Chlordiazepoxide 10mg capsules

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Chlordiazepoxide hydrochloride

Available from:

Kent Pharma (UK) Ltd

ATC code:

N05BA02

INN (International Name):

Chlordiazepoxide hydrochloride

Dosage:

10mg

Pharmaceutical form:

Oral capsule

Administration route:

Oral

Class:

Schedule 4 (CD Benz)

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 04010200; GTIN: 5015201007968

Patient Information leaflet

PATIENT INFORMATION LEAFLET
CHLORDIAZEPOXIDE 5MG AND 10MG CAPSULES
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 FURTHER QUESTIONS, ASK YOUR DOCTOR, NURSE 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, NURSE 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
Colours
CUSTOMER: Kent
DESIGNER: ABC (AWG)
PRODUCT: CDP 5mg x 10mg Capsules
ITEM CODE: CP.CDP.JNT.C.IS.V10P1
PROOF NO AND DATE: 1 12/04/2022
REVISION:
Removal Ashford as batch release site
ARTWORK FOR SUBMISSION
Supersedes: V9P1
Pantone
280 C
DIMENSIONS: 148mm x 500mm WHAT CHLORDIAZEPOXIDE CAPSULES ARE AND WHAT THEY ARE USED FOR
The name of your medicine is Chlordiazepoxide
5mg Capsules or Chlordiazepoxide 10mg
Capsules.
Chlordiazepoxide is a member of a group of
medicines called benzodiazepine anxiolytics
(calming effect medicines).
Your medicine can be used for the short-term
relief (2-4 weeks treatment only) of:
• muscle spasm of varied cause
• symptoms of alcohol withdrawal
• anxiety causing distress or insomnia (difficulty
sleeping)
• anxiety occurring with mental health problems WHAT YOU NEED TO KNOW BEFORE YOU TAKE CHLORDIAZEPOXIDE CAPSULES
DO NOT TAKE YOUR MEDICINE IF YOU:
• are allergic to chlordiazepoxide or any of the
other ingredients in chlordiazepoxide
capsules (listed in section 6), or to any
medicine known as a benzodiazepine (e.g.
nitrazepam, diazepam, flurazepam, o

Summary of Product characteristics

OBJECT 1
CHLORDIAZEPOXIDE 10MG CAPSULES
Summary of Product Characteristics Updated 13-Apr-2022 | Kent Pharma
UK 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 10mg Capsules
2. Qualitative and quantitative composition
Chlordiazepoxide Hydrochloride Ph. Eur. 10 mg
Excipient with known effect:
Each capsule contains 100mg Lactose
For the full list of excipients, see section 6.1.
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 adminis