Temodal 20 mg hard capsules

Patient Information Leaflet

Introduction

Patient Information Leaflet

Temodal 5mg hard capsules

Temodal 20mg hard capsules

Temodal 100mg hard capsules

Temodal 140mg hard capsules

Temodal 180mg hard capsules

Temodal 250mg hard capsules

temozolomide

Read the entire leaflet carefully before you start taking this medicine, as it contains important information for you.

• Keep this leaflet, as 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, and you should not give it to others, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if they are adverse effects not listed in this leaflet. See section 4.

Contents of the leaflet

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

1. What Temodal is and what it is used for

Temodal contains a medicine called temozolomide. This medicine is an antitumour agent.

Temodal is indicated for the treatment of specific forms of brain tumours:

• in adults with newly diagnosed glioblastoma multiforme. Temodal is initially used in combination with radiotherapy (concomitant phase of treatment) and subsequently used alone (monotherapy phase of treatment).
• in children aged 3 years and older and adults with malignant glioma, such as glioblastoma multiforme or anaplastic astrocytoma. Temodal is indicated for these tumours when they recur or progress after standard treatment.

2. What you need to know before taking Temodal

Do not take Temodal

• if you are allergic to temozolomide or to 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 referred to as DTIC). Signs of an allergic reaction include itching, shortness of breath or wheezing, swelling of the face, lips, tongue, or throat.
• if certain types of blood cells are significantly reduced (myelosuppression), including white blood cell and platelet counts. These blood cells are important in fighting infections and for proper blood clotting. Your doctor will perform blood tests to ensure you have sufficient levels of these cells before starting treatment.

Warnings and precautions

Talk to your doctor, pharmacist, or nurse before starting Temodal.

• as you must be closely monitored for the possible development of a serious respiratory infection called Pneumocystis jirovecii pneumonia (PCP). If you are a newly diagnosed patient (glioblastoma multiforme), you may be receiving Temodal in the 42-day regimen, in combination with radiotherapy. In this case, your doctor will also prescribe a medication to help prevent this type of pneumonia (PCP).
• if you have ever had or may currently have hepatitis B infection, as Temodal 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 (anaemia), white blood cells, and platelets, or blood clotting problems before or during treatment. Your doctor may reduce the dose of the medicine, interrupt treatment, or you may require additional therapy. In some cases, treatment with Temodal may need to be discontinued. You will have frequent blood tests to monitor the side effects of Temodal on your blood cells.
• as there is a low risk of other blood cell abnormalities, including leukaemia.
• if you experience nausea and/or vomiting, which are very common side effects with Temodal (see section 4), your doctor may prescribe an antiemetic (medication to prevent vomiting).

If you vomit frequently before or during treatment, ask your doctor about the best time to take Temodal until vomiting is under control. If you vomit after taking your dose, do not take a second dose on the same day.

• if you develop fever or signs of infection, contact your doctor immediately.
• if you are over 70 years of age, you may be more susceptible to infections and more prone to infections, bruising, and bleeding.
• if you have liver or kidney problems, your dose of Temodal 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. Limited information is available in patients over 3 years of age who have taken Temodal.

Other medicines and Temodal

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, think you might be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine, as you should not be treated with Temodal during pregnancy unless clearly indicated by your doctor.

Effective contraception methods are recommended for patients who can become pregnant during treatment with Temodal and for at least 6 months after completing treatment.

You must stop breastfeeding while being treated with Temodal.

Male fertility

Temodal 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 using machines

Temodal may make you feel tired or sleepy. If this occurs, do not drive or operate tools or machinery, or ride a bicycle, until you know how this medicine affects you (see section 4).

Temodal contains lactose

This medicine contains lactose (a type of sugar). If your doctor has informed you of an intolerance to certain sugars, consult with him before taking this medicine.

Temodal contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per capsule; therefore, it is essentially “sodium-free”.

3. How to take Temodal

Follow exactly the instructions for administering this medicine as given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Dosage and duration of treatment

Your doctor will determine your correct dose of Temodal based on your body size (height and weight), whether you have recurrent tumour, and whether you have previously received chemotherapy treatment.

