Oxazepam 10mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Oxazepam

Available from:

A A H 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: 5037563002375

Patient Information leaflet

Phama-
code
area
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
Oxazepam 10mg and 15mg Tablets
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.
•
•
•Keep•this•leaflet.•You•may•want•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
What Oxazepam is and
what it is used for
1
Oxazepam•belongs•to•a•group•of•medicines•known•as•
benzodiazepines.
Oxazepam•is•intended•for•short•term•use•(approximately•
2-4•weeks)•to•relieve•severe•anxiety.
What you need to know
before you take Oxazepam
2
DO NOT TAKE OXAZEPAM IF:
•
•
•You•are•allergic•(hypersensitive)•to•Oxazepam,•other•
benzodiazepines•or•any•of•the•other•ingredients•of•this•
medicine•(listed•in•section•6)
•
•
•You•have•a•phobia•(a•very•strong•fear•of•something),•
obsessions•or•other•mental•disorders•
•
•
•You•suffer•from•severe•liver•disorders•
•
•
•You•suffer•from•breathing•difficulties
•
•
•You•suffer•from•myasthenia•gravis•(muscle•weakness)•
•
•
•You•suffer•from•sleep•apnoea•syndrome•(a

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