Temozolomide Accord

Do not take it if

From the package leaflet in EMA’s product information, p. 62.

How to take it

These directions are for this exact strength and form. Another one is different.

• Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
• How to open sachet Open the sachet by folding and tearing along the fold line with the notch in the corner of the sachet.
• Temozolomide should only be prescribed by specialists experienced in brain tumours.
• Dosage and duration of treatment Your doctor will work out your dose of temozolomide. This is based on your size (height and weight)
• and if you have a recurrent tumour and have had chemotherapy treatment in the past. You may be given other medicines (anti-emetics) to take before and/or after taking temozolomide to prevent or control nausea and vomiting.
• Take your prescribed dose of Temozolomide Accord once a day. Take the dose 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 your skin, eyes or nose. Avoid inhaling the powder. If you accidentally get some in your eyes or nose, flush the area with water.
• If you are taking Temozolomide Accord in combination with radiotherapy (newly diagnosed patients):
• While the radiotherapy is ongoing your doctor will start temozolomide at a dose of 75 mg/m² and the actual daily dose you take will depend on your height and weight. You will take this dose every day for 42 days (up to 49 days) in combination with radiotherapy. Based on your blood counts and how you tolerate temozolomide, the dose may be delayed or stopped.
• Once the radiotherapy is completed, you will interrupt treatment for 4 weeks to give your body a chance to recover.
• Then, you will start the monotherapy phase.
• During the monotherapy phase, the dose and way you take Temozolomide Accord will be different.
• Your doctor will work out your exact dose. Then there may be up to 6 treatment cycles, and each one lasts 28 days. You will take your new dose of Temozolomide capsules initially at 150 mg/m² once daily for the first five days (“dosing days”) of each cycle, followed by 23 days without temozolomide;
• this adds up to a 28 day treatment cycle.
• After day 28, the next cycle will begin, in which you will again take this medicine once daily for five days followed by 23 days without temozolomide. Based on your blood counts and how you tolerate temozolomide during each treatment cycle, the dose may be adjusted, delayed or stopped.
• If you are taking Temozolomide Accord capsules alone (without radiotherapy):
• A treatment cycle with Temozolomide Accord comprises 28 days. You will take the capsules once daily for the first five days (“dosing days”) followed by 23 days without temozolomide, adding up to the 28 day treatment cycle.
• After Day 28, the next cycle will begin, in which you will again take this medicine once daily for five days followed by 23 days without temozolomide. Before each new treatment cycle, your blood will be tested to see if the temozolomide dose needs to be adjusted.
• If you have not been treated before with chemotherapy, you will take your first dose of temozolomide at 200 mg/m² once daily for the first five days (“dosing days”) followed by 23 days without temozolomide. If you have been treated before with chemotherapy, you will take your first dose of temozolomide at 150 mg/m² once daily for the first five days (“dosing days”) followed by 23 days without temozolomide.
• Depending on your blood test results, your doctor may adjust your dose for the next cycle.
• Each time you start a new treatment cycle, be sure you understand exactly how many capsules of each strength you need to take each day and how many days you will receive this dose.
• All patients Temozolomide comes in different strength capsules (shown on the outer label in mg). Each strength has a different colour cap. Depending on the dose of temozolomide that your doctor prescribes, you may have to take several capsules on each dosing day of the treatment cycle.
• Be sure you understand exactly how many capsules you need to take of each strength. Ask your doctor or pharmacist to write down the number of each strength (including colour) that you need to take each dosing day.
• Be sure you know exactly which days are your dosing days.
• Be sure you review the dose with your health care provider each time you start a new cycle.
• Sometimes the dose or the mix of capsules you need to take will be different from the last cycle.
• Once you take the medicine home, if you are confused or unsure about how to take your dose, call for re-instruction before beginning the treatment cycle. Errors in how you take this medicine may have serious health consequences.
• If you take more Temozolomide Accord than you should If you accidentally take more capsules than you were told to, contact your doctor, pharmacist or nurse immediately.
• If you forget to take Temozolomide Accord Take the missed dose as soon as possible during the same day. If a full day has gone by, check with your doctor. Do not double the next dose to make up for a forgotten 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.

From the package leaflet in EMA’s product information, p. 64–65.

Warnings and precautions

From the package leaflet in EMA’s product information, p. 62–63.

Pregnancy and breastfeeding

From the package leaflet in EMA’s product information, p. 63.

Other medicines

From the package leaflet in EMA’s product information, p. 63.

Driving and using machines

• Temozolomide Accord may make you feel tired or sleepy. In this case, do not drive or use any tools or machines or cycle until you see how this medicine affects you (see section 4).
• Temozolomide Accord contains lactose This medicine contains lactose (a kind of sugar). If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
• Temozolomide Accord contains sodium This medicine contains less than 1 mmol sodium (23 mg) per capsule, that is to say essentially ‘sodium- free’.

