Temozolomide 140 mg hard capsules – patient leaflet, side effects, dosage

1. What Temozolomide is and what it is used for

Temozolomide contains a medicine called temozolomide. 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

Do not 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 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. Your blood will be tested frequently during treatment to monitor the side effects of Temozolomide on your blood cells.
• 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 infections, bruising or bleeding.

• if you have liver or kidney problems, your dose of Temozolomide 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.

  Other medicines and Temozolomide

  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 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, and for at least 6 months following completion of treatment.

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

  Male fertility

  Temozolomide 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 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

  If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

  Temozolomide contains sodium

  This medicine contains less than 1 mmol sodium (23 mg) per dosage unit, 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 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 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 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 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 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 of the capsule cap is different for each strength (see in the 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.

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 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 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

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: www.mhra.gov.uk/yellowcard 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 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.

This medicinal product does not require any special temperature storage conditions.

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

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.

  Temozolomide 5 mg: Each capsule contains 5mg temozolomide. Temozolomide 20 mg: Each capsule contains 20mg temozolomide. Temozolomide 100 mg: Each capsule contains 100mg temozolomide. Temozolomide 140 mg: Each capsule contains 140mg temozolomide. Temozolomide 180 mg: Each capsule contains 180mg temozolomide. Temozolomide 250 mg: Each capsule contains 250mg temozolomide.

  • The other ingredients are:

    capsule content:

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

    capsule shell:

    gelatin,

    Temozolomide 5 mg: gelatin, titanium dioxide (E171), yellow iron oxide (E172), inidigocarmine (E132).

    Temozolomide 20 mg: gelatin, titanium dioxide (E171), yellow iron oxide (E172).

    Temozolomide 100 mg: gelatin, titanium dioxide (E171), red iron oxide (E172).

    Temozolomide 140 mg: gelatin, titanium dioxide (E171), inidigocarmine (E132).

    Temozolomide 180 mg: gelatin, titanium dioxide (E171), red iron oxide (E172).

    Temozolomide 250 mg: gelatin, titanium dioxide (E171). Printing ink:

    shellac, black iron oxide (E172), propylene glycol.

What Temozolomide looks like and contents of the pack

Temozolomide 5 mg:

Size 3 hard gelatin capsules with an opaque light green cap and an opaque white body imprinted with “5 mg”. The capsules are filled with white to light pink powder.

Temozolomide 20 mg:

Size 2 hard gelatin capsules with a rich yellow cap and an opaque white body imprinted with “20 mg”. The capsules are filled with white to light pink powder.

Temozolomide 100 mg:

Size 1 hard gelatin capsules with a flesh-coloured cap and an opaque white body imprinted with “100 mg”. The capsules are filled with white to light pink powder.

Temozolomide 140 mg:

Size 0 hard gelatin capsules with a transparent light blue cap and an opaque white body imprinted with “140 mg”. The capsules are filled with white to light pink powder.

Temozolomide180 mg:

Size 0 hard gelatin capsules with an opaque orange cap and an opaque white body imprinted with “180 mg”. The capsules are filled with white to light pink powder.

Temozolomide 250 mg:

Size 0 hard gelatin capsules with an opaque white cap and an opaque white body imprinted with “250 mg”. The capsules are filled with white to light pink powder.

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

The carton contains one bottle.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Devatis UK Limited

Lower GF Suite (LG35)

Belvedere House,

Basingstoke,

Hampshire,

United Kingdom,

RG21 4HG

Manufacturer

Elara Pharmaservices Limited

5 Garden Court, Lockington Hall,

Main Street, Lockington,

DE74 2RH,

United Kingdom

Devatis GmbH

Spitalstr. 22,

79539 Lörrach, Germany

This leaflet was last revised in December 2025.

75 mm

75 mm