MRP NL/H/269-01 05 July 2010 PACKAGE LEAFLET: INFORMATION FOR THE USER ZOPICLONE 3.75 mg 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 signs of illness 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 belongs to a group of medicines called hypnotics. These are medicines which help you sleep. Zopiclone is used for the short-term treatment of severe sleeping difficulties, which are causing you extreme distress. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE ZOPICLONE DO NOT take Zopiclone: if you are allergic (hypersensitive) 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 or pharmacist before taking Zopiclone Before treatment with Zopiclone Common-pl-zopiclone3_75mgjuly2010tracked 1 REG0047870 Version 0.10 Approved Page 1 of 10 MRP NL/H/269-01 05 July 2010 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) or other hypnotics which the prescribing doctor should consider is described in the following: When taking this medicine there is a risk of dependence (a need to keep taking the medicine). 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. 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. Common-pl-zopiclone3_75mgjuly2010tracked 2 REG0047870 Version 0.10 Approved Page 2 of 10 MRP NL/H/269-01 05 July 2010 The effect of some benzodiazepines or benzodiazepine-like substances may decrease after repeated use for a few 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 Zopiclone) should be administered with care in - Older people and debilitated patients They should receive a lower dose (see 3. “How to use Zopiclone”). Zopiclone 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 Zopiclone, 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. 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 Common-pl-zopiclone3_75mgjuly2010tracked 3 REG0047870 Version 0.10 Approved Page 3 of 10 MRP NL/H/269-01 05 July 2010 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. It should not be taken during pregnancy, especially not in the first trimester because no sufficient data is available to evaluate safe administration of Zopiclone during pregnancy and the lactation period. Although Zopiclone 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”).