Chlordiazepoxide 10mg 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:

10mg

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

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 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 OR
NURSE. THIS INCLUDES ANY POSSIBLE SIDE EFFECTS NOT LISTED IN THIS LEAFLET. SEE SECTION 4. WHAT IS IN THIS LEAFLET
1. What your medicine is and what it is used for
2. What you need to know before you take your medicine
3. How to take your medicine
4. Possible side effects
5. How to store your medicine
6. Contents of the pack and other information
Colours
CUSTOMER: IS
DESIGNER: AWG-MAT
PRODUCT: CDP 5mg x 100 Capsules
ITEM CODE: CP.CDP.JNT.C.IS.V5P1
PROOF NO AND DATE: 1 10/07/2018
REVISION: UPDATE TO ENTIRE PIL
ARTWORK FOR SUBMISSION
Supersedes: n/a
Pantone Blue
280 C
DIMENSIONS: 148mm x 400mm
CP.CDP.JNT.C.IS.V5P1
CP.CDP.JNT.C.IS.V5P1 WHAT YOUR MEDICINE IS AND WHAT IT IS 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.
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 YOUR MEDICINE
DO NOT TAKE YOUR MEDICINE IF YOU:
• are allergic to chlordiazepoxide or any of the
other ingredients in chlordiazepoxide
capsules. An allergic reaction may include a
rash, itching, difficulty breathing or swelling of
the face, lips, throat or tongue
• have reduced blood flow to the lungs -
symptoms may include coughing and
s

Summary of Product characteristics

OBJECT 1
CHLORDIAZEPOXIDE 10MG CAPSULES
Summary of Product Characteristics Updated 22-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 10mg Capsules
2. Qualitative and quantitative composition
Chlordiazepoxide Hydrochloride Ph. Eur. 10 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
sever