You may be prescribed another medicine (an antiemetic) to take before and/or after taking Temodal to prevent or control nausea and vomiting.

Patients with newly diagnosed glioblastoma multiforme:

If you are a newly diagnosed patient, treatment will consist of two phases:

• first, combination treatment with radiotherapy (concomitant phase)
• followed by treatment with Temodal alone (monotherapy phase).

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

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

After this, you will begin the monotherapy phase.

During the monotherapy phase, the dose and manner of taking Temodal will be different. Your doctor will inform you of the exact dose.

There may be up to 6 treatment periods (cycles). Each cycle lasts 28 days.

You will take your new dose of Temodal once daily for the first 5 days of each cycle (“dosing days”). The initial dose will be 150 mg/m². This will be followed by 23 days without Temodal. This makes one complete treatment cycle of 28 days.

After day 28, you will start the next cycle. You will again take Temodal once daily for 5 days, followed by 23 days without Temodal. The dose of Temodal may be adjusted, delayed, or omitted depending on your blood test results and how well you tolerate the medication during each treatment cycle.

Patients with recurrent or progressive tumours (malignant glioma, such as glioblastoma multiforme or anaplastic astrocytoma) receiving Temodal alone:

A treatment cycle with Temodal lasts 28 days.

You will take Temodal once daily for the first 5 days. This daily dose will depend on whether you have previously received chemotherapy or not.

If you have not previously received chemotherapy, your first dose of Temodal will be 200 mg/m² once daily for the first 5 days. If you have previously received chemotherapy, your first dose of Temodal will be 150 mg/m² once daily for the first 5 days.

This will be followed by 23 days without Temodal. This makes one complete treatment cycle of 28 days.

After day 28, you will start a new cycle. You will again receive Temodal once daily for 5 days, followed by 23 days without Temodal.

Each time a new treatment cycle begins, your blood will be tested to determine whether your Temodal dose needs to be adjusted. Depending on the results, your doctor may adjust your medication for the next cycle.

How to take Temodal

Take your prescribed dose of Temodal once daily, preferably at the same time each day.

Take the capsules on an empty stomach; for example, at least one hour before you plan to eat 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 powder accidentally gets into your eyes or nose, wash the area with water.

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

You must be certain that you fully understand and remember the following:

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

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

Always follow exactly the administration instructions for Temodal given by your doctor. If you have any doubts, consult your doctor or pharmacist. Errors in how you take this medicine may have serious health consequences.

If you take more Temodal than you should

If you accidentally take more Temodal capsules than prescribed, contact your doctor, pharmacist, or nurse immediately.

If you forget to take Temodal

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 forgotten doses, unless your doctor specifically instructs you to do so.

If you have any further 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 everyone experiences them.

Contact your doctor immediately if you experience any of the following:

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

Treatment with Temodal may cause a reduction in certain types of blood cells. This may increase your likelihood of bruising or bleeding, anemia (reduction in the number of red blood cells), fever, and decreased resistance to infections. Reduction in blood cell counts is usually temporary. In some cases, it may persist and may lead to a very severe form of anemia (aplastic anemia). Your doctor will frequently perform blood tests to monitor for any changes and will decide whether you need specific treatment. In some cases, the dose of Temodal may be reduced or treatment stopped.

The following are 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, diarrhea, constipation
• skin rash, hair loss
• fatigue

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

• infections, oral 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 alertness, tingling sensation
• dizziness, altered sensations, tingling, tremors, abnormal taste
• partial loss of vision, abnormal vision, double vision, 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 aches and pains
• joint pain, back pain
• frequent urination, difficulty controlling 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
• wound infections
• new or reactivated cytomegalovirus infections
• reactivated hepatitis B virus infections
• secondary cancers, including leukemia
• reduced red blood cell counts (pancytopenia, anemia, leucopenia)
• red spots under the skin
• diabetes insipidus (symptoms include increased urination and feeling thirsty), 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, hemorrhoids, dry mouth
• hepatitis and liver injury (including fatal liver failure), cholestasis, increased bilirubin
• blisters on the body or in the mouth, skin peeling, rash, painful red 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 color
• difficulty urinating
• vaginal bleeding, vaginal irritation, absent or heavy menstrual periods, breast pain, sexual impotence
• chills, facial swelling, discolored tongue, thirst, dental disorders
• dry eyes

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 Temodal

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

Do not use this medicine after the expiry date stated on the sachet and the carton. The expiry date refers to the last day of the month indicated.

