Temozolomide Accord 20 mg hard capsules EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Temozolomida Accord 5 mg hard capsules

Temozolomida Accord 20 mg hard capsules

Temozolomida Accord 100 mg hard capsules

Temozolomida Accord 140 mg hard capsules

Temozolomida Accord 180 mg hard capsules

Temozolomida Accord 250 mg hard capsules

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 questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms as you, because it could harm them.
• If you get any side effects, talk to your doctor, pharmacist or nurse, even if it is a side effect not listed in this leaflet. See section 4.

Leaflet contents:

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

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

Temozolomide is an anticancer medicine.

Temozolomide Accord capsules are taken for the treatment of specific types of brain tumours:

• Adults with specific forms of newly diagnosed brain tumours (glioblastoma multiforme).
• Temozolomide is first used with radiotherapy (concomitant phase of treatment) and then afterwards, alone (monotherapy phase of treatment).
• In children aged 3 years and older and adults with specific forms of brain tumours (e.g., glioblastoma multiforme or anaplastic astrocytoma) if they recur or progress after standard treatment.

2. What you need to know before taking Temozolomida Accord

Do not take Temozolomida Accord

• 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 another cancer medicine called dacarbazine. Signs of allergic reactions include itching, difficulty breathing or wheezing, swelling of the face, lips, tongue, or throat.
• if you have a low number of blood cells, such as white blood cell or platelet counts. These blood cells are important for fighting infection and proper blood clotting. Your doctor will perform blood tests to ensure you have enough of these cells before starting treatment.

Warnings and precautions

Talk to your doctor, pharmacist, or nurse before starting Temozolomida Accord

• your doctor will monitor you for the possible development of a serious chest infection called Pneumocystis carinii jirovecii pneumonia (PCP). If you are a newly diagnosed glioblastoma multiforme patient, you may receive temozolomide for 42 days 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 hepatitis B infection, as Temozolomida Accord 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 anemia, low blood counts (e.g. white blood cells or platelets), or blood clotting problems before or during treatment. Your doctor may need to reduce your dose, interrupt your treatment, or you may require additional treatment. Your doctor will decide whether any changes to your treatment are necessary. In some cases, treatment with temozolomide may need to be discontinued. You will have regular blood tests to monitor your condition. If you develop fever or signs of infection, contact your doctor immediately.

• There may be a small risk of other changes in blood cells, including leukemia.

• if you experience nausea or vomiting, which is a very common side effect of temozolomide (see section 4). If you vomit frequently before or during treatment, ask your doctor about medicines that can help prevent or control vomiting and the best time to take temozolomide until vomiting is under control. If you vomit after taking a dose, do not take a second dose on the same day.

• if you develop fever or symptoms of infection, contact your doctor immediately.

• if you are over 70 years old. Elderly patients are more likely to experience infections, bruising, and bleeding.

• if you have liver or kidney problems, as your dose may need to be adjusted.

Children and adolescents

Do not give this medicine to children under 3 years of age, as its effect has not been studied in this age group. Limited information is available in patients over 3 years of age who have taken Temozolomide.

Taking Temozolomida Accord with other medicines

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

Effective contraceptive methods must be used in women of childbearing potential during treatment with Temozolomida Accord and for at least 6 months after completing treatment.

You must not breastfeed during treatment with Temozolomida Accord.

Male fertility

Temozolomide 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.

Talk to your doctor or pharmacist before using any medicine.

Driving and using machines

You may feel tired or drowsy when taking temozolomide. If so, do not drive or operate tools or machinery, or ride a bicycle, until you know how this medicine affects you (see section 4).

Temozolomida Accord contains lactose

The capsules contain lactose (a type of sugar). If your doctor has told you that you have an intolerance to certain sugars, consult with him before taking this medicine.

Temozolomida Accord contains sodium

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

3. How to take Temozolomide Accord

Follow exactly the administration instructions for Temozolomide Accord given by your doctor. If in doubt, consult your doctor or pharmacist again.

How to open the sachet

Open the sachet by folding and tearing along the perforated line at the notch in the corner of the sachet.

Only specialists experienced in brain tumours should prescribe temozolomide.

Dosage and duration of treatment

Your doctor will decide the correct dose of temozolomide based on your body size (height and weight) and whether you have previously received chemotherapy. Your doctor may also prescribe other medicines to take before and/or after temozolomide to prevent or control vomiting.

Take the prescribed dose of Temozolomide Accord once daily 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 skin, eyes, or nose. Avoid inhaling the powder. If powder accidentally gets into your eyes or nose, wash the area thoroughly with water.

If you are taking Temozolomide Accord in combination with radiotherapy (newly diagnosed patients):

While receiving radiotherapy, your doctor will start temozolomide treatment at a dose of 75 mg/m², and the actual dose you take will depend on your height and weight. You will take this dose daily for 42 days (up to a maximum of 49 days) in combination with radiotherapy. Depending on your blood counts and how well you tolerate temozolomide, doses may be delayed or withheld.

