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Temodal (temozolomide) – Package leaflet - L01AX03

Updated on site: 10-Oct-2017

Medication nameTemodal
ATC CodeL01AX03
Substancetemozolomide
ManufacturerMerck Sharp

Package Leaflet: Information for the user

Temodal 5 mg hard capsules Temodal 20 mg hard capsules Temodal 100 mg hard capsules Temodal 140 mg hard capsules Temodal 180 mg hard capsules Temodal 250 mg hard capsules

temozolomide

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 Temodal is and what it is used for

2.What you need to know before you take Temodal

3.How to take Temodal

4.Possible side effects

5.How to store Temodal

6.Contents of the pack and other information

1.What Temodal is and what it is used for

Temodal contains a medicine called temozolomide. This medicine is an antitumour agent.

Temodal is used for the treatment of specific forms of brain tumours:

-in adults with newly-diagnosed glioblastoma multiforme. Temodal is first used together with radiotherapy (concomitant phase of treatment) and after that alone (monotherapy phase of treatment).

-in children 3 years and older and adult patients with malignant glioma, such as glioblastoma multiforme or anaplastic astrocytoma. Temodal is used in these tumours if they return or get worse after standard treatment.

2. What you need to know before you take Temodal

Do not take Temodal

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

-if you have had an allergic reaction to dacarbazine (an anticancer medicine sometimes called DTIC). Signs of allergic reaction include feeling itchy, breathlessness or wheezing, swelling of the face, lips, tongue or throat.

-if certain kinds of blood cells are severely reduced (myelosuppression), such as your white blood cell count and platelet count. These blood cells are important for fighting infection and for proper blood clotting. Your doctor will check your blood to make sure you have enough of these cells before you begin treatment.

Warnings and precautions

Talk to your doctor, pharmacist or nurse before taking Temodal,

-as you should be observed closely for the development of a serious form of chest infection called Pneumocystis jirovecii pneumonia (PCP). If you are a newly-diagnosed patient (glioblastoma multiforme) you may be receiving Temodal for 42 days in combination with radiotherapy. In this case, your doctor will also prescribe medicine to help you prevent this type of pneumonia (PCP).

-if you have ever had or might now have a hepatitis B infection. This is because Temodal could cause hepatitis B to become active again, which can be fatal in some cases. Patients will be carefully checked by their doctor for signs of this infection before treatment is started.

-if you have low counts of red blood cells (anaemia), white blood cells and platelets, or blood clotting problems before starting the treatment, or if you develop them during treatment. Your doctor may decide to reduce the dose, interrupt, stop or change your treatment. You may also need other treatments. In some cases, it may be necessary to stop treatment with Temodal. Your blood will be tested frequently during treatment to monitor the side effects of Temodal on your blood cells.

-as you may have a small risk of other changes in blood cells, including leukaemia.

-if you have nausea (feeling sick in your stomach) and/or vomiting which are very common side effects of Temodal (see section 4), your doctor may prescribe you a medicine (an anti-emetic) to help prevent vomiting.

If you vomit frequently before or during treatment, ask your doctor about the best time to take Temodal until the vomiting is under control. If you vomit after taking your dose, do not take a second dose on the same day.

-if you develop fever or symptoms of an infection, contact your doctor immediately.

-if you are older than 70 years of age, you might be more prone to infections, bruising or bleeding.

-if you have liver or kidney problems, your dose of Temodal may need to be adjusted.

Children and adolescents

Do not give this medicine to children under the age of 3 years because it has not been studied. There is limited information in patients over 3 years of age who have taken Temodal.

Other medicines and Temodal

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

Pregnancy, breast-feeding and fertility

If you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. This is because you must not be treated with Temodal during pregnancy unless clearly indicated by your doctor.

Effective contraceptive precautions must be taken by both male and female patients who are taking Temodal (see also “Male fertility” below).

You should stop breast-feeding while receiving treatment with Temodal.