Do not store above 30 °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 properly dispose of any unused medicines and their packaging. This helps protect the environment.

6. Contents of the pack and other information

Composition of Temodal

The active substance is temozolomide.

Temodal 5mg hard capsules: Each capsule contains 5 mg of temozolomide.

Temodal 20mg hard capsules: Each capsule contains 20 mg of temozolomide.

Temodal 100mg hard capsules: Each capsule contains 100 mg of temozolomide.

Temodal 140mg hard capsules: Each capsule contains 140 mg of temozolomide.

Temodal 180mg hard capsules: Each capsule contains 180 mg of temozolomide.

Temodal 250mg hard capsules: Each capsule contains 250 mg of temozolomide.

The other components are:

Capsule contents:

anhydrous lactose, colloidal anhydrous silica, sodium starch glycolate type A, tartaric acid, stearic acid (see section 2 "Temodal contains lactose").

Capsule shell:

Temodal 5mg hard capsules: gelatin, titanium dioxide (E 171), sodium lauryl sulfate, iron oxide yellow (E 172), indigo carmine (E 132).

Temodal 20mg hard capsules: gelatin, titanium dioxide (E 171), sodium lauryl sulfate, iron oxide yellow (E 172).

Temodal 100mg hard capsules: gelatin, titanium dioxide (E 171), sodium lauryl sulfate, iron oxide red (E 172).

Temodal 140mg hard capsules: gelatin, titanium dioxide (E 171), sodium lauryl sulfate, indigo carmine (E 132).

Temodal 180mg hard capsules: gelatin, titanium dioxide (E 171), sodium lauryl sulfate, iron oxide yellow (E 172) and iron oxide red (E 172).

Temodal 250mg hard capsules: gelatin, titanium dioxide (E 171), sodium lauryl sulfate.

Printing ink:

shellac, propylene glycol (E 1520), purified water, ammonium hydroxide, potassium hydroxide and iron oxide black (E 172).

Nature of the product and pack size

Temodal 5mg hard capsules have an opaque white body, an opaque green cap, and are printed in black ink. The cap is printed with “TEMODAL”. The body is printed with “5 mg”, the Schering-Plough logo, and two lines.

Temodal 20mg hard capsules have an opaque white body, an opaque yellow cap, and are printed in black ink. The cap is printed with “TEMODAL”. The body is printed with “20 mg”, the Schering-Plough logo, and two lines.

Temodal 100mg hard capsules have an opaque white body, an opaque pink cap, and are printed in black ink. The cap is printed with “TEMODAL”. The body is printed with “100 mg”, the Schering-Plough logo, and two lines.

Temodal 140mg hard capsules have an opaque white body, a blue cap, and are printed in black ink. The cap is printed with “TEMODAL”. The body is printed with “140 mg”, the Schering-Plough logo, and two lines.

Temodal 180mg hard capsules have an opaque white body, an opaque orange cap, and are printed in black ink. The cap is printed with “TEMODAL”. The body is printed with “180 mg”, the Schering-Plough logo, and two lines.

Temodal 250mg hard capsules have an opaque white body and cap, and are printed in black ink. The cap is printed with “TEMODAL”. The body is printed with “250 mg”, the Schering-Plough logo, and two lines.

The hard capsules (capsules) for oral administration are individually sealed in foil pouches and supplied in cartons containing 5 or 20 hard capsules.

Only certain pack sizes may be marketed.

You can request further information about this medicinal product by contacting the local representative of the marketing authorization holder:

Date of the most recent review of this leaflet:

Other sources of information

Detailed information on this medicine is available on the website of the European Medicines Agency: https://www.ema.europa.eu.