Clobazam 10mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Clobazam

Available from:

Waymade Healthcare Plc

ATC code:

N05BA09

INN (International Name):

Clobazam

Dosage:

10mg

Pharmaceutical form:

Oral tablet

Administration route:

Oral

Class:

Schedule 4 (CD Benz)

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 04080100

Patient Information leaflet

PATIENT INFORMATION LEAFLET
CLOBAZAM ACCORD 10MG TABLETS
(CLOBAZAM)
READ 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 later.
• If you have any further questions, ask your doctor or pharmacist.
• 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 or pharmacist.
This includes any possible side effects not
listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET:
1 What Clobazam 10mg Tablets are and what they are used for
2 What you need to know before you take Clobazam 10mg Tablets
3 How to take Clobazam 10mg Tablets
4 Possible side effects
5 How to store Clobazam 10mg Tablets
6 Contents of the pack and other information
1. WHAT CLOBAZAM 10MG TABLETS ARE AND WHAT THEY ARE USED FOR
Clobazam 10mg Tablets contain a medicine called clobazam. This belongs
to a group of medicines called benzodiazepines. It works by having a
calming
effect on the brain.
Clobazam 10mg Tablets 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)
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE CLOBAZAM 10MG TABLETS
DO NOT take Clobazam 10mg Tablets:
• if you are allergic to clobazam or any other ingredients of this
medicine (listed in section 6). An allergic reaction may include a
rash, itching, difficulty in
breathing or swelling of the face, lips, throat or tongue
• if you have a very severe form of muscle weakness namely
myasthenia gravis
• if you stop breathing for short periods during sleep (called
‘sleep apnoea syndrome’)
• if you have liver problems
• if 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)
• if you are breast feeding
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Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Clobazam Accord 10mg Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Clobazam 10 mg
Clobazam 10mg Tablets contain lactose. For full list of excipients,
see section 6.1.
3
PHARMACEUTICAL FORM
Tablet
White to off-white, circular tablet, one-side scored and the other
marked ‘CB 10’.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Clobazam is a 1,5-benzodiazepine indicated for the short-term relief
(2-4 weeks) only
of anxiety that is severe, disabling or subjecting the individual to
unacceptable
distress, occurring alone or in association with insomnia or short
term psychosomatic,
organic or psychotic illness. The use of clobazam to treat short-term
“mild” anxiety is
inappropriate and unsuitable.
Before treatment of anxiety states associated with emotional
instability, it must first
be determined whether the patient suffers from a depressive disorder
requiring
adjunctive or different treatment. Indeed, in patients with anxiety
associated with
depression, clobazam must be used only in conjunction with adequate
concomitant
treatment. Use of benzodiazepine (such as clobazam) alone, can
precipitate suicide in
such patients.
In patients with schizophrenic or other psychotic illnesses, use of
benzodiazepines is
recommended only for adjunctive, i.e. not for primary treatment.
Clobazam may be used as adjunctive therapy in epilepsy.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
_Treatment of anxiety _
The usual anxiolytic dose for adults is 20-30mg daily in divided doses
or as a
single dose given at night. Doses up to 60mg daily have been used in
the
treatment of adult in-patients with severe anxiety.
The lowest dose that can control symptoms should be used. After
improvement of the symptoms, the dose may be reduced.
It should not be used for longer than 4 weeks. Long term chronic use
as an
anxiolytic is not recommended. In certain cases, extension beyond the
maximum treatment period may be necessary; treatment must not be
extended
without re-evaluat