Male fertility

Temodal may cause permanent infertility. Male patients should use effective contraceptions and not father a child for up to 6 months after stopping treatment. It is recommended to seek advice on conservation of sperm prior to treatment.

Driving and using machines

Temodal may make you feel tired or sleepy. In this case, do not drive or use any tools or machines or cycle until you see how this medicine affects you (see section 4).

Temodal contains lactose

Temodal contains lactose (a kind of sugar). 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 Temodal

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

Dosage and duration of treatment

Your doctor will work out your dose of Temodal. This is based on your size (height and weight) and if you have a recurrent tumour and have had chemotherapy treatment in the past.

You may be given other medicines (anti-emetics) to take before and/or after taking Temodal to prevent or control nausea and vomiting.

Patients with newly-diagnosed glioblastoma multiforme:

If you are a newly-diagnosed patient, treatment will occur in two phases:

-treatment together with radiotherapy (concomitant phase) first

-followed by treatment with only Temodal (monotherapy phase).

During the concomitant phase, your doctor will start Temodal at a dose of 75 mg/m2 (usual dose). You will take this dose every day for 42 days (up to 49 days) in combination with radiotherapy. The Temodal dose may be delayed or stopped, depending on your blood counts and how you tolerate your medicine during the concomitant phase.

Once the radiotherapy is completed, you will interrupt treatment for 4 weeks. This will give your body a chance to recover.

Then, you will start the monotherapy phase.

During the monotherapy phase, the dose and way you take Temodal will be different. Your doctor will work out your exact dose. There may be up to 6 treatment periods (cycles). Each one lasts

28 days. You will take your new dose of Temodal alone once daily for the first 5 days (“dosing days”) of each cycle. The first dose will be 150 mg/m2. Then you will have 23 days without Temodal. This adds up to a 28-day treatment cycle.

After Day 28, the next cycle will begin. You will again take Temodal once daily for 5 days followed by 23 days without Temodal. The Temodal dose may be adjusted, delayed or stopped depending on your blood counts and how you tolerate your medicine during each treatment cycle.

Patients with tumours that have returned or worsened (malignant glioma, such as glioblastoma multiforme or anaplastic astrocytoma) taking Temodal only:

A treatment cycle with Temodal lasts 28 days.

You will take Temodal alone once daily for the first 5 days. This daily dose depends on whether or not you have received chemotherapy before.

If you have not been previously treated with chemotherapy, your first dose of Temodal will be 200 mg/m2 once daily for the first 5 days. If you have been previously treated with chemotherapy, your first dose of Temodal will be 150 mg/m2 once daily for the first 5 days.

Then, you will have 23 days without Temodal. This adds up to a 28-day treatment cycle.

After Day 28, the next cycle will begin. You will again receive Temodal once daily for 5 days, followed by 23 days without Temodal.

Before each new treatment cycle, your blood will be tested to see if the Temodal dose needs to be adjusted. Depending on your blood test results, your doctor may adjust your dose for the next cycle.

How to take Temodal

Take your prescribed dose of Temodal once a day, preferably at the same time each day.

Take the capsules on an empty stomach; for example, at least one hour before you plan to eat breakfast. Swallow the capsule(s) whole with a glass of water. Do not open, crush or chew the capsules. If a capsule is damaged, avoid contact of the powder with your skin, eyes or nose. If you accidentally get some in your eyes or nose, flush the area with water.

Depending on the prescribed dose, you may have to take more than one capsule together, eventually with different strengths (content of active substance, in mg). The colour of the capsule cap is different for each strength (see in the table below).

Strength

Colour of the cap

 

 

Temodal 5 mg hard capsules

green

 

 

Temodal 20 mg hard capsules

yellow

 

 

Temodal 100 mg hard capsules

pink

 

 

Temodal 140 mg hard capsules

blue

 

 

Temodal 180 mg hard capsules

orange

 

 

Temodal 250 mg hard capsules

white

 

 

You should make sure you fully understand and remember the following:

how many capsules you need to take every dosing day. Ask your doctor or pharmacist to write it down (including the colour).

which days are your dosing days.

