FRISIUM TABLETS 10MG

Active substance: CLOBAZAM

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• Keep this leaflet. You may need to
read it again.
• If you have any further questions,
ask you 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.

Read all of this leaflet
carefully before you start
taking this medicine.

Is this leaflet hard to see or
read?
Phone 01483 505515 for help

Clobazam

Frisium®
®
Tablets 10 mg

PACKAGE LEAFLET:
INFORMATION FOR THE USER

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R766340

Frisium contains a medicine called
Clobazam. This belongs to a group of
medicines called benzodiazepines. It
works by having a calming effect on
the brain.
Frisium can be used for:
• Severe anxiety over a short time
• Epilepsy (fits) over a longer time
• Mental illness such as schizophrenia
(in combination with other treatments)

1. WHAT FRISIUM IS AND
WHAT IT IS USED FOR

In this leaflet:
1. What Frisium is and what it is used for
2. Before you take Frisium
3. How to take Frisium
4. Possible side effects
5. How to store Frisium
6. Further information
clozabam, other benzodiazepine
medicines or any of the other
ingredients of Frisium (see section 6:
Further Information)
Signs of an allergic reaction include:
a rash, swallowing or breathing
problems, swelling of your lips, face,
throat or tongue
 You are in the first three months of
pregnancy or think you might be
pregnant (see below under
‘Pregnancy and breast-feeding’ for
more information)
 You are breast-feeding
 You have ever had problems with drugs
or alcohol dependence in the past
 You suffer from an illness that
causes muscle weakness (called
‘myasthenia gravis’)
 You have liver problems
 You have breathing problems
 You stop breathing for short periods
during sleep (called ‘sleep apnoea
syndrome’)
 The patient is under 6 years old
Do not take if any of the above apply
to you. If you are not sure, talk to
your doctor or pharmacist before
taking Frisium.

 You are allergic (hypersensitive) to

Do not take Frisium if:

2. BEFORE YOU TAKE FRISIUM

Taking Frisium with other
medicines
Please tell your doctor or pharmacist if
you are taking or have recently taken
any other medicines. This includes
medicines you buy without a
prescription, including herbal medicines.
This is because Frisium can affect the
way some other medicines work. Also
some medicines can affect the way
Frisium works.

Take special care with Frisium
Check with your doctor or pharmacist
before taking your medicine if:
L You have problems with controlling
your movements (called ‘spinal or
cerebellar ataxia’)
L You have depression, irrational fears
and obsessions
L You have delusions (believing things
which are not true) or hallucinations
(sensing things which are not there)
L You have kidney problems
L You have ever become dependent
upon another drug or alcohol
If you are not sure if any of the above
apply to you, talk to your doctor or
pharmacist before taking Frisium.

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In particular, tell your doctor if you are
taking any of the following:
• Medicines for epilepsy (such as
phenytoin, carbamazepine or valproic
acid)
• Medicines for depression (such as
MAOIs or tricyclic anti-depressants such as trazodone)
• Medicines for severe mental illness
called ‘neuroleptics’ (such as
chlorpromazine, haloperidol and
clozapine)
• Painkillers (such as medicines
containing codeine, dihydrocodeine
or morphine)
• Sleeping tablets (such as zolpidem)
• Tranquilisers (such as diazepam,
temazepam or lorazepam)
• Muscle relaxants (such as baclofen)
• Antihistamines that make you sleepy
(such as chlorphenamine,
promethazine or diphenenhydramine)
• Lithium - used for a mental illness
called ‘manic-depressive illness’
(mood changes between a state of
high excitability or exaggerated
emotions and depression)
• Cimetidine - used to treat ulcers and
heartburn
If you are not sure if any of the
above apply to you talk to your doctor
or pharmacist
Anaesthetics
If you are going to have an
anaesthetic, tell your doctor or
anaesthetist you are taking Frisium.
This is because your doctor may need
to change the amount of anaesthetic
or muscle relaxants to give you.
Taking Frisium with food and drink
• Do not drink alcohol while taking
Frisium. This is because alcohol can
change the way Frisium works
• Take your tablets with at least half a
glass of water
• Do not chew the tablets
Pregnancy and breast-feeding:
Do not take Frisium if you are:
• In the first three months of pregnancy
• Breast-feeding. This is because it may
pass into the mother’s milk
Talk to your doctor before taking this
medicine if you are pregnant, plan to get
pregnant, or think you may be pregnant.
This is because Frisium is not
recommended for use in pregnant women.
However, your doctor may give you this
medicine during late pregnancy or
during labour
• If this happens, there is a risk of
having a baby with a low body
temperature, floppiness, breathing or
feeding problems
• If this medicine is taken regularly in
late pregnancy, your baby may get
withdrawal symptoms

Always take Frisium exactly as your
doctor has told you. You should check
with your doctor or pharmacist if you
are not sure.
Taking this medicine
Swallow the tablets whole with half a
glass of water. Do not chew the tablets.
• If you feel the effect of your
medicine is too weak or too strong,
do not change the dose yourself, but
ask your doctor
• Keep taking Frisium until your doctor
tells you to stop
• Frisium is usually given for 2 to 4
weeks. After that, your doctor will
decide whether you should keep
taking this medicine

3. HOW TO TAKE FRISIUM

Driving and using machines
You may feel sleepy or have
concentration or memory problems
after taking this medicine. You may
also experience double vision or you
may react more slowly to things. If this
happens, do not drive or use any tools
or machines.
Important information about some of
the ingredients of Frisium
If you have been told by your doctor
that you cannot tolerate some sugars,
talk to your doctor before taking this
medicine. This is because Frisium
contains lactose.

