Zopiclone 3.75mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Zopiclone

Available from:

NorthStar Healthcare Unlimited Company

ATC code:

N05CF01

INN (International Name):

Zopiclone

Dosage:

3.75mg

Pharmaceutical form:

Oral tablet

Administration route:

Oral

Class:

Schedule 4 (CD Benz)

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 04010100; GTIN: 5051089990305

Patient Information leaflet

148x210 Leaflet Reel Fed Profile (BST)
Dimensions:
Component:
Date Sent:
Technologist: TECHNICALLY APPROVED
Pharmacode:
JDE No.:
Zopiclone, Film-coated Tablets,
3.75 & 7.5mg, 28s - UK
148x210 (Reel Fed)
50987317
Leaflet for Blisters
6755
RH
23-01-20
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GTIN 13
(Belgium & Slovenia):
[e-mail]
ZOPICLONE 3.75MG & 7.5MG 28 TABLET PIL - UK
Black
Profile
BBBA7536
C.Grant
10/02/20
27/04/20
C.Grant
148x210
7pt
Accord Barnstaple
n/a
04
Version 6
12.12.2019
German GTIN 14
(incorporating PZN):
Cartons and label leaflets only
(labels only when specified)
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, pharmacist or
nurse.
•
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, pharmacist or nurse.
This
includes any possible side effects not listed in this leaflet. See
section 4.
WHAT IS IN THIS LEAFLET:
1. WHAT ZOPICLONE TABLETS ARE AND WHAT THEY ARE USED FOR
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE ZOPICLONE TABLETS
3. HOW TO TAKE ZOPICLONE TABLETS
4. POSSIBLE SIDE EFFECTS
5. HOW TO STORE ZOPICLONE TABLETS
6. CONTENTS OF THE PACK AND OTHER INFORMATION
1. WHAT ZOPICLONE TABLETS ARE AND WHAT THEY ARE USED FOR
Zopiclone tablets are sleeping pills (hypnotics) which work by acting
on the brain to cause
sleepiness. They may be used for short

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Zopiclone 3.75mg Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Zopiclone 3.75mg Tablets contain 3.75 mg of Zopiclone per tablet.
Excipient(s) with known effect
Each tablet contains 30.89 mg lactose (as lactose monohydrate).
For the full list of excipients, see section 6.1
3
PHARMACEUTICAL FORM
Tablets.
Orange, odourless, round, biconvex film-coated tablets with embossing
“ZOC 3.75” on one
side. Diameter approximately 7.0 mm.
4
CLINICAL PARTICULARS
4.1.
THERAPEUTIC INDICATIONS
Zopiclone is indicated for the treatment of insomnia in adults
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Treatment with Zopiclone should be for as short a period as possible.
Long-term
continuous use is not recommended (see section 4.4).
The period of treatment should generally vary between a few days to 2
weeks, with a
maximum of 4 weeks including the tapering off phase. It is recommended
that the
patient should be informed of this prior to commencing treatment. In
certain cases it
may be necessary to prolong treatment to beyond the maximum period. If
this is the
case, however, it should only take place after re-evaluation of the
patient’s condition.
The usual dose of Zopiclone in healthy adults is 7.5 mg, taken by oral
administration
in an upright position 30 to 60 minutes before retiring.
Paediatric population
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 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 some cases, depending on
effectiveness
and acceptability.
Renal insufficiency
Accumulation of zopiclone or its metabolites has not been seen during
treatment of
insomnia in patients with renal insufficiency. However, it is