Oxazepam 15mg tablets

Valsts: Lielbritānija

Valoda: angļu

Klimata pārmaiņas: MHRA (Medicines & Healthcare Products Regulatory Agency)

Nopērc to tagad

Lietošanas instrukcija Lietošanas instrukcija (PIL)
04-10-2019
Produkta apraksts Produkta apraksts (SPC)
11-10-2018

Aktīvā sastāvdaļa:

Oxazepam

Pieejams no:

Kent Pharma (UK) Ltd

ATĶ kods:

N05BA04

SNN (starptautisko nepatentēto nosaukumu):

Oxazepam

Deva:

15mg

Zāļu forma:

Oral tablet

Ievadīšanas:

Oral

Klase:

Schedule 4 (CD Benz)

Receptes veids:

Valid as a prescribable product

Produktu pārskats:

BNF: 04010200

Lietošanas instrukcija

                                OXAZEPAM 15MG TABLETS
PATIENT INFORMATION LEAFLET
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.
Your medicine is called Oxazepam 15mg Tablets but will be referred to
as
Oxazepam Tablets throughout the leaflet. Please note that your
medicine is
available in another strength.
WHAT IS IN THIS LEAFLET
What Oxazepam Tablets are and what they are used for
Before you take Oxazepam Tablets
How to take Oxazepam Tablets
Possible side-effects
How to store
Further Information
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.
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 
                                
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Produkta apraksts

                                SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Oxazepam 15mg tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 15 mg of oxazepam.
Excipient with known effect:
Lactose monohydrate – 95 mg
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Tablet.
Pale yellow tablet marked “OM” break line “15” on one side and
“G” on the other
4.
CLINICAL PARTICULARS
4.1.
THERAPEUTIC INDICATIONS
Oxazepam tablets are indicated for the short-term relief (2-4 weeks)
only of anxiety that 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 Oxazepam to treat short-term ‘mild’ anxiety is
considered to be inappropriate and
unsuitable.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
All patients taking oxazepam should be carefully monitored and routine
repeat prescriptions
should be avoided. Patients who have taken benzodiazepines for a long
time may require an
extended withdrawal period during which doses are reduced. Long-term
chronic use is not
recommended.
Adults
Severe anxiety: The
recommended
dosage is 15-30mg three or four times daily.
Insomnia associated with anxiety
Most patients need a dose of 15-25mg but some patients may need up to
50mg. The dose
should be taken one hour before retiring.
Elderly patients and those who are particularly sensitive to
benzodiazepines
The recommended dosage is 10-20mg three or four times daily.
Children
Oxazepam is not recommended for the treatment of anxiety or insomnia
in children.
Treatment of anxiety should not be continued beyond 8-12 weeks
including a tapering off
period.
Treatment of insomnia should be as short as possible. Generally, the
duration of treatment
varies from a few days to two weeks with a maximum, including tapering
off process of four
weeks.
In all cases, the dosage of Oxazepam should be titrated according to
the needs of the
individual patient and the lowe
                                
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