Temozolomide Teva

Package leaflet: Information for the user

Temozolomide Teva 5 mg hard capsules, 20 mg hard capsules, 100 mg hard capsules, 140 mg hard capsules, 180 mg hard capsules, 250 mg hard capsules

temozolomide
Read this entire leaflet carefully before taking this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, as it could be harmful.
• If you experience any side effects, including those not listed in this leaflet, talk to your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet

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

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

Temozolomide Teva contains a medicine called temozolomide. This medicine is an antitumour agent.
Temozolomide Teva is used to treat specific types of brain tumour:

• in adults with newly diagnosed glioblastoma multiforme. Temozolomide Teva is initially used in combination with radiotherapy (concomitant phase of treatment) and subsequently used alone (monotherapy).
• in children aged 3 years and older and in adult patients with malignant glioma, such as glioblastoma multiforme or anaplastic astrocytoma. Temozolomide Teva is used in these tumours when recurrence or progression occurs after standard therapy.

2. What you need to know before taking Temozolomide Teva

Do not take Temozolomide Teva

• if you are allergic to temozolomide or to any of the other ingredients of this medicine (listed in section 6).
• if you have previously had an allergic reaction to dacarbazine (an anticancer medicine also known as DTIC). Signs of an allergic reaction include itching, shortness of breath or wheezing, swelling of the face, lips, tongue or throat.
• if the number of certain types of blood cells is severely reduced (myelosuppression), such as white blood cells and platelets. These blood cells are important for fighting infections and for blood clotting. Your doctor will perform blood tests to ensure that the number of these cells is adequate before starting treatment.

Warnings and precautions
Talk to your doctor, pharmacist or nurse before taking Temozolomide Teva,

• because you must be closely monitored for the development of a serious chest infection called Pneumocystis jirovecii pneumonia (PCP). If you are a newly diagnosed patient (glioblastoma multiforme), you may be given Temozolomide Teva for 42 days in combination with radiotherapy. In this case, your doctor will also prescribe medicines to help prevent this type of pneumonia (PCP).
• if you have ever had or may currently have hepatitis B infection. This is because hepatitis B may become reactivated during treatment with Temozolomide Teva, which in some cases can be fatal. Before starting treatment, your doctor will carefully check you for signs and symptoms of this infection.
• if you have a low number of red blood cells (anaemia), white blood cells and platelets, or problems with blood clotting before starting treatment, or if these develop during treatment. Your doctor may decide to reduce the dose, stop, suspend or change your treatment. You may also need additional treatments. In some cases, administration of Temozolomide Teva may need to be suspended. Blood samples will be frequently analysed during treatment to monitor for any adverse effects of Temozolomide Teva on your blood cells.
• because there is a low risk that you may develop other blood cell abnormalities, including leukaemia.
• if you experience nausea (feeling sick) and/or vomiting, which are very common side effects of Temozolomide Teva (see section 4), your doctor may prescribe a medicine (an anti-emetic) to help prevent vomiting.
• if you frequently vomit before or during treatment, ask your doctor about the best time to take Temozolomide Teva until vomiting is under control. If you vomit after taking a dose, do not take another dose on the same day.
• if you develop fever or signs of infection, contact your doctor immediately.
• if you are over 70 years old, you may be more prone to infections, bruising or bleeding.
• if you have liver or kidney problems, your dose of Temozolomide Teva may need to be adjusted.

Children and adolescents
Do not give this medicine to children under 3 years of age, as it has not been studied in this age group.
Limited information is available in patients over 3 years of age who have taken Temozolomide Teva.
Other medicines and Temozolomide Teva
Inform your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you may be pregnant, or are planning a pregnancy, consult your doctor or pharmacist before taking this medicine. This is because you should not be treated with Temozolomide Teva during pregnancy unless clearly indicated by your doctor.
Effective contraceptive precautions must be used by female patients of childbearing age during treatment with Temozolomide Teva and for at least 6 months after completion of treatment.
You must stop breastfeeding if you are being treated with Temozolomide Teva.
Male fertility
Temozolomide Teva may cause permanent infertility. Male patients should use an effective method of contraception and should not attempt to father a child for at least 3 months after stopping treatment. It is recommended to discuss sperm preservation before starting treatment.
Driving and using machines
Temozolomide Teva may cause fatigue or drowsiness. If so, do not drive or operate tools, machinery or bicycles until you know how this medicine affects you (see section 4).
Temozolomide Teva contains lactose
If your doctor has diagnosed you with an intolerance to certain sugars, contact him or her before taking this medicine.
Temozolomide Teva contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per capsule, i.e. it is essentially “sodium-free”.
Temozolomide Teva 20 mg hard capsules contain sunset yellow FCF (E110)
The excipient sunset yellow FCF (E110) is included in the shell of Temozolomide Teva 20 mg hard capsules and may cause allergic reactions.

