Chlordiazepoxide 5mg capsules

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Chlordiazepoxide hydrochloride

Available from:

Actavis UK Ltd

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 5mg Capsules
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Chlordiazepoxide Hydrochloride Ph. Eur. 5 mg
Excipient with known effect:
Each capsule contains 50mg Lactose
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Capsule.
4.1.
THERAPEUTIC INDICATIONS
FOR SHORT TERM USE (2 – 4 WEEKS ONLY)
•
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
Chlordiazepoxide is not recommended; for long term use (i.e. longer
than 4
weeks), mild anxiety or for use in children.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY:
ANXIETY
_Adults _
Usual dose 10mg, up to 30mg in divided doses. For severe symptoms
20mg, 2-4 times
a day. Maximum dose up to 100mg daily, in divided doses, adjusted on
an individual
basis.
Treatment should not continue as full dose for more than 4 weeks
including 2 week
tapering off process.
INSOMNIA ASSOCIATED WITH ANXIETY
_Adults _
10 – 30 mg at bedtime
Treatment would normally vary from a few days to two weeks with a
maximum of
four weeks, including two weeks tapering off.
MUSCLE SPASM OF VARIED AETIOLOGY
_Adults _
10mg to 30mg daily in divided doses
SYMPTOMATIC RELIEF OF ACUTE ALCOHOL WITHDRAWAL
_Adults _
25 to 100mg, repeated if necessary in 2 to 4hrs
SPECIAL POPULATIONS
Elderly or debilitated patients, patients with organic brain damage,
respiratory
impairment should normally not exceed half of the doses normally
recommended.
_Patients with impaired hepatic or renal function _
Dosage should not exceed half the adult dose and steps should be taken
to ensure that
there is no accumulation of plasma chlordiazepoxide
Contraindicated in severe hepatic insufficiency (see section 4.3)
_Paediatric patients_
Chlordiazepoxide Capsules are not for paedia