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TEMOZOLOMIDE ZENTIVA 250MG HARD CAPSULES

Active substance(s): TEMOZOLOMIDE

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Temozolomide 5mg hard capsules
Temozolomide 20mg hard capsules
Temozolomide 100mg hard capsules
Temozolomide 140mg hard capsules
Temozolomide 180mg hard capsules
Temozolomide 250mg 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. See section 4.
In this leaflet:
1.
2.
3.
4.
5.
6.

What temozolomide is and what it is used for
Before you take temozolomide
How to take temozolomide
Possible side effects
How to store temozolomide
Further information

1. WHAT TEMOZOLOMIDE IS AND WHAT IT IS
USED FOR
The name of your medicine is Temozolomide 5mg,
20mg, 100mg, 140mg, 180mg or 250mg hard capsules
(referred to as temozolomide throughout this leaflet).
Temozolomide 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. 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 pneumonia
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. 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 hard capsules contain lactose (a type
of sugar). If you have been told by your doctor that
you have an intolerance to some sugars, contact
your doctor before taking this medicinal product.
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 75mg/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.

Zentiva

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.

TEMOZOLOMIDE 5MG, 20MG, 100MG, 140MG, 180MG AND 250MG HARD CAPSULES

LEAFLET
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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 150mg/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 200mg/m2 once daily for the first 5 days. If you
have been previously treated with chemotherapy,
your first dose of temozolomide will be 150mg/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 with your skin, eyes or
nose. If you accidently 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).
Strength
Colour of the cap
Temozolomide 5mg hard capsules
Green
Temozolomide 20mg hard capsules
Orange
Temozolomide 100mg hard capsules
Purple
Temozolomide 140mg hard capsules
Blue
Temozolomide 180mg hard capsules Chocolate brown
Temozolomide 250mg hard capsules
White
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
or pharmacist 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
product, ask your doctor or pharmacist.

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Approved: Yes
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Date:FOR ZENTIVA
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- as required
Approved: Yes
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Date:
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4. POSSIBLE SIDE EFFECTS

5. HOW TO STORE TEMOZOLOMIDE

Like all medicines, this medicine can cause side
effects, although not everybody gets them.

Keep out of the sight and reach 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.
HDPE Bottle presentation
Store below 30oC
Store in the original bottle in order to protect from
moisture.
Keep the bottle tightly closed.
Sachet presentation
5mg, 20mg
Store below 25oC
100mg, 140mg, 180mg, 250mg
Store below 30oC
Tell your pharmacist if you notice any change in the
appearance of the capsules.
Do not throw away medicines via wastewater or
household waste. Ask your pharmacist how to throw
away medicines you no longer use. These measures
will help to protect the environment.

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,
- 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 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, convulsions, 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,
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 (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 number of 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.
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.

6. FURTHER INFORMATION
What temozolomide contains
- 5mg: The active substance is temozolomide.
Each capsule contains 5mg temozolomide.
- 20mg: The active substance is temozolomide.
Each capsule contains 20mg temozolomide.
- 100mg: The active substance is temozolomide.
Each capsule contains 100mg temozolomide.
- 140mg: The active substance is temozolomide.
Each capsule contains 140mg temozolomide.
- 180mg: The active substance is temozolomide.
Each capsule contains 180mg temozolomide.
- 250mg: The active substance is temozolomide.
Each capsule contains 250mg temozolomide.
The other ingredients are:
Capsule content
Lactose Anhydrous, Silica, Colloidal Anhydrous,
Sodium Starch Glycollate (Type A), Tartaric Acid,
Stearic Acid
Capsule shell, Size 0:
5mg: gelatin, titanium dioxide (E 171). yellow iron
oxide (E 172), indigotine FD & C blue 2 (E132)
20mg: gelatin, titanium dioxide (E 171), red iron
oxide (E 172), yellow iron oxide (E 172)
100mg: gelatin, titanium dioxide (E 171), indigotine
FD&C blue2 (E 132), red iron oxide (E172)
140mg: Gelatin, titanium dioxide (E 171),
indigotine FD&C blue 2 (E 132)
180mg: Gelatin, titanium dioxide (E 171), yellow
iron oxide (E 172), red iron oxide (E 172), black
iron oxide (E 172)
250mg: gelatin, titanium dioxide (E 171)
Printing ink
Shellac, propylene glycol, purified water, sodium
ammonia solution, potassium hydroxide, black
iron oxide (E 172)
What temozolomide looks like and the contents
of the pack
5mg: Hard gelatin capsules size 0 (green opaque
cap/white opaque body) with 5 printed in black ink
on the body.
20mg: Hard gelatin capsules size 0 (orange opaque
cap /white opaque body) with 20 printed in black ink
on the body.
100mg: Hard gelatin capsules size 0 (purple opaque
cap /white opaque body) with 100 printed in black ink
on the body
140mg: Hard gelatin capsules size 0 (blue opaque
cap /white opaque body) with 140 printed in black ink
on the body
180mg: Hard gelatin capsules size 0 (chocolate brown
opaque cap /white opaque body) with 180 printed in
black ink on the body
250mg: Hard gelatin capsules size 0 (white opaque
cap /white opaque body) with 250 printed in black ink
on the body
HDPE Bottle presentation
White opaque High Density Polyethylene Bottles
with Polpropylene push lock assembly closure, with
polyester coil and dessicant containing 5 capsules.
Sachet presentation
Sachets composed of paper on linear low density
polyethylene (outermost layer), aluminum and
ethylene acrylic acid co-polymer (innermost layer).
Each sachet contains 1 hard capsule and is
dispensed in a cardboard carton. The carton
contains 5 or 20 hard capsules, individually sealed in
sachets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and
Manufacturer
Marketing Authorisation Holder:
Zentiva, One Onslow Street, Guildford, Surrey, GU1
4YS, UK
Manufacturer:
EirGen Pharma Limited, Westside Business Park
Old Kilmeaden Road, Waterford, Ireland
This leaflet was last revised in May 2015
’Zentiva’ is a registered trademark © 2015 Zentiva

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.

00000

Zentiva
TEMOZOLOMIDE 5MG, 20MG, 100MG, 140MG, 180MG AND 250MG HARD CAPSULES

LEAFLET
000
00000
433547(iss3)
00000
474179
1-JUN-15
3
KY
2 of 2
N/A
180 X 600MM
N/A
N/A
N/A
N/A
Helvetica Neue
Minimum Point Size of Text: 10pt
1

Black

Cutter

FOR
ZENTIVA USE
ONLY
Zentiva Regulatory
Approved: Yes
No
Date:
Signature:

N/A

THESE
SIGNATURES
Zentiva
- Head of Regulatory ARE
Approved: Yes
No
N/A
Date:FOR ZENTIVA
Signature:
HEAD
OFFICE USE
Other
- as required
Approved: Yes
No
ONLY
Date:
Signature:

00000000
00000000

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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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