TEMOZOLOMIDE SUN 180 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 is Temozolomide SUN and what is it used for
2. What you need to know before you take Temozolomide SUN
3. How to take Temozolomide SUN
4. Possible side effects
5. Storage of Temozolomide SUN
6. Contents of the pack and other information

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

Temozolomide SUN contains a medicine called temozolomide. This medicine is an antitumoral agent.

Temozolomide SUN is used for the treatment of certain types of brain tumors:

• in adults with newly diagnosed glioblastoma multiforme. Temozolomide SUN is used initially 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 tumors if they recur or worsen 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, such as white blood cells or platelets, is considerably reduced (known as myelosuppression). These blood cells are important for fighting infection and for blood to clot properly. Your doctor will perform a blood test to make sure you have enough of these cells before starting treatment.

Warnings and precautions

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

• as you will be closely monitored for the development of a severe respiratory infection called Pneumocystis jirovecii (PCP pneumonia). If you have been recently diagnosed with glioblastoma multiforme, you may be prescribed 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 may have hepatitis B infection, as Temozolomide SUN could reactivate hepatitis B, which can be fatal in some cases. Before starting treatment, your doctor will carefully examine you for signs of this infection.
• if you have a low red blood cell count (anemia), low white blood cell and platelet count, or blood clotting problems before starting treatment, or if these problems develop during treatment. You will have regular blood tests during treatment to monitor the side effects of Temozolomide SUN on your blood cells. Your doctor may decide to reduce the dose, interrupt, discontinue, or modify your treatment. You may also need other treatments. In some cases, it may be necessary to discontinue treatment with Temozolomide SUN.
• as there may be a small risk of other changes in blood cells, including leukemia.
• if you have nausea (discomfort) or vomiting, very common side effects of Temozolomide SUN, (see section 4) your doctor may prescribe a medicine (antiemetic) to help prevent vomiting.
• If you vomit frequently before or during treatment, consult your doctor about the best time to take Temozolomide SUN until the vomiting is controlled. 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 prone to infections, bleeding, or bruising.
• if you have liver or kidney problems, your dose of Temozolomide SUN may need to be adjusted.

Children and adolescents

Do not give this medicine to children under 3 years old, as 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, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine, as you should not receive treatment with Temozolomide SUN during pregnancy unless your doctor clearly indicates it.

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

You must stop breastfeeding during treatment with Temozolomide SUN.

Male fertility

Temozolomide SUN may cause permanent infertility. Male patients should use an effective contraceptive method and not get their partner pregnant during and for at least 3 months after finishing treatment. It is recommended to consult about sperm preservation before treatment.

Driving and using machines

Temozolomide SUN may cause fatigue or drowsiness. If this happens, do not drive or use tools or machines, or ride a bicycle until you see 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, consult them before taking this medicine.

3. How to take Temozolomide SUN

Follow exactly the instructions for administration of this medicine given by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

Dose and duration of treatment

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

Patients with newly diagnosed glioblastoma multiforme

If you have been recently diagnosed, treatment will be carried out 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 have to take this dose every day for 42 to 49 days in combination with radiotherapy. The dose of Temozolomide SUN may be reduced or suspended depending on the results of blood tests and how you react to the medicine during the concomitant phase. Once radiotherapy is finished, treatment will be suspended for 4 weeks. This will help your body recover.

Then, you will start the monotherapy phase.

During the monotherapy phase, the dose and way of taking Temozolomide SUN may vary. Your doctor will decide the exact dose you need. You may have to undergo up to six treatment periods (cycles). Each cycle lasts 28 days. The first dose will be 150 mg/m2. You will have to take the new dose of Temozolomide SUN once a day for the first 5 days ("dosing days") of each cycle. Then, you will have to stay 23 days without taking Temozolomide SUN. This is a 28-day treatment cycle.

After day 28, the next cycle will start. You will have to 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 suspended depending on the results of blood tests and how you react to the medicine during each treatment cycle.

Patients with recurrent or worsening tumors (malignant gliomas, such as glioblastoma multiforme or anaplastic astrocytoma) taking only Temozolomide SUN.

A treatment cycle with Temozolomide SUN lasts 28 days.

You will have to take Temozolomide SUN only 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 have to stay 23 days without taking Temozolomide SUN. This is a 28-day treatment cycle.

After day 28, the next cycle will start. You will have to 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 adjusted. 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 every 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 prescribed for you, you may need to take more than one capsule at a time. You may need to take different amounts of active ingredient to reach the necessary dose. The capsule marking is different for each dose (see table below).

You must make sure you understand and remember the following:

• the number of capsules you need to take each day. Ask your doctor or pharmacist to write it down for you (including the marking on the capsules)
• which days you need to 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 consult your doctor or pharmacist if you are not sure. Mistakes in taking this medicine can have serious consequences for your health.

If you take more Temozolomide SUN than you should

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

If you forget to take Temozolomide SUN

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

If you have any doubts 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 everybody gets them.

Consult your doctor immediatelyif you have any of the following side effects:

• severe allergic reaction with hypersensitivity (hives, wheezing, or difficulty breathing)
• uncontrolled 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 can make you more prone to bleeding or bruising, anemia (lack of red blood cells), fever, as well as reduce your resistance to infections. The decrease in blood cells usually occurs during a short period. In some cases, it may be prolonged and cause a very strong type of anemia (aplastic anemia). Your doctor will perform 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 suspended.

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, diarrhea, 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 state or alertness, tingling sensation
• dizziness, altered sensations, tingling, tremors, abnormal taste
• partial loss of vision, abnormal vision, double vision, dry or painful eyes
• hearing loss, ringing in the ears, ear pain
• blood clots in the lungs or legs, high blood pressure
• pneumonia, shortness of breath, bronchitis, cough, nasal inflammation
• stomach or abdominal pain, discomfort/heartburn, difficulty swallowing
• dry skin, itching
• muscle damage, muscle weakness, muscle pain or discomfort
• joint pain, back pain
• frequent urination, 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 leukemia
• reduced red blood cell count (pancytopenia, anemia, leukopenia)
• 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 heartbeats), hot flashes
• swollen stomach, difficulty controlling bowel movements, hemorrhoids, 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, painful skin redness, 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 color
• difficulty urinating
• vaginal bleeding, vaginal irritation, absent or heavy menstrual periods, breast pain, sexual impotence
• chills, facial swelling, tongue discoloration, thirst, tooth disorder.

Reporting of side effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse, even if it is possible side effects not listed in this leaflet. You can also report side effects directly through 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 cabinet. Accidental ingestion may cause death in children.

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

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 needed. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Temozolomida SUN

• The active ingredient 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 glycolate starch (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 gum, propylene glycol, yellow iron oxide (E172), blue No. 1/Aluminum Blue Brilliant FCF (E133).

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

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

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

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

Temozolomida SUN 250 mg hard capsules:shellac gum, 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 presentations, 4 blisters of 5 capsules will be included in a box.

Only some pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Sun Pharmaceutical Industries Europe B.V.

Polarisavenue 87

2132 JH Hoofddorp

Netherlands

You can request more information about this medicine by contacting the local representative of the marketing authorization 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/Hоландія/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./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.