Package Insert: Information for the User

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

temozolomida

Read this package insert carefully before starting to take this medicine, as it contains important information for you.

• Keep this package insert, as you may need to read it again.
• If you have any questions, consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed to you alone, and you must not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this package insert. See section 4.

Temozolomida SUN contains a medicine called temozolomida. This medicine is an antitumoral agent.

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

• in adults with a recent diagnosis of glioblastoma multiforme. Temozolomida SUN is used initially in combination with radiation therapy (concomitant phase of treatment) and afterwards, 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 combat these tumors if they recur or worsen after standard treatment.

Do not take Temozolomida SUN if:

• You are allergic to temozolomida or to any of the other components of this medication (listed in section 6).
• You have had a reaction to dacarbazina (a cancer medication sometimes called DTIC). Signs of an allergic reaction include itching, difficulty breathing or wheezing, or swelling of the face, lips, tongue, or throat.
• Your blood cell count, such as white blood cells or platelets, is significantly 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

Consult your doctor, pharmacist, or nurse before starting to take Temozolomida SUN

• Since you will be closely monitored for the development of a severe form of respiratory infection called Pneumocystis jirovecii (PCP pneumonia). If you have recently been diagnosed with glioblastoma multiforme, you may be prescribed Temozolomida SUN for 42 days in combination with radiation therapy. In this case, your doctor will also prescribe a medication to help you avoid this type of pneumonia (PCP).
• Since you have had hepatitis B infection at any time or may have it now, as Temozolomida SUN could reactivate hepatitis B, which in some cases can be fatal. Before starting treatment, your doctor will thoroughly examine patients for signs of this infection.
• Since you have low red blood cell count (anemia), white blood cells, or platelets, or blood clotting problems before starting treatment, or if these problems develop during treatment. Blood tests will be performed frequently during treatment to monitor the side effects of Temozolomida SUN on your blood cells. Your doctor may decide to reduce your dose, interrupt, suspend, or modify your treatment. You may also need other treatments. In some cases, treatment with Temozolomida SUN may need to be interrupted.
• Since there may be a small risk of other changes in blood cells, including leukemia.
• Since you have nausea (discomfort) or vomiting, very common side effects of Temozolomida SUN (see section 4), your doctor may prescribe an antiemetic medication to help prevent vomiting.
• If you frequently vomit before or during treatment, consult your doctor about the best time to take Temozolomida SUN until your vomiting is controlled. If you vomit after taking the medication, 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 Temozolomida SUN dose may need to be adjusted.

Children and adolescents

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

Taking Temozolomida SUN with other medications

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication.

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 medication, as you should not receive treatment with Temozolomida SUN during pregnancy unless your doctor clearly indicates otherwise.

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

You should stop breastfeeding during treatment with Temozolomida SUN.

Male fertility

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

Driving and operating machinery

Temozolomida SUN may cause you to feel tired or drowsy. If so, do not drive, use tools or machines, or ride a bike until you see how this medication 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 medication.

Follow exactly the administration instructions of this medication as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

Dose and duration of treatment

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

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

Patients with recent diagnosis of glioblastoma multiforme

If you have recently been diagnosed, treatment will be performed in two phases:

• firstly, treatment with radiation therapy (concomitant phase)
• followed by treatment with Temozolomida SUN only (monotherapy phase).

During the concomitant phase, your doctor will prescribe a dose of Temozolomida SUN of 75 mg/m2(usual dose). You will have to take this dose every day for 42 to 49 days in combination with radiation therapy. The dose of Temozolomida SUN may be reduced or suspended depending on the results of blood tests and how you react to the medication during the concomitant phase.

Once radiation therapy is completed, treatment will be suspended for 4 weeks. This will help your body recover.

Next, you will begin the monotherapy phase.

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

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

Patients with recurrent tumors or who have worsened (malignant gliomas, such as glioblastoma multiforme or anaplastic astrocytoma) who only take Temozolomida SUN

A treatment cycle with Temozolomida SUN lasts 28 days.

You will have to take Temozolomida SUN only once a day for the first 5 days. This daily dose will depend on whether you have received previous chemotherapy.

If you have not received previous chemotherapy, your first dose of Temozolomida SUN will be 200 mg/m2once a day for the first 5 days. If you have received previous chemotherapy, your first dose of Temozolomida SUN will be 150 mg/m2once a day for the first 5 days. Then, you will have to remain 23 days without taking Temozolomida SUN. This means a treatment cycle of 28 days.

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

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

How to take Temozolomida SUN

Take the dose of Temozolomida SUN prescribed by your doctor once a day, preferably at the same time each day.

Take the capsules with 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 with the powder on the skin, eyes, or nose. If it accidentally gets into your eyes or nose, rinse the area with water.

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

Make sure you understand and remember the following:

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

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

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

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

If you have any doubts about the use of this medication, consult your doctor, pharmacist, or nurse.

Like medicines, this medicine can cause side effects, although not everyone will experience them.

Consult your doctorimmediatelyif you have any of the following side effects:

• Severe allergic reaction with hypersensitivity (hives, sneezing, or difficulty breathing)
• Uncontrolled bleeding
• Seizures (convulsions)
• Fever
• Chills
• Severe headache that does not go away.

Temozolomida SUN treatment may cause a decrease in the number of certain types of blood cells. This may make you more prone to bruising or bleeding, anemia (low red blood cell count), fever, and decrease your resistance to infections. The decrease in blood cells usually occurs during a brief period of time. 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 the treatment with Temozolomida SUN may be suspended.

Side effects observed in clinical trials

Temozolomida SUN in combination with radiation therapy in newly diagnosed glioblastoma

Patients receiving treatment with Temozolomida SUN along with radiation therapy may experience some of the side effects suffered by patients who only receive treatment with Temozolomida SUN. The following side effects may require medical attention.

