STILNOX 10MG FILM COATED TABLET

Country: Малезија

Језик: Енглески

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

Активни састојак:

ZOLPIDEM HEMITARTRATE

Доступно од:

SANOFI-AVENTIS (MALAYSIA) SDN. BHD.

INN (Међународно име):

ZOLPIDEM HEMITARTRATE

Јединице у пакету:

20Tablet Tablets; 14 Tablets

Произведен од:

SANOFI WINTHROP INDUSTRIE

Информативни летак

_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

Карактеристике производа

MY/STI/0521/CCDS V16
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 single 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 dose 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 in 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 under
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 hypnotics, 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
use). _
MY/STI/0521/CCDS V16
The duration of treatment must be explained to the patient:
•
2 to 5 days for transient insomnia (when traveling, for example),
•
2 to 3 weeks for short-term insom