Diazepam 5mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Diazepam

Available from:

Sun Pharma UK 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; GTIN: 5015525040153 5015525040122

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 5 mg Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 5 mg diazepam.
Excipient(s) with known effect
Each 5 mg tablet contains 134.5 mg of lactose
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Flat, pale yellow tablets with bevelled edges, 8 mm diameter. One face
embossed
with “DZ” and “5” separated by a breakline. The reverse face
is plain.
4
CLINICAL PARTICULARS
_4.1 _
_THERAPEUTIC INDICATIONS _
Adults
Benzodiazepines, including diazepam, are indicated for the short-term
relief (up to 4
weeks only) 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.
Cerebral palsy.
Muscle spasm.
As an adjunct to certain types of epilepsy (eg myoclonus).
Symptomatic treatment of acute alcohol withdrawal.
As oral premedication for the nervous dental patient.
For premedication before surgery.
Children
Control of tension and irritability in cerebral spasticity in selected
cases.
As an adjunct to the control of muscle spasm in tetanus.
Oral premedication (see section 4.4).
_4.2 _
_POSOLOGY AND METHOD OF ADMINISTRATION _
Recommended dose and dosage schedule: As directed by a physician.
POSOLOGY
As an anxiolytic, the lowest dose which can control symptoms should be
used. It
should not be continued beyond 4 weeks. Long-term chronic use is not
recommended. Treatment should always be tapered off gradually.
Patients who have
taken benzodiazepines for a long time may require a longer period
during which
doses are reduced.
ADULTS
Anxiety states, obsessive-compulsive neuroses, and other psychiatric
disorders: 5 –
30 mg daily in divided doses.
Alcohol withdrawal: 5-20 mg, repeated if necessary in 2-4 hours.
Insomnia associated with anxiety: 5-15 mg before bedtime.
Cerebral palsy: 5-60mg daily in divided doses.
Upper motor neuronic spasticity: 5-60mg daily in divided