Review the dose with your doctor each time you start a new cycle, since it may be different from the last cycle.

Always take Temodal exactly as your doctor has told you. It is very important to check with your doctor or pharmacist if you are not sure. Errors in how you take this medicine may have serious health consequences.

If you take more Temodal than you should

If you accidentally take more Temodal capsules than you were told to, contact your doctor, pharmacist or nurse immediately.

If you forget to take Temodal

Take the missed dose as soon as possible during the same day. If a full day has gone by, check with your doctor. Do not take a double dose to make up for a forgotten dose, unless your doctor tells you to do so.

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.

Contact your doctor immediately if you have any of the following:

-a severe allergic (hypersensitive) reaction (hives, wheezing or other breathing difficulty),

-uncontrolled bleeding,

-seizures (convulsions),

-fever,

-severe headache that does not go away.

Temodal treatment can cause a reduction in certain kinds of blood cells. This may cause you to have increased bruising or bleeding, anaemia (a shortage of red blood cells), fever, and reduced resistance to infections. The reduction in blood cell counts is usually short-lived. In some cases, it may be prolonged and may lead to a very severe form of anaemia (aplastic anaemia). Your doctor will monitor your blood regularly for any changes, and will decide if any specific treatment is needed. In some cases, your Temodal dose will be reduced or treatment stopped.

Side effects from clinical studies:

Temodal in combination treatment with radiotherapy in newly-diagnosed glioblastoma

Patients receiving Temodal in combination with radiotherapy may experience different side effects than patients taking Temodal alone. The following side effects may occur, and may require medical attention.

Very common (may affect more than 1 in 10 people): loss of appetite, headache, constipation (difficulty passing stools), nausea (feeling sick in your stomach), vomiting, rash, hair loss, tiredness.

Common (may affect up to 1 in 10 people): oral infections, wound infection, reduced number of blood cells (neutropenia, thrombocytopenia, lymphopenia, leukopenia), increased sugar in the blood, loss of weight, change in mental status or alertness, anxiety/depression, sleepiness, difficulty speaking, impaired balance, dizziness, confusion, forgetfulness, difficulty concentrating, inability to fall asleep or stay asleep, tingling sensation, bruising, shaking, abnormal or blurry vision, double vision, hearing impairment, shortness of breath, cough, blood clot in the legs, fluid retention, swollen legs, diarrhoea, stomach or abdominal pain, heartburn, upset stomach, difficulty swallowing, dry mouth, skin irritation or redness, dry skin, itching, muscle weakness, painful joints, muscle aches and pains, frequent urination, difficulty with holding your urine, allergic reaction, fever, radiation injury, face swelling, pain, abnormal taste, abnormal liver function tests.

Uncommon (may affect up to 1 in 100 people): flu-like symptoms, red spots under the skin, low potassium level in the blood, weight gain, mood swings, hallucination and memory impairment, partial paralysis, impaired coordination, impaired sensations, partial loss of vision, dry or painful eyes, deafness, infection of the middle ear, ringing in the ears, earache, palpitations (when you can feel your heart beat), blood clot in the lung, high blood pressure, pneumonia, inflammation of your sinuses, bronchitis, a cold or the flu, swollen stomach, difficulty controlling your bowel movements, haemorrhoids, peeling skin, increased skin sensitivity to sunlight, change in skin colour, increased sweating, muscle damage, back pain, difficulty in urinating, vaginal bleeding, sexual impotence, absent or heavy menstrual periods, vaginal irritation, breast pain, hot flushes, shivering, discolouration of your tongue, change in your sense of smell, thirst, tooth disorder.

Temodal monotherapy in recurrent or progressive glioma

The following side effects may occur, and may require medical attention.

Very common (may affect more than 1 in 10 people): reduced number of blood cells (neutropenia or lymphopenia, thrombocytopenia), loss of appetite, headache, vomiting, nausea (feeling sick in your stomach), constipation (difficulty passing stools), tiredness.

