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ZOPICLONE 7.5 MG FILM COATED TABLETS

Active substance(s): ZOPICLONE / ZOPICLONE / ZOPICLONE

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Package leaflet: Information for the user
Zopiclone 7.5mg Film-coated 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 or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm
them, even if their symptoms are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side
effects not listed in this leaflet. See section 4.

What is in this leaflet:
1. What Zopiclone is and what it is used for
2. What you need to know before you take Zopiclone
3. How to take Zopiclone
4. Possible side effects
5. How to store Zopiclone
6. Contents of the pack and other information
1. What Zopiclone is and what it is used for
Zopiclone Tablets are benzodiazepine-like hypnotics, which work by acting on the brain to
cause sleepiness. They may be used for short term treatment of difficulty in sleeping which is
severe, disabling or causing great distress.
2. What you need to know before you take Zopiclone
Do not take Zopiclone Tablets and tell your doctor:
• if you are allergic to zopiclone or any of the other ingredients of this medicine (listed in
section 6). An allergic reaction may include a rash, itching, difficulty breathing or swelling of
the face, lips, throat or tongue
• if you are allergic to any other benzodiazepines or benzodiazepine-like hypnotics, such as
nitrazepam or diazepam
• if you have severe liver problems. In patients with severe liver problems encephalopathy (a
brain disorder) may develop
• if you suffer from breathing problems whilst sleeping (sleep apnoea)
• if you suffer from severe muscle weakness (myasthenia gravis)
• if you have severe breathing problems or your lungs do not work properly
• if you are under the age of 18 years
Warnings and precautions
Talk to your doctor or pharmacist before taking Zopiclone Tablets:
• if you are elderly or frail. Due to the muscle relaxing effect of Zopiclone, there is a danger
of falls, particularly for the elderly when getting up at night
• if you have any kidney problems
• if you have mild or moderate liver problems
• if you have breathing difficulties
• if you suffer from or have a history of depression or anxiety (as suicidal thoughts may
occur)





if you have psychiatric problems or mental illness (including personality disorders)
if you have recently taken Zopiclone or other similar medicines for more than 4 weeks
if you do not feel you will ever be able to stop taking Zopiclone Tablets or other
medicines used to treat sleep problems.

If you are elderly, you are more likely to experience certain of the side effects.

Please tell your doctor if you have any of the conditions listed above.
Other considerations:
• Dependence (a need to keep taking the medicine) – when taking this type of medicine there
is a risk of dependence, which increases with dose and length of treatment. This may be
physical dependence, where the body becomes used to the presence of the medicine and
stopping treatment causes withdrawal symptoms and/or mental dependence, where you
develop a craving for the medicine. There is a greater risk in patients with a history of
alcohol or drug abuse, of suffer from a personality disorder..
• Withdrawal – treatment should be withdrawn gradually. Withdrawal effects are unlikely
when duration of treatment is limited to 4 weeks. Withdrawal effects may also occur between
doses, especially if you are taking a high dose of Zopiclone. See Section 3, If you stop taking
Zopiclone.
• Amnesia – Zopiclone Tablets can cause memory loss. To reduce this risk you should ensure
that you are able to have 7-8 hours uninterrupted sleep.
• Behavioural effects may occur while taking Zopiclone (see Section 4, Possible side effects).
Blood test
• Zopiclone tablets can change the levels of liver enzymes shown up in blood tests. This can
mean that your liver is not working properly. If you are going to have a blood test, it is
important to tell your doctor that you are taking Zopiclone tablets.
Behavioural effects may occur while taking Zopiclone.
During the use of benzodiazepines and benzodiazepine-like substances, the following
psychiatric and paradoxical reactions may occur: restlessness, agitation, irritability,
aggression, having false beliefs that persist even with having evidence that the belief is not
true (delusions), outbursts of rage, nightmares, seeing, hearing or feeling things that are not
real (hallucinations), severe mental disorders characterized by disturbance of personality and
loss of contact with reality (psychoses), unsuitable behaviour, other behavioural disturbances.
The risk of these reactions is higher in elderly patients. If you feel any of the symptoms listed
above, you should stop taking Zopiclone. Ask your doctor for advice.
Sleep walking (somnambulism) and other associated behaviours such as “sleep driving”,
preparing and eating food, or making phone calls, with memory loss (amnesia) for the event,
have been reported in patients who have taken zopiclone and were not fully awake.
Other medicines and Zopiclone
Tell your doctor or pharmacist if you are taking or have recently taken any other medicines,
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 medicine may increase the sedating effects of Zopiclone Tablets:
• medicines to treat mental illness (antipsychotics)