From the package leaflet in EMA’s product information, p. 64.

Side effects

• Like all medicines, this medicine can cause side effects, although not everybody gets them.
• Patients taking temozolomide in combination with radiation therapy may experience different side effects than patients taking temozolomide alone.
• Contact your doctor immediately if you have any of the following:
• a severe allergic reaction (hypersensitive) (hives, wheezing or other breathing difficulty),
• uncontrolled bleeding,
• seizures (convulsions),
• fever,
• chills,
• severe headache that does not go away.
• Temozolomide treatment can cause a reduction in certain kinds of blood cells. This may cause you to have increased bruising or bleeding, anaemia (a shortage of red blood cells), fever, and/or a reduced resistance to infections. The reduction of blood cells is usually temporary, but in some cases may be for longer and may lead to a very severe form of anaemia (aplastic anaemia). Your doctor will monitor your blood regularly for any changes, and will decide if any specific treatment is needed. In some cases, your temozolomide dose will be reduced or discontinued.
• Other side effects that have been reported are listed below:
• Very Common side effects (may affect more than 1 in 10 people) are:
• loss of appetite, difficulty speaking, headache
• vomiting, nausea, diarrhoea, constipation
• rash, hair loss
• tiredness Common side 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 impairment, depression, anxiety, confusion, inability to fall asleep or stay asleep
• impaired coordination and balance
• difficulty concentrating, change in mental status or alertness, forgetfulness
• dizziness, impaired sensations, tingling sensations, shaking, abnormal taste
• partial loss of vision, abnormal vision, double vision, dry or painful eyes
• deafness, ringing in the ears, earache
• blood clot in lung or legs, high blood pressure
• pneumonia, shortness of breath, bronchitis, cough, inflammation of your sinuses
• stomach or abdominal pain, upset stomach/heartburn, difficulty swallowing
• dry skin, itching
• muscle damage, muscle weakness, muscle aches and pain
• painful joint, back pain
• frequent urination, difficulty withholding your urine
• fever, flu-like symptoms, pain, feeling unwell, a cold or the flu
• fluid retention, swollen legs
• liver enzyme elevations
• loss of weight, weight gain
• radiation injury Uncommon sideeffects (may affect up to 1 in 100 people) are:
• brain infections (meningoencephalitis herpetic) including fatal cases
• wound infections
• new or reactivated cytomegalovirus infections
• reactivated hepatitis B virus infections
• secondary cancers including leukaemia
• reduced blood cell counts (pancytopenia, anaemia, leukopenia)
• red spots under the skin
• diabetes insipidus (symptoms include increased urination and feeling thirsty), low potassium level in the blood
• mood swings, hallucination
• partial paralysis, change in your sense of smell
• hearing impairment, infection of the middle ear
• palpitations (when you can feel your heart beat), hot flushes
• swollen stomach, difficulty controlling your bowel movements, haemorrhoids, dry mouth
• hepatitis and injury to the liver (including fatal liver failure), cholestasis, increased bilirubin
• blisters on body or in mouth, skin peeling, skin eruption, painful reddening of the skin, severe rash with skin swelling (including palms and soles)
• increased sensitivity to sunlight, urticaria (hives), increased sweating, change in skin colour
• difficulty in urinating
• vaginal bleeding, vaginal irritation, absent or heavy menstrual periods, breast pain, sexual impotence
• shivering, face swelling, discolouration of the tongue, thirst, tooth disorder
• dry eyes Reporting of side effects If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.

From the package leaflet in EMA’s product information, p. 65–67.

How to store it

• Keep this medicine out of the sight and reach of children, preferably in a locked cupboard.
• Accidentally ingestion can be lethal for children.
• Do not use this medicine after the expiry date which is stated on the label and carton. The expiry date refers to the last day of that month.
• Do not store above 25°C.
• Sachet Store in the original package in order to protect from moisture.
• Tell your pharmacist if you notice any change in the appearance of the capsules.
• Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

From the package leaflet in EMA’s product information, p. 67.

Same active substance, strength and form in other countries

Matched on active substance, strength and kind of form only. This is not a statement that the products are equivalent or interchangeable: other ingredients, release and approved uses can differ — ask a pharmacist before swapping.

Medicine passport: one printable page to show a pharmacist abroad

Details

Source: European Medicines Agency — medicine data · 2026-09-30 · not reviewed by a clinician

Source: European Medicines Agency (EMA). Product information as published by EMA. Reuse terms: EMA legal notice (reproduction authorised).

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Same active substance

These contain the same substance. That does not mean one can replace another — ask a pharmacist.

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