TEMOZOLOMIDE SUN 20 MG HARD CAPSULES - Patient leaflet, side effects, dosage

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Package Leaflet: Information for the user Temozolomide SUN 20 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 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 get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet

• 1. What Temozolomide SUN is and what it is used for

• 2. What you need to know before you take Temozolomide SUN

• 3. How to take Temozolomide SUN

• 4. Possible side effects

• 5. How to store Temozolomide SUN

• 6. Contents of the pack and other information

1. what temozolomide sun is and what it is used for

Temozolomide SUN contains a medicine called temozolomide. This medicine is an antitumour agent.

Temozolomide SUN is used for the treatment of specific forms of brain tumours:

• – in adults with newly-diagnosed glioblastoma multiforme. Temozolomide SUN is at 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.

Temozolomide SUN is used in these tumours if they return or get worse after standard treatment.

2. what you need to know before you take temozolomide sundo not take temozolomide sun- if you are allergic 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 medicine sometimes called DTIC). Signs of allergic reaction include itchiness, breathlessness or wheezing, or swelling of the face, lips, tongue or throat.

• – if the numbers of certain kinds of blood cells, such as your white blood cells or platelets are severely reduced (known as myelosuppression). These blood cells are important for fighting infection and for proper blood clotting. Your doctor will check your blood to make sure you have enough of these cells before you begin treatment.

Warnings and precautions

Talk to your doctor, pharmacist or nurse before taking Temozolomide SUN, – as you should be observed closely for the development of a serious form of chest infection called Pneumocystis jirovecii pneumonia (PCP). If you have been newly-diagnosed with glioblastoma multiforme you may be receiving Temozolomide SUN for 42 days in combination with radiotherapy. In this case, your doctor will also prescribe medicine to help you prevent this type of pneumonia (PCP).

• – if you have ever had or might now have a hepatitis B infection. This is because Temozolomide SUN could cause hepatitis B to become active again, which can be fatal in some cases. Patients will be carefully checked by their doctor for signs of this infection before treatment is started.

• – if you have low counts of red blood cells (anaemia), white blood cells and platelets, or blood clotting problems before starting the treatment, or if you develop them during treatment. Your blood will be tested frequently during treatment to monitor the side effects of Temozolomide SUN on your blood cells. Your doctor may decide to reduce the dose, interrupt, stop or change your treatment. You may also need other treatments. In some cases, it may be necessary to stop treatment with

Temozolomide SUN.

• – as you may have a small risk of other changes in blood cells, including leukaemia.

• – if you have nausea (feeling sick) and/or vomiting which are very common side effects of Temozolomide SUN (see section 4), your doctor may prescribe you a medicine (an anti-emetic) to help prevent vomiting. If you vomit frequently before or during treatment, ask your doctor about the best time to take Temozolomide SUN 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 develop fever or symptoms of an infection contact your doctor immediately.

• – if you are older than 70 years of age, you might be more prone to infection, bruising or bleeding.

• – if you have liver or kidney problems, your dose of Temozolomide SUN may need to be adjusted.

Children and adolescents

Do not give this medicine to children under the age of 3 years because it has not been studied. There is limited information in patients over 3 years of age who have taken Temozolomide SUN.

Other medicines and Temozolomide SUN

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

Pregnancy, breast-feeding 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. This is because you must not be treated with Temozolomide SUN during pregnancy unless clearly indicated by your doctor.

Effective contraceptive precautions must be taken by female patients who are able to become pregnant during treatment with Temozolomide SUN, and for at least 6 months following completion of treatment.

You should stop breast-feeding while receiving treatment with Temozolomide SUN.

Male fertility

Temozolomide SUN may cause permanent infertility. Male patients should use effective contraception and not father a child for at least 3 months after stopping treatment. It is recommended to seek advice on conservation of sperm prior to treatment.

Driving and using machines

Temozolomide SUN 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 SUN contains lactose

Temozolomide SUN 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.

3. how to take temozolomide sun

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You should make sure you fully understand and remember the following: – the number of capsules you need to take every dosing day. Ask your doctor or pharmacist to write it down (including the marking) – 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 Temozolomide SUN exactly as your doctor has told you. It is very important to check with your doctor or pharmacist if you are not sure. Making a mistake in how you take this medicine may have serious health consequences.

If you take more Temozolomide SUN than you should

If you accidentally take more Temozolomide SUN capsules than you were told to, contact your doctor, pharmacist or nurse immediately.

If you forget to take Temozolomide SUN

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 take a double 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.

4. possible side effects

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.

Temozolomide SUN 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 Temozolomide SUN 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, wound 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 side effects (may affect up to 1 in 100 people) are:

• – brain infections (meningoencep­halitis herpetic) including fatal cases

• – 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.

5. how to store temozolomide sun

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 label and carton. The expiry date refers to the last day of that month.

Do not store above 25°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.

6. contents of the pack and other informationwhat temozolomide sun contains- the active substance is temozolomide. each hard capsule contains

20 mg temozolomide.

– The other ingredients are:

capsule content: lactose, sodium starch glycolate (Type B), tartaric acid, stearic acid (see section 2 „Temozolomide SUN contains lactose“) capsule shell : gelatin, titanium dioxide (E171), sodium laurilsulfate printing ink: shellac, propylene glycol, yellow iron oxide (E172).

What Temozolomide SUN looks like and contents of the pack

Temozolomide SUN 20 mg hard capsules have a white opaque body and cap, imprinted in yellow ink. The cap is imprinted with ‘891’ The body is imprinted with '20 mg’ and two stripes.

The hard capsules are available in blister packs containing 5 capsules. For the 20 capsules packs, 4 blisters of 5 capsules will be included in a carton.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Sun Pharmaceutical Industries Europe B.V.

Polarisavenue 87

2132 JH Hoofddorp

The Netherlands

This leaflet was last revised in 02/2022.

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