TEMOZOLOMIDE SUN 5 mg HARD CAPSULES

Introduction

Package Leaflet: Information for the User

Temozolomide SUN 5 mg hard capsules EFG

Temozolomide SUN 20 mg hard capsules EFG

Temozolomide SUN 100 mg hard capsules EFG

Temozolomide SUN 140 mg hard capsules EFG

Temozolomide SUN 180 mg hard capsules EFG

Temozolomide SUN 250 mg hard capsules EFG

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.

Contents of the pack

1. What Temozolomide SUN is and what it is used for
2. What you need to know before you take Temozolomide SUN
3. How to take Temozolomide SUN
4. Possible side effects
5. Storing Temozolomide SUN
6. Contents of the pack and other information

1. What Temozolomide SUN is and what it is used for

Temozolomide SUN contains a medicine called temozolomide. This medicine is an anti-tumour agent.

Temozolomide SUN is used to treat certain types of brain tumours:

• in adults with newly diagnosed glioblastoma multiforme. Temozolomide SUN is used first in combination with radiotherapy (concomitant phase of treatment) and then alone (monotherapy phase of treatment).
• in children aged 3 years and older and adults with malignant glioma, such as glioblastoma multiforme or anaplastic astrocytoma. Temozolomide SUN is used to treat these tumours if they come back or get worse after standard treatment.

2. What you need to know before you take Temozolomide SUN

Do not take Temozolomide SUN

• 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 (a cancer medicine sometimes called DTIC). Signs of an allergic reaction include itching, difficulty breathing or wheezing, or swelling of the face, lips, tongue or throat.
• if the number of certain types of blood cells is greatly reduced (known as myelosuppression). These blood cells are important for fighting infection and for blood to clot properly. Your doctor will do a blood test to make sure you have enough of these cells before you start treatment.

Warnings and precautions

Talk to your doctor, pharmacist or nurse before you start taking Temozolomide SUN

• because you will be closely watched to see if you develop a serious respiratory infection called Pneumocystis jirovecii (PCP pneumonia). If you have been newly diagnosed with glioblastoma multiforme, you may be given Temozolomide SUN for 42 days in combination with radiotherapy. In this case, your doctor will also prescribe a medicine to help you avoid this type of pneumonia (PCP).
• if you have ever had or might have hepatitis B infection, because Temozolomide SUN could cause the hepatitis B virus to become active again, which in some cases can be fatal. Before starting treatment, your doctor will carefully examine you for signs of this infection.
• if you have a low blood cell count (anaemia), low white blood cell count and low platelet count, or blood clotting problems before you start treatment, or if these problems develop during treatment. You will have regular blood tests during treatment to check for side effects of Temozolomide SUN on your blood cells. Your doctor may decide to reduce your dose, interrupt, stop or change your treatment. You may also need other treatments. In some cases, it may be necessary to stop treatment with Temozolomide SUN.
• because there may be a small risk of other changes in your blood cells, including leukaemia.
• if you have nausea (feeling sick) or vomiting, very common side effects of Temozolomide SUN (see section 4), your doctor may prescribe you a medicine (antiemetic) to help prevent vomiting.
• If you vomit frequently before or during treatment, ask your doctor when the best time is to take Temozolomide SUN until the vomiting is under control. If you vomit after taking the medicine, do not take a second dose on the same day.
• if you have a fever or symptoms of an infection, contact your doctor immediately.
• if you are over 70 years old, you may be more likely to suffer from infections, bleeding or bruising.
• if you have liver or kidney problems, it may be necessary to adjust your dose of Temozolomide SUN.

Children and adolescents

Do not give this medicine to children under 3 years old, because its effect in this age group has not been studied. There is limited information available in patients over 3 years who have taken Temozolomide SUN.

Other medicines and Temozolomide SUN

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 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. You should not receive treatment with Temozolomide SUN during pregnancy unless your doctor tells you to.

Effective contraceptive methods are recommended for female patients who could become pregnant during treatment with Temozolomide SUN and for at least 6 months after completing treatment.

You must stop breast-feeding while taking Temozolomide SUN.

Male fertility

Temozolomide SUN may cause permanent infertility. Male patients should use effective contraception and not father a child during and for at least 3 months after treatment. It is recommended to seek advice on sperm conservation before treatment.

Driving and using machines

Temozolomide SUN may make you feel tired or sleepy. If this happens, do not drive or use any tools or machines, or ride a bicycle until you know how this medicine affects you (see section 4).

