Valium Tablets 5mg

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

DIAZEPAM

Available from:

Roche Products Limited 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom

ATC code:

N05BA01

INN (International Name):

DIAZEPAM 5 mg

Pharmaceutical form:

TABLET

Composition:

DIAZEPAM 5 mg

Prescription type:

POM

Therapeutic area:

PSYCHOLEPTICS

Authorization status:

Withdrawn

Authorization date:

2006-05-26

Patient Information leaflet

1
mt-pl-tracked
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
VALIUM® 5 MG TABLETS
ROCHE
Diazepam
PLEASE 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 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 Valium is and what it is used for
2.
Before you take Valium
3.
How to take Valium
4.
Possible side effects
5.
How to store Valium
6.
Contents of the pack and other information
1.
WHAT VALIUM IS AND WHAT IT IS USED FOR
Valium contains a medicine called diazepam. This belongs to a group of
medicines called
‘benzodiazepines’.
Valium is used to treat anxiety and problems sleeping (insomnia),
muscle spasms (cramps) such as those
caused by cerebral spasticity, epilepsy (fits), making you relaxed
before an operation (premedication).
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE VALIUM
DO NOT TAKE VALIUM IF YOU ARE ALLERGIC (HYPERSENSITIVE) TO:

Diazepam or any of the other ingredients of Valium (listed in Section
6: Contents of the pack and other
information).

Other ‘benzodiazepine’ medicines. These include clonazepam,
flurazepam and temazepam.
Do not take Valium if any of the above applies to you. If you are not
sure, talk to your doctor or pharmacist
before taking Valium.
DO NOT TAKE VALIUM IF:

You have breathing or lung problems.

You have severe liver problems.

You have a condition called ‘myasthenia gravis’ (where your
muscles become weak and get tired easily).

You have a condition called ‘sleep apnoea syndrome’ (where your
breathing stops when you are asleep).

You have problems with phobias (strong fea

Summary of Product characteristics

Page 1 of 12
Malta
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Valium

5 mg Tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 5 mg Diazepam.
Excipients: Also contains 100 mg lactose monohydrate.
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Tablet.
Round, pale yellow tablet with “ROCHE” imprinted on one face and a
single break-
bar on the other.
The tablet can be divided into equal halves to facilitate dosing.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
1.
Anxiety.
2.
Insomnia.
Benzodiazepines are only indicated when the disorder is severe,
disabling
or subjecting the individual to extreme distress.
3.
In the control of muscle spasm including that associated with cerebral
spasticity.
In the management of epilepsy.
4.
As pre-operative medication in minor surgery.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_STANDARD DOSAGE_
For optimal effect, the dosage should be carefully individualised.
Treatment
should
begin
at
the
lowest
effective
dose
appropriate
to
the
particular
condition.
_ _
_DURATION OF TREATMENT _
Page 2 of 12
The duration of treatment should be as short as possible (see _
section 4.4_)
depending on the indication, but should not exceed 4 weeks for
insomnia and
eight to twelve weeks in cases of anxiety, including tapering off
process.
Extension beyond these periods should not take place without
re-evaluation of
the situation.
It may be useful to inform the patient when treatment is started that
it will be
of
limited
duration
and
to
explain
precisely
how
the
dosage
will
be
progressively decreased. Moreover it is important that the patient
should be
aware of the possibility of rebound phenomena, thereby minimising
anxiety
over such symptoms should they occur while the medicinal product is
being
discontinued.
There
are indications, that, in the case of benzodiazepines with a short
duration of action, withdrawal phenomena can become manifest within
the
dosage interval, especially when the dosage is high. When
benz