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ZOPICLONE 3.75MG TABLETS

Active substance(s): ZOPICLONE

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Package leaflet: Information for the patient

Zopiclone 3.75mg and 7.5mg Tablets
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 term treatment of difficulties in falling asleep,
waking up at night or early in the morning or difficulty in
sleeping caused by events, situations or mental illness, which
is severe, disabling or causing great distress.

2. What you need to know before you take
Zopiclone tablets

Do not take Zopiclone tablets:
• if you are allergic (hypersensitive) to zopiclone or any
of the other ingredients in the tablet (see section 6). An
allergic reaction may include a rash, itching, difficulty
breathing or swelling of the face, lips, throat or tongue.
• if you have severe liver problems
• if you suffer from breathing problems whilst sleeping
(Sleep Apnoea Syndrome)
• if you suffer from severe muscle weakness (myasthenia
gravis)
• if you have severe breathing problems

Warnings and precautions

Talk to your doctor, pharmacist or nurse before taking
Zopiclone tablets:
• if you have any kidney or liver problems.
• if you have a history of mental illness
• if you have or have ever had a history of, or tendency to
alcohol or drug abuse or personality disorders. The risk
of dependence to Zopiclone tablets (physical or mental
effects produced by a compulsion to keep taking the
medicine) increases in these patients, and with dose and
length of treatment.
Continued top of next column

Other considerations

• Habituation – if after a few weeks you notice that the
tablets are not working as well as they did when first
starting treatment, you should go and see your doctor as
an adjustment to your dosage may be required.
• Dependence – when taking this type of medicine there
is a risk of dependence, which increases with dose and
length of treatment. There is a greater risk in patients with
a history of alcohol or drug abuse or personality disorders.
• Withdrawal – treatment should be gradually withdrawn.
A transient syndrome whereby the symptoms that led to
treatment with Zopiclone tablets recur in an enhanced
form, may occur on withdrawal. It may be accompanied
by other reactions including mood changes, anxiety and
restlessness.
• Sleep walking and other associated behaviours such as
“sleep driving”, sleep eating, with memory loss can occur if
Zopiclone tablets are taken when not fully awake.
• Amnesia – Zopiclone tablets can cause memory loss. To
reduce this risk you should ensure that you are able to
have a full night of uninterrupted sleep.

Children and adolescents

Zopiclone tablets should not be used in children.

Other medicines and Zopiclone tablets

Tell your doctor or pharmacist if you are taking or have
recently taken, or might take any other medicines.
Zopiclone tablets may influence the effect and/or side
effects of other medicines. If you see another doctor or go
into hospital, particularly if you are having an operation
under anaesthesia, tell the doctor which medicines you use.
The following medicines may increase the sedating effect
of Zopiclone tablets:
• medicines to treat mental illness (antipsychotics)
• medicines to treat depression
• other sleeping pills
• medicines to treat anxiety and other tranquillizers
• narcotics (strong pain killers) e.g. codeine, morphine
• medicines used to treat epilepsy
• anaesthetics (used during surgery)
• antihistamine medicines which cause sleepiness
• medicines inhibiting liver enzymes e.g. cimetidine,
allopurinol, propranolol. Ask your doctor or pharmacist
which medicines have this effect.
• erythromycin (an antibiotic to treat infections).

Zopiclone tablets with alcohol

Alcohol should not be consumed when taking Zopiclone
tablets, as the sedating effect may be increased.

Pregnancy, breast-feeding and fertility

Zopiclone tablets should not be taken during pregnancy.
If for urgent medical reasons, Zopiclone tablets are taken
during late pregnancy or during labour the baby may
have low body temperature or breathing difficulties and
show withdrawal symptoms after birth because of physical
dependence.
If you are planning to become pregnant or suspect you
may already be pregnant, do not take Zopiclone tablets and
contact your doctor as soon as possible for advice.
Continued over page

148x210 Leaflet Reel Fed Profile (BST)

Zopiclone 3.75mg & 7.5mg tablet leaflet - UK

colours/plates:
1. Black

item no:
print proof no:

AAAI9256
4

origination date: 08.04.16
approved for print/date

originated by:

jh

revision date:

11.08.16

dimensions:

148 x 210

pharmacode:
min pt size:

JDE No.:

3.

Dimensions: 148x210 (Reel Fed)
Component: Leaflet for Blisters

5.
6.

Technical Approval

revised by:

jh

date sent:

supplier:

UK

technically app. date: N/A

N/A

50896351

2.
4.

7

Zopiclone Tablets
3.75 & 7.5mg x 28’s (UK)

Non Printing Colours
1. Profile
2.
3.

Pharmacode: 7246
Date Sent:
05/04/16
Technologist: R.Wrey
Technically Approved
Actavis BST - Packing Technical
BSTCutterGuideReq@actavis.com

Zopiclone will appear in breast milk in small amounts, therefore
breast-feeding mothers should not take this medicine.

4. Possible side effects

Like all medicines, Zopiclone tablets can cause unwanted side
effects, although not everybody gets them.

If you are pregnant or breast-feeding, think you may be pregnant
or are planning to have a baby, ask your doctor or pharmacist for
advice before taking this medicine.

If you experience the following rare, but very serious side
effects, stop taking Zopiclone tablets and tell your doctor
immediately or contact the casualty department at your
nearest hospital:
• an allergic reaction: skin rash, swelling of the face, lips, tongue
or throat, or difficulty breathing or swallowing.

Driving and using machines

Zopiclone tablets may affect your ability to drive or operate
machinery. Make sure you are not affected before driving or
operating machinery, especially if taken with alcohol.

