Chlordiazepoxide 5mg capsules

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Chlordiazepoxide hydrochloride

Available from:

DE Pharmaceuticals

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

OBJECT 1
CHLORDIAZEPOXIDE 5MG CAPSULES
Summary of Product Characteristics Updated 21-Aug-2018 | Kent
Pharmaceuticals Ltd
•
1. Name of the medicinal product
•
2. Qualitative and quantitative composition
•
3. Pharmaceutical form
•
4. Clinical particulars
•
4.1 Therapeutic indications
•
4.2 Posology and method of administration
•
4.3 Contraindications
•
4.4 Special warnings and precautions for use
•
4.5 Interaction with other medicinal products and other forms of
interaction
•
4.6 Fertility, pregnancy and lactation
•
4.7 Effects on ability to drive and use machines
•
4.8 Undesirable effects
•
4.9 Overdose
•
5. Pharmacological properties
•
5.1 Pharmacodynamic properties
•
5.2 Pharmacokinetic properties
•
5.3 Preclinical safety data
•
6. Pharmaceutical particulars
•
6.1 List of excipients
•
6.2 Incompatibilities
•
6.3 Shelf life
•
6.4 Special precautions for storage
•
6.5 Nature and contents of container
•
6.6 Special precautions for disposal and other handling
•
7. Marketing authorisation holder
•
8. Marketing authorisation number(s)
•
9. Date of first authorisation/renewal of the authorisation
•
10. Date of revision of the text
1. Name of the medicinal product
Chlordiazepoxide 5mg Capsules
2. Qualitative and quantitative composition
Chlordiazepoxide Hydrochloride Ph. Eur. 5 mg
3. Pharmaceutical form
Capsule
4. Clinical particulars
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_
Starting dose 5mg daily: usual dose up to 30mg in divided doses. For
severe s