TEMOZOLOMIDE TEVA 140 mg HARD CAPSULES

Introduction

Package Leaflet: Information for the User

Temozolomide Teva 5 mg hard capsules EFG

Temozolomide Teva 20 mg hard capsules EFG

Temozolomide Teva 100 mg hard capsules EFG

Temozolomide Teva 140 mg hard capsules EFG

Temozolomide Teva 180 mg hard capsules EFG

Temozolomide Teva 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 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 other information

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

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

Temozolomide Teva is indicated for the treatment of patients with specific forms of brain tumors:

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 indicated for these tumors 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 a 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 a sufficient number 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 currently have a 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 counts (anemia), low white blood cell counts, and low platelet counts, or blood clotting problems before treatment, or if you develop them during treatment. Your doctor may reduce your dose of Temozolomide Teva or interrupt it. You may also need other treatments. In some cases, it may be necessary to interrupt treatment with Temozolomide Teva. 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 leukemia.
• 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 antiemetic 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 available 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 methods are recommended for female patients who can become pregnant during treatment with Temozolomide Teva and for at least 6 months after completing treatment.

You should stop breastfeeding while being treated with Temozolomide Teva.

Male fertility

Temozolomide Teva can cause permanent infertility. Male patients should use effective contraceptive methods and not get their partner pregnant during and for at least 3 months after completing treatment. It is recommended to consult about sperm preservation before treatment.

Driving and using machines

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

Temozolomide Teva contains lactose

If your doctor has told you that you have an intolerance to some sugars, consult with them before taking this medicine.

Temozolomide Teva contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per capsule; this is essentially "sodium-free".

Temozolomide Teva 20 mg hard capsules EFG contain orange yellow FCF (E110)Also, 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, consult your doctor or pharmacist again.

Dose and duration of treatment

Your doctor will determine the correct dose of Temozolomide Teva for you, based on your body size (height and weight), whether you have a recurrent tumor, and whether you have been previously treated 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.

Patient with newly diagnosed glioblastoma multiforme

If you are a newly diagnosed patient, treatment will be carried out in two phases:

• first, concomitant treatment with radiotherapy (concomitant phase)
• followed by treatment with only Temozolomide Teva (monotherapy 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 you tolerate the medication during the concomitant phase.

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

Then, you will start the 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. You may have 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, you will start the next cycle. 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 skipped, depending on your blood tests and how you tolerate your medication during each treatment cycle.

Patient with recurrent or progressive tumors (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 previously treated with chemotherapy or not.

If you have not been previously treated 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 previously treated 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, you will start a new cycle. 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 medication 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 the 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 concentrations (active ingredient content, in mg). The color of the capsule cap is different for each concentration (see the table below).

You must be sure you understand and remember the following:

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

Review the 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 have any doubts, consult 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 other questions about 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,
• chills,
• severe headache that does not go away.

Treatment with Temozolomide Teva may cause a reduction in certain types of blood cells. This can make it more likely that you will have bruises or bleeding, anemia (reduction in the number of red blood cells), fever, and a reduced ability to fight infections. The reduction in blood cell count is usually temporary. In some cases, it may be prolonged and can 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 stopped.

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

• infections, oral 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, 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, stomach upset/acid reflux, difficulty swallowing
• dry skin, itching
• muscle damage, muscle weakness, muscle pain
• 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 adverse effects (may affect up to 1 in 100 people) are:

• brain infections (herpetic meningoencephalitis), including fatal cases
• wound infections
• 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 heartbeat), 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, painful red skin, severe skin rash with swelling of the skin (including the palms of the hands and soles of the feet)
• increased sensitivity to sunlight, hives (urticaria), increased sweating, skin color changes
• difficulty urinating
• vaginal bleeding, vaginal irritation, absent or heavy menstrual periods, breast pain, sexual impotence
• chills, swollen face, tongue discoloration, thirst, tooth disorder
• dry eyes

Reporting 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 Pharmacovigilance System for Human Use Medicines: 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 stated on the label and carton after EXP. The expiration date is the last day of the month indicated.

Store in the original packaging.

Do not store 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 via wastewater or household waste. Ask your pharmacist how to dispose of the packaging and any unused medicine. 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: