ZOPICLONE 7.5MG TABLETS

Active substance: ZOPICLONE

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Zopiclone 3.75mg and 7.5mg Tablets
Please read all of this leaflet carefully before
you start to take this medicine.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your
pharmacist or doctor.
• This medicine has been prescribed for you.
Do not pass it on to others. It may harm them,
even if their symptoms are the same as yours.
• If any of the side effects gets serious, or if you
notice any side effects not listed in this leaflet,
please tell your doctor or pharmacist.

In this leaflet:
1. What Zopiclone tablets are and what they
are used for
2. Before you take Zopiclone tablets
3. How to take Zopiclone tablets
4. Possible side effects
5. How to store Zopiclone tablets
6. Further 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. Before you take Zopiclone tablets

Do not take Zopiclone tablets and tell your doctor 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.
• have severe liver problems
• suffer from breathing problems whilst sleeping (Sleep
Apnoea Syndrome)
• suffer from severe muscle weakness (myasthenia gravis)
• have severe breathing problems
• these tablets are not recommended for use in children.

Check with your doctor or pharmacist before taking
Zopiclone tablets if you:

• have any kidney or liver problems.
• have a history of mental illness
• 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.

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.
• 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.

Taking other medicines

Tell your doctor or pharmacist if you are taking or have recently
taken any other medicine including medicines obtained without
a prescription. 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).

Taking Zopiclone with alcohol

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

Pregnancy and breast-feeding

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

Please tell your doctor if you have any of the conditions listed above.
AAAE2625 50687891



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148x210 reel fed leaflet profile small margins UK BST

(DR/RW/MC 10.02.11)

Zopiclone tablets 3.75mg & 7.5mg x 28 (UK)

colours/plates:
1. black

item no:

AAAE2625

print proof no:

3

origination date: 4.9.12

50687891

dimensions:

148x210 reel fed

3.

pharmacode: 2547

4.

min pt size:

5.
6.

originated by:
approved for print/date

2.

db

revision date:

13.9.12

Technical Approval

revised by:

db

date sent:

30/08/12

supplier:

uk bst

technically app. date:

30/08/12

Non Printing Colours
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4. Possible side effects

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.

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

If you experience the following rare, but very serious side
effect, stop taking Zopiclone tablets and tell your doctor
immediately or contact the casualty department at your
nearest hospital:

Important information about some of the ingredients of
Zopiclone tablets

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.

• an allergic reaction: skin rash, swelling of the face, lips, tongue or throat,
or difficulty breathing or swallowing or light headedness, lack
of co-ordination.

3. How to take Zopiclone tablets

Tell your doctor or pharmacist if any of the following side
effects occur or worsen:

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

• 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, drowsiness,
irritability, aggressiveness, confusion, depression, amnesia,
hallucinations or nightmares.
• Other: sometimes sleeplessness has occurred on stopping the tablets,
usually following prolonged use.

The tablet should be taken together with liquid immediately before
going to bed.
The usual 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.

If any of the side effects get worse, or if you notice any side effects not
listed in this leaflet, please tell your doctor or pharmacist.

5. How to store Zopiclone tablets

Keep out of the reach and sight 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.
Medicines should not be disposed of via wastewater or household
waste. Ask your pharmacist how to dispose of medicines no longer
required. These measures will help to protect the environment.

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.

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.

6. Further information

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, carmellose sodium
and magnesium stearate, methylhydroxypropylcellulose,
titanium dioxide, the 3.75mg tablets also contain iron
oxide yellow and iron oxide red.

If you forget to take Zopiclone tablets

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

Contents of the pack
Pack size: 28

• Treatment should be gradually withdrawn as the symptoms you are
treated for will return more intense 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).

Marketing authorisation holder
Actavis, Barnstaple, EX32 8NS, UK
Manufacturer
Synthon Hispania SL, C/ Castelló, 1- Poligono Las Salinas, 08830 Sant
Boi De Llobraegat, Barcelona
Date of last Revision: September 2012

Actavis, Barnstaple, EX32 8NS, UK

AAAE2625 50687891



148x210 reel fed leaflet profile small margins UK BST

(DR/RW/MC 10.02.11)

Zopiclone tablets 3.75mg & 7.5mg x 28 (UK)

colours/plates:
1. black

item no:

AAAE2625

print proof no:

3

origination date: 4.9.12

50687891

dimensions:

148x210 reel fed

3.

pharmacode: 2547

4.

min pt size:

5.
6.

originated by:
approved for print/date

2.

db

revision date:

13.9.12

Technical Approval

revised by:

db

date sent:

30/08/12

supplier:

uk bst

technically app. date:

30/08/12

Non Printing Colours
1.
2.
3.

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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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