After completion of radiotherapy, treatment will be interrupted for 4 weeks to allow your body time to recover.

There may be up to 6 treatment cycles, each lasting 28 days. Your initial dose of temozolomide capsules will be 150 mg/m² once daily for the first 5 days of each cycle ("dosing days"), followed by 23 days without temozolomide. This makes one complete treatment cycle of 28 days.

On day 28, you will begin the next cycle, during which you will again take the medicine once daily for 5 days, followed by 23 days without temozolomide. Depending on your blood counts and how well you tolerate temozolomide during each treatment cycle, your dose may be adjusted, delayed, or withheld.

If you are taking Temozolomide Accord capsules alone (without radiotherapy):

A treatment cycle with Temozolomide Accord consists of 28 days. You will take the capsules once daily for the first 5 days ("dosing days"), followed by 23 days without temozolomide. This makes one complete treatment cycle of 28 days.

After day 28, you will begin the next cycle, during which you will again take the medicine once daily for 5 days, followed by 23 days without temozolomide. Before each new treatment cycle, you will have a blood test to determine whether the temozolomide dose needs adjustment.

If you have not previously received chemotherapy, your first dose of temozolomide will be 200 mg/m² once daily for the first 5 days ("dosing days"), followed by 23 days without temozolomide. If you have previously received chemotherapy, your first dose of temozolomide will be 150 mg/m² once daily for the first 5 days ("dosing days"), followed by 23 days without temozolomide.

Depending on the results of blood tests, your doctor may adjust your dose for the next cycle.

Each time you start a new treatment cycle, make sure you clearly understand exactly how many capsules of each strength you should take each day and for how many days you should take this dose.

All patients

Temozolomide is available in capsules of different strengths (shown on the box label in mg). Each strength has a cap of a different colour. Depending on the temozolomide dose prescribed by your doctor, you may need to take several capsules each day during the dosing days of the treatment cycle.

• Make sure you clearly understand exactly how many capsules of each strength you need to take. Ask your doctor or pharmacist to write down the number of capsules of each strength (including the colour) you should take each dosing day.
• Make sure you know exactly which days are your dosing days.
• Make sure you review the dose with your doctor each time you start a new treatment cycle. Sometimes the dose or the mix of capsules you need to take may differ from the previous cycle.
• Once you have the medicine at home, if you have any doubts or need clarification about how to take the dose, call your healthcare provider for further instructions before starting the treatment cycle. Errors in taking this medicine may have serious consequences for your health.

If you take more Temozolomide Accord than you should

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

If you forget to take Temozolomide Accord

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 a missed dose 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 will experience them.

Patients who take temozolomide in combination with radiotherapy may experience different adverse effects compared to those who take temozolomide alone.

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

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

Treatment with temozolomide may reduce certain types of blood cells. This may increase the likelihood of developing bruises or bleeding, anaemia (lack of red blood cells), fever and/or reduced resistance to infections. Reduction in blood cell counts is usually temporary, but in some cases it may persist and lead to a very severe form of anaemia (aplastic anaemia). Your doctor will frequently perform blood tests to detect any changes and will decide whether you need specific treatment. In some cases, your doctor may reduce or stop your dose of temozolomide.

Other adverse effects that have been reported are:

Very common adverse effects (may affect more than 1 in 10 people):

• Loss of appetite, difficulty speaking, headache
• Vomiting, nausea, diarrhoea, constipation
• Rash, hair loss
• Tiredness

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

• Infections, oral infections, wound infections
• Reduced blood cell count (neutropenia, lymphopenia, thrombocytopenia)
• Allergic reaction
• Increased blood sugar
• Memory disturbances, depression, anxiety, confusion, difficulty falling or staying asleep
• Impaired balance and coordination
• Difficulty concentrating, changes in mental state or lack of alertness, forgetfulness
• Dizziness, altered sensations, tingling, tremors, abnormal taste
• Partial loss of vision, abnormal vision, double vision, dry or painful eyes
• Deafness, ringing in the ears, ear pain
• Blood clot in lungs or legs, high blood pressure
• Pneumonia, breathing difficulty, bronchitis, cough, sinusitis
• Stomach or abdominal pain, heartburn, difficulty swallowing
• Dry skin, itching
• Muscle damage, muscle weakness, muscle pain
• Joint pain, back pain
• Frequent urge to urinate, difficulty controlling urine
• Fever, flu-like symptoms, pain, feeling unwell, cold or flu
• Fluid retention, swelling of legs
• Increased liver enzymes
• Weight loss, weight gain

Radiation injury

Uncommon adverse effects (may affect up to 1 in 100 people):

