TEMOZOLOMIDE 250MG HARD CAPSULES
Temozolomide 5/20/100/140/180/250 mg hard capsules
Read all of this leaflet carefully before you start taking this medicine.
Keep this leaflet. You may need to read it again.
If you have any further questions, ask your doctor or pharmacist.
This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their
symptoms are the same as yours.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell
your doctor or pharmacist.
In this leaflet:
What Temozolomide is and what it is used for
Before you take Temozolomide
How to take Temozolomide
Possible side effects
How to store Temozolomide
WHAT TEMOZOLOMIDE IS AND WHAT IT IS USED FOR
Temozolomide is an antitumour agent.
Temozolomide is used for the treatment of patients with speciic forms of brain tumours:
Newly-diagnosed glioblastoma multiforme. Temozolomide is first used together with radiotherapy
(concomitant phase of treatment) and after that alone (monotherapy phase of treatment).
Malignant glioma, such as glioblastoma multiforme or anaplastic astrocytoma.Temozolomide is used
in these tumours if they return or get worse after standard treatment.
BEFORE YOU TAKE TEMOZOLOMIDE
Do not take TEMOZOLOMIDE
If you are allergic (hypersensitive) to temozolomide or any of the other ingredients of Temozolomide.
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
Take special care with Temozolomide
You should be observed closely for the development of a serious form of pneumonia called
Pneumocystis carinii 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 duirng treatment to monitor the side effects of Temozolomide on your blood cells.
Your blood will be tested frequently during treatment to monitor the side effects of Temozolomide on
your blood cells.
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 “Possible side effects”), your doctor may prescribe you a medicine
(an anti-emetic) to help prevent vomiting. If youvomit 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. 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 accientally get some in your eyes or nose, flush the area
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, you dose of Temozolomide may need to be adjusted.
Due to lack of experience, Temozolomide should not be used in children younger than 3 years.
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.
Using other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including
medicines obtained without a prescription.
Pregnancy and breast-feeding
Tell your doctor if you are pregnant, think you might be or are planning to get pregnant. You must not be
treated with Temozolomide during pregnancy unless clearly indicated by your doctor.
Effective contraceptive precautions must be taken by both male and female patients who are taking
Temozolomide (see also “Take special care with Temozolomide, Infertility” above).
You should stop breast-feeding while receiving treatment with Temozolomide.
Driving and using machines
Temozolomide may make you feel tired or sleepy. In this case, do not drive or use any tools or machines.
Important information about some of the ingredients of Temozolomide.
Temozolomide hard capsules contain lactose. If you have been told by your dotor that you have an
intolerance to some sugars, contact your doctor before taking this medicinal product.
Temozolomide 20 mg: The excipient sunset yellow FCF (E110) included in the capsules shell may cause
HOW TO TAKE TEMOZOLOMIDE
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 takingTemozolomide to prevent or control nausea and
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 retured 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 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 you blood test results, your doctor may adjust your dose for the next cycle.
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 or chew the capsules. If a capsule is
damaged, avoid contact with your skin, eyes or nose. If it occurs, wash the affected area thoroughly.
Depending on the presecribed 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).
TEMOZOLOMIDE 5 mg
TEMOZOLOMIDE 20 mg
TEMOZOLOMIDE 100 mg
Two strips in green ink on the cap and “T 5 mg” in green ink on the
Two strips in orange ink on the cap and “T 20 mg” in orange ink on
Two strips in pink ink on the cap and “T 100 mg” in pink ink on the
TEMOZOLOMIDE 140 mg
TEMOZOLOMIDE 180 mg
TEMOZOLOMIDE 250 mg
Two strips in blue ink on the cap and “T 140 mg” in blue ink on the
Two strips in red ink on the cap and “T 180 mg” in red ink on the
Two strips in black ink on the cap and “T 250 mg” in black ink on
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
If you take more Temozolomide than you should
If you accidentally take more Temozolomide capsules than you were told to, contact your doctor or
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 or pharmacist.
POSSIBLE SIDE EFFECTS
Like all medicines, Temozolomide 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),
A 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 anaelia (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.
Side effects from clinical sttudies:
Side effects may occur with certain frequencies, which are defined as follows:
very common: affects more than 1 user in 10
common: affects 1 to 10 users in 100
uncommon: affects 1 to 10 users in 1,000
rare: affects1 to 10 users in 10,000
very rare: affects less than 1 user in 10,000
not known: frequency cannot be estimated from the available data.
Temozolomide in combination treatment with radiotherapy in newly-diagnosed glioblastoma
Patients receiving Temozolomide in combination with radiotherapy may experience different side effects
than patients taking Temozolomide alone. The following side effects may occur, and may require medical
Very common: Loss of appetite, headache, constipation (difficulty passing stools), nausea (feling sick in
your stomach), vomiting, rash, hair loss, tiredness.
Common: oral infections, would infection, reduced number of blood cells (neutropenia, thrombocytopenia,
lymphopenia, leukopenia), increased sugar in the blood, loss of weight, change in mental status or alertness,
anxiety/ depression, sleepiness, difficulty speaking, impaired balance, dizziness, confusion, forgetfulness,
difficulty concentrating, inability to fall asleep or stay asleep, tingling sensation, bruising, shaking, abnormal
or blurry vision, double vision, hearing impairment, shortness of breath, cough, blood clot in the legs, fluid
retention, swollen legs, diarrhoea, stomach or abdominal pain, heartburn, upset stomach, difficulty
swallowing, dry mouth, skin irritation or redness, dry skin, itching, muscle weakness, painful joints, muscle
aches and pains, frequent urination, difficulty with holding you urine, allergic reaction, fever, radiation
injury, face swelling, pain, abnormal taste, abnormal liver function tests.