3. How to take Temozolomide Teva

Take this medicine exactly as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
Dosage and duration of treatment
Your doctor will determine your dose of Temozolomide Teva. This depends on your body size (height and weight) and, if you have a recurrent tumour, on any previous chemotherapy treatment you may have had.
Other medicines (anti-emetics) may be prescribed to take before and/or after taking Temozolomide Teva to prevent or control nausea and vomiting.

Patients with newly diagnosed glioblastoma multiforme:
If you are a patient with newly diagnosed tumour, treatment will consist of two phases:

• initial treatment in combination with radiotherapy (concomitant phase)
• followed by treatment with Temozolomide Teva alone (monotherapy).

During the concomitant phase, your doctor will start Temozolomide Teva at a dose of 75 mg/m² (usual dose). You will take this dose daily for 42 days (up to a maximum of 49 days) in combination with radiotherapy. The administration of Temozolomide Teva may be delayed or interrupted based on your blood cell counts and how you tolerate the medicine during the concomitant phase. Once radiotherapy is completed, you will stop treatment for 4 weeks. This will give your body a chance to recover. Then, you will start monotherapy.

During the monotherapy phase, the dose and way of taking Temozolomide Teva will be different. Your doctor will determine your correct dose. There may be up to 6 treatment periods (cycles). Each cycle lasts 28 days. You will take your new dose of Temozolomide Teva alone once daily for the first 5 days (“treatment days”) of each cycle. The first dose will be 150 mg/m². This will be followed by 23 days without Temozolomide Teva. This completes the 28-day treatment cycle. After Day 28, the next cycle will begin. You will again take Temozolomide Teva once daily for 5 days, followed by 23 days without Temozolomide Teva. The dose of Temozolomide Teva may be adjusted, delayed, or interrupted based on your blood counts and how you tolerate the medicine during each treatment cycle.

Patients with tumours that have recurred or worsened (malignant gliomas, such as glioblastoma multiforme or anaplastic astrocytoma) treated with Temozolomide Teva alone:
A treatment cycle with Temozolomide Teva lasts 28 days.
You will take Temozolomide Teva alone once daily for the first 5 days. This daily dose depends on any previous chemotherapy treatments you may have received.
If you have not previously received chemotherapy, your first dose of Temozolomide Teva will be 200 mg/m² once daily for the first 5 days. If you have previously received chemotherapy, your first dose of Temozolomide Teva will be 150 mg/m² once daily for the first 5 days.
For the following 23 days, you will not receive Temozolomide Teva. This completes the 28-day cycle.
After Day 28, the next cycle will begin. You will again take Temozolomide Teva once daily for five days, followed by 23 days without Temozolomide Teva.
Before each new cycle, you will have blood tests to check whether the dose of Temozolomide Teva needs to be changed. Based on the results of your blood tests, your doctor may adjust your dose for the next cycle.

How to take Temozolomide Teva
Take the dose of Temozolomide Teva prescribed once daily, 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 skin, eyes, or nose. If powder accidentally comes into contact with eyes or nose, rinse the affected area with water.
Depending on the prescribed dose, you may need to take more than one capsule at the same time, possibly with different strengths (active substance content in mg). The colour and number on the capsule cap differ for each strength (see table below).

It is important to make sure you fully understand and remember the following:

• how many capsules you need to take for your daily dose. Ask your doctor or pharmacist to write this down for you (including the colour).
• which days you need to take your treatment. Review the dose with your doctor each time you start a new cycle, as it may differ from the previous cycle.

Always take Temozolomide Teva exactly as instructed by your doctor. If you have any doubts, consult your doctor or pharmacist. Mistakes in taking this medicine could cause serious harm to your health.
If you take more Temozolomide Teva than you should
In case of accidental ingestion of more capsules than prescribed, contact your doctor, pharmacist, or nurse immediately.
If you forget to take Temozolomide Teva
Take the missed dose as soon as possible on the same day. If a full day has passed, contact your doctor. Do not take a double dose to make up for a forgotten dose, unless instructed by your doctor.
If you have any questions about the use of this medicine, consult your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
Contact your doctor immediately if you experience:

• a severe allergic reaction (hypersensitivity) (hives, shortness of breath or other breathing difficulties),
• uncontrolled bleeding,
• seizures,
• fever,
• chills,
• severe headache that does not go away.