Common (may affect up to 1 in 10 people): loss of weight, sleepiness, dizziness, tingling sensation, shortness of breath, diarrhoea, abdominal pain, upset stomach, rash, itching, hair loss, fever, weakness, shivering, feeling unwell, pain, change in taste.

Uncommon (may affect up to 1 in 100 people): reduced blood cell counts (pancytopenia, anaemia, leukopenia).

Rare (may affect up to 1 in 1,000 people): cough, infections including pneumonia.

Very rare (may affect up to 1 in 10,000 people): skin redness, urticaria (hives), skin eruption, allergic reactions.

Other side effects:

Cases of elevations of liver enzymes have been commonly reported. Cases of increased bilirubin, problems with bile flow (cholestasis), hepatitis and injury to the liver, including fatal liver failure, have been uncommonly reported.

Very rare cases of severe rash with skin swelling, including on the palms of the hands and soles of the feet, or painful reddening of the skin and/or blisters on the body or in the mouth have been observed. Tell your doctor immediately if this occurs.

Very rare cases of lung side effects have been observed with Temodal. Patients usually present with shortness of breath and cough. Tell your doctor if you notice any of these symptoms.

In very rare cases, patients taking Temodal and medicines like it may have a small risk of developing secondary cancers, including leukaemia.

New or reactivated (recurring) cytomegalovirus infections and reactivated hepatitis B virus infections have been uncommonly reported. Cases of brain infections caused by herpes virus (meningoencephalitis herpetic), including fatal cases, have been uncommonly reported.

Cases of diabetes insipidus have been uncommonly reported. Symptoms of diabetes insipidus include passing a lot of urine and feeling thirsty.

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 Temodal

Keep this medicine out of the sight and reach of children, preferably in a locked cupboard. Accidental ingestion can be lethal for children.

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

Bottle presentation

Do not store above 30 C.

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

Keep the bottle tightly closed.

Sachet presentation

Do not store above 30 C

Tell your pharmacist if you notice any change in the appearance of the capsules.

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 Temodal contains

The active substance is temozolomide.

Temodal 5 mg hard capsules: Each capsule contains 5 mg temozolomide. Temodal 20 mg hard capsules: Each capsule contains 20 mg temozolomide. Temodal 100 mg hard capsules: Each capsule contains 100 mg temozolomide. Temodal 140 mg hard capsules: Each capsule contains 140 mg temozolomide. Temodal 180 mg hard capsules: Each capsule contains 180 mg temozolomide. Temodal 250 mg hard capsules: Each capsule contains 250 mg temozolomide.

The other ingredients are: capsule content:

anhydrous lactose, colloidal anhydrous silica, sodium starch glycolate type A, tartaric acid, stearic acid (see section 2 "Temodal contains lactose").

capsule shell:

Temodal 5 mg hard capsules: gelatin, titanium dioxide (E 171), sodium laurilsulfate, yellow iron oxide (E 172), indigo carmine (E 132).

Temodal 20 mg hard capsules: gelatin, titanium dioxide (E 171), sodium lauril sulfate, yellow iron oxide (E 172),

Temodal 100 mg hard capsules: gelatin, titanium dioxide (E 171), sodium lauril sulfate, red iron oxide (E 172),

Temodal 140 mg hard capsules: gelatin, titanium dioxide (E 171), sodium lauril sulfate, indigo carmine (E 132),

Temodal 180 mg hard capsules: gelatin, titanium dioxide (E 171), sodium lauril sulfate, yellow iron oxide (E 172), and red iron oxide (E 172),

Temodal 250 mg hard capsules: gelatin, titanium dioxide (E 171), sodium lauril sulfate. printing ink:

shellac, propylene glycol, purified water, ammonium hydroxide, potassium hydroxide, and black iron oxide (E 172).

