TEMOZOLOMIDE TEVA 250 mg HARD CAPSULES

Introduction

Package Leaflet: Information for the User

Temozolomide Teva 5mg hard capsules EFG

Temozolomide Teva 20mg hard capsules EFG

Temozolomide Teva 100mg hard capsules EFG

Temozolomide Teva 140mg hard capsules EFG

Temozolomide Teva 180mg hard capsules EFG

Temozolomide Teva 250mg 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, as 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 experience any of the 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 Teva and what is it used for
2. What you need to know before you take Temozolomide Teva
3. How to take Temozolomide Teva
4. Possible side effects
5. Storage of Temozolomide Teva
6. Contents of the pack and further information

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

Temozolomide Teva contains a medicine called temozolomide. This medicine is an antitumour agent.

Temozolomide Teva is used to treat patients with specific forms of brain tumours:

• in adults with newly diagnosed glioblastoma multiforme. Temozolomide Teva 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 Teva is used for these tumours if they recur or worsen after standard treatment.

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

Do not take Temozolomide Teva

• if you are allergic (hypersensitive) to temozolomide or any of the other ingredients of this medicine (listed in section 6).

• if you have had an allergic reaction to dacarbazine (an anticancer drug, sometimes called DTIC). Signs of an allergic reaction include itching, shortness of breath or wheezing, swelling of the face, lips, tongue, or throat.
• if you have significantly reduced certain types of blood cells (myelosuppression), as well as low white blood cell count and low platelet count. These blood cells are important for fighting infections and for proper blood clotting. Your doctor will ask for blood tests to check that you have enough of these cells before starting treatment.

Warnings and precautions

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

• as you will need to be closely monitored for the possible development of a severe respiratory infection called Pneumocystis jirovecii pneumonia (PCP). If you are a newly diagnosed patient (glioblastoma multiforme), you may be taking Temozolomide Teva in the 42-day regimen, 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 have hepatitis B infection, as Temozolomide Teva 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 low red blood cell count, low white blood cell count, and low platelet count, or bleeding problems before treatment, or if you develop them during treatment. Your doctor may reduce your dose or interrupt treatment. You may also need other treatments. In some cases, treatment with Temozolomide Teva may need to be interrupted. You will have frequent blood tests to monitor the effects of Temozolomide Teva on your blood cells.
• as you may have a low risk of other blood cell disorders, including leukaemia.
• if you have nausea (feeling sick) and/or vomiting, which are very common side effects with Temozolomide Teva (see section 4). Your doctor may prescribe an anti-sickness medicine to prevent vomiting.

If you vomit frequently before or during treatment, ask your doctor about the best time to take Temozolomide Teva until the vomiting is under control. If you vomit after taking your dose, 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 of age, you may be more susceptible to infection and more prone to infections, bruising, and bleeding.
• if you have liver or kidney problems, your dose of Temozolomide Teva will 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. There is limited information in patients over 3 years who have taken Temozolomide Teva.

Using other medicines and Temozolomide Teva

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, 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 be treated with Temozolomide Teva during pregnancy unless clearly indicated by your doctor.

Effective contraceptive measures are recommended for both male and female patientswho are taking Temozolomide Teva (see also "Male fertility" below).

You should stop breastfeeding while being treated with Temozolomide Teva.

Male fertility

Temozolomide Teva may cause permanent infertility. Male patients should use effective contraceptive methods and not get their partner pregnant until 6 months after finishing treatment. It is recommended to consult about sperm preservation before treatment.

Driving and using machines

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

Temozolomide Teva contains lactose

Temozolomide Teva 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.

Temozolomide Teva contains orange yellow FCF (E110)

Additionally, the body of the Temozolomide Teva 20 mg capsules contains the excipient orange yellow FCF (E110), which may cause allergic reactions.

3. How to take Temozolomide Teva

Follow exactly the instructions for administration of this medicine given by your doctor or pharmacist. If you are unsure, ask your doctor or pharmacist again.

Dose and duration of treatment

Your doctor will decide your correct dose of Temozolomide Teva, based on your body size (height and weight), whether you have a recurrent tumour, and whether you have been treated before with chemotherapy.

You may be prescribed another medicine (antiemetic) 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 newly diagnosed patient, treatment will be given in two phases:

• first, treatment in combination with radiotherapy (concomitant phase)
• followed by treatment with only Temozolomide Teva (monotherapy phase).

