TEMOZOLOMIDE 140 MG CAPSULES - patient leaflet, side effects, dosage

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 is and what it is used for

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

• 3. How to take Temozolomide

• 4. Possible side effects

• 5. How to store Temozolomide

• 6. Contents of the pack and other information

1. what temozolomide is and what it is used for

This medicine is an antitumour agent.

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

• – in adults with newly-diagnosed glioblastoma multiforme. Temozolomide 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. Temozolomide is used in these tumours if they return or get worse after standard treatment.

2. what you need to know before you take temozolomide- 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 feeling itchy, breathlessness or wheezing, swelling of the face, lips, tongue or throat.

• – if certain kinds of blood cells are severely reduced (myelosuppression), such as your white blood cell

count and platelet count. 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

• – as you should be observed closely for the development of a serious form of chest infection called

Pneumocystis jirovecii pneumonia (PCP). If you are a newly-diagnosed patient (glioblastoma multiforme) you may be receiving temozolomide 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 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 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.

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

• – if you have nausea (feeling sick in your stomach) and/or vomiting which are very common side effects

of temozolomide (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 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 may need to be adjusted.

Laboratory tests

• – Your blood will be tested frequently during treatment to monitor the side effects of temozolomide on

your blood cells.

• – Your doctor may carry out liver function tests before and after each treatment cycle.

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.

Other medicines and Temozolomide

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

• – valproic acid (a medicine used to treat seizures)

• – medicines which would supress the immune system (such as ciclosporin, azathioprine)

Pregnancy, breast-feeding and fertility

Pregnancy

If you are pregnant or breast-feeding, 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 should not be treated with temozolomide during pregnancy unless clearly indicated by your doctor.

Breast-feeding

You should stop breast-feeding while receiving treatment with temozolomide.

Fertility

Effective contraceptive precautions must be taken by both male and female patients who are taking temozolomide (see also “Male fertility” below).

Male fertility

Temozolomide may cause permanent infertility. Male patients should use effective contraceptions and not father a child for up to 6 months after stopping treatment. It is recommended to seek advice on conservation of sperm prior to treatment.

Driving and using machines

Temozolomide 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 contains lactose

Temozolomide capsules contain 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 contains sodium

This medicine contains less than 1 mmol sodium (23 mg) per capsule, that is to say essentially ‘sodium-free’.

3. how to take temozolomide

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 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.

Patients with newly-diagnosed glioblastoma multi forme

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 temozolomide (monotherapy phase).

During the concomitant phase, your doctor will start temozolomide 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 temozolomide dose may be delayed or stopped, depending on you 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 temozolomide 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 temozolomide 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 temozolomide. This adds up to a 28-day treatment cycle.

After Day 28, the next cycle will begin. You will again take temozolomide once daily for 5 days followed by 23 days without temozolomide. The second dose will be 200 mg/m2. The temozolomide 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 temozolomide only

A treatment cycle with temozolomide lasts 28 days.

You will take temozolomide 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 temozolomide will be 200 mg/m2 once daily for the first 5 days. If you have been previously treated with chemotherapy, your first dose of temozolomide will be 150 mg/m2 once daily for the first 5 days.

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

After Day 28, the next cycle will begin. You will again receive temozolomide once daily for 5 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. Depending on your blood test results, your doctor may adjust your dose for the next cycle.

How to take Temozolomide

Take your prescribed dose of temozolomide 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 and marking of the capsule is different for each strength (see table below).

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 Temozolomide 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 take more Temozolomide than you should

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

If you forget to take Temozolomide

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,

• – flu-like symptoms with a rash, fever, swollen glands, and abnormal blood test results (including

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 Yellow Card Scheme at: or search for MHRA Yellow Card in the Google Play or Apple App Store.

By reporting side effects you can help provide more information on the safety of this medicine.

5. how to store temozolomide

Keep this medicine out of the sight and the 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 after EXP. The expiry date refers to the last day of that month.

Bottle packs

Do not store above 30°C. Store in the original package in order to protect from light. Keep the bottles tightly closed in order to protect from moisture.

After first opening, the medicinal product should be used within 21 days.

Sachets 140 mg – 250 mg only

Do not store above 30°C. Store in the original package in order to protect from light.

Do not use this medicine 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 information

What Temozolomide contains

The active substance is temozolomide. Each capsule contains 140 mg/180 mg/250 mg temozolomide.

The other ingredients are:

o capsule content: anhydrous lactose, colloidal anhydrous silica, sodium starch glycolate type A, tartaric acid, stearic acid.

o capsule shell : gelatin, titanium dioxide (E 171)

Temozolomide 140 mg:

o Printing ink: shellac, propylene glycol, indigo carmine (E132) aluminium lake Temozolomide 180 mg:

o Printing ink: red iron oxide (E 172), shellac, propylene glycol

Temozolomide 250 mg:

o Printing ink: shellac, propylene glycol, black iron oxide (E 172).

What Temozolomide looks like and contents of the pack

Temozolomide 140 mg hard capsules have a white opaque body and cap with two stripes in blue ink on the cap and with “T 140 mg” in blue ink on the body.

Temozolomide 180 mg hard capsules have a white opaque body and cap with two stripes in red ink on the cap and with “T 180 mg” in red ink on the body.

Temozolomide 250 mg hard capsules have a white opaque body and cap with two stripes in black ink on the cap and with “T 250 mg” in black ink on the body.

Bottle packs

The hard capsules for oral use are dispensed in amber glass bottles containing 5 or 20 capsules. The carton contains 1 bottle.

Sachets

The hard capsules for oral use are individually sealed in sachets and dispensed in cartons containing 5 or 20 hard capsules.

Not all pack sizes may be marketed.

Marketing Authorization Holder

Mylan, Potters Bar, Hertfordshire, EN6 1TL, United Kingdom.

Manufacturer

Nerpharma S.r.l. Pharmaceutical Sciences, Viale Pasteur, 10, 20014 Nerviano (MI), Italy

Haupt Pharma Amareg GmbH, Donaustaufer StraBe 378, 93055 Regensburg, Germany

Delorbis Pharmaceuticals Ltd, 17 Athinon Street, Ergates Industrial Area, 2643 Ergates, P.O.BOX 28629, 2081 Lefkosia, Cy­prus

This leaflet was revised in April 2020.

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