Diazepam 5mg tablets

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:

A A H Pharmaceuticals Ltd

ATC代码:

N05BA01

INN（国际名称）:

Diazepam

剂量:

5mg

药物剂型:

Oral tablet

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; GTIN: 5025903001553

资料单张

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

产品特点

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Diazepam Tablets BP 5 mg.
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 5mg of Diazepam Ph.Eur
For a full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Tablet.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
ADULTS
1.
The short-term relief (24 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 muscle spasm in tetanus
3.
Oral premedication (see section 4.4)
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
For oral administration.
The lowest dose which can control the symptoms should be used.
Long-term chronic
use is not recommended; treatment should be as short as possible. The
patient should
be reassessed regularly and the need for continued treatment
evaluated, especially if
the patient is symptom free. It should not exceed 2-3 months for
anxiety and 4 weeks
for insomnia, including the tapering off period. Extension beyond
these periods
should not take place without re-evaluation of the situation.
Treatment with
benzodiazepines should always be withdrawn gradually. Patients who
have been
receiving treatment for a long time may require longer periods during
which the doses
are reduced.
_Anxiety States: Adults _
Usual dose of 2mg three times daily.
Severe anxiety states: 15-30mg daily in divided doses.
_Insomnia associated with anxiety: Adults _
5-15mg before retiring.
The maximum dose should not be exceeded.
_Conditions associated with muscle spasm: _
Spastic children with minimal brain damage: 2