IMOVANE TABLET 7.5MG

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

ZOPICLONE

Boleh didapati daripada:

SANOFI-AVENTIS (MALAYSIA) SDN. BHD.

INN (Nama Antarabangsa):

ZOPICLONE

Unit dalam pakej:

20Tablet Tablets

Dikeluarkan oleh:

SANOFI WINTHROP INDUSTRIE

Risalah maklumat

_ _
1
_ _
_Consumer Medication Information Leaflet (RiMUP) _
IMOVANE
® TABLET
Zopiclone
(7.5 mg)
WHAT IS IN THIS LEAFLET
1.
What Imovane is used for
2.
How Imovane works
3.
Before you use Imovane
4.
How to use Imovane
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of Imovane
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
WHAT IMOVANE IS USED FOR
Imovane may be used for short term
treatment of difficulties in falling
asleep, waking up at night or early in
the morning or difficulty in sleeping.
HOW IMOVANE WORKS
Imovane tablets are sleeping pills
(hypnotics) which work by acting on
the brain to cause sleepiness.
BEFORE YOU USE IMOVANE
_- When you must not use it _
Do not take Imovane if you:
•
are allergic
(hypersensitive) to
zopiclone or any of the other
ingredients in the tablet (see section
PRODUCT DESCRIPTION
). An allergic
reaction may include a rash, itching,
difficulty breathing or swelling of the
face, lips, throat or tongue.
•
have severe liver
problems
•
suffer from breathing problems whilst
sleeping
(sleep apnoea syndrome)
•
suffer from severe muscle weakness
(myasthenia gravis)
•
have severe breathing
problems
These tablets are not recommended for
use in children and pregnant women.
_- Before you start to use it _
Warnings:
Anaphylaxis (severe allergic reaction)
and angioedema (severe facial
swelling) which can occur as early as
the first time the product is taken.
Complex sleep-related behaviors which
may include sleep-driving, making
phone calls, preparing and eating food
while asleep.
Check with your doctor or pharmacist
before taking Imovane tablets if you:
•
have any kidney or liver problems.
•
have a history of mental illness.
•
have or have ever had a history of or
tendency to alcohol or drug abuse or
personality disorders.
•
you have been told you have an
intolerance to some sugars (e.g.
lactose).
•
If you are pregnant or breastfeeding,
or planning to become pregnant.
_Other considerations _
•
_Tolerance_
–

Ciri produk

IMOVANE ® 7.5 mg
Zopiclone
film -coated scored tablets
1. Name of the medicinal product
Imovane 7.5 mg film -coated tablets
2. Qualitative and quantitative composition
7.5 mg zopiclone.
3. Pharmaceutical form
Film -coated tablet (tablet)
White, elliptical, biconvex film -coated tablets with a score -line on one side. The tablet can
be divided into equal halves.
4. Clinical particulars
4.1 Therapeutic indications
Short term treatment of insomnia in adults, including difficulties in falling asleep, nocturnal
aw akening and early awakening, transient, situational or chronic insomnia, and insomnia
secondary to psychiatric disturbances, in situations where the insomnia is debilitating or is
causing severe distress for the patient. Long term continuous use is not rec ommended. A
course of treatment should employ the lowest effective dose.
4.2 Posology and method of administration
Use the lowest effective dose. Imovane should be taken in a single intake and not be re -
administered during the same night.
Adults
The reco mmended dose is one Imovane tablet (7.5 mg zopic lone) by the oral route shortly
before retiring.
Elderly patients
A lower dose of 3.75 mg zopiclone should be employed to start treatment in the elderly.
Depending on effectiveness and acceptability, the dos age subsequently may be increased
if clinically necessary.
Paediatric population
Zopiclone should not be used in children and adolescents less than 18 years. The safety
and efficacy of zopiclone in children and adolescents aged less than 18 years have not
been established.
Patients with hepatic insufficiency
As elimination of zopiclone may be reduced in patients with hepatic dysfunction, a lower
dose of 3.75 mg zopiclone nightly is recommended.
The standard dose of 7.5 mg zopiclone may be used with cautio n in some cases,
depending on effectiveness and acceptability.
Renal insufficiency
Accumulation of zopiclone or its metabolites has not been seen during treatment of
insomnia in patients with renal insufficiency. However, it is recommended that patie