Diazepam 5mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Diazepam

Available from:

Viatris UK Healthcare Ltd

ATC code:

N05BA01

INN (International Name):

Diazepam

Dosage:

5mg

Pharmaceutical form:

Oral tablet

Administration route:

Oral

Class:

Schedule 4 (CD Benz)

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 04010200

Patient Information leaflet

1
PACKAGE LEAFLET
2
PACKAGE LEAFLET: INFORMATION FOR THE USER
DIAZEPAM GSP 2 MG TABLETS
DIAZEPAM GSP 5 MG TABLETS
DIAZEPAM GSP 10 MG TABLETS
Diazepam
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 Diazepam GSP is and what it is used for
2.
What you need to know before you take Diazepam GSP
3.
How to take Diazepam GSP
4.
Possible side effects
5.
How to store Diazepam GSP
6.
Contents of the pack and further information
1.
WHAT DIAZEPAM GSP IS AND WHAT IT IS USED FOR
Diazepam GSP contains the active substance diazepam which belongs to a
group of medicines called
benzodiazepines.
Diazepam GSP is indicated in the treatment of the following
conditions:
In Adults:
-
symptoms of anxiety.
-
symptoms that occur during alcohol withdrawal.
In Adults and Children over 6 years old:
-
muscle spasms or pain caused by inflammation of muscles and joints,
trauma, including
spasms caused by diseases such as cerebral palsy (group of disorders
that affect the ability to
move, maintain balance and posture) and paraplesia (paralysis of the
lower half of the body,
affecting both legs) as well as athetosis (continuous, involuntary,
slow movements and
unusual fingers and hands) and stiff-person syndrome.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE DIAZEPAM GSP
DO NOT TAKE DIAZEPAM GSP:
-
if you are allergic to diazepam or any of the other ingredients of
this medicine (listed in
section 6).
-
if you have a condition called myasthenia gravis which causes muscles
to weaken and tire
easily.
-
if you have acute respiratory probl

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Diazepam Tablets BP 5mg
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 5mg Diazepam PhEur.
Excipient with known effect
Each tablet contain 152.00mg lactose
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Yellow uncoated tablets.
Yellow, circular, flat, bevelled-edge uncoated tablets, impressed
“C” and the
identifying letters “DB” either side of a central division line on
one face.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Adults
1)
The
short-term
relief
(2-4
weeks)
only,
of
anxiety
which
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)
Cerebral palsy.
3)
Muscle spasm.
4)
As an adjunct to certain types of epilepsy (eg myoclonus).
5)
Symptomatic treatment of acute alcohol withdrawal.
6)
As oral premedication for the nervous dental patient.
7)
For premedication before surgery
Children
1) Control of tension and irritability in cerebral spasticity in
selected cases
2)
As an adjunct to the control of muscel spasm in tetanus
3)
Oral premedication (see section 4.4)
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
As an anxiolytic, the lowest effective dose should be employed; dosage
regimes should not exceed beyond 4 weeks and treatment should be
gradually
withdrawn. Patients who have received benzodiazepines for a long time
may
require an extended withdrawal period. Long-term chronic use is not
recommended.
_ _
_Adults: _
_Anxiety states, obsessive-compulsive neuroses, and other psychiatric
_
_disorders:_ 5-30mg daily in divided doses.
_Insomnia associated with anxiety:_ 5-15mg before retiring.
_Cerebral palsy:_ 5-60mg daily in divided doses.
_Upper motor neuronic spasticity:_ 5-60mg daily in divided doses.
_Muscle spasm of varied aetiology, fibrositis, cervical spondylosis:_
5-15mg
daily in divided doses.
_Adjunct to the management of some types of epilepsy:_