What Temodal looks like and contents of the pack

Temodal 5 mg hard capsules have an opaque white body, an opaque green cap, and are imprinted with black ink.

Temodal 20 mg hard capsules have an opaque white body, an opaque yellow cap, and are imprinted with black ink.

Temodal 100 mg hard capsules have an opaque white body, an opaque pink cap, and are imprinted with black ink.

Temodal 140 mg hard capsules have an opaque white body, a blue cap, and are imprinted with black ink.

Temodal 180 mg hard capsules have an opaque white body, an opaque orange cap, and are imprinted with black ink.

Temodal 250 mg hard capsules have an opaque white body and cap, and are imprinted with black ink.

Bottle presentation

The hard capsules for oral use are dispensed in amber glass bottles containing 5 or 20 capsules. The carton contains 1 bottle.

Sachet presentation

The hard capsules (capsules) for oral use are individually sealed in sachets and dispensed in cartons containing 5 or 20 hard capsules.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder: Merck Sharp & Dohme Limited, 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 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: 0800 38 693 (+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 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 (+31 23 5153153)

e-mail@msd.de

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

Portugal

MSD France

Merck Sharp & Dohme, Lda.

Tél: +33 (0) 1 80 46 40 40

Tel: +351 21 446 57 00

 

clic@merck.com

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

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 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 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.

Package Leaflet: Information for the user

Temodal 2.5 mg/ml powder for solution for infusion temozolomide

Read all of this leaflet carefully before you start using 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.

-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 Temodal is and what it is used for

2.What you need to know before you use Temodal

3.How to use Temodal

4.Possible side effects

5.How to store Temodal

6.Contents of the pack and other information

1. What Temodal is and what it is used for

Temodal contains a medicine called temozolomide. This medicine is an antitumour agent.

Temodal is used for the treatment of specific forms of brain tumours:

-in adults with newly-diagnosed glioblastoma multiforme. Temodal is first used together with radiotherapy (concomitant phase of treatment) and after that alone (monotherapy phase of treatment).

-in children 3 years and older and adult patients with malignant glioma, such as glioblastoma multiforme or anaplastic astrocytoma. Temodal is used in these tumours if they return or get worse after standard treatment.

2. What you need to know before you use Temodal

Do not use Temodal

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

-if you have had an allergic reaction to dacarbazine (an anticancer medicine sometimes called DTIC). Signs of allergic reaction include feeling itchy, breathlessness or wheezing, swelling of the face, lips, tongue or throat.

-if certain kinds of blood cells are severely reduced (myelosuppression), such as your white blood cell count and platelet count. These blood cells are important for fighting infection and for proper blood clotting. Your doctor will check your blood to make sure you have enough of these cells before you begin treatment.

Warnings and precautions

Talk to your doctor, pharmacist or nurse before using Temodal,

-as you should be observed closely for the development of a serious form of chest infection called Pneumocystis jirovecii pneumonia (PCP). If you are a newly-diagnosed patient (glioblastoma multiforme) you may be receiving Temodal for 42 days in combination with radiotherapy. In this case, your doctor will also prescribe medicine to help you prevent this type of pneumonia (PCP).

-if you have ever had or might now have a hepatitis B infection. This is because Temodal could cause hepatitis B to become active again, which can be fatal in some cases. Patients will be carefully checked by their doctor for signs of this infection before treatment is started.

-if you have low counts of red blood cells (anaemia), white blood cells and platelets, or blood clotting problems before starting the treatment, or if you develop them during treatment. Your doctor may decide to reduce the dose, interrupt, stop or change your treatment. You may also need other treatments. In some cases, it may be necessary to stop treatment with Temodal. Your blood will be tested frequently during treatment to monitor the side effects of Temodal on your blood cells.

-as you may have a small risk of other changes in blood cells, including leukaemia.

-if you have nausea (feeling sick in your stomach) and/or vomiting which are very common side effects of Temodal (see section 4), your doctor may prescribe you a medicine (an anti-emetic) to help prevent vomiting.

