Librium 10mg Hard Capsule

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

CHLORDIAZEPOXIDE HYDROCHLORIDE

Available from:

Mylan IRE Healthcare Limited

ATC code:

N05BA; N05BA02

INN (International Name):

CHLORDIAZEPOXIDE HYDROCHLORIDE

Dosage:

10 milligram(s)

Pharmaceutical form:

Capsule, hard

Prescription type:

Product subject to prescription which may not be renewed (A)

Therapeutic area:

Benzodiazepine derivatives; chlordiazepoxide

Authorization status:

Marketed

Authorization date:

1977-04-01

Patient Information leaflet

PACKAGE LEAFLET
PACKAGE LEAFLET: INFORMATION FOR THE USER
LIBRIUM
LIBRIUM 5 MG HARD CAPSULES
LIBRIUM 10 MG HARD CAPSULES
CHLORDIAZEPOXIDE HYDROCHLORIDE
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. This
includes any possible side effects
not listed in this leaflet. See section 4.
The name of your medicine is Librium 5 mg and 10 mg Hard Capsules,
which will be called Librium
capsules throughout this leaflet.
WHAT IS IN THIS LEAFLET:
1.
What Librium capsules are and what they are used for
2.
What you need to know before you take Librium capsules
3.
How to take Librium capsules
4.
Possible side effects
5.
How to store Librium capsules
6.
Contents of the pack and other information
1.
WHAT LIBRIUM CAPSULES ARE AND WHAT THEY ARE USED FOR
Librium capsules contain the active ingredient chlordiazepoxide
hydrochloride, which belongs to a group of
medicines called benzodiazepines.
Librium capsules are used:

For the short-term (2-4 weeks) treatment of severe anxiety, which may
occur alone or in association
with sleeplessness (insomnia) or personality/behavioural disorders.

To control muscle spasm

In the management of alcohol withdrawal
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE LIBRIUM CAPSULES
DO NOT TAKE LIBRIUM CAPSULES:
–
If you have a condition called myasthenia gravis
–
If you have severe breathing difficulties
–
If you have sleep apnoea syndrome (breathing problems when asleep)
–
If you have severe liver disease
–
If you suffer from spinal or cerebral ataxia (loss of full control of
bodily movements)
–
If you are allergic to chlordiazepoxide, other similar drugs
(benzodiazepines), or a

Summary of Product characteristics

Health Products Regulatory Authority
26 November 2020
CRN00C1YH
Page 1 of 8
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Librium 10mg Hard Capsule
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains 10 mg of chlordiazepoxide hydrochloride.
Excipients: Each capsule contains 100.8 mg of lactose monohydrate.
Full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Capsule, hard (capsule)
Size No. 4, opaque hard gelatin capsules having a green body and a
black cap, imprinted with the monogram 'LIB 10' in
red-brown and containing a white to off-white powder.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
1. Short-term (2-4 weeks) symptomatic treatment 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.
2. In the control of muscle spasm.
3. In the management of alcohol withdrawal.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Anxiety_
Treatment should be as short as possible. The patient should be
reassessed regularly and the need for continued treatment
should be evaluated, especially in case the patient is symptom free.
The overall duration of treatment generally should not be
more than 4 weeks, including a tapering off process.
In certain cases, extension beyond the maximum treatment period may be
necessary; if so, it should not take place without
re-evaluation of the patient's status with special expertise. Little
is known regarding the efficacy or safety of benzodiazepines in
long-term use. Long-term chronic use is not recommended.
Treatment should always be tapered off gradually. Patients who have
taken benzodiazepines for a prolonged period may
require a longer period during which doses are reduced. Specialist
help may be appropriate.
_Adults_
_Anxiety states including muscle spasms:_
The usual total daily dosage is up to 30mg in divided doses. In severe
cases this may be increased to a total daily dosage of 40
to 10