Temozolomide SUN contains lactose

Temozolomide SUN contains lactose (a type of sugar). If your doctor has told you that you have an intolerance to some sugars, contact them before taking this medicine.

3. How to take Temozolomide SUN

Follow exactly the instructions given to you by your doctor or pharmacist. If you are not sure, ask your doctor or pharmacist.

Dose and duration of treatment

Your doctor will decide the dose of Temozolomide SUN that you need. The dose will depend on your size (height and weight) and whether you have a recurrent tumour and have received chemotherapy before.

You may be prescribed other medicines (antiemetics) to take before and/or after Temozolomide SUN to prevent or control nausea and vomiting.

Patient with newly diagnosed glioblastoma multiforme

If you have been newly diagnosed, treatment will be given in two phases:

• first, treatment with radiotherapy (concomitant phase)
• followed by treatment with Temozolomide SUN alone (monotherapy phase).

During the concomitant phase, your doctor will prescribe a dose of Temozolomide SUN of 75 mg/m2 (usual dose). You will take this dose every day for 42 to 49 days in combination with radiotherapy. The dose of Temozolomide SUN may be reduced or stopped depending on the results of your blood tests and how you react to the medicine during the concomitant phase. Once radiotherapy is finished, treatment will be stopped for 4 weeks. This will help your body recover.

Then you will start the monotherapy phase.

During the monotherapy phase, the dose and the way you take Temozolomide SUN may vary. Your doctor will decide the exact dose that you need. You may have up to 6 treatment periods (cycles). Each cycle lasts 28 days. The first dose will be 150 mg/m2. You will take the new dose of Temozolomide SUN once a day for the first 5 days ("dosing days") of each cycle. Then you will not take Temozolomide SUN for 23 days. This is a 28-day treatment cycle.

After day 28, the next cycle will start. You will take Temozolomide SUN once a day for 5 days, followed by 23 days without taking it. The dose of Temozolomide SUN may be adjusted, reduced or stopped depending on the results of your blood tests and how you react to the medicine during each treatment cycle.

Patient with recurrent or progressive tumours (malignant gliomas, such as glioblastoma multiforme or anaplastic astrocytoma) taking only Temozolomide SUN.

A treatment cycle with Temozolomide SUN lasts 28 days.

You will take Temozolomide SUN once a day for the first 5 days. This daily dose will depend on whether you have received chemotherapy before.

If you have not received chemotherapy before, your first dose of Temozolomide SUN will be 200 mg/m2 once a day for the first 5 days. If you have received chemotherapy before, your first dose of Temozolomide SUN will be 150 mg/m2 once a day for the first 5 days. Then you will not take Temozolomide SUN for 23 days. This is a 28-day treatment cycle.

After day 28, the next cycle will start. You will take Temozolomide SUN once a day for 5 days, followed by 23 days without taking it.

Before each new treatment cycle, you will have blood tests to check if the dose of Temozolomide SUN needs to be changed. Depending on the results of the blood tests, your doctor may adjust the dose for the next cycle.

How to take Temozolomide SUN

Take the dose of Temozolomide SUN that has been prescribed for you once a day, preferably at the same time each day.

Take the capsules on an empty stomach, for example, at least one hour before 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 the skin, eyes or nose. If it accidentally gets into your eyes or nose, rinse the area with water.

Depending on the dose that you have been prescribed, you may need to take more than one capsule at the same time. You may need to take different amounts of active ingredient to reach the required dose. The marking on the capsule is different for each dose (see table below).

You must make sure that you understand and remember the following:

• the number of capsules that you should take each day. Ask your doctor or pharmacist to write it down for you (including the marking on the capsules)
• which days you should take the medicine.

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

Take Temozolomide SUN exactly as your doctor has told you. It is very important that you talk to your doctor or pharmacist if you are not sure. Taking this medicine incorrectly can have serious consequences for your health.

If you take more Temozolomide SUN than you should

If you accidentally take more capsules of Temozolomide SUN than you should, contact your doctor or pharmacist or nurse immediately.

If you forget to take Temozolomide SUN

Take the dose that you missed as soon as possible on the same day. If a whole day has passed, ask your doctor. Do not take a double dose to make up for a forgotten dose, unless your doctor tells you to.

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.

See your doctor immediatelyif you get any of the following side effects:

• severe allergic reaction with hypersensitivity (hives, wheezing or difficulty breathing)
• uncontrolled bleeding
• seizures (fits)
• fever
• chills
• severe headache that does not go away.