Very common (may affect more than 1 in 10 people):Loss of appetite, headache, constipation (difficulty evacuating), nausea (discomfort), vomiting, skin rash, hair loss, fatigue.

Common (may affect up to 1 in 10 people):Oral infections, wound infections, decrease in the number of blood cells (neutropenia, thrombocytopenia, lymphopenia, leucopenia), increased blood sugar, weight loss, change in mental state or alertness, anxiety/depression, drowsiness, difficulty speaking, balance alteration, dizziness, confusion, memory loss, difficulty concentrating, inability to fall asleep or stay asleep, numbness, bruises, tremors, abnormal vision or blurred vision, double vision, hearing problems, shortness of breath, cough, blood clots in the legs, fluid retention, swollen legs, diarrhea, abdominal or stomach pain, stomach burning, stomach discomfort, difficulty swallowing, dry mouth, skin irritation or redness, dry skin, itching, muscle weakness, joint pain, muscle pain, frequent urination, difficulty retaining urine, allergic reaction, fever, radiation injury, facial swelling, pain, taste alteration, liver function test alterations.

Uncommon (may affect up to 1 in 100 people):Symptoms similar to the flu, red spots under the skin, low potassium levels in the blood, weight gain, mood changes, hallucinations, and memory loss, partial paralysis, coordination loss, sensation alteration, partial vision loss, dry or painful eyes, hearing loss, middle ear infection, ringing in the ears, ear pain, palpitations (feeling the heartbeat), blood clots in the lungs, high blood pressure, pneumonia, sinusitis, bronchitis, flu or cold, stomach swelling, difficulty controlling bowel movements, hemorrhoids, skin peeling, increased skin sensitivity to sunlight, skin color changes, increased sweating, muscle damage, back pain, difficulty urinating, vaginal bleeding, impotence, absence or heavy menstrual periods, vaginal irritation, breast pain, hot flashes, chills, tongue discoloration, change in sense of smell, thirst, and dental alterations.

Monotherapy with Temozolomida SUN in recurrent or progressive glioma

The following side effects may require medical attention.

Very common (may affect more than 1 in 10 people):Decrease in the number of blood cells (neutropenia or lymphopenia, thrombocytopenia), loss of appetite, headache, vomiting, nausea (discomfort), constipation (difficulty evacuating), fatigue.

Common (may affect up to 1 in 10 people):Weight loss, drowsiness, dizziness, numbness, difficulty breathing, diarrhea, abdominal or stomach pain, stomach burning, skin rash, itching, hair loss, fever, weakness, chills, discomfort, pain, taste alteration.

Uncommon (may affect up to 1 in 100 people):Decrease in the number of blood cells (pancytopenia, anemia, leucopenia).

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):Redness of the skin, urticaria (hives), skin rash, allergic reactions.

Other side effects

Frequent cases of elevated liver enzymes have been reported. Rare cases of increased bilirubin, bile flow problems (cholestasis), hepatitis, liver damage, including fatal liver failure, have been reported.

Very rare cases of severe skin rash with swelling of the skin, even on the palms of the hands and soles of the feet, or painful redness of the skin or blisters on the body or in the mouth, have been observed. Consult your doctorimmediatelyif this occurs.

Very few side effects in the lungs have been observed as a result of Temozolomida SUN. Patients usually experience difficulty breathing and cough. Consult your doctor if you notice any of these symptoms.

In very rare cases, patients receiving treatment with Temozolomida SUN and similar medications may be at a minimum risk of developing a secondary cancer, such as leukemia.

Rare cases of new or recurrent infections (reactivations) caused by cytomegalovirus and reactivated infections caused by hepatitis B virus have been reported. Rare cases of central nervous system infections caused by the herpes virus (herpetic encephalitis), including fatal cases, have been reported. Rare cases of sepsis (when bacteria and their toxins circulate in the blood and begin to damage organs) have been reported.

Rare cases of diabetes insipidus have been reported. Symptoms of diabetes insipidus include frequent urination and thirst.

Reporting side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through the national notification system included in theAppendix V. By reporting side effects, you can contribute to providing more information on the safety of this medication.

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

Do not use this medication after the expiration date that appears on the label and packaging. 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.

Medications should not be disposed of through the drain or trash. Ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

Temozolomida SUN Composition

The active ingredient is temozolomida.

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

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

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

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

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

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

• The other components are:

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

capsule coating:gelatine, titanium dioxide (E171), sodium lauryl sulfate

printing ink:

Temozolomida SUN 5 mg hard capsules: shellac, propylene glycol, yellow iron oxide (E172), blue No.1/Aluminium Lake 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/Aluminium Lake 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 packaging contents

5 mg hard capsules

Temozolomida SUN 5 mg hard capsules of gelatine 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 capsules of gelatine 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 capsules of gelatine 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 capsules of gelatine 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 capsules of gelatine 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 capsules of gelatine 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 packaging sizes may be marketed.

Marketing authorisation holder and manufacturer responsible

Sun Pharmaceutical Industries Europe B.V.

Polarisavenue 87

2132 JH Hoofddorp

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/Ελλ?δα/Hrvatska/Ireland/Ísland/

Κ?προς/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

Netherlands/Pays-Bas/Niederlande/???????????/Nizozemsko/

Nederlandene/Holland/Ολλανδ?α/Nizozemska/The Netherlands/Holland/

Ολλανδ?α/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 34278 90

France

Ranbaxy Pharmacie Generiques

11-15, Quai de Dion Bouton

92800 Puteaux

France

Tel. +33 1 41 44 44 50

Italia

Ranbaxy Italia S.p.A.

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

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

Last update of this prospectus:March 2022

Other sources of information

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