Temozolomide Sun 20 mg hard capsules EFG

Patient Information Leaflet

Introduction

Patient Information Leaflet

Temozolomida SUN 5 mg hard capsules EFG

Temozolomida SUN 20 mg hard capsules EFG

Temozolomida SUN 100 mg hard capsules EFG

Temozolomida SUN 140 mg hard capsules EFG

Temozolomida SUN 180 mg hard capsules EFG

Temozolomida 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 questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not give it to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any side effects, talk to your doctor, pharmacist, or nurse, even if they are side effects not listed in this leaflet. See section 4.

Contents of this leaflet

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

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

Temozolomida SUN contains a medicine called temozolomide. This medicine is an antitumour agent.

Temozolomida SUN is used to treat certain types of brain tumour:

• in adults with newly diagnosed glioblastoma multiforme. Temozolomida SUN is initially used 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. Temozolomida SUN is used to treat these tumours if they recur or progress after standard treatment.

2. What you need to know before starting Temozolomida SUN

Do not take Temozolomida SUN if:

• you are allergic to temozolomide or to any of the other ingredients of this medicine (listed in section 6).
• you have had an allergic reaction to dacarbazine (a cancer medicine sometimes referred to as 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, such as white blood cells or platelets, is considerably reduced (known as myelosuppression). These blood cells are important for fighting infection and for proper blood clotting. Your doctor will perform a blood test to ensure you have enough of these cells before starting treatment.

Warnings and precautions

Talk to your doctor, pharmacist, or nurse before starting Temozolomida SUN

• as you will be closely monitored for the development of a serious type of lung infection called Pneumocystis jirovecii pneumonia (PCP). If you have recently been diagnosed with glioblastoma multiforme, you may be prescribed Temozolomida SUN for 42 days in combination with radiotherapy. In this case, your doctor will also prescribe a medicine to help prevent this type of pneumonia (PCP).
• if you have ever had or may currently have hepatitis B infection, as Temozolomida SUN could reactivate hepatitis B, which in some cases can be fatal. Before starting treatment, your doctor will carefully examine you for signs of this infection.
• if you have low counts of red blood cells (anemia), white blood cells, or platelets, or problems with blood clotting before starting treatment, or if these problems develop during treatment. You will have frequent blood tests during treatment to monitor the side effects of Temozolomida SUN on your blood cells. Your doctor may decide to reduce your dose, interrupt, stop, or modify your treatment. You may also need other treatments. In some cases, treatment with Temozolomida SUN may need to be interrupted.
• as there may be a small risk of other changes in blood cells, including leukemia.
• if you experience nausea (feeling unwell) or vomiting, very common side effects of Temozolomida SUN (see section 4), your doctor may prescribe an antiemetic medicine to help prevent vomiting.
• If you vomit frequently before or during treatment, consult your doctor about the best time to take Temozolomida SUN until vomiting is controlled. If you vomit after taking the medicine, do not take a second dose on the same day.
• if you have fever or symptoms of infection, contact your doctor immediately.
• if you are over 70 years old, you may be more prone to infections, bleeding, or bruising.
• if you have liver or kidney problems, your dose of Temozolomida SUN may need to be adjusted.

Children and adolescents

Do not give this medicine to children under 3 years of age, as its effect in this age group has not been studied. Limited information is available in patients over 3 years of age who have taken Temozolomida SUN.

Other medicines and Temozolomida SUN

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

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine, as you should not receive Temozolomida SUN during pregnancy unless clearly instructed by your doctor.

Effective contraception is recommended for patients who are able to become pregnant, both during treatment with Temozolomida SUN and for at least 6 months after completing treatment.

You must stop breastfeeding during treatment with Temozolomida SUN.

Male fertility

Temozolomida SUN may cause permanent infertility. Male patients should use an effective contraceptive method and avoid getting their partner pregnant for at least 3 months after completing treatment. It is recommended to discuss sperm preservation before starting treatment.

Driving and use of machines

Temozolomida SUN may cause fatigue or drowsiness. If so, do not drive, operate tools or machinery, or ride a bicycle until you know how this medicine affects you (see section 4).

Temozolomida SUN contains lactose

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

3. How to take Temozolomida SUN

Follow exactly the instructions for using this medicine as given by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist again.

Dosage and duration of treatment

Your doctor will decide the dose of Temozolomida SUN you need. The dose will depend on your body size (height and weight) and whether you have a recurrent tumor and have previously received chemotherapy treatment.

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

Patients with newly diagnosed glioblastoma multiforme

If you have recently been diagnosed, treatment will consist of two phases:

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

During the concomitant phase, your doctor will prescribe a dose of Temozolomida SUN of 75 mg/m² (standard dose). You will need to take this dose every day for 42 to 49 days, in combination with radiotherapy. The dose of Temozolomida SUN may be reduced or stopped depending on blood test results and how you react to the medicine during the concomitant phase.