medicines to treat depression e.g. amitriptyline, fluoxetine, and those known as
monoamine oxidase inhibitors (MAOIs) e.g. phenelzine
other benzodiazepines or benzodiazepine-like hypnotics used to treat insomnia or anxiety
e.g. nitrazepam, diazepam
other tranquillizers e.g. chlorpromazine
some medicines for moderate to severe pain (narcotic analgesics) such as codeine,
methadone, morphine, oxycodone, pethidine, tramadol and morphine. Feelings of
excitement (euphoria) may increase, which in turn increase the chance of physical or
mental dependence
medicines used to treat epilepsy e.g. carbamazepine
anaesthetics (used during surgery)
antihistamine medicines which cause sleepiness e.g. alimemazine, chlorphenamine
erythromycin (an antibiotic)
medicines for hay fever, rashes or other allergies that can make you sleepy (sedative
antihistamines) such as chlorphenamine or promethazine

The following medicines may increase the risk of you getting side effects when taken with
Zopiclone. To make this less likely, your doctor may lower your dose Zopiclone:
• Some medicines for fungal infections such as ketoconazole and itraconazole
• Some antibiotics including erythromycin and clarithromycin
• Ritonavir (a protease inhibitor) used to treat HIV infections
The following medicines can make Zopiclone work less well:
• Some medicines for epilepsy such as carbamazepine, phenobarbital or phenytoin
• Rifampicin (an antibiotic) – for infections
• St John’s Wort (a herbal medicine) – for mood swings and depression
The effect of the following medicines is increased when taken with Zopiclone:
• muscle relaxants e.g. baclofen
Zopiclone with food, drink and alcohol
DO NOT drink grapefruit juice whilst taking Zopiclone, as the sedating effect may be
increased.
DO NOT drink alcohol when taking Zopiclone Tablets, as the sedating effect may be
increased. Alcohol increase the effect of Zopiclone tablets and make you sleep very deeply so
that you do not breath properly or have difficulty waking.
Pregnancy and breast-feeding
• Talk to your doctor before taking this medicine if you are pregnant, might become
pregnant or think you may be pregnant
• Zopiclone is not recommended if you are pregnant or planning to become pregnant. Ask
your doctor for advice before taking this medicine. Do not take Zopiclone during the last 3
months of pregnancy or during labour because it may be harmful to your baby
• Do not breast-feed if you are taking Zopiclone. This is because small amounts may pass
into mother’s milk. If you are breast-feeding or plan to breast-feed, talk to your doctor or
pharmacist before taking Zopiclone.
Ask your doctor or pharmacist for advice before taking any medicine if you are pregnant or
breast-feeding.

Driving and using machines
• Zopiclone may make you feel drowsy, cause loss of concentration or muscle weakness.
DO NOT drive or operate machinery after taking a dose of Zopiclone.
• DO NOT drive or operate machinery the day after taking Zopiclone until you are sure that
you are not affected by Zopiclone
• If Zopiclone is taken with alcohol, the effects of Zopiclone may be increased the next
morning. DO NOT drive or operate machinery until you are sure that you are not affected.
Zopiclone contains Lactose
If you have been told that you have an intolerance to some sugars, tell your doctor or
pharmacist before taking Zopiclone Tablets as this medicine contains lactose (See section 6).

3. How to take Zopiclone
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 tablets should be taken together with
liquid immediately before going to bed. The tablet should be swallowed whole. DO NOT
break, chew, or suck the tablet.
The recommended dose is:
• Adults: 7.5mg immediately before going to bed. DO NOT take more than one 7.5 mg tablet
a day.
• Elderly patients, or those with liver or kidney problems, or breathing difficulties: a lower
dose of 3.75mg at night may be used. This dose may be increased to 7.5mg by your doctor
• Children and adolescents under 18: Zopiclone tablets are not intended for patients under 18
years of age
How long should you take Zopiclone Tablets?
Treatment with Zopiclone usually lasts from a few days to two weeks, up to a maximum of
four weeks, as directed by your doctor. Your treatment with Zopiclone should be for as short
a time and as low a dose as possible to reduce the risk of dependence occurring.
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.
An overdose is likely to cause drowsiness, sleeping deeply, confusion and lethargy. In more
serious cases, overdose may cause loss of co-ordination, muscle weakness, low blood
pressure (feeling dizzy and faint), breathing problems, falling over or losing your balance,
rarely coma and very rarely death. The effects of an overdose may be more severe if the
tablets have been taken with alcohol or other medicines such as antidepressants or sedatives.
Please take this leaflet, any remaining tablets, and the container with you to the hospital or
doctor so that they know which tablets were consumed.
If you forget to take Zopiclone Tablets
If you forget to take a dose immediately before going to bed but remember during the night,
only take the missed dose if you will still be able to have 7-8 hours of uninterrupted sleep. If
this is not possible, take the next dose at the usual time the next night.

