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; 14 Tablets

Dikeluarkan oleh:

Opella Healthcare International SAS

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 is used for short term
treatment of sleep problems (insomnia)
such as:
•
Difficulty falling asleep
•
Waking in the middle of the night
•
Waking too early
•
Severe or upsetting sleep problems
that are caused by your mood or
mental health problems
Do not take Imovane as long-term
treatment. Treatment should be as short
as possible because the risk of
dependence increases with the duration
of treatment.
Ask your doctor for advice if you are
unsure.
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 o

Ciri produk

MY/IMO/0822/CCDS V12
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.
Excipient(s) with known effect:
Lactose
Wheat starch (containing gluten) (see section 4.4 Special warnings and
precautions for use).
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
awakening 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 recommended. 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 recommended dose is one Imovane tablet (7.5 mg zopiclone) 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 dosage 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 caution in some
cases, depending
on effectiveness and acceptability.
_Renal insufficiency _
MY/IMO/082