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ZOPICLONE 7.5MG

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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.

• 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.

What is in this leaflet:

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.

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 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
• are under the age of 18. The safety and efficacy has not been established.

Warnings and precautions

Talk to your doctor, pharmacist or nurse before taking Zopiclone tablets if you:
• have any kidney or liver problems
• suffer from mild breathing problems
• taken Zopiclone or other similar medicines for more than 4 weeks
• 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.
Continued top of next column

Before taking Zopiclone, it is important to make sure that you can have at least 7 to 8
hours of uninterrupted sleep to help reduce the risk of some side effects (see section
4 – Possible side effects).

Children and adolescents

Zopiclone tablets should not be used in children.

Other medicines and Zopiclone tablets

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

Driving and using machines

Like other medicines used for sleep problems, Zopiclone can cause slowing of your
normal brain function (central nervous system depression). The risk of psychomotor
impairment including driving ability is increased if:
• You take Zopiclone within 12 hours of performing activities that require mental
alertness
• You take higher than the recommended dose of Zopiclone
• You take Zopiclone while already taking another central nervous system
depressant or another medicine that increases levels of Zopiclone in your blood,
or while drinking alcohol.
Do not engage in hazardous activities requiring complete mental alertness such as
driving or operating machinery after taking Zopiclone, and in particular during the
12 hours after taking your medicine.
Continued over page

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Zopiclone 3.75 & 7.5mg x 28’s (UK)

Zopiclone 3.75mg & 7.5mg 28 Tablets PIL - UK
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For more information about possible side effects which could affect your driving see
section 4 of this leaflet.

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.
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.

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 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).

4. Possible side effects

Like all medicines, Zopiclone tablets can cause unwanted side effects, although not
everybody gets them.
Stop taking Zopiclone and see a doctor or go to a hospital straight away if:
• You have an allergic reaction. The signs may include: a rash, swallowing or breathing
problems, swelling of your lips, face, throat or tongue.
Tell your doctor as soon as possible if you have any of the following side effects:
Rare (affects 1 to 10 users in 10,000)
• Poor memory since taking Zopiclone (amnesia). By having 7-8 hours of uninterrupted
sleep after taking Zopiclone, this is less likely to cause you a problem.
• Seeing or hearing things that are not real (hallucinations)
• Falling, especially in the elderly
Not known (frequency cannot be estimated from available data)
• Thinking things that are not true (delusions)
• Feeling low or sad (depressed mood)
Tell your doctor or pharmacist if any of the following side effects get serious or lasts
longer than a few days:
Common (affects 1 to 10 users in 100)
• A mild bitter or metallic taste in your mouth or a dry mouth
• Feeling drowsy or sleepy
• Dry mouth

Uncommon (affects 1 to 10 users in 1,000)
• Feeling sick (nausea) or being sick (vomiting)
• Feeling dizzy or sleepy
• Headache
• Nightmares
• Feeling physically or mentally tired
• Agitation
Rare (affects 1 to 10 users in 10,000)
• Feeling confused
• Itchy, lumpy rash (urticaria)
• Feeling irritable or aggressive
• Reduced sex drive
• Difficulty breathing or being short of breath
Not known (frequency cannot be estimated from available data)
• Feeling restless or angry
• Feeling light headed or having problems with your coordination
• Double vision
• Moving unsteadily or staggering
• Muscular weakness
• Indigestion
• Becoming dependent on Zopiclone
• Slower breathing (respiratory depression)
• Unusual skin sensations such as numbness, tingling, pricking, burning or creeping on
the skin (paraesthesia)
• Mental problems such as poor memory
• Difficulty paying attention, drowsiness
• Disrupted normal speech
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.

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.

6.  Contents of the pack and other 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
This leaflet was last revised in January 2016

Continued top of next column
50917175 BBBA0382

Actavis, Barnstaple, EX32 8NS, UK

148x210 Leaflet Reel Fed Profile (BST)

Zopiclone 3.75 & 7.5mg x 28’s (UK)

Zopiclone 3.75mg & 7.5mg 28 Tablets PIL - UK
approved for print/date

Proof Round

1

UK-Eire-Artwork-Support@Actavis.com

Item no:

BBBA0382

Originator:
S.Anson
Origination Date: 23.12.16
Revision Date:
Revised By:

Technical
Approval

Date sent:
n/a
Date received: n/a

Dimensions:
148 x 210
Min Body Text Size: 7pts
Supplier:
Actavis UK

JDE No.:
Colours

Non Printing Colours

1. Black

1. Text Safe Area

2.

2.

3.

3.

4.
5.
6.

* Please note that only Artwork Studio is permitted to make changes to the above artwork.
No changes are permitted by any 3rd party other than added notes and mark ups for required changes.

50917175

Dimensions: 148x210 (Reel Fed)
Component: Leaflet for Blisters
Pharmacode: 4294
Date Sent:
23/12/16
Technologist: R.Wrey
Technically Approved
Actavis BST - Packing Technical
BSTCutterGuideReq@actavis.com

Expand Transcript

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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