Uncommon: flu-like symptoms, red spots under the skin, appearance of a swollen face or muscle weakness,
low potassium level in the blood, weight gain, mood swings, hallucination and memory impairment, partial
paralysis, impaired coordination, difficulty swallowing, impaired sensations, partial loss of vision, dry or
painful eyes, deafness, infection of the middle ear, ringing in the ears, earache, palpitations (when you can
feel your heart beat), blood clot in the lung, high blood pressure, pneumonia, inflammation of your sinuses,
bronchitis, a cold or the flu, swollen stomach, difficulty controlling your bowel movements, haemorrhoids,
peeling skin, increased skin sensitivity to sunlight, change in skin colour, increased sweating, muscle
damage, back pain, difficulty in urinating, vaginal bleeding, sexual impotence, absent or heavy menstrual
periods, vaginal irritation, breast pain, hot flushes, shivering, discolouration of your tongue, change in your
sense of smell, thirst, tooth disorder.
Temozolomide monotherapy in recurrent or progressive glioma
The following side effects may occur, and may require medical attention.
Very common: reduced number of blood cells (neutropenia or lymphopenia, thrombocytopenia), loss of
appetite, headache, vomiting, nausea (feeling sick in your stomach), constipation (difficulty passing stools).
Common: loss of weight, tiredness, dizziness, tingling sensation, shortness of breath, diarrhoea, abdominal
pain, upset stomach, rash, itching, hair loss, fever, weakness, shivering, feeling unwell, pain, change in taste.
Uncommon: reduced number of blood cell counts (pancytopenia, anaemia, leukopenia).
Rare: cough, infections including pneumonia.
Very rare: skin redness, urticaria (hives), skin eruption, allergic reactions.
Other side effects:
Very rare cases of severe rash with skin swelling, including on the palms of the hands and soles of the feet,
or painful reddening of the skin and/or blisters on the body or in the mouth have been observed. Tell your
doctor immediately if this occurs.
Very rare cases of lung side effects have been observed with Temozolomide. Patients usually present with
shortness of breath and cough. Tell your doctor if you notice any of these symptoms.
In very rare cases, patients taking Temozolomide and medicines like it may have a small risk of developing
secondary cancers, including leukaemia.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your
doctor or pharmacist.
HOW TO STORE TEMOZOLOMIDE
Keep out of the reach and sight of children, preferably in a locked cupboard. Accidental ingestion can
be lethal for children.
Do not use Temozolomide 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 30 °C.
Store in the original package in order to protect from light. Keep the bottles tightly closed in order to protect
Do not store above 30 °C.
Tell your pharmacist if you notice any change in the appearance of the capsules.
Medicines should not be disposed of via wastewater of household waste. Ask your pharmacist how to
dispose of medicines no longer required. These measures will help to protect the environment.
What Temozolomide contains
The active substance is temozolomide.
Each capsule contains 5/20/100/140/180/250 mg temozolomide.
The other ingredients are:
capsule content: anhydrous lactose, colloidal anhydrous silica, sodium starch glycolate type A, tartaric acid,
Temozolomide 5 mg: capsule shell: gelatin, titanium dioxide (E 171), shellac, propylene glycol, Indigo
carmine aluminium lake (E132), yellow Ironoxide (E172)
Temozolomide 20 mg: capsule shell: gelatine, titanium dioxide (E 171), shellac, propylene glycol, Sunset
yellow FCF Aluminium Lake (E110)
Temozolomide 100 mg: capsule shell: gelatin, titanium dioxide (E 171), red iron oxide (E 172), shellac,
propylene glycol and yellow iron oxide (E 172).
Temozolomide 140 mg: capsule shell: gelatin, titanium dioxide (E 171), shellac, propylene glycol, Indigo
carmine (E132) aluminium lake
Temozolomide 180 mg: capsule shell: gelatin, titanium dioxide (E 171), red iron oxide (E 172), shellac,
Temozolomide 250 mg: capsule shell: gelatin, titanium dioxide (E 171), shellac, propylene glycol, black
iron oxide (E 172).
What Temozolomide looks like and contents of the pack
Temozolomide 5 mg hard capsules have a white opaque body and cap with two stripes in green ink on the
cap and with “T 5 mg” in green ink on the body.
Temozolomide 20 mg hard capsules have a white opaque body and cap with two stripes in orange ink on the
cap and with “T 20 mg” in orange ink on the body.
Temozolomide 100 mg hard capsules have a white opaque body and cap with two stripes in pink ink on the
cap and with “T 100 mg” in pink ink on the body.
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.
The hard capsules for oral use are dispensed in amber glass bottles containing 5 or 20 capsules and
multipacks of 20 capsules (comprising 4 bottles, each containing 5 capsules).
Each hard capsule is individually packed in a sachet. Each carton contains 5 or 20 hard capsules.
Not all pack sizes may be marketed.
Marketing Authorization Holder:
ratiopharm GmbH, Graf-Arco-Str. 3, 89079 Ulm, Germany.
Nerviano Medical Sciences S.r.l., Pharmaceutical Sciences, Viale Pasteur, 10, 20014 Nerviano (MI), Italy.
Merckle GmbH, Ludwig-Merckle-Straße 3, 89143 Blaubeuren, Germany.
Haupt Pharma Amareg GmbH, Donaustaufer Straße 378, 93055 Regensburg, Germany.
This leaflet was last revised in: January 2012.
Source: Medicines and Healthcare Products Regulatory Agency
Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.