Zopitan 3.75 mg Film-Coated Tablet

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Zopiclone

Available from:

Clonmel Healthcare Ltd

ATC code:

N05CF; N05CF01

INN (International Name):

Zopiclone

Dosage:

3.75 milligram(s)

Pharmaceutical form:

Film-coated tablet

Prescription type:

Product subject to prescription which may not be renewed (A)

Therapeutic area:

Benzodiazepine related drugs; zopiclone

Authorization status:

Marketed

Authorization date:

1999-06-25

Patient Information leaflet

Page 1 of 5
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
ZOPITAN 3.75 MG FILM-COATED TABLETS
ZOPITAN 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 of the side effects, talk to your doctor or pharmacist.
This includes any possible side
effect not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Zopitan is and what it is used for
2.
What you need to know before you take Zopitan
3.
How to take Zopitan
4.
Possible side effects
5.
How to store Zopitan
6.
Contents of the pack and other information
1.
WHAT ZOPITAN IS AND WHAT IT IS USED FOR
The name of your medicine is Zopitan film-coated tablets. Zopitan
tablets are part of a group of drugs
known as hypnotics and sedatives.
In adults zopitan tablets are prescribed for the short-term treatment
of insomnia (sleeplessness) which
disrupts normal functioning or which causes extreme suffering. Zopitan
tablets make you fall asleep more
quickly.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE ZOPITAN
DO NOT TAKE ZOPITAN

if you are allergic to zopiclone or any of the other ingredients of
this medicine (listed in section 6)

if you have ever had any severe problems with your liver

if you have ever had any problems with your lungs

if you have any difficulties with your breathing

if you have a condition called myasthenia gravis (muscle weakness)

if you have severe sleep apnoea syndrome caused by upper airway
obstruction during sleep, associated
with frequent awakening and often with daytime sleepiness.
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before taking Zopitan

if you are elderly

if you are taking anti-depressants or dr

Summary of Product characteristics

Health Products Regulatory Authority
12 April 2019
CRN008MPD
Page 1 of 8
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Zopitan 3.75 mg Film-Coated Tablet
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains Zopiclone 3.75 mg.
Excipient with known effect
Contains lactose monohydrate 30.8 mg.
For the full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Film coated tablet.
Orange, round, biconvex, film-coated tablets with a diameter of
approximately 7.0 mm and a height of 3.5-4.0 mm. Embossed
with “Zoc 3.75” on one side.
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.
Posology
The recommended dose for adults is 7.5 mg. This dose should not be
exceeded.
_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.
Treatment of the elderly and patients with impaired liver function or
chronic respiratory insufficiency should be initiated on a
dose of 3.75 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 3.75 mg.
Method of administration
Oral.
4.3 CONTRAINDICATIONS
Hypersensitivity to zopiclone to the active substance or to any of the
excip