Oxazepam 10mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Oxazepam

Available from:

Genus Pharmaceuticals Ltd

ATC code:

N05BA04

INN (International Name):

Oxazepam

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; GTIN: 5030451001245

Patient Information leaflet

PATIENT INFORMATION LEAFLET
OXAZEPAM 10MG AND 15MG 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.
WHAT IS IN THIS LEAFLET
1. What Oxazepam Tablets are and what they are used for
2.
Before you take Oxazepam Tablets
3.
How to take Oxazepam Tablets
4.
Possible side-effects
5.
How to store
6.
Further Information
1. WHAT OXAZEPAM TABLETS ARE AND WHAT THEY ARE USED FOR
The name of your medicine is Oxazepam Tablets. Oxazepam is a member of
a
group of medicines called ‘benzodiazepines’. Oxazepam is
prescribed for the
short term (maximum of 2-4 weeks) treatment of anxiety, which is
disabling or
distressing and may be associated with sleeplessness or other
illnesses.
This medicine should be used for as short a time as possible and
should not be
used for more than four weeks. If used for too long without a break,
there is a risk
of becoming dependant or of having problems when you stop taking it.
When taking this medicine there is a risk of dependence (a need to
keep taking
the medicine). The risk increases with the dose and length of
treatment period.
The risk is greater if you have ever had a history of alcohol or drug
abuse.
2. BEFORE YOU TAKE OXAZEPAM TABLETS
DO NOT TAKE OXAZEPAM TABLETS AND TELL YOUR DOCTOR:
� if you are allergic (hypersensitive) to Oxazepam or to other
benzodiazepine
medicines or any of the ingredients in your tablets (see section 6)
� have a phobia (a fear of a particular object or situation),
obsessions or other
mental illness
� if you have severe breathing or chest problems
� if you suffer from sl

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Oxazepam Tablets 10mg
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Oxazepam tablets containing oxazepam 10mg
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 10mg are white, round tablets, approx. 6.5mm in
diameter,
having flat faces with bevelled edges. A break bar on one face and
“10” 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 ADMINISTR