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Adults
• The usual dose is 20 mg to 30 mg
each day. This can be taken as two
separate doses or as a single dose at
night
• Your doctor may increase your dose
to up to 60 mg each day
• Your doctor may lower the dose to
suit you
Children (6 years and above)
• The usual dose is 5 mg each day
Elderly
• The usual dose for anxiety is 10 mg
to 20 mg each day
If you take more Frisium than you
should
If you take more Frisium than you
should, tell your doctor or go to your
nearest hospital casualty department
straight away. Do not drive yourself,
because you may start to feel sleepy.
Remember to take with you any tablets
that are left and the pack. This is so
the doctor knows what you have taken.
If you forget to take Frisium
• If you forget a dose, take it as soon
as you remember it
• However, if it is nearly time for the
next dose, skip the missed dose
• Do not take a double dose to make
up for a forgotten tablet
Like all medicines, Frisium can cause
side effects, although not everybody
gets them.
You may feel ill after taking the
tablets, or notice unusual or
unexpected symptoms. If this happens,
tell your doctor.
Tell your doctor straight away if you
have any of the following side effects:
• Feeling restless, have difficulty
sleeping or nightmares
• Feeling irritable or anxious
• Believing things which are not true
(delusions)
• Sensing things which are not
there (hallucinations)
• Feeling suicidal

4. POSSIBLE SIDE EFFECTS

If you stop taking Frisium
Keep taking this medicine until your
doctor tells you to stop. Do not stop
taking Frisium just because you feel better
• When your doctor says that you can
stop taking Frisium, you need to do
this gradually. Your doctor will help
you to do this.
• Stopping the tablets can make you
feel stressed (anxiety), confused or
depressed. You may also lose your
appetite and have difficulty sleeping.
Tell your doctor if this happens.
If you have any further questions on
the use of this product, ask your
doctor or pharmacist.

If you get any of the above side
effects, your doctor may decide that
your treatment needs to be stopped.
These side-effects are more likely to
happen in elderly people and children.
Tell your doctor or pharmacist if any
of the following side effects get
serious or lasts longer than a few
days, or if you notice any side
effects not listed in this leaflet.
The following side effects are more likely
to happen at the start of treatment.
They usually last for a short time.
• Feeling sleepy or dizzy
• Dry mouth, constipation
• Loss of appetite, feeling sick
• Shaking fingers
Other side-effects include:
• Headache
• Breathing problems
• Loss of memory, confusion
• Skin rash
• Muscle weakness
• Problems walking or other movement
problems
• Being aggressive
• Reacting to things more slowly than
usual
• Eye problems such as double vision
• Difficulty in staying awake or alert
• Becoming dependent on Frisium (also
called ‘physical or mental
dependence’)
• Weight gain
• Loss of sexual drive



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R766340

What Frisium contains
Each tablet contains 10 mg clobazam
as active ingredient. They also contain
the following inactive ingredients:
lactose, maize starch, talc, colloidal
silicon dioxide and magnesium stearate.
What Frisium looks like and contents
of the pack
The tablets are white and round.
Frisium is presented in a blister pack
of 30 tablets.

6. FURTHER INFORMATION

• Keep out of the reach and sight of
children.
• Do not use Frisium after the expiry
date which is stated on the label.
The expiry date refers to the last
day of that month.
• If your tablets go out of date take them
to your pharmacist for safe disposal.
• Store below 25°C.
Medicines should not be disposed of via
wastewater or household waste. Ask your
pharmacist how to dispose of medicines
no longer required. These measures will
help to protect the environment.

5. HOW TO STORE FRISIUM

If you take this medicine for a long
time, you are more likely to get the
following side effects: anxiety, confusion,
depression, loss of appetite and
difficulty sleeping.

This leaflet was last revised in
May 2012
© Sanofi, 1997 - 2012

Marketing Authorisation Holder and
Manufacturer
Marketing Authorisation Holder
Sanofi
One Onslow Street
Guildford
Surrey
GU1 4YS
Tel: 01483 505515
Fax: 01483 535432
email: ukmedicalinformation@sanofi.com
Manufacturer
Sanofi Winthrop Industrie
56, route de Choisy au Bac
60205 Compiègne, France
This leaflet does not contain all
the information about your
medicine. If you have any
questions or are not sure about
anything, ask your doctor or
pharmacist.

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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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