Chlordiazepoxide 5mg capsules

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Chlordiazepoxide hydrochloride

Available from:

Sigma Pharmaceuticals Plc

ATC code:

N05BA02

INN (International Name):

Chlordiazepoxide hydrochloride

Dosage:

5mg

Pharmaceutical form:

Oral capsule

Administration route:

Oral

Class:

Schedule 4 (CD Benz)

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 04010200

Patient Information leaflet

Product:
Chlordazepoxide 5mg & 10mg
Item Code:
P0971T
Size:
210 x 297 mm
Min. Point size:
8.5pt
O. Artwork:
19/09/19
Proof No.
7
Amendment Date
11/05/20
Process Black
Keyline - Does not print
Colours Used
PATIENT INFORMATION LEAFLET
CHLORDIAZEPOXIDE
Capsules
5mg & 10mg
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 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 Chlordiazepoxide Capsules are and what they are
used for
2. What you need to know before you take Chlordiazepoxide
Capsules
3. How to take Chlordiazepoxide Capsules
4. Possible side effects
5. How to store Chlordiazepoxide Capsules
6. Contents of the pack and other information
This medicine belongs to the group of medicines known as
benzodiazepines. These are used for depressing the central nervous
system (CNS) (medicines that slow down the nervous system).
This medicine is used for the short term relief of severe anxiety,
treatment of insomnia (trouble in sleeping), control of muscle spasms
and symptomatic relief of acute alcohol withdrawal.
This medicine should be used for as short a time as possible and
should not be used for more than four weeks. If used for too long
without a break, there is a risk of becoming dependent or of having
problems when you stop taking it.
The risk of dependence (a need to keep taking the medicine)
increases with dose and length of treatment period and is greater if
you have ever had a history of alcohol or drug abuse, or in patients
with personality disorders. Your doctor will monitor you whilst you
are taking this medicine and will withdraw

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Chlordiazepoxide 5 mg Capsules
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains 5 mg of the active ingredient Chlordiazepoxide
Hydrochloride.
Each capsule also contains 127.0 mg lactose. For the full list of
excipients, see
section 6.1
3
PHARMACEUTICAL FORM
Capsule, hard
Size 4 capsule with yellow body and black cap, printed MP1 in white.
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
Posology
ANXIETY
_Adults: _
The usual dose should be 10 mg, 2 – 3 times daily and up to 30 mg
daily in divided
doses
For severe symptoms 20 mg, 2 – 4 times a day and maximum dose up to
100 mg
daily in divided doses, adjusted on an individual basis.
Generally, duration of treatment should not be more than 4 weeks,
including a
tapering-off process.
INSOMNIA ASSOCIATED WITH ANXIETY
_Adults: _
10-30 mg before retiring. Generally, duration of treatment varies from
a few days to
two weeks, with a maximum including a tapering-off process of four
weeks.
SYMPTOMATIC RELIEF OF ACUTE ALCOHOL WITHDRAWAL
_Adults: _
25-100 mg dose, repeated if necessary in 2 - 4 hours.
MUSCLE SPASM OF VARIED AETIOLOGY
_Adults: _
10-30 mg daily in divided doses.
PAEDIATRIC PATIENTS
Chlordiazepoxide is not for paediatric use
SPECIAL POPULATIONS
_Elderly and/or debilitated patients/patients with organic brain
damage, respiratory _
_impairment_
Dosage should not exceed half the adult dose.
_Hepatic or renal function;_
•
Dosage should not exceed half the adult dose and steps should be taken
to ensure
that