-if you develop fever or symptoms of an infection, contact your doctor immediately.

-if you are older than 70 years of age, you might be more prone to infections, bruising or bleeding.

-if you have liver or kidney problems, your dose of Temodal may need to be adjusted.

Children and adolescents

Do not give this medicine to children under the age of 3 years because it has not been studied. There is limited information in patients over 3 years of age who have used Temodal.

Other medicines and Temodal

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

Pregnancy, breast-feeding and fertility

If you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine. This is because you must not be treated with Temodal during pregnancy unless clearly indicated by your doctor.

Effective contraceptive precautions must be taken by both male and female patients who are using Temodal (see also “Male fertility” below).

You should stop breast-feeding while receiving treatment with Temodal.

Male fertility

Temodal may cause permanent infertility. Male patients should use effective contraceptions and not father a child for up to 6 months after stopping treatment. It is recommended to seek advice on conservation of sperm prior to treatment.

Driving and using machines

Temodal may make you feel tired or sleepy. In this case, do not drive or use any tools or machines or cycle until you see how this medicine affects you (see section 4).

Temodal contains sodium

This medicine contains 2.4 mmol sodium per vial. This should be taken into consideration by patients on a controlled sodium diet.

3.How to use Temodal

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

Your doctor will work out your dose of Temodal. This is based on your size (height and weight) and if you have a recurrent tumour and have had chemotherapy treatment in the past.

You may be given other medicines (anti-emetics) to take before and/or after receiving Temodal to prevent or control nausea and vomiting.

Patients with newly-diagnosed glioblastoma multiforme:

If you are a newly-diagnosed patient, treatment will occur in two phases:

-treatment together with radiotherapy (concomitant phase) first

-followed by treatment with only Temodal (monotherapy phase).

During the concomitant phase, your doctor will start Temodal at a dose of 75 mg/m2 (usual dose). You will receive this dose every day for 42 days (up to 49 days) in combination with radiotherapy. The Temodal dose may be delayed or stopped, depending on your blood counts and how you tolerate your medicine during the concomitant phase.

Once the radiotherapy is completed, you will interrupt treatment for 4 weeks. This will give your body a chance to recover.

Then, you will start the monotherapy phase.

During the monotherapy phase, the dose and way you receive Temodal in this phase will be different. Your doctor will work out your exact dose.

There may be up to 6 treatment periods (cycles). Each one lasts 28 days.

You will receive your new dose of Temodal alone once daily for the first 5 days of each cycle. The first dose will be 150 mg/m2. Then you will have 23 days without Temodal. This adds up to a 28-day treatment cycle.

After Day 28, the next cycle will begin. You will again receive Temodal once daily for 5 days followed by 23 days without Temodal.

The Temodal dose may be adjusted, delayed or stopped depending on your blood counts and how you tolerate your medicine during each treatment cycle.

Patients with tumours that have returned or worsened (malignant glioma, such as glioblastoma multiforme or anaplastic astrocytoma) receiving Temodal only:

A treatment cycle with Temodal lasts 28 days.

You will receive Temodal alone once daily for the first 5 days. This daily dose depends on whether or not you have received chemotherapy before.

If you have not been previously treated with chemotherapy, your first dose of Temodal will be 200 mg/m2 once daily for the first 5 days. If you have been previously treated with chemotherapy, your first dose of Temodal will be 150 mg/m2 once daily for the first 5 days.

Then, you will have 23 days without Temodal. This adds up to a 28 day treatment cycle.

After Day 28, the next cycle will begin. You will again receive Temodal once daily for 5 days, followed by 23 days without Temodal.

Before each new treatment cycle, your blood will be tested to see if the Temodal dose needs to be adjusted. Depending on your blood test results, your doctor may adjust your dose for the next cycle.

How Temodal is given

Temodal will be given to you by your doctor in a drip into a vein (intravenous infusion), only over approximately 90 minutes. No infusion site other than a vein is acceptable.

