Diazepam 5mg tablets

Land: Storbritannien

Språk: engelska

Källa: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktiva substanser:

Diazepam

Tillgänglig från:

Waymade Healthcare Plc

ATC-kod:

N05BA01

INN (International namn):

Diazepam

Dos:

5mg

Läkemedelsform:

Oral tablet

Administreringssätt:

Oral

Klass:

Schedule 4 (CD Benz)

Receptbelagda typ:

Valid as a prescribable product

Produktsammanfattning:

BNF: 04010200

Bipacksedel

REGULATORY AUTHORITY
APPROVAL CONFIRMATION
Confirmation that this artwork has been approved by
the appropriate market authority (if applicable, e.g.
MHRA, IMB, etc and that Waymade Plc have license
approval to distribute this component for sale in the
relevent market.
Accept Artwork
................................................................
Reject Artwork
.................................................................
Signature
..........................................................................
Name
................................................................................
Date
..................................................................................
PAGE 1 OF 2
Received Date:
09/07/2019
CDL JOB No. :
67635
Required By :
12/7/2019
PRODUCT NAME:
Diazepam Tabs
2, 5, 10mg 28s
PIP CODE:
GB 674-7299-APIL
COMPONENT:
Leaflet
SIZE:
210x550 mm
MARKET:
Grat Britain
PRODUCT SITE:
TBC
SCALE:
100%
COLOURS:
Black
DATE:
26/07/2016
FONT SIZE:
9 pt
VERSION NO:
1
AMENDED BY:
SP
PROJECT:
Sovereign Medical
GB 674-7299-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,

Produktens egenskaper

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Diazepam 5 mg Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains Diazepam 5 mg.
Also contains lactose. For excipients, see section 6.1
3
PHARMACEUTICAL FORM
Tablet
Flat, pale yellow, bevelled tablets. Engraved MP58 on one side.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Adults
• Short-term use in anxiety or insomnia.
• Adjunct in acute alcohol withdrawal.
• Muscle spasm in association with fibrositis, cervical spondylosis,
arthritis
and bursitis.
• May be useful in cerebral spasticity in selected cases; as an
adjunct to some
types of epilepsy e.g. myclonus; and sedative cover for some minor
surgical
procedures, endoscopy, cardiac catheterisation cardioversion.
Children
• Night terrors and somnambulism.
• May be useful in controlling tension and irritability in cerebral
spasticity in
selected cases.
Benzodiazepines are only indicated when the disorder is severe,
disabling or
subjecting the individual to extreme distress.
The use of benzodiazepines to treat short-term ‘mild’ anxiety is
considered to
be inappropriate and unsuitable.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Route of administration: oral
When treatment is started it may be useful to inform the patient that
treatment 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 has been discontinued.
ANXIETY
_Adults:_
The starting dose should be 2 mg 3 times daily increased if necessary
to 15 - 30 mg
daily, in divided doses adjusted on an individual basis. Treatment
should always be
as short as possible and should not take place without re-evaluation
of the situation.
_Elderly and debilitated patients:_
Dosage should not exceed half the adult dose. The same applies to
patients with
impaired liver or renal function