TEVA UK Ref: 231-30-85167-ZA LEA ZOPICLONE A/S TAB TUK Version: 2    10 December 2015

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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 (swelling of the lips, face or neck leading to severe difficulty in breathing; skin rash or hives).

This is a very serious but rare side effect. You may need urgent medical attention or hospitalisation.

The following side effects have been observed in patients treated with zopiclone: Very common (may affect more than 1 in 10 people)

•    a bitter taste or metallic after-taste is the most common adverse reaction of zopiclone.

Common (may affect up to 1 in 10 people):

•    drowsiness during the following day

•    reduced alertness

•    headache

•    dizziness

•    stomach upsets (including feeling or being sick).

Rare (may affect up to 1 in 1,000 people):

•    numbed emotions

•    confusion

•    depressed mood

•    paradoxal reactions such as restlessness, agitation, irritability, aggression, having false beliefs that persist even with having evidence that the belief is not true (delusions), outburst of rage, nightmares, seeing, hearing or feeling things that are not real (hallucinations), a severe mental disorder in which contact with reality is lost or highly distorted (psychosis), inappropriate behaviour or any other changes in behaviour and sleep walking (see section 2 "Take special care with Zopiclone").

•    amnesia (loss of memory)

•    loss of co-ordination

•    difficulty in controlling movements (predominantly at the beginning of treatment; generally disappears after repeated administration)

•    risk of fall (especially in the elderly)

•    light-headedness

•    problems with sight (double vision)

•    skin rashes including hives (urticaria)

•    muscle weakness

•    tiredness

•    dry mouth

•    dyspepsia

•    slight to moderate changes in liver function tests

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

•    changes in sex drive

•    swelling of the limbs and face, serious skin reactions (Stevens-Johnson syndrome, toxic epidermal necrolysis/Lyell's syndrome and erythema multiforme)

Not known (frequency cannot be estimated from the available data)

•    physical and mental dependence

Even when taken normally as prescribed, (short-term) memory loss can occur, sometimes associated with inappropriate behaviour. The risk of this increases at higher doses.

During treatment with zopiclone, pre-existing depression can be unmasked.

The use of zopiclone can lead to physical or psychological dependence, so that stopping treatment can result in withdrawal reactions or the recurrence of insomnia. Consult also the section: 'Take special care with zopiclone.

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

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.

How to store Zopiclone

Keep this medicine out of the sight and reach of children.

Do not store above 25° C.

Do not use this medicine after the expiry date which is stated on the outer packaging after EXP The expiry date refers to the last day of that month.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment.

©Contents of the pack and other information

What Zopiclone tablets contain:

•    The active substance is zopiclone.

•    The other ingredients are lactose monohydrate, calcium hydrogen phosphate dihydrate, maize starch, sodium carmellose, magnesium stearate, titanium dioxide (E171) and hypromellose. The 3.75 mg tablets also contain red and yellow iron oxide (E172).

What Zopiclone tablets look like and contents of the pack:

•    Zopiclone 3.75 mg Film-Coated Tablets are orange, round, biconvex film-coated tablets. They are embossed with 'ZOC 3.75'.

•    Zopiclone 7.5 mg Film-Coated Tablets are white, round, biconvex, scored, film-coated tablets. They are embossed with 'ZOC 7.5' on one side and division mark on both sides.

•    Zopiclone Film-Coated Tablets are available in pack sizes of 10, 14, 20, 28, 30, 50, 56, and 60 tablets.

Not all pack sizes may be marketed.

Marketing Authorisation holder and company responsible for manufacture: TEVA UK Limited, Eastbourne, BN22 9AG, England.

This leaflet was last revised: December 2015

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ZOPICLONE 3.75 mg AND 7.5 mg FILM-COATED TABLETS

Zopiclone

Package leaflet: Information for the user

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 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

OWhat Zopiclone is and what it is used for

Zopiclone belongs to a group of medicines called hypnotics. These are medicines which help you sleep.

Zopiclone is used in adults for the short-term treatment of severe sleeping difficulties, which are causing you extreme distress.

What you need to know before you take Zopiclone

Do not take Zopiclone:

•    if you are allergic to zopiclone or any of the other ingredients of this medicine (listed in section 6).

•    if you are allergic to any other sleeping tablets or tablets taken for anxiety

•    if you have myasthenia gravis (a muscle disease where the muscles become weak and tire easily)

•    if you have severe breathing difficulties, including difficulty in breathing or stopping of breathing for very short periods when asleep (sleep apnoea)

•    if you have severe liver problems. In patients with severe liver problems encephalopathy (a brain disorder) may develop

•    if you are under the age of 18

Warnings and precautions

Talk to your doctor, pharmacist or nurse

before taking Zopiclone

General

Before treatment with Zopiclone

•    the cause of the sleep disturbances should be clarified

•    underlying diseases should be treated.

•    General information about effects observed after use of benzodiazepines and benzodiazepine-like agents (such as Zopiclone-PCH 3.75 mg) or other hypnotics which the prescribing doctor should consider is described in the following:

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. The risk is greater if you have ever had a history of alcohol or drug abuse, or suffer from a personality disorder.

•    When stopping this medicine you may experience withdrawal effects (rebound insomnia) (see section 3, If you stop taking Zopiclone). Withdrawal effects may also occur between doses, especially if you are taking a high dose of Zopiclone. It may be accompanied by other reactions: mood changes, sleep disturbances, anxiety and restlessness.

•    It is important that you are aware of the possibility of such symptoms in order to minimize your anxiety.