Once radiotherapy is completed, treatment will be paused for 4 weeks. This will allow your body to recover.

Then, you will start the monotherapy phase.

During the monotherapy phase, the dose and way of taking Temozolomida SUN may vary. Your doctor will determine the exact dose you need. You may undergo up to six treatment periods (cycles). Each cycle lasts 28 days. The initial dose will be 150 mg/m². You must take the new dose of Temozolomida SUN once daily for the first 5 days ("dosing days") of each cycle. Then, you must stop taking Temozolomida SUN for 23 days. This completes one 28-day treatment cycle.

After day 28, the next cycle will begin. You will again take Temozolomida SUN once daily for 5 days, followed by 23 days without taking it. The dose of Temozolomida SUN may be adjusted, reduced, or stopped depending on blood test results and your response to the medicine during each treatment cycle.

Patients with recurrent or worsening tumors (malignant gliomas, such as glioblastoma multiforme or anaplastic astrocytoma) who are taking Temozolomida SUN alone.

A treatment cycle with Temozolomida SUN lasts 28 days.

You must take Temozolomida SUN once daily for the first 5 days only. This daily dose depends on whether you have previously received chemotherapy.

If you have not previously received chemotherapy, your first dose of Temozolomida SUN will be 200 mg/m² once daily for the first 5 days. If you have previously received chemotherapy, your first dose of Temozolomida SUN will be 150 mg/m² once daily for the first 5 days. Then, you must stop taking Temozolomida SUN for 23 days. This completes one 28-day treatment cycle.

After day 28, the next cycle will begin. You will again take Temozolomida SUN once daily for 5 days, followed by 23 days without taking it.

Before each new treatment cycle, blood tests will be performed to determine whether the dose of Temozolomida SUN needs to be adjusted. Depending on the blood test results, your doctor may adjust the dose for the next cycle.

How to take Temozolomida SUN

Take the prescribed dose of Temozolomida SUN 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 breaks, avoid contact of the powder with skin, eyes, or nose. If the powder accidentally comes into contact with your eyes or nose, rinse the area thoroughly with water.

Depending on the prescribed dose, you may need to take more than one capsule at a time. You may need to take different strengths of active ingredient to achieve the required dose. The capsule marking differs for each strength (see table below).

You must ensure that you fully understand and remember the following:

• the number of capsules you must take each day. Ask your doctor or pharmacist to write this down for you (including the imprint printed on the capsules)
• on which days you must take the medicine.

Check the dose with your doctor each time you start a new cycle, as it may differ from the previous cycle.

Take Temozolomida SUN exactly as your doctor has instructed you. It is very important to consult your doctor or pharmacist or nurse if you are unsure. Making a mistake in how you take this medicine may have serious health consequences.

If you take more Temozolomida SUN than you should

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

If you forget to take Temozolomida SUN

Take the missed dose as soon as possible on the same day. If a full day has passed, consult 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 questions about the use of this medicine, consult your doctor, pharmacist, or nurse.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.

Consult your doctor immediately if you experience any of the following side effects:

• severe allergic reaction with hypersensitivity (hives, wheezing or difficulty breathing)
• uncontrollable bleeding
• seizures (convulsions)
• 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 may make you more prone to bruising or bleeding, anaemia (lack of red blood cells), fever, and may reduce your resistance to infections. The reduction in blood cells usually occurs for a short period of time. In some cases, it may persist and lead to a severe form of anaemia (aplastic anaemia). Your doctor will perform regular blood tests to detect any changes and decide whether you need specific treatment. In some cases, the dose may be reduced or treatment with Temozolomide SUN may be stopped.

The following is a list of other adverse effects that have been reported:

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

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

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

• infections, oral infections, wound infections
• reduced number of blood cells (neutropenia, lymphopenia, thrombocytopenia)
• allergic reaction
• increased blood sugar
• memory disturbances, depression, anxiety, confusion, inability to sleep or stay asleep
• impaired coordination and balance
• difficulty concentrating, changes in mental state or level of 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 clot in the lungs or legs, high blood pressure
• pneumonia, shortness of breath, bronchitis, cough, nasal inflammation
• stomach or abdominal pain, indigestion/heartburn, difficulty swallowing
• dry skin, itching
• muscle damage, muscle weakness, muscle pains and discomfort
• joint pain, back pain
• frequent urination, difficulty holding urine
• fever, flu-like symptoms, pain, malaise, cold or flu
• fluid retention, swollen legs
• elevated liver enzymes
• weight loss, weight gain
• radiation injury.

