Clobazam Thame 5mg/5ml Oral Suspension

Country: Ireland

Bahasa: Inggeris

Sumber: HPRA (Health Products Regulatory Authority)

Bahan aktif:

Clobazam

Boleh didapati daripada:

SYRI Limited, t/a Thame Laboratories

Kod ATC:

N05BA; N05BA09

INN (Nama Antarabangsa):

Clobazam

Dos:

5 mg/5ml

Borang farmaseutikal:

Oral suspension

Jenis preskripsi:

Product subject to prescription which may not be renewed (A)

Kawasan terapeutik:

Benzodiazepine derivatives; clobazam

Status kebenaran:

Not marketed

Tarikh kebenaran:

2016-02-19

Risalah maklumat

VAR/IB-010
1.3.1 Package leaflet
PACKAGE LEAFLET: INFORMATION FOR THE USER
CLOBAZAM THAME 5MG/5ML ORAL SUSPENSION
CLOBAZAM THAME 10MG/5ML ORAL SUSPENSION
(clobazam)
READ ALL OF 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.

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 of the side effects, talk to your doctor or pharmacist.
This includes any
possible side effects not listed in this leaflet. See section 4.
The name of your medicine is Clobazam Thame 5mg/5ml or 10mg/5ml Oral
Suspension but
will be referred to as Clobazam throughout this leaflet.
WHAT IS IN THIS LEAFLET:
1. WHAT CLOBAZAM IS AND WHAT IT IS USED FOR
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE CLOBAZAM
3. HOW TO TAKE CLOBAZAM
4. POSSIBLE SIDE EFFECTS
5. HOW TO STORE CLOBAZAM
6. CONTENTS OF THE PACK AND OTHER INFORMATION
1.
WHAT CLOBAZAM IS AND WHAT IT IS USED FOR
This medicine contains the active substance clobazam which belongs to
a group of medicines
called benzodiazepines.
It works by having a calming effect on the brain.
CLOBAZAM 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
DO NOT TAKE CLOBAZAM IF:

You are allergic (hypersensitive) to clobazam, other benzodiazepine
medicines or any of
the other ingredients of Clobazam (see section 6). 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

Ciri produk

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Clobazam Thame 5mg/5ml Oral Suspension
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
The active substance is clobazam.
Each 5ml of oral suspension contains 5mg clobazam.
Excipients with known effect:
Each 5ml of oral suspension contains 7.5mg of methyl
parahydroxybenzoate (E218), 10mg sucralose (E955) and
2.24mg of sodium.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Oral Suspension
White to off-white viscous suspension.
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
Posology
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.
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