Concomitant phase

During the concomitant phase, your doctor will start with Temozolomide Teva at a dose of 75 mg/m2 (standard dose). You will take this dose every day for 42 days (up to a maximum of 49 days) in combination with radiotherapy. The dose of Temozolomide Teva may be delayed or interrupted, depending on your blood counts and how well you tolerate the medicine during the concomitant phase.

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

Then, the monotherapy phase will start.

Monotherapy phase

During the monotherapy phase, the dose and the way you take Temozolomide Teva will be different. Your doctor will tell you the exact dose. There may be up to 6 treatment cycles. Each cycle lasts 28 days. You will take your new dose of Temozolomide Teva once a day for the first 5 days of each cycle ("dosing days"). The first dose will be 150 mg/m2. Then, there will be 23 days without Temozolomide Teva. This adds up to a total treatment cycle of 28 days.

After Day 28, the next cycle will start. You will take Temozolomide Teva once a day for 5 days, followed by 23 days without Temozolomide Teva. The dose of Temozolomide Teva may be adjusted, delayed, or interrupted, depending on your blood counts and how well you tolerate your medicine during each treatment cycle.

Patients with recurrent or progressive tumours (malignant glioma, such as glioblastoma multiforme or anaplastic astrocytoma) taking only Temozolomide Teva

A treatment cycle with Temozolomide Teva is 28 days.

You will take Temozolomide Teva once a day for the first 5 days. This daily dose will depend on whether you have been treated before with chemotherapy or not.

If you have not been treated before with chemotherapy, your first dose of Temozolomide Teva will be 200 mg/m2 once a day for the first 5 days. If you have been treated before with chemotherapy, your first dose of Temozolomide Teva will be 150 mg/m2 once a day for the first 5 days. Then, there will be 23 days without Temozolomide Teva. This adds up to a total treatment cycle of 28 days.

After Day 28, a new cycle will start. You will take Temozolomide Teva once a day for 5 days, followed by 23 days without Temozolomide Teva.

Each time you start a new treatment cycle, your blood will be tested to check if your dose of Temozolomide Teva needs to be adjusted. Depending on the results, your doctor may adjust your medicine for the next cycle.

How to take Temozolomide Teva

Take your prescribed dose of Temozolomide Teva once a day, preferably at the same time each day.

Take the capsules on an empty stomach; for example, at least one hour before you plan to have 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 your skin, eyes, or nose. If you accidentally get it in your eyes or nose, rinse the area with water.

Depending on the prescribed dose, you may need to take more than one capsule at a time, with different strengths (active ingredient content, in mg). The colour of the capsule cap is different for each strength (see the table below).

Make sure you understand and remember the following:

• how many capsules you need to take each dosing day. Ask your doctor or pharmacist to write it down for you (including the colour).
• what your dosing days are.

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

Follow exactly the instructions for administration of Temozolomide Teva given by your doctor. If you are unsure, ask your doctor or pharmacist. Errors in the way you take this medicine can have serious consequences for your health.

If you take more Temozolomide Teva than you should

If you accidentally take more Temozolomide Teva capsules than you should, 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 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 further questions on the use of this medicine, ask your doctor, pharmacist, or nurse.

4. Possible Adverse Effects

Like all medicines, this medicine can cause adverse effects, although not all people suffer from them.

Contact your doctor immediatelyif you have any of the following:

• a severe allergic (hypersensitive) reaction (hives, wheezing, or other breathing difficulties),
• uncontrolled bleeding,
• seizures (attacks),
• fever,
• severe headache that does not go away.

Treatment with Temozolomide Teva may cause a reduction in certain types of blood cells. This can increase the likelihood of bruising or bleeding, anemia (reduction in the number of red blood cells), fever, and decreased resistance to infections. The reduction in blood cell count is usually temporary. In some cases, it can be prolonged and may cause a very severe form of anemia (aplastic anemia). Your doctor will frequently perform blood tests to detect any changes that may occur and will decide if you need specific treatment. In some cases, the dose of Temozolomide Teva will be reduced or suspended.

Adverse effects seen in clinical studies:

Temozolomide Teva in combination with radiotherapy in patients with newly diagnosed glioblastoma

Patients who receive Temozolomide Teva in combination with radiotherapy may experience different adverse reactions than those who receive Temozolomide Teva alone. The following adverse effects may occur and may require medical attention.

