of epilepsy or relevant medical history. The causality was assessed as possible for each case, based on temporal association and positive dechallenge. Based on these new data, it could be concluded that desloratadine may aggravate pre-existing seizures in patients (and mainly in children) with medical history of seizures, and that caution should be recommended in treating epileptic patients or those susceptible to convulsions with desloratadine.

Based on 4 new publications regarding a possible association between desloratadine and QT prolongation were reported in the literature and the fact that ‘QT prolongation’ is already listed as an ADR of desloratadine-containing products, this adverse reaction should be listed as an ADR of any desloratadine-containing product.

The CHMP agrees with the scientific conclusions made by the PRAC.

Grounds for the variation to the terms of the Marketing Authorisation(s)

On the basis of the scientific conclusions for desloratadine the CHMP is of the opinion that the benefit-risk balance of the medicinal product(s) containing desloratadine is unchanged subject to the proposed changes to the product information

The CHMP recommends that the terms of the marketing authorisation(s) should be varied.

Comments

A B C D E F G H I J K L M N O P Q R S T U V W X Y Z
  • Help
  • Get it on Google Play
  • About
  • Info on site by:

  • Presented by RXed.eu

  • 27558

    prescription drugs listed