•    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.

The risk of such behaviours is increased

•    if alcohol or certain other medicines (such as narcotic analgesics, antipsychotic agents, hypnotics or anxiolytics/sedatives) are used during treatment with Zopiclone

•    if Zopiclone is used at doses exceeding the maximum recommended dose

If you develop such behaviours, please

inform your doctor immediately. Your

doctor may discontinue the treatment

with Zopiclone.

•    After stopping the treatment with a benzodiazepine or a benzodiazepine-like substance, a temporary syndrome called rebound insomnia may occur. Sleeplessness (insomnia) may return in a more severe form. Other symptoms may be mood changes, anxiety and restlessness. The risk of withdrawal or rebound symptoms is higher if you stop the treatment suddenly. Therefore, your doctor will advise you to reduce your dose of Zopiclone gradually.

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• When taking this medicine there is a risk of dependence (a need to keep taking the medicine).This may be

• The effect of some benzodiazepines or benzodiazepine-like substances may decrease after repeated use for a few

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weeks. This process is called tolerance. Please ask your doctor, if you have the feeling that the effect of Zopiclone decreases after repeat use for a few weeks.

•    Benzodiazepines and benzodiazepine-like substances may cause a short-term memory loss (anterograde amnesia). This occurs particularly a few hours after taking the medicine. In order to reduce this risk, make sure you will be able to have an uninterrupted sleep of 7-8 hours.

Special patient groups

Benzodiazepines and benzodiazepine-like

agents (such as Zopiclon-ratiopharm 75 mg)

should be administered with care in

•    Older people and debilitated patients They should receive a lower dose (see 3. "How to use Zopiclon-ratiopharm 75 mg"). Zopiclon-ratiopharm 75 mg has a muscle-relaxant effect. For this reason, especially elderly patients are at risk of falling and consequently of hip joint fractures when getting out of bed at night.

•    Patients with chronic dyspnoea

It is proven that benzodiazepines can impair breathing. It should be considered as well that anxiety or inner restlessness has been described as signs of dyspnoea.

•    Patients with alcohol and drug abuse in their medical history

Extreme caution is required. These patients should carefully be supervised during treatment with Zopiclon-ratiopharm 75 mg, as they are at risk of habituation and psychological dependence.

Talk to your doctor before taking

Zopiclone 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

•    have a history of alcohol or drug abuse

•    have psychiatric problems or mental illness (including personality disorders), depression or anxiety (as thoughts of suicide may occur)

•    have breathing difficulties

•    have mild or moderate liver problems. You are at risk of brain damage (encephalopathy).

•    have kidney problems.

If you are elderly, you are more likely to experience certain of the side effects. Children and adolescents Zopiclone should not be used in children and adolescents less than 18 years. The safety and efficacy of zopiclone in children and adolescents aged less than 18 years have not been established.

Other medicines and Zopiclone Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

Talk to your doctor if you are taking any of the following:

•    muscle relaxants e.g. baclofen, as their muscle relaxing effect may be increased

•    medicines which may increase the effect of Zopiclone, such as:

•    other hypnotics e.g. nitrazepam, used as short-term treatments to help you to sleep

•    anxiolytics or sedatives e.g. diazepam,

used to alleviate anxiety

•    antidepressants e.g. amitriptyline, fluoxetine, and those known as monoamine oxidase inhibitors (MAOIs) e.g. phenelzine

•    antipsychotic drugs also known as neuroleptics or tranquillisers e.g. chlorpromazine, used to treat mental illness

•    strong (narcotic) painkillers e.g. codeine, morphine

•    drugs to treat epilepsy e.g. carbamazepine, phenytoin

•    anaesthetics

•    sedative antihistamines e.g. alimemazine, chlorphenamine, used to treat allergies and allergic reactions and which also cause drowsiness

•    Medicines which may reduce the effect of Zopiclone, such as:

•    erythromycin (an antibiotic)

•    antibiotics of the macrolide class (used to treat bacterial infections), e.g. erythromycin

•    antimycotics of the azole group (used to treat fungal infections)

•    HIV protease inhibitors (used to treat AIDS).

•    Medicines which may reduce the effect of Zopiclone, such as:

•    phenobarbital and phenytoin (used to treat seizures)

•    carbamazepine (used to treat seizures and mood disorders)

•    rifampicin (antibiotic)

•    products containing St. John's wort (herb used to treat depression and anxiety).

Tell the hospital or dentist you are taking Zopiclone if you are to have an operation or treatment requiring an anaesthetic. Zopiclone with food, drink and alcohol

•    Do NOT drink alcohol whilst taking these tablets as the sedative effect of Zopiclone may be increased.

You should not take the tablets with grapefruit juice, as this will change and intensify the effect of Zopiclone- in an unforeseeable way.

Pregnancy and breast-feeding

•    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.

• Zopiclone is not recommended if you are pregnant or planning to become pregnant. Ask your doctor for advice before taking this medicine. It should not be taken during pregnancy, especially not in the first trimester because no sufficient data is available to evaluate safe administration of Zopiclon-ratiopharm 75 mg during pregnancy and the lactation period. Although Zopiclon-ratiopharm 75 mg did not show any malformations or any effect damaging the embryo in animal studies, the safety during human pregnancy has not been verified.

If your doctor has decided that you should take Zopiclone during the last three months of pregnancy or during labour, your baby may have a low body temperature, breathing problems, decreased muscle tone, and suckling reflex ("floppy infant syndrome"). If Zopiclone has been taken for a