Zopiclone Pinewood 7.5 mg Film-Coated Tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Zopiclone

Available from:

Pinewood Laboratories Ltd

ATC code:

N05CF01

INN (International Name):

Zopiclone

Pharmaceutical form:

Film-coated tablet

Therapeutic area:

zopiclone

Authorization status:

Not marketed

Authorization date:

2022-07-08

Patient Information leaflet

1
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
ZOPICLONE PINEWOOD 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 or pharmacist. This
includes any possible side
effects not listed in this leaflet. See section 4.
The name of this medicine is Zopiclone Pinewood 7.5 mg film-coated
tablets, which will be called
Zopiclone Pinewood throughout this leaflet.
WHAT IS IN THIS LEAFLET
1.
What Zopiclone Pinewood is and what it is used for
2.
What you need to know before you take Zopiclone Pinewood
3.
How to take Zopiclone Pinewood
4.
Possible side effects
5.
How to store Zopiclone Pinewood
6.
Contents of the pack and other information
1.
WHAT ZOPICLONE PINEWOOD ARE 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 YOU TAKE ZOPICLONE PINEWOOD
DO NOT TAKE ZOPICLONE PINEWOOD
-
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
Talk to your doctor or pharmacist before taking Zopiclone Pinewood.
-
If you are pregnant or think

Summary of Product characteristics

Health Products Regulatory Authority
11 July 2022
CRN009YZZ
Page 1 of 8
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Zopiclone Pinewood 7.5 mg Film-Coated Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 7.5mg of zopiclone.
Excipient(s) with known effect
Each tablet contains 33.5 mg of lactose monohydrate.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated Tablet.
Blue coloured, oval shaped, film-coated tablets, debossed with '7.5'
and break line on one side and plain on the other 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 7.5 mg. 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 3.75 mg and if necessary increased to 7.5 mg.
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
H