Treatment with Temozolomide Teva may cause a reduction in certain types of blood cells.
This may lead to increased bruising or bleeding, anaemia (reduced number of red blood cells), fever,
and reduced resistance to infections. 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 regularly monitor your blood and decide whether specific treatment is needed. In some cases, the dose of Temozolomide Teva may be reduced or treatment stopped.
Other side effects that have been reported are listed below:
Very common side effects (may affect more than 1 in 10 people):

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

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

• infections, mouth infections
• reduction in blood cell counts (neutropenia, lymphopenia, thrombocytopenia)
• allergic reaction
• increased blood sugar levels
• memory loss, depression, anxiety, confusion, difficulty falling or staying asleep
• coordination problems and balance disorders
• difficulty concentrating, altered mental state or attention, memory loss
• dizziness, sensory disturbances, tingling sensation, tremor, altered taste
• partial loss of vision, abnormal vision, double vision, eye pain
• deafness, ringing in the ears, earache
• blood clots in the lung or legs, high blood pressure
• pneumonia, shortness of breath, bronchitis, cough, nasal inflammation
• stomach or abdominal pain, stomach discomfort/heartburn, difficulty swallowing
• dry skin, itching
• muscle damage, muscle weakness, muscle pain and twitches
• joint pain, back pain
• frequent urination, difficulty holding urine
• fever, flu-like symptoms, pain, feeling unwell, 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):

• brain infections (herpes encephalitis), including cases that have led to death
• wound infections
• new or reactivated cytomegalovirus infections
• infections caused by reactivated hepatitis B virus
• secondary tumours including leukaemia
• reduction in blood cell counts (pancytopenia, anaemia, leucopenia)
• red spots under the skin
• diabetes insipidus (symptoms include increased urine output and feeling thirsty), low blood potassium levels
• mood changes, hallucinations
• partial paralysis, changes in smell perception
• hearing disorders, middle ear infection
• palpitations (when you can feel your heartbeat), hot flushes
• abdominal swelling, difficulty controlling bowel movements, haemorrhoids, dry mouth
• hepatitis and liver damage (including liver failure leading to death), cholestasis, increased bilirubin
• blisters on the body or in the mouth, skin peeling, skin rash, painful redness of the skin, severe skin rash with skin swelling (including palms of hands and soles of feet)
• increased skin sensitivity to sunlight, hives (wheals), increased sweating, skin colour changes
• difficulty urinating
• vaginal bleeding, vaginal irritation, absent or heavy menstrual periods, breast pain, sexual impotence
• chills, facial swelling, discolouration of the tongue, thirst, dental disorders
• dry eyes

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

5. How to store Temozolomide Teva

Keep this medicine out of sight and reach of children, preferably in a locked cabinet. Accidental ingestion may be fatal for children.
Do not use this medicine after the expiry date stated on the carton after "EXP". The expiry date refers to the last day of that month.
Store in the original packaging.
Do not store above 30 °C.
Keep the bottle tightly closed to protect the medicine from moisture.
Inform your pharmacist if you notice any signs of deterioration in the appearance of the capsules.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Temozolomide Teva contains
The active substance is temozolomide.
Temozolomide Teva 5 mg hard capsules: each capsule contains 5 mg of temozolomide
Temozolomide Teva 20 mg hard capsules: each capsule contains 20 mg of temozolomide
Temozolomide Teva 100 mg hard capsules: each capsule contains 100 mg of temozolomide
Temozolomide Teva 140 mg hard capsules: each capsule contains 140 mg of temozolomide
Temozolomide Teva 180 mg hard capsules: each capsule contains 180 mg of temozolomide
Temozolomide Teva 250 mg hard capsules: each capsule contains 250 mg of temozolomide

The excipients are:
Capsule content:
lactose, anhydrous colloidal silica, sodium carboxymethyl starch type A, tartaric acid, stearic acid
(see section 2 “Temozolomide Teva contains lactose”).

Capsule cap:
Temozolomide Teva 5 mg hard capsules (including printing ink): gelatin, titanium dioxide (E171), shellac, propylene glycol, indigo carmine aluminium lake (E132), yellow iron oxide (E172).
Temozolomide Teva 20 mg hard capsules (including printing ink): gelatin, titanium dioxide (E171), shellac, propylene glycol, sunset yellow FCF aluminium lake (E110).
Temozolomide Teva 100 mg hard capsules (including printing ink): gelatin, titanium dioxide (E171), red iron oxide (E172), shellac, propylene glycol, and yellow iron oxide (E172).
Temozolomide Teva 140 mg hard capsules (including printing ink): gelatin, titanium dioxide (E171), shellac, propylene glycol, indigo carmine aluminium lake (E132).
Temozolomide Teva 180 mg hard capsules (including printing ink): gelatin, titanium dioxide (E171), shellac, propylene glycol, red iron oxide (E172).
Temozolomide Teva 250 mg hard capsules (including printing ink): gelatin, titanium dioxide (E171), shellac, propylene glycol, black iron oxide (E172), ammonium hydroxide (E527).

