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ZOPICLONE 3.75MG TABLETS

Active substance(s): 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.
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148x210 Leaflet Reel Fed Profile (BST)

Zopiclone 3.75mg & 7.5mg 28 Tablets PIL - UK
item no: AAAH7010

dimensions: 148 x 210 Reel fed

print proof no: 2

pharmacode:

origination date: 23.02.15

min pt size: 7

1. Black
2.
3.
4.
5.
6.

originated by: S.Anson
approved for print/date

colours/plates:

revision date: 24.02.15

Technical Approval

revised by: S.Anson

date sent: n/a

supplier: Actavis UK

technically app. date:

Non Printing Colours
1. Text safe area
2.
3.

Zopiclone Tablets
3.75 & 7.5mg x 28’s (UK)
JDE No.:

50847314

Dimensions: 148x210 (Reel Fed)
Component: Leaflet for Blisters
Pharmacode: 6916
Date Sent:
20/02/15
Technologist: R.Wrey
Technically Approved
Actavis BST - Packing Technical
BSTCutterGuideReq@actavis.com

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.

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.

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.
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.

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.

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

• 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).

4. Possible side effects

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:
• 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.

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

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 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.

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, 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: February 2015

Continued top of next column
50847314 AAAH7010

Actavis, Barnstaple, EX32 8NS, UK

148x210 Leaflet Reel Fed Profile (BST)

Zopiclone 3.75mg & 7.5mg 28 Tablets PIL - UK
item no: AAAH7010

dimensions: 148 x 210 Reel fed

print proof no: 2

pharmacode:

origination date: 23.02.15

min pt size: 7

1. Black
2.
3.
4.
5.
6.

originated by: S.Anson
approved for print/date

colours/plates:

revision date: 24.02.15

Technical Approval

revised by: S.Anson

date sent: n/a

supplier: Actavis UK

technically app. date:

Non Printing Colours
1. Text safe area
2.
3.

Zopiclone Tablets
3.75 & 7.5mg x 28’s (UK)
JDE No.:

50847314

Dimensions: 148x210 (Reel Fed)
Component: Leaflet for Blisters
Pharmacode: 6916
Date Sent:
20/02/15
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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