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TEMOZOLOMIDE 180MG CAPSULES

Active substance: TEMOZOLOMIDE

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Mylan Design Department,
Albany Gate, Darkes Lane,
Potters Bar, Herts, EN6 1AG

Font & Point Size:
Myriad Pro 22pt & 10.5 pt

PACKAGE LEAFLET: INFORMATION FOR THE USER

TEMOZOLOMIDE 140 mg CAPSULES
TEMOZOLOMIDE 180 mg CAPSULES
TEMOZOLOMIDE 250 mg CAPSULES
(temozolomide)

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:
1. What Temozolomide is and what it is used for.
2. Before you take Temozolomide.
3. How to take Temozolomide.
4. Possible side effects.
5. How to store Temozolomide.
6. Further information.
1. WHAT TEMOZOLOMIDE IS AND WHAT IT IS USED FOR

Proof Revision Reason: Text / Style changes

Change/Creation Reason: 1B variation register batch release site

ARTWORK FOR SUBMISSION

Black

Pharma: TBC
Supersedes: 10003858
PL: 04569/1048/1049/1050

Packed @: Amareg

AWCC: 1501
Code: 10004377
Proof # & Date: 4 08/10/12

Dimensions: 148 x 889 mm

Designer: Damian Crosby
Customer: Mylan

Colours
PMS:

Product: Temozolomide Capsules 140, 180 & 250 mg

00000000-09/12

Temozolomide is an antitumour agent. Temozolomide is used for the treatment of
patients with specific 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.
2.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
begin treatment.
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 during 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 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.
• 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 accidentally get some in your eyes or nose, flush the area with water.
• 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 - Due to lack of experience, Temozolomide should not be used in children
younger than 3 years.
Infertility - 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).

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 medicine, ask your doctor or
pharmacist.
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
• 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:
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: affects 1 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 newlydiagnosed 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: loss of appetite, headache, constipation (difficulty passing stools),
nausea (feeling sick in your stomach), vomiting, rash, hair loss, tiredness.
Common: 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: 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.

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

Very rare: skin redness, urticaria (hives), skin eruption, allergic reactions.

Driving and using machines - Temozolomide may make you feel tired or sleepy. In
this case, do not drive or use any tools or machines.

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.

Important information about some of the ingredients of Temozolomide Temozolomide capsules contain 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.
3. 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 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).
Concomitant 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.
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.
Administration - 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 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.

Strength

Colour/marking

Temozolomide 140 mg

Two stripes in blue ink on the cap and 'T 140 mg'
in blue ink on the body

Temozolomide 180 mg

Two stripes in red ink on the cap and 'T 180 mg'
in red ink on the body

Temozolomide 250 mg

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.
5. 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.
Bottle presentation
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.
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.
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.
6. FURTHER INFORMATION
What Temozolomide contains:
The active substance is temozolomide. Each capsule contains 140/180/250 mg
temozolomide.
The other ingredients are:
capsule content: anhydrous lactose, colloidal anhydrous silica, sodium starch
glycolate type A, tartaric acid, stearic acid.
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,
propylene glycol.
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 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 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 Authorisation 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.
Aegis Ltd, 17 Athinon Street, Ergates Industrial Area, 2643 Ergates, P.O.BOX 28629,
2081 Lefkosia, Cyprus.

Two stripes in black ink on the cap and 'T 250 mg'
in black ink on the body
This leaflet was revised in: September 2012

10004377

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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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