Description of the appearance of Temozolomide Teva and package contents
Temozolomide Teva 5 mg hard capsules have an opaque white body, a cap with two green lines, and “T 5 mg” printed in green ink on the body. Each capsule is approximately 16 mm long.
Temozolomide Teva 20 mg hard capsules have an opaque white body, a cap with two orange lines, and “T 20 mg” printed in orange ink on the body. Each capsule is approximately 18 mm long.
Temozolomide Teva 100 mg hard capsules have an opaque white body, a cap with two pink lines, and “T 100 mg” printed in pink ink on the body. Each capsule is approximately 19.5 mm long.
Temozolomide Teva 140 mg hard capsules have an opaque white body, a cap with two blue lines, and “T 140 mg” printed in blue ink on the body. Each capsule is approximately 22 mm long.
Temozolomide Teva 180 mg hard capsules have an opaque white body, a cap with two red lines, and “T 180 mg” printed in red ink on the body. Each capsule is approximately 22 mm long.
Temozolomide Teva 250 mg hard capsules have an opaque white body, a cap with two black lines, and “T 250 mg” printed in black ink on the body. Each capsule is approximately 22 mm long.

The hard capsules are supplied in amber glass bottles containing 5 or 20 capsules.
Not all pack sizes may be marketed.

Marketing Authorization Holder
Teva B.V.
Swensweg 5
2031GA Haarlem
The Netherlands

Manufacturer
NerPharMa S.r.l.
Viale Pasteur, 10
20014 Nerviano (MI)
Italy
Haupt Pharma Amareg GmbH
Donaustaufstraße 378
93055 Regensburg
Germany

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

België/Belgique/Belgien Lietuva
Teva Pharma Belgium N.V./S.A./AG UAB Teva Baltics
Tél/Tel: +32 38207373 Tel: +370 52660203

България Luxembourg/Luxemburg
Тева Фарма ЕАД Teva Pharma Belgium N.V./S.A./AG
Teл: +359 24899585 Belgique/Belgien
Tél/Tel: +32 38207373

Česká republika Magyarország
Teva Pharmaceuticals CR, s.r.o. Teva Gyógyszergyár Zrt.
Tel: +420 251007111 Tel: +36 12886400

Danmark Malta
Teva Denmark A/S Teva Pharmaceuticals Ireland
Tlf: +45 44985511 Ireland
Tel: +44 2075407117

Deutschland Nederland
TEVA GmbH Teva Nederland B.V.
Tel: +49 73140208 Tel: +31 8000228400

Eesti Norge
UAB Teva Baltics Eesti filiaal Teva Norway AS
Tel: +372 6610801 Tlf: +47 66775590

Ελλάδα Österreich
TEVA HELLAS Α.Ε. ratiopharm Arzneimittel Vertriebs-GmbH
Τηλ: +30 2118805000 Tel: +43 1970070

España Polska
Teva Pharma, S.L.U. Teva Pharmaceuticals Polska Sp. z o.o.
Tel: +34 913873280 Tel: +48 223459300

France Portugal
Teva Santé Teva Pharma - Produtos Farmacêuticos, Lda.
Tél: +33 155917800 Tel: +351 214767550

Hrvatska România
Pliva Hrvatska d.o.o. Teva Pharmaceuticals S.R.L.
Tel: +385 13720000 Tel: +40 212306524

Ireland Slovenija
Teva Pharmaceuticals Ireland Pliva Ljubljana d.o.o.
Tel: +44 2075407117 Tel: +386 15890390

Ísland Slovenská republika
Teva Pharma Iceland ehf. TEVA Pharmaceuticals Slovakia s.r.o.
Sími: +354 5503300 Tel: +421 257267911

Italia Suomi/Finland
Teva Italia S.r.l. Teva Finland Oy
Tel: +39 028917981 Puh/Tel: +358 201805900

Κύπρος Sverige
TEVA HELLAS Α.Ε. Teva Sweden AB
Greece Tel: +46 42121100
Τηλ: +30 2118805000

Latvija United Kingdom (Northern Ireland)
UAB Teva Baltics filiāle Latvijā Teva Pharmaceuticals Ireland
Tel: +371 67323666 Ireland
Tel: +44 2075407117

Other sources of information
More detailed information on this medicinal product is available on the website of the European Medicines Agency: http://www.ema.europa.eu.