Diazepam 10mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Diazepam

Available from:

Sigma Pharmaceuticals Plc

ATC code:

N05BA01

INN (International Name):

Diazepam

Dosage:

10mg

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

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PAGE 1 OF 2
Received Date:
22/07/2016
CDL JOB No. :
62281
Required By :
27/07/2016
PRODUCT NAME:
Diazepam Tabs
2, 5, 10mg 28s
PIP CODE:
GB 724-8115-APIL
COMPONENT:
Leaflet
SIZE:
210x477 mm
MARKET:
Grat Britain
PRODUCT SITE:
TBC
SCALE:
100%
COLOURS:
Black
DATE:
26/07/2016
FONT SIZE:
9 pt
VERSION NO:
5
AMENDED BY:
VK
PROJECT:
Sovereign Medical
GB 724-8115-APIL
PACKAGE LEAFLET: INFORMATION FOR THE USER
DIAZEPAM 2 mg, 5 mg and 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. 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 effect not listed in this leaflet.
See section 4.
WHAT IS IN THIS LEAFLET
1. What Diazepam Tablets are and what they are used for
2. What you need to know before you take Diazepam Tablets
3. How to take Diazepam Tablets
4. Possible side effects
5. How to store Diazepam Tablets
6. Contents of the pack and other information
1. WHAT DIAZEPAM TABLETS ARE AND WHAT THEY ARE
USED FOR
The name of your medicine is Diazepam 2 mg

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Diazepam 10 mg Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 10 mg diazepam.
Excipient(s) with known effect
Each 10 mg tablet contains 130.86 mg of lactose
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Flat, blue tablets with bevelled edges, 8 mm diameter. One face
embossed with “DZ”
and “10” 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 d