FRISIUM TABLETS 10MG

Active substance: CLOBAZAM

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R771890

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COMPIÈGNE
COMPIÈGNE



A1-02.06.2006
CRGB-V1-05/2012
1-606062
606062-1d
150 x 210 mm
10 pts




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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

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Do not take Frisium if:

 You are allergic (hypersensitive) to

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2. BEFORE YOU TAKE FRISIUM
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
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.
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

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. Alcohol should
not be taken during treatment with
Frisium as there is an increased risk of
experiencing side effects.
L You are over 65. This is due to the
increased sensitivity to adverse
reactions in the elderly such as
drowsiness, dizziness and muscle
weakness. There is also an increased risk
of fall that may result in serious injury.
L You have difficulty digesting medicines.
Some patients liver may not metabolise
(break down) medicines adequately. In
these patients the medicine may
remain in the body for a longer
period of time. This may result in

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Frisium
R771890
10 mg
30 cprs

Clobazam

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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)

Couleur
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Frisium®
®
10 mg Tablets

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.

Sanofi
Grande-Bretagne

1. WHAT FRISIUM IS AND
WHAT IT IS USED FOR

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 You stop breathing for short periods

PACKAGE LEAFLET:
INFORMATION FOR THE USER

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Frisium
R771890
10 mg
30 cprs

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Couleur
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A1-02.06.2006
CRGB-V1-05/2012
1-606062
606062-1d
150 x 210 mm
10 pts

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Taking Frisium with food and drink
• Do not drink alcohol while taking
Frisium. This is because there is
increased risk of sleepiness and other
side effects.
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. In this case the
newborn should be closely monitored
during the postnatal period.

Sanofi
Grande-Bretagne

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.
In particular, tell your doctor if you are
taking any of the following:
• Medicines for epilepsy (such as
phenytoin, carbamazepine, stiripentol
or valproic acid)
• Medicines for depression (such as
Monoamine Oxidase Inhibitors (MAOIs)
or tricyclic anti-depressants - such as
trazodone or Selective Serotonin
Re-uptake Inhibitors (SSRIs) such as
fluvoxamine or paroxetine
• Medicines for severe mental illness
called 'antipsychotics' (such as
chlorpromazine, haloperidol, clozapine
and pimozide)
• 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
• Omeprazole - used to treat the
symptoms of acid reflux such as
heartburn or acid regurgitation.
• Ticlopidine - an antiplatelet medication
used in patients with an increased risk
of stroke
• Fluconazole - used in the treatment of
fungal conditions
• Dextromethorphan - used to relieve dry,
irritating coughs
• Nebivolol - medicine used to treat high
blood pressure.
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.

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side effects. If you are known to poorly
metabolise certain medicines please
speak to your doctor.
If you are not sure if any of the above
apply to you, talk to your doctor or
pharmacist before taking 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.

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A1-02.06.2006
CRGB-V1-05/2012
1-606062
606062-1d
150 x 210 mm
10 pts

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)

Frisium
R771890
10 mg
30 cprs

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4. POSSIBLE SIDE EFFECTS

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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, or crushed and
mixed with apple sauce. The tablets can be
divided into equal halves of 5mg. Frisium
can be taken with or without food.

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3. HOW TO TAKE FRISIUM

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• 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
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.

Sanofi
Grande-Bretagne

H

• 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
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

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The medicine can affect your ability to
drive as it may make you sleepy or dizzy.
• Do not drive while taking this medicine
until you know how it affects you.
• It is an offence to drive if this medicine
affects your ability to drive.
• However, you would not be committing
an offence if:
The medicine has been prescribed to
treat a medical or dental problem and
You have taken it according to the
instructions given by the prescriber or
in the information provided with the
medicine and
It was not affecting your ability to
drive safely.
Talk to your doctor or pharmacist if you
are not sure whether it is safe for you to
drive while taking this medicine.
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.

Code sécurité
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Version N°

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21/03/2014
E Wasczczyk
Nom du produit
Référence article
Dosage
Quantité

Type Article

Frisium
R771890
10 mg
30 cprs

Notice double

N° version Logo/Name
N° version Country Ex.
N° plan Dimensionnel
N° plan positionnement
Dimensions
Taille mini caractères
A1-02.06.2006
CRGB-V1-05/2012
1-606062
606062-1d
150 x 210 mm
10 pts
Code sécurité
771890

R771890

This leaflet was last revised in March 2014
© Sanofi, 1997 - 2014

Numéro de Pages
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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.
Marketing Authorisation Holder and
Manufacturer
Marketing Authorisation Holder
Sanofi
One Onslow Street
Guildford
Surrey
GU1 4YS
Tel: 0845 372 7101
email: uk-medicalinformation@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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• Keep out of the sight and reach 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

6. FURTHER INFORMATION

1

5. HOW TO STORE FRISIUM

no longer required. These measures will
help to protect the environment.

Couleur
Nbre/Réf.

• Problems walking or other movement
problems
• Being aggressive
• Reacting to things more slowly than usual
• Eye problems such as double vision and
rapid uncontrollable movement of the eyes
• Difficulty in staying awake or alert
• Becoming dependent on Frisium (also
called ‘physical or mental dependence’)
• Weight gain
• Loss of sexual drive
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.
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.

Sanofi
Grande-Bretagne

• Feeling suicidal
• increased possibility of tripping or falling
especially in elderly patients.
• Blistering or bleeding of the skin around
the lips, eyes, mouth, nose and genitals.
Also flu-like symptoms and fever. This
may be something called 'Stevens
Johnson Syndrome' which is a severe
blistering rash where layers of the skin
may peel off to leave large areas of raw
exposed skin over the body. Also a feeling
of being generally unwell, fever, chills
and aching muscles. This is something
called 'Toxic epidermal necrolysis'
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

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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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