Chlordiazepoxide 10mg tablets

Țară: Regatul Unit

Limbă: engleză

Sursă: MHRA (Medicines & Healthcare Products Regulatory Agency)

Ingredient activ:

Chlordiazepoxide hydrochloride

Disponibil de la:

Dr Reddy's Laboratories (UK) Ltd

Codul ATC:

N05BA02

INN (nume internaţional):

Chlordiazepoxide hydrochloride

Dozare:

10mg

Forma farmaceutică:

Oral tablet

Calea de administrare:

Oral

Clasă:

Schedule 4 (CD Benz)

Tip de prescriptie medicala:

Valid as a prescribable product

Rezumat produs:

BNF: 04010200

Prospect

PACKAGE LEAFLET: INFORMATION FOR THE USER
CHLORDIAZEPOXIDE 5MG & 10MG FILM-COATED TABLETS
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU STARTS 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 are Chlordiazepoxide film-coated Tablets and what they are used
for
2.
What you need to know before you take Chlordiazepoxide
film-coated Tablets
3.
How to take Chlordiazepoxide film-coated Tablets
4.
Possible side effects
5.
How to store Chlordiazepoxide film-coated Tablets
6.
Contents of the pack and other information
1. WHAT CHLORDIAZEPOXIDE FILM-COATED TABLETS ARE AND WHAT THEY ARE
USED FOR
The
active
ingredient
(which
makes
the
tablets
work)
is
chlordiazepoxide
hydrochloride. It belongs to a group of drugs known as benzodiazepines
and has a
calming effect.
Chlordiazepoxide film-coated Tablets are used for the short-term
relief (2-4 weeks only) OF SEVERE OR DISABLING ANXIETY occurring alone
or along with
sleeping problems, MUSCLE SPASM OF VARIED CAUSES and for the RELIEF OF
SYMPTOMS
OF SUDDEN ALCOHOL WITHDRAWAL.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE CHLORDIAZEPOXIDE FILM-COATED TABLETS
DO NOT TAKE CHLORDIAZEPOXIDE TABLETS if you:
•
have had any UNUSUAL OR ALLERGIC
REACTIONS to chlordiazepoxide,
other benzodiazepine medicines or
to any of the other ingredients in
the tablets (see Section 6).
•
have a disorder known as
MYASTHENIA GRAVIS a condition
where muscles become easily tired
and weak leading to difficulty
breathing
•
have SEVERE LIVER DISEASE
•
suffer from lung disease or
BREATHING DIFFICULTIES
•
have a condition called SLEEP
APNOEA wher

Caracteristicilor produsului

CHLORDIAZEPOXIDE 10MG FILM-COATED TABLETS
Summary of Product Characteristics Updated 22-Mar-2016 | Dr. Reddy's
Laboratories (UK) Ltd
1. Name of the medicinal product
Chlordiazepoxide 10 mg Film-coated Tablets
2. Qualitative and quantitative composition
Chlordiazepoxide hydrochloride equivalent to 10mg Chlordiazepoxide
For a full list of excipients, see section 6.1
3. Pharmaceutical form
Film-coated tablet
Plain, biconvex, mid-green, film coated tablets
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 (ie 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