Chlordiazepoxide 10mg capsules

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Chlordiazepoxide hydrochloride

Available from:

Sandoz 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

Patient Information leaflet

PATIENT INFORMATION LEAFLET- KENT & ALMUS
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.
1.
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
2.
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 shortness of breath

have any problems with your breathing

have anxiety disorders due to unreasonable thoughts and fears
(obsessional states)

havea long-term mental condition causing hallucinations and delusions
etc.

have sleep apnoea (stopping breathing while asleep)

have a severe liver disorder

have a muscle weakness disorder known as myasthenia gravis

suffer from depression that is not being treated.

Chlordiazepoxide capsules are not to be used in anyone under 18 years
of age.
WHAT IS IN THIS

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Chlordiazepoxide 10mg Capsules
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Chlordiazepoxide Hydrochloride 10 mg
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 _
Starting dose 5mg daily: usual dose 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
_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
impairmentshould 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 paediatric use.
Treatment should be given at the lowest effective dose. The dosage and
duration of
treatment should be deter