Treatment with Temozolomide SUN may cause a decrease in the number of certain types of blood cells. This can make you more likely to get infections, bruising or bleeding, anaemia (lack of red blood cells), fever, as well as reduce your resistance to infections. The decrease in blood cells is usually temporary. In some cases, it may be prolonged and lead to a very strong type of anaemia (aplastic anaemia). Your doctor will do regular blood tests to detect any changes that may occur and decide if you need specific treatment. In some cases, the dose may be reduced or treatment with Temozolomide SUN stopped.

The following are other side effects that have been reported:

Very common side effects (may affect more than 1 in 10 people) are:

• loss of appetite, difficulty speaking, headache
• vomiting, nausea, diarrhoea, constipation
• skin rash, hair loss
• fatigue.

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

• infections, oral infections, wound infections
• reduced blood cell count (neutropenia, lymphopenia, thrombocytopenia)
• allergic reaction
• increased blood sugar
• memory changes, depression, anxiety, confusion, inability to sleep or stay asleep
• coordination and balance changes
• difficulty concentrating, changes in mental status or alertness, tingling sensation
• dizziness, altered sensations, tingling, tremors, abnormal taste
• partial loss of vision, abnormal vision, double vision, dry or painful eyes
• deafness, ringing in the ears, ear pain
• blood clots in the lungs or legs, high blood pressure
• pneumonia, shortness of breath, bronchitis, cough, inflammation of the nasal passages
• stomach or abdominal pain, stomach upset/indigestion, difficulty swallowing
• dry skin, itching
• muscle damage, muscle weakness, muscle pain
• joint pain, back pain
• urinary frequency, difficulty holding urine
• fever, flu-like symptoms, pain, discomfort, cold or flu
• fluid retention, swollen legs
• increased liver enzymes
• weight loss, weight gain
• radiation injury.

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

• brain infections (herpetic meningoencephalitis), including fatal cases
• new or reactivated cytomegalovirus infections
• reactivated hepatitis B virus infections
• secondary cancers, including leukaemia
• reduced red blood cell count (pancytopenia, anaemia, leucopenia)
• red spots under the skin
• diabetes insipidus (symptoms include increased urination and thirst), low potassium levels in the blood
• mood changes, hallucinations
• partial paralysis, change in sense of smell
• hearing impairment, middle ear infection
• palpitations (when you can feel your heart beating), hot flushes
• swollen stomach, difficulty controlling bowel movements, haemorrhoids, dry mouth
• hepatitis and liver damage (including fatal liver failure), cholestasis, increased bilirubin
• blisters on the body or in the mouth, skin peeling, skin rash, redness of the skin, severe skin rash with skin peeling (including on the palms of the hands and soles of the feet)
• increased sensitivity to sunlight, hives (urticaria), increased sweating, changes in skin colour
• difficulty urinating
• vaginal bleeding, vaginal irritation, absent or heavy menstrual periods, breast pain, impotence
• chills, swelling of the face, discolouration of the tongue, thirst, tooth disorder.

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. Storage of Temozolomida SUN

Keep this medicine out of the sight and reach of children, preferably in a locked cupboard. Accidental ingestion may cause death in children.

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

Do not store above 25°C.

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

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and additional information

Composition of Temozolomida SUN

• The active substance is temozolomide.

Temozolomida SUN 5 mg hard capsules:Each hard capsule contains 5 mg of temozolomide.

Temozolomida SUN 20 mg hard capsules:Each hard capsule contains 20 mg of temozolomide.

Temozolomida SUN 100 mg hard capsules:Each hard capsule contains 100 mg of temozolomide.

Temozolomida SUN 140 mg hard capsules:Each hard capsule contains 140 mg of temozolomide.

Temozolomida SUN 180 mg hard capsules:Each hard capsule contains 180 mg of temozolomide.

Temozolomida SUN 250 mg hard capsules:Each hard capsule contains 250 mg of temozolomide.

• The other ingredients are:

capsule content:lactose, sodium starch glycolate (Type B), tartaric acid, stearic acid (see section 2 “Temozolomida SUN contains lactose”)

capsule shell: gelatin, titanium dioxide (E171), sodium lauryl sulfate

printing ink:

Temozolomida SUN 5 mg hard capsules:shellac, propylene glycol, yellow iron oxide (E172), blue No. 1/Aluminum Blue Brilliant FCF (E133).

Temozolomida SUN 20 mg hard capsules:shellac, propylene glycol, yellow iron oxide (E172).

Temozolomida SUN 100 mg hard capsules:shellac, propylene glycol, red iron oxide (E172), yellow iron oxide (E172), titanium dioxide (E171).

