Chlordiazepoxide 10mg capsules

Land: Verenigd Koninkrijk

Taal: Engels

Bron: MHRA (Medicines & Healthcare Products Regulatory Agency)

Werkstoffen:

Chlordiazepoxide hydrochloride

Beschikbaar vanaf:

A A H Pharmaceuticals Ltd

ATC-code:

N05BA02

INN (Algemene Internationale Benaming):

Chlordiazepoxide hydrochloride

Dosering:

10mg

farmaceutische vorm:

Oral capsule

Toedieningsweg:

Oral

klasse:

Schedule 4 (CD Benz)

Prescription-type:

Valid as a prescribable product

Product samenvatting:

BNF: 04010200; GTIN: 5025903001102

Bijsluiter

Athlone Laboratories Limited
Module 1 Administrative
Chlordiazepoxide 5mg & 10mg Capsules 1.3.1 Summary of Product
Characteristics, Labeling and Package Leaflet
Confidential
1
1.3.1
SUMMARY OF PRODUCT CHARACTERISTICS, LABELING AND
PACKAGE LEAFLET
1.3.2
PATIENT INFORMATION LEAFLET
PATIENT INFORMATION LEAFLET
CHLORDIAZEPOXIDE 5mg AND 10mg CAPSULES
Read all of this leaflet carefully before you start taking this
medicine.
•
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. Do not pass it on to
others. It may
harm them, even if their symptoms are the same as yours.
•
If any of the side effects get serious, or if you notice any side
effects not listed in
this leaflet, please tell your doctor or pharmacist.
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


symptoms of alcohol withdrawal


anxiety causing distress or insomnia (difficulty sleeping)


anxiety occurring with mental health problems
2.
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
IN THIS LEAFLET
1.
What your medicine is and what it is used for
2.
Before you take your medicine
3.
How to take your medicine
4.
Possible side effects
5.
How to store your medicine
6.
Further information
Athlone Laboratories Limited
Module 1 Administrative
Chlordiazepoxide 5mg & 10mg Capsules 1.3.1 Summary of Product
Characteristics, Labeling and Package Leaflet
Confide

Productkenmerken

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Chlordiazepoxide 10mg Capsules
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Chlordiazepoxide Hydrochloride 10 mg
For a full list of excipients, see section 6.1
3
PHARMACEUTICAL FORM
Capsule
Size 4 Capsule. Body: white Cap: green
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
FOR SHORT TERM (2 – 4 WEEKS ONLY) USE
•
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.
NOT FOR USE
•
Long term (i.e. longer than 4 weeks)
•
For mild anxiety
•
In children
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Route of administration: oral
Posology:
Treatment to be given
•
under close medical supervision
•
at the lowest effective dose
•
for the shortest possible duration (not exceeding 4 weeks)
The dosage and duration of treatment should be determined on an
individual
basis dependent by the patient's response and severity of the
disorder. Given
that chlordiazepoxide is a long-acting benzodiazepine, the patient
should be
monitored regularly at the start of the treatment to decrease, if
necessary, the
dose or frequency of administration to prevent overdose due to
accumulation.
The
patient
should
be
reassessed
regularly
and
the
need
for
continued
treatment should be evaluated, especially in case the patient is
symptom free.
Extension of use should not take place without further clinical
evaluation
Chronic use not recommended (little is known of the long term safety
and
efficacy: potential for dependence – see section 4.4).
When treatment is started the patient should be informed that
•
treatment will be of limited duration
•
the dosage will be progressively decreased
•
there is the possibility of rebound phenomena.
ANXIETY
_Adults _
•
Starting dose 5 mg daily: usual dose up to 30mg in divided