Chlordiazepoxide 5mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Chlordiazepoxide hydrochloride

Available from:

Alliance Healthcare (Distribution) Ltd

ATC code:

N05BA02

INN (International Name):

Chlordiazepoxide hydrochloride

Dosage:

5mg

Pharmaceutical form:

Oral tablet

Administration route:

Oral

Class:

Schedule 4 (CD Benz)

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 04010200

Patient Information leaflet

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 become serious, or if you
notice any side effects not listed in this leaflet,
please tell your doctor or pharmacist.
THIS LEAFLET CONTAINS
1. WHAT CHLORDIAZEPOXIDE IS FOR
2. BEFORE YOU TAKE CHLORDIAZEPOXIDE
PACKAGE LEAFLET: INFORMATION FOR THE USER
CHLORDIAZEPOXIDE
5 MG & 10 MG TABLETS
1. WHAT CHLORDIAZEPOXIDE IS FOR
2. BEFORE YOU TAKE CHLORDIAZEPOXIDE
3. HOW TO TAKE CHLORDIAZEPOXIDE
4. POSSIBLE SIDE EFFECTS
5. HOW TO STORE CHLORDIAZEPOXIDE
6. FURTHER INFORMATION
Chlordiazepoxide belongs to a group of medicines called
benzodiazepines. It can be used in the SHORT-TERM (2-4
weeks only) treatment of:
IN ADULTS:

severe anxiety, occurring alone or in association with
insomnia (difficulty in sleeping), stress or a loss of
control with reality (psychosis)

muscle spasms

the symptoms of alcohol withdrawal.
Chlordiazepoxide tablets are NOT FOR USE IN CHILDREN.
If you are not sure why you have been prescribed this
medicine then please ask your doctor.
DO NOT TAKE CHLORDIAZEPOXIDE AND TELL YOUR DOCTOR IF
YOU:

are allergic to Chlordiazepoxide, any of the other
ingredients in the tablets (listed in section 6 of this
leaflet) or to other benzodiazepines

have severe liver, lung or breathing problems

have muscle weakness sometimes causing difficulty
breathing (myasthenia gravis)

suffer from breathing problems whilst asleep (sleep
apnoea)

suffer from depression, mental health problems,
irrational fears (phobias) or obsessions

are pregnant, planning to become pregnant or are
breast-feeding, (see ‘Pregnancy and breast-feeding’
below)
TAKE SPECIAL CARE WITH CHLORDIAZEPOXIDE
Tell your doctor BEFORE you take this medicine if you:

have a h

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Chlordiazepoxide 5 mg Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Chlordiazepoxide Hydrochloride 5.6 mg
Also contains lactose and sunset yellow E110, for a full list of
excipients, see
section 6.1
3
PHARMACEUTICAL FORM
Film-coated tablet
Mid-green, round, biconvex film-coated tablets with MP3 engraved on
one side.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
For short-term (2-4 weeks only) use:
•
symptomatic relief 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.
•
Muscle spasm of varied aetiology
•
Symptomatic relief of acute alcohol withdrawal
Not for use:
•
Long term (i.e. longer than 4 weeks)
•
For mild anxiety
•
In children
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Route of administration: oral
Treatment to be given
•
under close medical supervision
•
at the lowest effective dose
•
for the shortest possible duration (not exceeding 4 weeks)
Extension of use should not take place without further clinical
evaluation
Chronic use not recommended (little is known of the long term safety
and
efficacy: potential for dependence - see section 4.4).
When treatment is started it may be useful to inform the patient that
treatment
will be of limited duration and to explain precisely how the dosage
will be
progressively decreased. Moreover, it is important that the patient
should be
aware of the possibility of rebound phenomena, thereby minimising
anxiety
over such symptoms should they occur while the medicinal product has
been
discontinued.
Anxiety
Adults:
The starting dose should be 5 mg daily increasing to a usual dose of
up to 30
mg in divided doses, but up to a maximum dose of 100 mg daily, in
divided
doses adjusted on an individual basis.
Treatment should always be as short as possible and should not
continue at full
dose for more than 2 weeks with a 2 week tapering off pro