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

Common (may affect up to 1 in 10 people):oral infections, wound infections, reduced blood cell count (neutropenia, thrombocytopenia, lymphopenia, leucopenia), increased blood sugar, weight loss, changes in mental state or alertness, anxiety/depression, drowsiness, difficulty speaking, balance disturbance, dizziness, confusion, memory changes, difficulty concentrating, inability to sleep or stay asleep, tingling sensation, bruising, agitation, abnormal or blurred vision, double vision, hearing loss, difficulty breathing, cough, leg thrombosis, fluid retention, swollen legs, diarrhea, abdominal or stomach pain, stomach upset, difficulty swallowing, dry mouth, skin irritation or redness, dry skin, itching, muscle weakness, joint pain, muscle pain, frequent urination, difficulty controlling urine, allergic reaction, fever, radiation injury, facial swelling, pain, taste changes, changes in liver function tests.

Uncommon (may affect up to 1 in 100 people):flu-like symptoms, red spots under the skin, low potassium levels in the blood, weight gain, mood changes, hallucinations, and memory loss, partial paralysis, coordination failure, decreased sensitivity, partial loss of vision, dry or painful eyes, hearing loss, middle ear infection, ringing in the ears, ear pain, palpitations (when the heartbeat can be felt), pulmonary thrombosis, high blood pressure, pneumonia, nasal passage inflammation, bronchitis, cold or flu, stomach distension, difficulty controlling bowel movements, hemorrhoids, increased skin sensitivity to sunlight, skin color changes, increased sweating, muscle damage, back pain, difficulty urinating, vaginal bleeding, sexual impotence, heavy or absent menstrual periods, vaginal irritation, breast pain, hot flashes, chills, tongue color changes, changes in sense of smell, thirst, dental changes.

Monotherapy with Temozolomide Teva in recurrent or progressive brain glioma

The following adverse reactions may occur and may require medical attention.

Very common (may affect more than 1 in 10 people):reduction in blood cell count (neutropenia or lymphopenia, thrombocytopenia), loss of appetite, headache, vomiting, nausea (vomiting), constipation (difficulty evacuating feces).

Common (may affect up to 1 in 10 people):weight loss, fatigue, dizziness, tingling sensation, difficulty breathing, diarrhea, abdominal pain, stomach upset, skin rash, itching, hair loss, fever, weakness, chills, feeling unwell, pain, taste changes.

Uncommon (may affect up to 1 in 100 people):reduction in blood cell count (pancytopenia, anemia, leucopenia).

Rare (may affect up to 1 in 1,000 people):cough, infections such as pneumonia.

Very rare (may affect up to 1 in 10,000 people):skin redness, hives, skin rash, allergic reactions.

Other adverse effects

There have been frequent reports of elevated liver enzymes. Cases of increased bilirubin, bile flow problems (cholestasis), hepatitis, and liver damage, including fatal liver failure, have been reported infrequently.

Very rare cases of severe skin rash with skin swelling, including the palms of the hands and soles of the feet, or skin redness with pain and/or blisters on the body or in the mouth have been observed.

If this occurs, inform your doctor immediately.

Very rare cases of adverse effects on the lungs with Temozolomide Teva have been observed. Patients usually present with difficulty breathing and cough. Inform your doctor if you notice any of these symptoms.

Very rarely, patients taking Temozolomide Teva and similar medicines may have a small risk of developing secondary cancers, including leukemia.

Infrequent cases of new or recurrent infections (reactivations) due to cytomegalovirus and reactivated hepatitis B virus infections have been reported. Infrequent cases of brain infections caused by the herpes virus (herpetic meningoencephalitis), including fatal cases, have been reported.

Infrequent cases of diabetes insipidus have been reported. The symptoms of diabetes insipidus include frequent urination and thirst.

Reporting of adverse effects:

If you experience adverse effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this leaflet. You can also report them directly through the Spanish Medicines Surveillance System for Human Use: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of Temozolomide Teva

Keep this medicine out of the sight and reach of children, preferably in a locked cabinet. Accidental ingestion can be fatal in children.

Do not use this medicine after the expiration date that appears on the label and packaging after EXP. The expiration date is the last day of the month indicated.

Store in the original packaging.

Do not store at a temperature above 30°C.

Keep the bottle tightly closed to protect it from moisture.

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

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

6. Package Contents and Additional Information

Composition of Temozolomide Teva

The active ingredient 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 other ingredients are:

Capsule content: