Diazepam 2mg/5ml oral solution

国家: 英国

语言: 英文

来源: MHRA (Medicines & Healthcare Products Regulatory Agency)

有效成分:

Diazepam

可用日期:

Actavis UK Ltd

ATC代码:

N05BA01

INN（国际名称）:

Diazepam

剂量:

400microgram/1ml

药物剂型:

Oral solution

给药途径:

Oral

类:

Schedule 4 (CD Benz)

处方类型:

Valid as a prescribable product

產品總結:

BNF: 04010200

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DIAZEPAM 2MG/5ML ORAL SOLUTION SUGAR FREE PIL - UK
Black
BBBA0066
S.Anson
04.10.16
25/01/17
C.Grant
296 x 170
8pts
Martindale Pharma
04.10.16
10.10.16
08
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 effects not listed in this
leaflet. See section 4.
• The full name of this medicine is Diazepam 2mg/5ml Oral
Solution Sugar Free but within this leaflet it will be referred
to as Diazepam Oral Solution.
WHAT IS IN THIS LEAFLET
1. WHAT DIAZEPAM ORAL SOLUTION IS AND WHAT IT
IS USED FOR
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE
DIAZEPAM ORAL SOLUTION
3. HOW TO TAKE DIAZEPAM ORAL SOLUTION
4. POSSIBLE SIDE EFFECTS
5. HOW TO STORE DIAZEPAM ORAL SOLUTION
6. CONTENTS OF THE PACK AND OTHER INFORMATION
1. WHAT DIAZEPAM ORAL SOLUTION IS AND WHAT IT
IS USED FOR
Diazepam belongs to a group of medicines called
benzodiazepines. Diazepam helps in the treatment of
anxiety, muscle spasms and convulsions (fits). It is used to
treat:
IN ADULTS
• short term relief (14 days) of severe anxiety and may occur
alone or with insomnia (trouble sleeping) or mental health
problems
• cerebral palsy
• muscle spasm caused by tetanus (when

产品特点

OBJECT 1
DIAZEPAM 2MG/5ML ORAL SOLUTION
SUGAR FREE
Summary of Product Characteristics Updated 16-Mar-2017 | Accord-UK Ltd
1. Name of the medicinal product
DIAZEPAM 2mg/5ml ORAL SOLUTION SUGAR FREE
2. Qualitative and quantitative composition
Each 5ml spoonful contains 2mg Diazepam.
EXCIPIENTS WITH KNOWN EFFECT
Each 5ml contains:
3.000ml (1.91g to 2.58g) Sorbitol, liquid (Non-crystallising) (E420)
PhEur
2.500mg of Propyl parahydroxybenzoate (E216) PhEur
5.000mg of Methyl parahydroxybenzoate (E218) PhEur
5.00ml (0.63g) of Glycerol (E422) PhEur.
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
A pink syrup with an odour of raspberries.
4. Clinical particulars
4.1 Therapeutic indications
Diazepam has potent anxiolytic, anticonvulsant and central
muscle-relaxing properties; these effects are
probably mediated through special areas in the CNS. It also has uses
in pre-operative medication and is
used in the treatment of skeletal-muscle spasm, and the associated
pain.
The main uses are:
_Adults:_
1) The short term relief (14 days) 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.
The use of benzodiazepines to treat short-term anxiety is considered
to be inappropriate.
2) Cerebral palsy.
3) Muscle spasm; as an adjunct to the control of muscle spasm in
tetanus.
4) As an adjunct to the management of certain types of epilepsy (e.g.
myoclonus).
5) Symptomatic treatment of acute alcohol withdrawal.
6) As oral premedication for the nervous dental patient.
_Paediatric population:_
1) Control of tension and irritability in cerebral spasticity in
selected cases.
2) Oral premedication.
4.2 Posology and method of administration
Posology
As an anxiolytic, the lowest effective dose should be employed; dosage
regimes should not exceed
beyond 14 days. Patients who have received benzodiazepines for a long
time may require an extended
withdrawal period. Long-term