Zolpidem Aurobindo 5mg film-coated Tablets

Riik: Malta

keel: inglise

Allikas: Medicines Authority

Toimeaine:

ZOLPIDEM TARTRATE

Saadav alates:

Aurobindo Pharma (Malta) Limited Vault 14, Level 2, Valletta Waterfront, Floriana FRN 1913, Malta

ATC kood:

N05CF02

INN (Rahvusvaheline Nimetus):

ZOLPIDEM TARTRATE 5 mg

Ravimvorm:

FILM-COATED TABLET

Koostis:

ZOLPIDEM TARTRATE 5 mg

Retsepti tüüp:

POM

Terapeutiline ala:

PSYCHOLEPTICS

Volitamisolek:

Authorised

Loa andmise kuupäev:

2013-09-12

Infovoldik

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PACKAGE LEAFLET: INFORMATION FOR THE USER
ZOLPIDEM AUROBINDO 5 MG FILM-COATED TABLETS
ZOLPIDEM AUROBINDO 10 MG FILM-COATED TABLETS
zolpidem tartarate
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 Zolpidem Aurobindo is and what it is used for
2.
What you need to know before you take Zolpidem Aurobindo
3.
How to take Zolpidem Aurobindo
4.
Possible side effects
5.
How to store Zolpidem Aurobindo
6.
Contents of the pack and other information
1.
WHAT ZOLPIDEM AUROBINDO IS AND WHAT IT IS USED FOR
Zolpidem belongs to agroup of medicines known as benzodiazepine-like
agents.
Zolpidem Aurobindo Tablets are sleeping pills (hypnotics) which work
by acting on the brain to
cause sleepiness. It may be used for short-term treatment of insomnia
which is severe, disabling or
causing great distress. Insomnia is a difficulty in falling asleep or
sleeping properly.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE ZOLPIDEM AUROBINDO
DO NOT TAKE ZOLPIDEM AUROBINDO:
•
if you are allergic to zolpidem tartrate or any of the other
ingredients of this medicine (listed in
Section 6). An allergic reaction may include a rash, itching,
difficulty breathing or swelling of
the face, lips, throat or tongue.
•
if you have severe liver problems
•
if you suffer from sleep apnoea (a condition where you stop breathing
for very short periods
whilst sleeping)
•
if you suffer from severe muscle weakness (myasthenia gravis)
•
if you have acute and severe breathing problems
•
if you are under the age of 18 years
•
If y

Toote omadused

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SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Zolpidem Aurobindo 5 mg film-coated tablets
Zolpidem Aurobindo 10 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
_Zolpidem Aurobindo 5 mg film-coated tablets _
Each film-coated tablet contains 5 mg of zolpidem, tartarate.
Excipient with known effect: Each 5mg film-coated tablet contains 43.8
mg lactose monohydrate.
_Zolpidem Aurobindo 10 mg film-coated tablets _
Each film-coated tablet contains 10 mg of zolpidem, tartarate.
Excipient with known effect: Each 10 mg film-coated tablet contains
87.6 mg lactose monohydrate.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
_Zolpidem Aurobindo 5 mg film-coated tablets _
White to off-white, circular, biconvex, film- coated tablets, debossed
with “E” on one side and “78”
on the other side.
_Zolpidem Aurobindo 10 mg film-coated tablets _
White to off-white, oval shaped, biconvex film- coated tablets,
debossed with “E” on one side and
debossed with “80” with a score line between “8” and “0”
on the other side.
The tablet can be divided into equal doses.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Short-term treatment of insomnia.
Benzodiazepines or benzodiazepine-like agents are only indicated when
the disorder is severe,
disabling or subjecting the individual to extreme distress.
_ _
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Duration of treatment
Treatment should be as short as possible. Generally the duration of
treatment varies from a few days
to two weeks with a maximum, including the tapering off process, of
four weeks. The tapering off
process should be tailored to the individual.
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As with all hypnotics, long-term use is not recommended and a course
of treatment should not
exceed four weeks. In certain cases extension beyond the maximum
treatment period may be
necessary; if so, it should not take place without re-evaluation of
the patient‘s status.
Posology
_Adults _
Zolpidem acts