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TEMOZOLOMIDE 100MG CAPSULES

Active substance(s): TEMOZOLOMIDE

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PACKAGE LEAFLET: INFORMATION FOR THE USER
Temozolomide 5 mg capsules
Temozolomide 20 mg capsules
Temozolomide 100 mg 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.
2.
3.
4.
5.
6.

What Temozolomide is and what it is used for
What you need to know before you take Temozolomide
How to take Temozolomide
Possible side effects
How to store Temozolomide
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

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).
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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. 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 infection, 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 both male and female patients who are taking
Temozolomide (see also “Male fertility” below).
You should stop breast-feeding while receiving treatment with Temozolomide.
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 20 mg
The excipient sunset yellow FCF (E110) included in the capsules shell may cause allergic reactions.
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.
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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 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 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.
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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).
Strength
Temozolomide 5 mg
Temozolomide 20 mg
Temozolomide 100 mg

Colour/marking
two stripes in green ink on the cap
and “T 5 mg” in green ink on the
body
two stripes in orange ink on the cap
and “T 20 mg” in orange ink on the
body
two stripes in pink ink on the cap
and “T 100 mg” in pink ink on the
body

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, 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)
 uncontrolled bleeding
 seizures (convulsions)
 fever
 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
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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.
Side effects from clinical studies:
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
attention.
Very common (may affect more than 1 in 10 people): loss of appetite, headache, constipation (difficulty
passing stools), nausea (feeling sick in your stomach), vomiting, rash, hair loss, tiredness.
Common (may affect up to 1 in 10 people): oral infections, wound 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 your urine, allergic reaction, fever, radiation injury, face swelling, pain, abnormal taste, abnormal
liver function tests.
Uncommon (may affect up to 1 in 100 people): flu-like symptoms, red spots under the skin, , low
potassium level in the blood, weight gain, mood swings, hallucination and memory impairment, partial
paralysis, impaired coordination, , 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 (may affect more than 1 in 10 people): reduced number of blood cells (neutropenia or
lymphopenia, thrombocytopenia), loss of appetite, headache, vomiting, nausea (feeling sick in your
stomach), constipation (difficulty passing stools) , tiredness.
Common (may affect up to 1 in 10 people): loss of weight, sleepiness, 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 (may affect up to 1 in 100 people): reduced blood cell counts (pancytopenia, anaemia,
leukopenia).
Rare (may affect up to 1 in 1,000 people): cough, infections including pneumonia.
Very rare (may affect up to 1 in 10,000 people): skin redness, urticaria (hives), skin eruption, allergic
reactions.
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Other side effects:
Cases of elevations of liver enzymes have been commonly reported. Cases of increased bilirubin, problems
with bile flow (cholestasis), hepatitis and injury to the liver, including fatal liver failure, have been
uncommonly reported.
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.
New or reactivated (recurring) cytomegalovirus infections and reactivated hepatitis B virus infections have
been uncommonly reported.
Cases of diabetes insipidus have been uncommonly reported. Symptoms of diabetes insipidus include
passing a lot of urine and feeling thirsty.
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
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 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.
Bottle presentation
Do not store above 30oC. 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.
Sachet presentation
Do not store above 30°C. Store in the original package in order to protect from light.
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 INFORMATION

What Temozolomide contains
The active substance is temozolomide. Each capsule contains 5/20/100 mg temozolomide.
The other ingredients are:
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capsule content: anhydrous lactose, colloidal anhydrous silica, sodium starch glycolate type A, tartaric acid,
stearic 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).
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.
Bottle presentation
The hard capsules for oral use are dispensed in amber glass bottles containing 5 or 20 capsules. The carton
contains 1 bottle.
Sachet presentation
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 Straße 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 November 2015.

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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.

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