• Brain infections (herpes meningoencephalitis), including fatal cases
• New or reactivated cytomegalovirus infections
• Reactivated hepatitis B virus infections
• Secondary cancers including leukaemia
• Reduced blood cell count (pancytopenia, anaemia, leucopenia)
• Red spots under the skin
• Diabetes insipidus (symptoms include increased need to urinate and feeling thirsty), low levels of potassium in blood
• Mood changes, hallucinations
• Partial paralysis, changes in sense of smell
• Hearing disturbances, middle ear infection
• Palpitations (when you can feel your heartbeat), hot flushes
• Swollen stomach, difficulty controlling bowel movements, haemorrhoids, dry mouth
• Hepatitis and liver damage (including fatal liver failure), cholestasis, increased bilirubin
• Blisters on body and in mouth, skin peeling, skin rash, painful red skin, severe rash with skin swelling (including palms and soles)
• Increased sensitivity to sunlight, urticaria, increased sweating, change in skin colour
• Difficulty urinating
• Vaginal bleeding, vaginal irritation, absent or heavy menstrual periods, breast pain, sexual impotence
• Chills, facial swelling, discoloured tongue, thirst, dental disorder

Reporting of adverse effects

If you experience any adverse effects, talk to your doctor, pharmacist or nurse, even if they are adverse effects not listed in this leaflet. You can also report them directly through the national reporting system listed in Appendix V. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Temozolomide Accord

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

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

Bottle

Do not store above 25°C.

Store in the original bottle. Keep the bottle tightly closed to protect it from moisture.

Sachet

Do not store above 25°C.

Keep in the original container to protect it from moisture.

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

Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Doing so helps protect the environment.

6. Contents of the pack and other information

Composition of Temozolomide Accord

The active substance is temozolomide.

Temozolomide Accord 5 mg hard capsules: Each capsule contains 5 mg of temozolomide.

Temozolomide Accord 20 mg hard capsules: Each capsule contains 20 mg of temozolomide.

Temozolomide Accord 100 mg hard capsules: Each capsule contains 100 mg of temozolomide.

Temozolomide Accord 140 mg hard capsules: Each capsule contains 140 mg of temozolomide.

Temozolomide Accord 180 mg hard capsules: Each capsule contains 180 mg of temozolomide.

Temozolomide Accord 250 mg hard capsules: Each capsule contains 250 mg of temozolomide.

• Other ingredients are:

Contents of the capsule:

anhydrous lactose, colloidal anhydrous silica, sodium starch glycolate type A, tartaric acid, stearic acid.

Capsule shell:

Temozolomide Accord 5 mg hard capsules: gelatin, titanium dioxide (E 171), yellow iron oxide (E 172), indigo carmine (E 132), water.

Temozolomide Accord 20 mg hard capsules: gelatin, titanium dioxide (E 171), yellow iron oxide (E 172), water.

Temozolomide Accord 100 mg hard capsules: gelatin, titanium dioxide (E 171), red iron oxide (E 172), water.

Temozolomide Accord 140 mg hard capsules: gelatin, titanium dioxide (E 171), indigo carmine (E 132), water.

Temozolomide Accord 180 mg hard capsules: gelatin, titanium dioxide (E 171), yellow iron oxide (E 172), red iron oxide (E 172), water.

Temozolomide Accord 250 mg hard capsules: gelatin, titanium dioxide (E 171), water.

Printing ink:

shellac, propylene glycol, black iron oxide (E 172) and potassium hydroxide.

Appearance of the product and contents of the pack

Temozolomide Accord 5 mg hard capsules have a white body, a green cap, and are printed in black ink with "TMZ" on the cap and "5" on the body of the capsule.

Temozolomide Accord 20 mg hard capsules have a white body, a yellow cap, and are printed in black ink with "TMZ" on the cap and "20" on the body of the capsule.

Temozolomide Accord 100 mg hard capsules have a white body, a pink cap, and are printed in black ink with "TMZ" on the cap and "100" on the body of the capsule.

Temozolomide Accord 140 mg hard capsules have a white body, a blue cap, and are printed in black ink with "TMZ" on the cap and "140" on the body of the capsule.

Temozolomide Accord 180 mg hard capsules have a white body, a maroon cap, and are printed in black ink with "TMZ" on the cap and "180" on the body of the capsule.

Temozolomide Accord 250 mg hard capsules have a white body, a white cap, and are printed in black ink with "TMZ" on the cap and "250" on the body of the capsule.

The hard capsules are supplied in amber glass bottles containing 5 or 20 capsules. Each carton contains one bottle.

The hard capsules are also dispensed in sachets containing 1 capsule each.

Each box contains 5 or 20 sachets.

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer:

Marketing Authorization Holder

Accord Healthcare S.L.U.

World Trade Center, Moll de Barcelona, s/n,

Edifici Est, 6th floor,

08039 Barcelona, Spain

Manufacturer

Accord Healthcare Polska Sp. z o.o.,

ul. Lutomierska 50, 95-200 Pabianice, Poland

Accord Healthcare B.V.,

Winthontlaan 200,

3526 KV Utrecht,

The Netherlands

The latest revision of this leaflet was in XX/YYYY

Other sources of information

Detailed information on this product is available on the website of the European Medicines Agency (EMA): http://www.ema.europa.eu/