If you use more Temodal than you should

Your medicine is given to you by health care professionals. It is therefore unlikely that you will receive more Temodal than you should. However, if you do, the doctor or nurse will treat you accordingly.

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. Contact your doctor immediately if you have any of the following:

-a severe allergic (hypersensitive) reaction (hives, wheezing or other breathing difficulty),

-uncontrolled bleeding,

-seizures (convulsions),

-fever,

-severe headache that does not go away.

Temodal treatment can cause a reduction in certain kinds of blood cells. This may cause you to have increased bruising or bleeding, anaemia (a shortage of red blood cells), fever, and reduced resistance to infections. The reduction in blood cell counts is usually short-lived. In some cases, it may be prolonged and may lead to a very severe form of anaemia (aplastic anaemia). Your doctor will monitor your blood regularly for any changes, and will decide if any specific treatment is needed. In some cases, your Temodal dose will be reduced or treatment stopped.

Side effects from clinical studies:

Temodal powder for solution for infusion

In addition to the side effects listed below, the following may also occur with the use of Temodal powder for solution for infusion: pain, irritation, itching, warmth, swelling or redness at the injection site; also bruising (haematoma).

Temodal in combination treatment with radiotherapy in newly-diagnosed glioblastoma

Patients receiving Temodal in combination with radiotherapy may experience different side effects than patients using Temodal alone. The following side effects may occur, and may require medical attention.

Very common (may affect more than 1 in 10 people): loss of appetite, headache, constipation (difficulty passing stools), nausea (feeling sick in your stomach), vomiting, rash, hair loss, tiredness.

Common (may affect up to 1 in 10 people): oral infections, wound infection, reduced number of blood cells (neutropenia, thrombocytopenia, lymphopenia, leukopenia), increased sugar in the blood, loss of weight, change in mental status or alertness, anxiety/depression, sleepiness, difficulty speaking, impaired balance, dizziness, confusion, forgetfulness, difficulty concentrating, inability to fall asleep or stay asleep, tingling sensation, bruising, shaking, abnormal or blurry vision, double vision, hearing impairment, shortness of breath, cough, blood clot in the legs, fluid retention, swollen legs, diarrhoea, stomach or abdominal pain, heartburn, upset stomach, difficulty swallowing, dry mouth, skin irritation or redness, dry skin, itching, muscle weakness, painful joints, muscle aches and pains, frequent urination, difficulty with holding your urine, allergic reaction, fever, radiation injury, face swelling, pain, abnormal taste, abnormal liver function tests.

Uncommon (may affect up to 1 in 100 people): flu-like symptoms, red spots under the skin, low potassium level in the blood, weight gain, mood swings, hallucination and memory impairment, partial paralysis, impaired coordination, impaired sensations, partial loss of vision, dry or painful eyes, deafness, infection of the middle ear, ringing in the ears, earache, palpitations (when you can feel your heart beat), blood clot in the lung, high blood pressure, pneumonia, inflammation of your sinuses, bronchitis, a cold or the flu, swollen stomach, difficulty controlling your bowel movements, haemorrhoids, peeling skin, increased skin sensitivity to sunlight, change in skin colour, increased sweating, muscle damage, back pain, difficulty in urinating, vaginal bleeding, sexual impotence,

absent or heavy menstrual periods, vaginal irritation, breast pain, hot flushes, shivering, discolouration of your tongue, change in your sense of smell, thirst, tooth disorder.

Temodal monotherapy in recurrent or progressive glioma

The following side effects may occur, and may require medical attention.

Very common (may affect more than 1 in 10 people): reduced number of blood cells (neutropenia or lymphopenia, thrombocytopenia), loss of appetite, headache, vomiting, nausea (feeling sick in your stomach), constipation (difficulty passing stools), tiredness.

Common (may affect up to 1 in 10 people): loss of weight, sleepiness, dizziness, tingling sensation, shortness of breath, diarrhoea, abdominal pain, upset stomach, rash, itching, hair loss, fever, weakness, shivering, feeling unwell, pain, change in taste.