Temozolomida SUN 140 mg hard capsules:shellac, propylene glycol, titanium dioxide (E171), blue No. 1/Aluminum Blue Brilliant FCF (E133).

Temozolomida SUN 180 mg hard capsules:shellac, propylene glycol, red iron oxide (E172).

Temozolomida SUN 250 mg hard capsules:shellac, propylene glycol, black iron oxide (E172).

Appearance of Temozolomida SUN and package contents

5 mg hard capsules

Temozolomida SUN 5 mg hard gelatin capsules have a white opaque cap and body and are printed with green ink. The cap is printed with ‘890’. The body is printed with ‘5 mg’ and two lines.

20 mg hard capsules

Temozolomida SUN 20 mg hard gelatin capsules have a white opaque cap and body and are printed with yellow ink. The cap is printed with ‘891’. The body is printed with ‘20 mg’ and two lines.

100 mg hard capsules

Temozolomida SUN 100 mg hard gelatin capsules have a white opaque cap and body and are printed with pink ink. The cap is printed with ‘892’. The body is printed with ‘100 mg’ and two lines.

140 mg hard capsules

Temozolomida SUN 140 mg hard gelatin capsules have a white opaque cap and body and are printed with blue ink. The cap is printed with ‘929’. The body is printed with ‘140 mg’ and two lines.

180 mg hard capsules

Temozolomida SUN 180 mg hard gelatin capsules have a white opaque cap and body and are printed with red ink. The cap is printed with ‘930’. The body is printed with ‘180 mg’ and two lines.

250 mg hard capsules

Temozolomida SUN 250 mg hard gelatin capsules have a white opaque cap and body and are printed with black ink. The cap is printed with ‘893’. The body is printed with ‘250 mg’ and two lines.

The hard capsules are available in blisters containing 5 capsules. For the 20-capsule pack, 4 blisters of 5 capsules are included in a box.

Only certain pack sizes may be marketed.

Marketing authorisation holder and manufacturer

Sun Pharmaceutical Industries Europe B.V.

Polarisavenue 87

2132 JH Hoofddorp

Netherlands

You can request more information about this medicine from the local representative of the marketing authorisation holder.

België/Belgique/Belgien/България/Česká republika/

Danmark/Eesti/Ελλάδα/Hrvatska/Ireland/Ísland/

Κύπρος/Latvija/Lietuva/Luxembourg/Luxemburg/Magyarország/

Malta/Nederland/Norge/Österreich/Portugal/

Slovenija/Slovenská republika/Suomi/Finland/Sverige

Sun Pharmaceutical Industries Europe B.V.

Polarisavenue 87

2132 JH Hoofddorp

Nederland/Pays-Bas/Niederlande/България/Nizozemsko/

Nederlandene/Holland/Ελλάδα/Nizozemska/The Netherlands/Holland/

Ελλάδα/Niderlande/Nyderlandai/Pays-Bas/Niederlande/Hollandia/

L-Olanda/Nederland/Nederland/Niederlande/Países Baixos/

Nizozemska/Holandsko/Alankomaat/Nederländerna/Nederländerna

Tel./Τηλ./tlf./τηλ./Sími/τηλ./Tlf./Puh./

+31 (0)23 568 5501

Deutschland

Sun Pharmaceuticals Germany GmbH

Hemmelrather Weg 201

51377 Leverkusen

Deutschland

tel. +49 214 403 990

España

Sun Pharma Laboratorios, S.L.

Rambla de Catalunya 53-55

08007 Barcelona

España

tel. +34 93 342 78 90

France

Sun Pharma France

11-15, Quai de Dion Bouton

92800 Puteaux

France

Tel. +33 1 41 44 44 50

Italia

Sun Pharma Italia Srl

Viale Giulio Richard, 1

20143 – Milano

Italia

tel. +39 02 33 49 07 93

Polska

Ranbaxy (Poland) Sp. Z o. o.

ul. Kubickiego 11

02-954 Warszawa

Polska

Tel. +48 22 642 07 75

România

Terapia S.A.

Str. Fabricii nr 124

Cluj-Napoca, Judetul Cluj

România

Tel. +40 (264) 501 500

United Kingdom (Northern Ireland)

Ranbaxy UK Ltd

a Sun Pharma Company

Millington Road 11

Hyde Park, Hayes 3

5th Floor

UB3 4AZ HAYES

United Kingdom

Tel. +44 (0) 208 848 8688

Date of last revision of this leaflet

Other sources of information

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