Oxazepam 15mg tablets

Land: Storbritannia

Språk: engelsk

Kilde: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktiv ingrediens:

Oxazepam

Tilgjengelig fra:

Sigma Pharmaceuticals Plc

ATC-kode:

N05BA04

INN (International Name):

Oxazepam

Dosering :

15mg

Legemiddelform:

Oral tablet

Administreringsrute:

Oral

Klasse:

Schedule 4 (CD Benz)

Resept typen:

Valid as a prescribable product

Produkt oppsummering:

BNF: 04010200

Informasjon til brukeren

PAGE 1 OF 7
PACKAGE LEAFLET
PAGE 2 OF 7
PACKAGE LEAFLET: INFORMATION FOR THE USER
OXAZEPAM 10 MG AND 15 MG TABLETS
(oxazepam)
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 Oxazepam is and what it is used for
2.
What you need to know before you take Oxazepam
3.
How to take Oxazepam
4.
Possible side effects
5.
How to store Oxazepam
6.
Contents of the pack and other information
1.
WHAT OXAZEPAM IS AND WHAT IT IS USED FOR
Oxazepam belongs to a group of medicines called benzodiazepines.
Oxazepam increases the actions of
a naturally occurring substance called GABA, in the brain.
Oxazepam is used for the short-term (2 - 4 weeks) treatment of
anxiety, which is severe, disabling,
distressing and which may be associated with sleeplessness or with
other illnesses.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE OXAZEPAM
DO NOT TAKE OXAZEPAM

if you are allergic to oxazepam, other benzodiazepines, or any of the
other ingredients of this
medicine (listed in section 6)

if you have severe breathlessness or breathing difficulties

if you suffer from Myasthenia Gravis (a condition which causes muscles
to weaken and tire
easily)

if you have a phobia or obsession, or you are being treated for a
mental illness

if you suffer from sleep apnoea (a condition where you stop breathing
when asleep)

if you have severe problems with your liver

if you are pregnant, might become pregnant or are breast-feeding
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before taking Oxazepam

if you hav

Preparatomtale

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Oxazepam Tablets 15mg
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Oxazepam tablets containing oxazepam 15mg.
Oxazepam (INN, BAN) is chemically defined as 7-chloro-1,3-dihydro-3-
hydroxy-5-phenyl-2H-1,4-benzodiazepine-2-one.
3
PHARMACEUTICAL FORM
Oxazepam Tablets 15mg are white round tablets, 6.5mm in diameter,
having
flat faces with bevelled edges. A breakbar on one face and “15” on
the other.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Oxazepam is indicated for the short term relief (2-4 weeks) of anxiety
that is
disabling or subjecting the individual to unacceptable distress,
occurring alone
or in association with insomnia or short-term psychosomatic, organic
and
psychotic illness.
The use of benzodiazepines to treat short-term anxiety is considered
to be
inappropriate.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
Dosage and duration of therapy should be individualised and all
patients
receiving oxazepam should be carefully monitored and re-evaluated
before
any
extension
of
the
treatment
period.
Long-term
chronic
use
is
not
recommended.
As an anxiolytic, the lowest effective dose should be employed for the
shortest
time
possible.
Dosage
regimes
should
not
exceed
beyond
4
weeks
and
treatment should be withdrawn gradually to minimise possible
withdrawal
symptoms (See Special Warnings and Precautions for Use).
Please note that in patients with renal or hepatic impairment, lower
doses may
be sufficient (see Special Warnings and Precautions for Use).
_Adults: _
•
Anxiety – one to two 15mg tablets three (or four) times daily
•
Insomnia associated with anxiety – In most cases, 15-25mg dose taken
1 hour before retiring. This may be increased to a maximum of 50mg
where necessary
_Elderly _
_or _
_patients _
_who _
_are _
_particularly _
_sensitive _
_to _
_the _
_effects _
_of _
_benzodiazepines: _
10-20mg three or four times daily
_Children: _
Oxazepam is not recommended for the treatment of children
METHOD OF ADMINISTRATION
Oral