Zimoclone 7.5 mg Film-coated Tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Zopiclone

Available from:

Generics (UK) Limited

ATC code:

N05CF; N05CF01

INN (International Name):

Zopiclone

Dosage:

7.5 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:

2000-04-28

Patient Information leaflet

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Zopiclone 7.5 mg 28
Leaflet
1437885
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Gerard Labs
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25 Oct 2018
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1. WHAT ZIMOCLONE IS AND WHAT IT IS
USED FOR
Zimoclone tablets are sleeping pills (hypnotics)
which work by acting on the brain to cause
sleepiness. Zimoclone may be used for the short
term treatment of difficulty in sleeping which
is severe, disabling or causing great distress in
adults.
2. WHAT YOU NEED TO KNOW BEFORE YOU
TAKE ZIMOCLONE
Do not take Zimoclone if you
•
are allergic (hypersensitive) to zopiclone or any
of the other ingredients of this medicine (listed
in section 6). An allergic reaction may include a
rash, itching, difficulty breathing or swelling of
the face, lips, throat or tongue
•
suffer from a disease of the muscles causing
drooping eyelids, double vision, difficulty
speaking and swallowing and sometimes
muscle weakness in the arms and legs
(myasthenia gravis)
•
have severe liver problems
•
suffer from irregular breathing while asleep
(sleep apnoea syndrome)
•
have severe breathing problems
•
are under the age of 18
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before taking
Zimoclone if you:
•
are elderly or at risk of becoming confused.
Taking zopiclone may mean an increased risk
of falling and consequential injuries.
•
suffer from liver or kidney problems, as your
doctor may start you on a lower dose
•
have a history of breathing problems. Taking
zopiclone will reduce the force of your
breathing
•
suffer from or have a history of depression,
anxiety or psychotic il

Summary of Product characteristics

Health Products Regulatory Authority
11 January 2019
CRN008LF4
Page 1 of 16
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Zimoclone 7.5 mg Film-coated Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 7.5 mg of the active ingredient
zopiclone.
Excipient with known effect
Each film-coated tablet contains 30.8 mg lactose anhydrous
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet.
White, film-coated, oval tablet with a breakline, marked with “ZZ”
on one side and
“7.5” on the other.
The tablet can be divided into equal halves.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Zimoclone is indicated for the 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. Long
term continuous use is not recommended. A course of treatment should
employ the
lowest effective dose.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
The lowest effective dose should be used.
Zopiclone should be taken in a single dose and not re-administered
during the same
night.
_Treatment duration_
Treatment with zopiclone should be as short as possible. Generally the
duration of
treatment varies from a few days to two weeks with a maximum,
including the
tapering off, of four weeks.
Health Products Regulatory Authority
11 January 2019
CRN008LF4
Page 2 of 16
In certain cases an extension beyond the maximum treatment period may
be
necessary; if so it should take place after re-evaluation of the
patient’s status (see
section 4.4).
Posology
_Adults:_
The recommended dose for adults is 1 tablet (7.5 mg zopiclone). This
dose should
not be exceeded. The tablet should be taken just before retiring.
_Impaired renal function:_
Although accumulation of zopiclone and/or its metabolites has not been
shown in
patients with impaired renal function, a starting dose of 3.75 mg is
recommended in
these patients.
_Impaired hepatic