Do not take a double dose to make up for a forgotten dose. If you are worried ask your
pharmacist or doctor for advice.
If you stop taking Zopiclone Tablets
When your doctor decides to stop your tablets, the dose will be reduced gradually over a
period of time. DO NOT stop taking your tablets suddenly.
Stopping Zopiclone may lead to “re-bound insomnia”. This means the symptoms that required
you to take your tablets in the first place may reappear and be more severe for a short time.
These symptoms may also be accompanied by mood changes, sleeping difficulties, anxiety
and restlessness. Therefore, the dose of these tablets must always be reduced gradually.
These effects will disappear in time.
If you have become physically dependent on Zopiclone Tablets, sudden withdrawal of
treatment will lead to side effects such as headaches, tremor, sweating, agitation, fast heart
beat (palpitations), uneven heartbeat (tachycardia), relaxed grip on reality, panic attacks,
stomach problems, muscle pain, tension, restlessness, confusion, sleeping difficulties,
nightmares, a lower level of awareness and problems with focusing or concentrating and
irritability.
In severe cases other effects may appear, such as:
• hypersensitivity to light, noise and physical contact
• sounds seeming louder than usual, and painful sensitivity to sound
• hallucinations
• numbness and tingling in the fingers and toes
• derealisation (feeling the world around you is not real)
• a feeling of detachment from your surroundings
• depersonalisation (feeling your mind is becoming separated from your body)
• epileptic seizures (violent fitting or shaking).
These symptoms may also be experienced between doses, especially if the dose is high.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Side effects are most common at the beginning of treatment, during the first hour after taking
your tablet.
If the following happens, stop taking the tablets and tell your doctor immediately or go to the
casualty department at your nearest hospital:


an allergic reaction (includes skin rash, swelling of the face, lips, tongue or throat, or
difficulty breathing or swallowing.).

This is a very serious but rare side effect. You may need urgent medical attention or
hospitalisation.
The following side effects of Zopiclone should disappear after a few days. Tell your doctor or
pharmacist if any of the following side effects last more than a few days or become serious:

Very common (may affect more than 1 in 10 people):
• a bitter (metallic) taste in the mouth
Common (may affect up to 1 in 10 people):
• stomach upsets (including feeling sick (nausea) or being sick)
• drowsiness (during the following day)
• reduced alertness
• headache
• dizziness.
Rare (may affect up to 1 in 1,000 people):
• confusion
• depression
• tiredness
• numbed emotions
• hallucinations (seeing or hearing things that are not real)
• depressed mood (feeling low or sad)
• restlessness, agitation or irritability
• aggressiveness or anger
• nightmares
• psychiatric problems
• unsuitable behaviour or any other change in behaviour
• sleep walking (somnambulism)
• poor memory (amnesia)
• dry mouth


dyspepsia (indigestion)








light-headedness
loss of co-ordination
difficulty in controlling movements
risk of fall (especially in the elderly)
muscle weakness
abnormal blood test results for liver function.

Very rare (may affect up to 1 in 10,000 people):


reduced sex drive

Not known (frequency cannot be estimated from the available data):
• physical and mental dependence
• problems with sight (double vision)
Sleep-walking and other strange behaviours
There have been some reports of people (when asleep) performing tasks that they do not
remember on waking up after taking a sleep medicine. This includes sleep-driving, eating and
sleep walking. Alcohol and some medicines for depression or anxiety can increase the
likelihood of this serious effect happening. If you are concerned this side effect may have
happened to you after taking Zopiclone, tell your doctor as soon as possible.

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. 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
Keep this medicine out of the sight and reach of children.
Do not store above 25°C. Store in the original packaging.
Do not use Zopiclone Tablets 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. Contents of the pack and other information
What Zopiclone Tablet contains
The active substance is zopiclone. Each tablet contains 7.5mg of the active ingredient.
The other ingredients are: calcium hydrogen phosphate dihydrate, lactose monohydrate,
maize starch, sodium starch glycollate type A, magnesium stearate,
hydroxypropylmethylcellulose, propylene glycol, titanium dioxide, talc.
What Zopiclone Tablet looks like and contents of the pack
Zopiclone Tablets are white, round with a score line on one side. The tablets are packed in
blisters inserted into a carton.
Pack size: 28

Marketing Authorisation Holder
TEVA UK Limited, Eastbourne, BN22 9AG
Manufacturer
PSI Supply nv
Axxes Business Park
Guldensporenpark 22 – Block C
9820 Merelbeke
Belgium
This leaflet was last revised in February 2016
PL 00289/1478

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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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