IMOVANE

Țară: Israel

Limbă: engleză

Sursă: Ministry of Health

Ingredient activ:

ZOPICLONE

Disponibil de la:

SANOFI ISRAEL LTD

Codul ATC:

N05CF01

Forma farmaceutică:

FILM COATED TABLETS

Compoziție:

ZOPICLONE 7.5 MG

Calea de administrare:

PER OS

Tip de prescriptie medicala:

Required

Produs de:

SANOFI WINTHROP INDUSTRIE, FRANCE

Grupul Terapeutică:

ZOPICLONE

Zonă Terapeutică:

ZOPICLONE

Indicații terapeutice:

Imovane is indicated for the short-term treatment of insomnia in adults

Data de autorizare:

2021-05-31

Prospect

PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE
PHARMACISTS’ REGULATIONS (PREPARATIONS) - 1986
The medicine is dispensed with a doctor’s prescription only
IMOVANE
FILM-COATED TABLETS 7.5 MG
Composition:
Each tablet contains: Zopiclone 7.5 mg
For information about inactive and allergenic ingredients in the
preparation: see section 2 “Important information about some of the
ingredients of the medicine” and section 6 “Further
information”.
READ THIS LEAFLET CAREFULLY IN ITS ENTIRETY BEFORE USING THE MEDICINE.
This leaflet contains concise information about the medicine. If you
have
further questions, refer to the doctor or pharmacist.
This medicine has been prescribed to treat you. Do not pass it on to
others. It may harm them even if it seems to you that their medical
condition is similar.
This medicine is not intended for children and adolescents under 18
years of age.
1. WHAT IS THE MEDICINE INTENDED FOR?
Imovane is intended for treatment of the following conditions of
severe
sleep disorders: a. transient insomnia. b. short-term insomnia.
THERAPEUTIC GROUP: Hypnotic and sedative from the cyclopyrrolone
group.
2. BEFORE USING THE MEDICINE
DO NOT USE THE MEDICINE IF:
• you are sensitive (allergic) to zopiclone or to any of the
additional
ingredients contained in the medicine (see section 6). Signs of an
allergic reaction include: a rash, swallowing or breathing problems,
swelling of the lips, face, throat or tongue.
• you suffer from a problem that causes severe muscle weakness
(myasthenia gravis).
• you suffer from a problem in lung function (respiratory failure).
• you suffer from a problem in which you stop breathing for short
periods at night (sleep apnoea).
• you suffer from severe liver problems.
• you are under the age of 18. The safety and efficacy of Imovane
in children and adolescents aged less than 18 years have not been
established.
• you have ever experienced sleepwalking or any other unusual
behavior (such as driving, eating, making a phone call or having
sex, etc.) while you a

Caracteristicilor produsului

IMOV-PO-7.5MG-SPC-24.1
SUMMARY OF PRODUCT CHARACTERISTICS
IMOVANE
1
.
NAME OF THE MEDICINAL PRODUCT
Imovane
2
.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Zopiclone 7.5 mg
Excipient(s) with known effect:
Lactose Wheat starch (containing gluten) (see section 4.4)
For the full list of excipients, see section 6.1.
3
.
PHARMACEUTICAL FORM
Film
coated tablet
.
White, elliptical 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
Imovane is indicated for the short-term treatment of insomnia in
adults.
4.2
Posology and method of administration
Dose
Use the lowest effective dose. Imovane should be taken in a single
intake and not be re-
administered during the same night.
As with all hypnotics, long-term use of zopiclone is not recommended
Treatment should be as short as possible, and should not exceed four
weeks, including the period
of tapering-off. Extension beyond the maximum treatment period should
not take place without
re-evaluation of the patient’s status, since the risk of abuse and
dependence increases with the
duration of treatment (see Section 4.4).
The product should be taken just before retiring for the night.
_Adults_
_:_
The recommended dose is one Imovane tablet (7.5mg zopiclone) by the
oral route shortly
before retiring.
_Elderly patients_
_:_
A lower dose of 3.75mg 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 p_
_opulation_
_:_
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
Page 2
established.
_Patients with hepatic insufficiency_
_:_
As elimination of zopiclone may be reduced in patients with hepatic
dysfunction, a lower
dose of 3.75mg zopiclone nightly is recommended.
The standard dose of 7.5mg zopiclone may be used with caution in so