STILNOX 10MG FILM COATED TABLET

Nchi: Malesia

Lugha: Kiingereza

Chanzo: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Viambatanisho vya kazi:

ZOLPIDEM HEMITARTRATE

Inapatikana kutoka:

SANOFI-AVENTIS (MALAYSIA) SDN. BHD.

INN (Jina la Kimataifa):

ZOLPIDEM HEMITARTRATE

Vitengo katika mfuko:

20Tablet Tablets

Viwandani na:

SANOFI WINTHROP INDUSTRIE

Taarifa za kipeperushi

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
STILNOX
®
Zolpidem tartrate 10 mg
_ _
1
_ _
WHAT IS IN THIS LEAFLET
1.
What Stilnox is used for
2.
How Stilnox works
3.
Before you use Stilnox
4.
How to use Stilnox
5.
While you are using it
6.
Side effects
7.
Storage and disposal of Stilnox
8.
Product description
9.
Manufacturer and product
registration holder
10.
Date of revision
WHAT STILNOX IS USED FOR
This medicine belongs to a group of
medicines called benzodiazepines.
It is used as short-term treatment for
insomnia in adults.
Due to a lack of data, the use of this
medicine is not recommended in
children and adolescents under 18
years of age.
HOW STILNOX WORKS
Stilnox tablets are sleeping pills
(hypnotics) which work by acting on
the brain to help you sleep.
Stilnox is not meant to be used every
day for long periods of time. Ask your
doctor for advice if you are unsure
BEFORE YOU USE STILNOX
-
_When you must not use it _
Do not take Stilnox and tell your
doctor if:
• You are allergic (hypersensitive) to
zolpidem tartrate, the family of
medicines that belong to the
benzodiazepine group or any of the
other ingredients in the tablet
• Signs of an allergic reaction may
include: a rash, swallowing or
breathing problems, swelling of the
face, lips, throat or tongue.
• You have serious respiratory failure.
• You have serious liver disease
(serious liver failure).
• Your lungs do not work properly
(respiratory failure)
• You have sleep apnea syndrome
(condition where you stop breathing
for short periods in your sleep).
• You have myasthenia (muscle
disease).
• You have been told by a doctor that
you cannot tolerate lactose
• You are under the age of 18
-
_Before you start to use it _
Talk to your doctor or pharmacist
before taking Stilnox 10 mg tablets.
-
_Taking other medicines _
Tell your doctor or pharmacist if you
are taking or have recently taken any
other medicine including medicines
obtained without a prescription. Stilnox
tablets can affect the way some other
medicines work. Also some med

Tabia za bidhaa

STILNOX®
COMPOSITION
Each scored film -coated tablet contains:
Zolpidem tartrate.......................................................................... 10 mg
PHARMACEUTICAL FORM
Scored film -coated tablets.
CLINICAL PARTICULARS
Therapeutic indications
Indications are limited to treatment of severe sleep disorders in adults with :
 Transient insomnia
 Short -term insomnia
Posology and method of administration
Posology
Dose
The treatment should be taken as a sin gle dose and not be re -administered during the
same night.
The recommended daily dose for adults is 10 mg to be taken immediately at bedtime.
Treatment should be started at the lowest effective dose and the maximum do se must
not exceed 10 mg.
Elderly or debilitated subjects
As elderly or debilitated patients are especially sensitive to the effects of zolpidem, the
recommended dose i n this population is 5 mg (i.e. 1/2 a tablet).
Liver failure
As the clearance and metabolism of zolpidem are reduced in liver failure, treatment
should begin at 5 mg per day in these patients, with particular caution being exercised in
elderly patients.
Under no circumstances should the daily dose exceed 10 mg.
Stilnox may be prescribed for use continuously or as required, depending on the signs
and symptoms.
Pediatric population
The safety and efficacy of zolpidem in children and adolescents unde r 18 years of age
have not been demonstrated. Therefore, use of zolpidem is not recommended in this
population. The available evidence from placebo -controlled clinical trials is presented in
section Pharmacodynamic properties .
Duration
As with all hypnoti cs, long -term use of zolpidem is not recommended. Treatment should
be as short as possible, and should not exceed four weeks, including the tapering -off
period (see section Special warnings and special precautions for us e).