Tell your doctor or pharmacist if any of the following side
effects occur or worsen:
• Effects on the gastrointestinal system: a bitter or metallic taste
in the mouth, dry mouth and feeling sick or being sick.
• Effects on the nervous system: headache, dizziness, light
headedness, lack of co-ordination.
• Psychiatric effects: drowsiness, irritability, aggressiveness,
confusion, depression, amnesia, hallucinations or nightmares.
Sometimes sleeplessness has occurred on stopping the tablets,
usually following prolonged use.

Zopiclone tablets contain lactose

If you have been told you have an intolerance to some sugars, tell
your doctor or pharmacist before taking Zopiclone tablets as this
medicine contains lactose.

3. How to take Zopiclone tablets

Always take Zopiclone tablets exactly as your doctor has told you.
You should check with your doctor or pharmacist when you are
not sure.

Sleep-Driving and other strange behaviour
There have been some reports of people doing things while
asleep that they do not remember when waking up after taking
a sleep medicine. This includes sleep-driving and sleep walking.
Alcohol and some medicines for depression or anxiety can
increase the chance that this serious effect will happen.

The tablet should be taken together with liquid immediately
before going to bed.
The recommended dose is:
• Adults: 7.5mg before going to bed.
• Elderly: A lower dose of 3.75mg may be used initially. This dose
may be increased to 7.5mg.
• Patients with liver disease: Usually a lower dose of 3.75mg at
night. Up to 7.5mg can be given.
• Patients with kidney disease: Treatment should be started with
a dose of 3.75mg.
• Children: not recommended.

How long should you take Zopiclone tablets?

Treatment should be as short as possible. In general, it should not
exceed 4 weeks including the withdrawal period. Your doctor will
choose a withdrawal regime based on your individual needs.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse.
This includes any possible side effects not listed in this leaflet. You
can also report side effects directly via the Yellow Card Scheme at:
www.mhra.gov.uk/yellowcard
By reporting side effects you can help provide more information
on the safety of this medicine.

5. How to store Zopiclone tablets

Keep out of the sight and reach of children.
Store below 25°C in a dry place and protected from light.
Do not use Zopiclone after the expiry date which is stated on the
product packaging. The expiry date refers to the last day of that
month.
Do not throw away medicines via wastewater or
household waste. Ask your pharmacist how to dispose
of medicines you no longer use. These measures will
help protect the environment.

If you take more Zopiclone tablets than you should

If you, (or someone else) swallow a lot of the tablets at the same
time, or if you think a child has swallowed any of the tablets,
contact your nearest hospital casualty department or your doctor
immediately. Do not go unaccompanied to seek medical help.
If an overdose has been taken, you may become increasingly
drowsy very quickly, with high doses probably leading to a coma.

If you forget to take Zopiclone tablets

6. Contents of the pack and other
information

If you forget to take a tablet, take one as soon as you remember,
unless it is nearly time to take the next one. Never take two doses
together. Take the remaining doses at the correct time.

If you stop taking Zopiclone tablets

• Treatment should be gradually withdrawn as the symptoms
you are treated for will return more intensely than before
(rebound insomnia), also anxiety, restlessness and mood
changes may occur. These effects will disappear in time.
• If you have become physically dependent to Zopiclone tablets,
sudden withdrawal of treatment will lead to side effects such as
headaches, muscle pain, extreme anxiety, tension, restlessness,
confusion, irritability. In severe cases other effects may appear,
such as hypersensitivity to light, noise and physical contact,
abnormally acute hearing and painful sensitivity to sound,
hallucinations, numbness and tingling of the extremities,
derealisation (feeling the world around you is not real),
depersonalisation (feeling your mind is becoming separated
from your body) or epileptic seizures (violent fitting or shaking).

What Zopiclone tablets contain
• The active substance (the ingredient that makes the
medicine work) is zopiclone. Each tablet contains
either 3.75mg or 7.5mg of the active ingredient.
• The tablets also contain lactose monohydrate,
calcium hydrogen phosphate, maize starch,
croscarmellose sodium, magnesium stearate,
hypromellose and titanium dioxide. The 3.75mg
tablets also contain iron oxide yellow, iron oxide red
and macrogol.
Contents of the pack
Pack size: 28
Marketing authorisation holder
Actavis, Barnstaple, EX32 8NS, UK
Manufacturer
Actavis, Barnstaple, EX32 8NS, UK
Synthon Hispania SL, C/ Castelló, 1- Poligono Las
Salinas, 08830 SanBoi De Llobraegat, Barcelona
Date of last Revision: August 2016

Continued top of next column
50896351 AAAI9256

Actavis, Barnstaple, EX32 8NS, UK

148x210 Leaflet Reel Fed Profile (BST)

Zopiclone 3.75mg & 7.5mg tablet leaflet - UK

colours/plates:
1. Black

item no:
print proof no:

AAAI9256
4

origination date: 08.04.16
approved for print/date

originated by:

jh

revision date:

11.08.16

dimensions:

148 x 210

pharmacode:
min pt size:

JDE No.:

3.

Dimensions: 148x210 (Reel Fed)
Component: Leaflet for Blisters

5.
6.

Technical Approval

revised by:

jh

date sent:

supplier:

UK

technically app. date: N/A

N/A

50896351

2.
4.

7

Zopiclone Tablets
3.75 & 7.5mg x 28’s (UK)

Non Printing Colours
1. Profile
2.
3.

Pharmacode: 7246
Date Sent:
05/04/16
Technologist: R.Wrey
Technically Approved
Actavis BST - Packing Technical
BSTCutterGuideReq@actavis.com

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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