Temodal Capsules

Temodal® 5 mg hard capsules

Temodal® 20 mg hard capsules

Temodal® 100 mg hard capsules

Temodal® 140 mg hard capsules

Temodal® 180 mg hard capsules

Temodal® 250 mg hard capsules

temozolomide

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

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

• in adults with newly-diagnosed glioblastoma multiforme. Temodal is first used together with radiotherapy (concomitant phase of treatment) and after that alone (monotherapy phase of treatment).
• in children 3 years and older and adult patients with malignant glioma, such as glioblastoma multiforme or anaplastic astrocytoma. Temodal is used in these tumours if they return or get worse after standard treatment.

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

Dosage and duration of treatment

Your doctor will work out your dose of Temodal. 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 Temodal to prevent or control nausea and vomiting.

Patients with newly-diagnosed glioblastoma multiforme:

If you are a newly-diagnosed patient, treatment will occur in two phases:

• treatment together with radiotherapy (concomitant phase) first
• followed by treatment with only Temodal (monotherapy phase).

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

Once the radiotherapy is completed, you will interrupt treatment for 4 weeks. This will give your body a chance to recover.

Then, you will start the monotherapy phase.

During the monotherapy phase, the dose and way you take Temodal will be different. Your doctor will work out your exact dose. There may be up to 6 treatment periods (cycles). Each one lasts 28 days. You will take your new dose of Temodal alone once daily for the first 5 days (“dosing days”) of each cycle. The first dose will be 150 mg/m². Then you will have 23 days without Temodal. This adds up to a 28-day treatment cycle.

After Day 28, the next cycle will begin. You will again take Temodal once daily for 5 days followed by 23 days without Temodal. The Temodal dose may be adjusted, delayed or stopped depending on your blood counts and how you tolerate your medicine during each treatment cycle.

Patients with tumours that have returned or worsened (malignant glioma, such as glioblastoma multiforme or anaplastic astrocytoma) taking Temodal only:

A treatment cycle with Temodal lasts 28 days.

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

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

Then, you will have 23 days without Temodal. This adds up to a 28-day treatment cycle.

After Day 28, the next cycle will begin. You will again receive Temodal once daily for 5 days, followed by 23 days without Temodal.

Before each new treatment cycle, your blood will be tested to see if the Temodal dose needs to be adjusted. Depending on your blood test results, your doctor may adjust your dose for the next cycle.

How to take Temodal

Take your prescribed dose of Temodal 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 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. If you accidentally get some in your eyes or nose, flush the area with water.

Depending on the prescribed dose, you may have to take more than one capsule together, eventually with different strengths (content of active substance, in mg). The colour of the capsule cap is different for each strength (see in the table below).

Strength Colour of the cap

Temodal 5 mg hard capsules green

Temodal 20 mg hard capsules yellow

Temodal 100 mg hard capsules pink

Temodal 140 mg hard capsules blue

Temodal 180 mg hard capsules orange

Temodal 250 mg hard capsules white

You should make sure you fully understand and remember the following:

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

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

Always take Temodal exactly as your doctor has told you. It is very important to check with your doctor or pharmacist if you are not sure. Errors in how you take this medicine may have serious health consequences.

If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.

Like all medicines, this medicine can cause side effects, although not everybody gets them.

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

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

Temodal 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 reduced resistance to infections. The reduction in blood cell counts is usually short-lived. In some cases, it may be prolonged 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 Temodal dose will be reduced or treatment stopped.

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, 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 side effects (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

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

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

Do not store above 30 °C

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.