Zimovane 7.5 mg Film-coated Tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Zopiclone

Available from:

Mylan IRE Healthcare Limited

ATC code:

N05CF; N05CF01

INN (International Name):

Zopiclone

Dosage:

7.5 milligram(s)

Pharmaceutical form:

Film-coated tablet

Therapeutic area:

Benzodiazepine related drugs; zopiclone

Authorization status:

Marketed

Authorization date:

2006-08-18

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
ZIMOVANE 7.5 MG FILM-COATED TABLETS
zopiclone
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor or pharmacist.
-
This medicine has been prescribed for you only. Do not pass it on to
others. It may
harm them, even if their signs of illness are the same as yours.
-
If you get any side effects, talk to your doctor. This includes any
possible side effects
not listed in this leaflet. See section 4.
The name of your medicine is Zimovane 7.5mg Film-Coated Tablets, which
will be called
Zimovane tablets through out this leaflet.
WHAT IS IN THIS LEAFLET:
1.
What Zimovane tablets are and what they are used for
2.
What you need to know before you take Zimovane tablets
3.
How to take Zimovane tablets
4.
Possible side effects
5.
How to store Zimovane tablets
6.
Contents of the pack and further information
1.
WHAT ARE ZIMOVANE TABLETS AND WHAT THEY ARE USED FOR
The active ingredient in these tablets is zopiclone. This belongs to a
group of medicines
called hypnotics. It works by acting on your brain to help you sleep.
The tablets are normally used for the short-term treatment of severe
sleeping difficulties in
adults.
2.
WHAT YOU NEED TO KNOW BEFORE TAKING ZIMOVANE TABLETS
DO NOT TAKE ZIMOVANE TABLETS
-
If you are allergic to zopiclone or any of the other ingredients of
this medicine (listed
in section 6).
-
If you suffer from myasthenia gravis (a condition where the muscles
easily tire and
become weak)
-
If you have any severe breathing problems, if your lungs do not work
properly (e.g.
respiratory failure)
-
If you suffer from severe sleep apnoea syndrome
-
If the patient is under 18 years of age
-
If you suffer from severe liver problems.
WARNINGS AND PRECAUTIONS
Tell your doctor or pharmacist before taking Zimovane if any of the
following apply:
-
If you are pregnant or think you might be pregnant
-
If y

Summary of Product characteristics

Health Products Regulatory Authority
16 June 2020
CRN009QZ2
Page 1 of 8
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Zimovane 7.5 mg Film-coated Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 7.5mg of zopiclone.
Excipients: Each tablet also contains 31.57mg of lactose monohydrate
For a full list of excipients see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated Tablet.
White, elliptical film-coated tablet 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
Benzodiazepines and benzodiazepine-like agents are only indicated when
the disorder is severe, disabling or subjecting the
individual to extreme distress.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Treatment should be as short as possible. Generally, the duration of
treatment varies from a few days to two weeks with a
maximum, including tapering off of four weeks. In certain cases,
extension beyond the maximum treatment period may be
necessary; if so it should not take place without re-evaluation of the
patient's status. The product should be taken just before
retiring for the night.
Dose
The recommended dose for adults is 7.5mg. This dose should not be
exceeded.
Treatment of the elderly and patients with impaired liver function or
chronic respiratory insufficiency should be initiated on a
dose of 3.75mg and if necessary increased to 7.5mg.
Although in case of renal insufficiency no accumulation of zopiclone
or of its metabolites has been detected, it is
recommended that patients with impaired renal function should start
treatment with 3.75mg.
_Paediatric population:_
Zopiclone should not be used in children and adolescents aged less
than 18 years. The safety and efficacy of zopiclone in
children and adolescents aged less than 18 years have not been
established.
4.3 CONTRAINDICATIONS
Myasthenia gravis
Hypersensitivity to zopiclone
Severe respiratory insufficiency
Severe sleep apnoea syndrome
Severe hep