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

• brain infections (herpes meningoencephalitis), including fatal cases
• new or reactivated cytomegalovirus infections
• reactivated hepatitis B virus infections
• secondary cancers, including leukaemia
• reduced red blood cell counts (pancytopenia, anaemia, leucopenia)
• red spots under the skin
• diabetes insipidus (symptoms include increased urination and thirst), low blood potassium levels
• mood changes, hallucinations
• partial paralysis, change in sense of smell
• hearing impairment, middle ear infection
• palpitations (when you can feel your heartbeat), hot flushes
• bloated stomach, difficulty controlling bowel movements, haemorrhoids, dry mouth
• hepatitis and liver injury (including fatal liver failure), cholestasis, increased bilirubin
• blisters on the body or in the mouth, skin peeling, skin rash, painful redness of the skin, severe skin rash with swelling of the skin (including palms of hands and soles of feet)
• increased sensitivity to sunlight, hives (rash), increased sweating, changes in skin colour
• 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.

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor, pharmacist or nurse, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly through the national reporting system included in Appendix V. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Temozolomide SUN

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

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

Do not store above 25°C.

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

Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines and packaging that you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Temozolomide SUN

• The active substance is temozolomide.

Temozolomide SUN 5 mg hard capsules: Each hard capsule contains 5 mg of temozolomide.
Temozolomide SUN 20 mg hard capsules: Each hard capsule contains 20 mg of temozolomide.

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

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

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

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

• The other components are:

Capsule contents: lactose, sodium starch glycolate (Type B), tartaric acid, stearic acid (see section 2 “Temozolomide SUN contains lactose”)

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

Printing ink:

Temozolomide SUN 5 mg hard capsules: shellac, propylene glycol, yellow iron oxide (E172), blue no. 1/aluminium lake of brilliant blue FCF (E133).

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

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

Temozolomide SUN 140 mg hard capsules: shellac, propylene glycol, titanium dioxide (E171), blue no. 1/aluminium lake of brilliant blue FCF (E133).

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

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

Appearance of Temozolomide SUN and contents of the pack

5 mg hard capsules

Temozolomide SUN 5 mg hard gelatin capsules have an opaque white cap and body, printed with green ink. The cap is printed with '890'. The body is printed with '5 mg' and two lines.

20 mg hard capsules

Temozolomide SUN 20 mg hard gelatin capsules have an opaque white cap and body, printed with yellow ink. The cap is printed with '891'. The body is printed with '20 mg' and two lines.

100 mg hard capsules

Temozolomide SUN 100 mg hard gelatin capsules have an opaque white cap and body, printed with pink ink. The cap is printed with '892'. The body is printed with '100 mg' and two lines.

140 mg hard capsules

Temozolomide SUN 140 mg hard gelatin capsules have an opaque white cap and body, printed with blue ink. The cap is printed with '929'. The body is printed with '140 mg' and two lines.

180 mg hard capsules

Temozolomide SUN 180 mg hard gelatin capsules have an opaque white cap and body, printed with red ink. The cap is printed with '930'. The body is printed with '180 mg' and two lines.

250 mg hard capsules

Temozolomide SUN 250 mg hard gelatin capsules have an opaque white cap and body, 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. Packs containing 20 capsules include 4 blisters of 5 capsules in a box.

Only certain pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer Responsible

Sun Pharmaceutical Industries Europe B.V.
Polarisavenue 87
2132 JH Hoofddorp
The Netherlands

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

België/Belgique/Belgien/Ceská 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/Nizozemsko/Nederlandene/Holland/Ολλανδία/Nizozemska/The Netherlands/Holland/Ολλανδία/Niderlande/Nyderlandai/Pays-Bas/Niederlande/Hollandia/L-Olanda/Nederland/Nederland/Niederlande/Países Baixos/Nizozemska/Holandsko/Alankomaat/Nederländerna/Nederländerna
Tel././tlf./τηλ./Sími/τηλ./Tlf./Puh./
+31 (0)23 568 5501

Deutschland

Sun Pharmaceuticals Germany GmbH
Hemmelrather Weg 201
51377 Leverkusen
Germany
Tel. +49 214 403 990

España

Sun Pharma Laboratorios S.L.
Rambla de Catalunya, 53
08007 Barcelona
Spain
Tel. +34 93 342 78 90

France

Ranbaxy Pharmacie Génériques
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
Italy
Tel. +39 02 33 49 07 93

Polska

Ranbaxy (Poland) Sp. z o.o.
ul. Kubickiego 11
02-954 Warszawa
Poland
Tel. +48 22 642 07 75

România

Terapia S.A.
Str. Fabricii nr 124
Cluj-Napoca, Judetul Cluj
Romania
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 the most recent revision of this leaflet:

Other sources of information

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