Uncommon (may affect up to 1 in 100 people): reduced blood cell counts (pancytopenia, anaemia, leukopenia).

Rare (may affect up to 1 in 1,000 people): cough, infections including pneumonia.

Very rare (may affect up to 1 in 10,000 people): skin redness, urticaria (hives), skin eruption, allergic reactions.

Other side effects:

Cases of elevations of liver enzymes have been commonly reported. Cases of increased bilirubin, problems with bile flow (cholestasis), hepatitis and injury to the liver, including fatal liver failure, have been uncommonly reported.

Very rare cases of severe rash with skin swelling, including on the palms of the hands and soles of the feet, or painful reddening of the skin and/or blisters on the body or in the mouth have been observed. Tell your doctor immediately if this occurs.

Very rare cases of lung side effects have been observed with Temodal. Patients usually present with shortness of breath and cough. Tell your doctor if you notice any of these symptoms.

In very rare cases, patients receiving Temodal and medicines like it may have a small risk of developing secondary cancers, including leukaemia.

New or reactivated (recurring) cytomegalovirus infections and reactivated hepatitis B virus infections have been uncommonly reported. Cases of brain infections caused by herpes virus (meningoencephalitis herpetic), including fatal cases, have been uncommonly reported.

Cases of diabetes insipidus have been uncommonly reported. Symptoms of diabetes insipidus include passing a lot of urine and feeling thirsty.

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 Temodal

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 label and carton. The expiry date refers to the last day of that month.

Store in a refrigerator (2°C – 8°C).

Once your medicine is prepared for infusion (reconstituted), the solution may be stored at room temperature (25°C) for up to 14 hours, including infusion time.

The reconstituted solution should not be used if discolouration or particulate matter is observed.

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 Temodal contains

The active substance is temozolomide. Each vial contains 100 mg temozolomide. After reconstitution, each ml solution for infusion contains 2.5 mg of temozolomide.

The other ingredients are mannitol (E421), threonine, polysorbate 80, sodium citrate (for pH-adjustment) and hydrochloric acid concentrated (for pH-adjustment) (see section 2).

What Temodal looks like and contents of the pack

The powder for solution for infusion is a white powder. Temodal is available in a glass vial, with a butyl rubber stopper and aluminium seal with a flip-off bonnet.

Each pack contains 1 vial of 100 mg temozolomide.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder: Merck Sharp & Dohme Limited, 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 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: 0800 38 693 (+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

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

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

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 21 446 57 00 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 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 804650 info@msd.fi

Sverige

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

Latvija

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

This leaflet was last revised in

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.

The following information is intended for medical or health care professional use only:

Caution must be exercised in handling Temodal 2.5 mg/ml powder for solution for infusion. The use of gloves and aseptic technique is required. If Temodal 2.5 mg/ml comes into contact with skin or mucosa, it should be washed immediately and thoroughly with soap and water.

Each vial must be reconstituted with 41 ml sterilised water for injections. The resulting solution contains 2.5 mg/ml TMZ. The vials should be gently swirled and not shaken. The solution should be inspected and any vial containing visible particulate matter should not be used. Reconstituted product must be used within 14 hours, including infusion time.

A volume up to 40 ml reconstituted solution should be withdrawn, according to the total prescribed dose and transferred into an empty 250 ml infusion bag (PVC or polyolefin). The pump tubing should be attached to the bag, the tubing purged and then capped. Temodal 2.5 mg/ml must be administered by intravenous infusion only over a period of 90 minutes.

Temodal 2.5 mg/ml powder for solution for infusion may be administered in the same IV line with 0.9% Sodium Chloride injection. It is incompatible with dextrose solutions.

In absence of additional data this medicinal product must not be mixed with other medicinal products or infused simultaneously through the same intravenous line.

This medicinal product is for single use only. Any unused product or waste material should be disposed of in accordance with local requirements.

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