Zopiclone 7.5 Mg Film Coated Tablets
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HOWTO STORE ZOPICLONE
Keep out of the reach and sight of children.
Do not store above 25°C.
Do not use after the expiry date that is stated on the outer 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 howto dispose of medicines no longer required.These measures will help to protect the environment.
Q FURTHER INFORMATION
What Zopiclone tablets contain:
• The active ingredient 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-CoatedTablets are orange, round, biconvex film-coated tablets.They are embossed with 'ZOC 3.75'.
• Zopiclone 7.5 mg Film-CoatedTablets 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-CoatedTablets 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 Manufacturer
Marketing Authorisation holder and company responsible for manufacture:
TEVA UK Limited, Eastbourne, BN22 9AG, England.
This leaflet was last revised: June 2011
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ZOPICLONE 3.75 mg AND 7.5 mg FILM-COATED TABLETS
PACKAGE LEAFLET: INFORMATION FORTHE USER
Read all of this leaflet carefully before you
start taking this medicine.
• 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. 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 get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
INTHIS LEAFLET:
1. What Zopiclone is and what it is used for
2. Before you take Zopiclone
3. How to take Zopiclone
4. Possible side effects
5. How to store Zopiclone
6. Further 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 for the short-term treatment of severe sleeping difficulties, which are causing you extreme distress.
BEFORE YOU TAKE ZOPICLONE
DO NOT take Zopiclone if you:
• are allergic (hypersensitive) to Zopiclone or any of the other ingredients of this medicine
• are allergic to any other sleeping tablets or tablets taken for anxiety
• have myasthenia gravis (a muscle disease where the muscles become weak and tire easily)
• have severe breathing difficulties, including difficulty in breathing or stopping breathing for very short periods when asleep (sleep apnoea)
• have severe liver problems. In patients with severe liver problems encephalopathy (a brain disorder) may develop
• are under the age of 18.
Take special care with Zopiclone
General
Before treatment with Zopiclone
• the cause of the sleep disturbances should be clarified
• underlying diseases should be treated.
• 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 (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.
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.
Sleepwalking (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.
• 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.
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Talk to your doctor before you start to take this medicine 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
• have kidney problems.
If you are elderly, you are more likely to experience certain side effects.
Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription, as they might alter the effects of Zopiclone.
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
• sedative antihistamines e.g. alimemazine, chlorphenamine, used to treat allergies and allergic reactions and which also cause drowsiness
• 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.
Taking Zopiclone with food and drink
• DO NOT drink alcohol whilst taking these tablets as the sedative effect of Zopiclone may be increased.
Pregnancy and breast-feeding
• Ask your doctor or pharmacist for advice before taking any medicine.
• Zopiclone is not recommended if you are pregnant or planning to become pregnant.
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 prolonged period during the last months of pregnancy, your baby may suffer withdrawal symptoms.
• You should not take Zopiclone if you are breast-feeding. Zopiclone is excreted in breast milk.
Driving and using machines
• Rarely, Zopiclone can cause you to feel sleepy during the day. It can also cause reduced alertness, confusion, tiredness, headache, dizziness, muscle weakness, double vision, loss of memory, difficulty concentrating, loss of coordination, and clumsiness.
• If Zopiclone is taken with alcohol effects of sleepiness, loss of memory, difficulty concentrating and difficulty co-ordinating movements will be increased
• If you are affected in any way by these effects, DO NOT drive or operate machinery.
Important information about some of the ingredients of Zopiclone
• Zopiclone contains milk sugar (lactose). If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
HOWTO TAKE ZOPICLONE
Always take Zopiclone exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.
The tablets should be swallowed preferably with a drink of water immediately before going to bed. DO NOT crush, chew, or suck the tablet. DO NOT break the 3.75 mg tablet. The usual dose is:
• Adults
One 7.5 mg tablet (or two 3.75 mg tablets) a day. DO NOT take more than one 7.5 mg tablet (or two 3.75 mg tablets) a day.
• Children and adolescents under the age of 18 years
Zopiclone should not be used in children and adolescents under the age of 18 years.
• The elderly and patients with breathing difficulties, kidney or liver problems
A starting dose of one 3.75 mg tablet (or half a 7.5 mg tablet) is recommended, which may be increased if necessary by your doctor.
Treatment with Zopiclone usually lasts from a few days to two weeks, up to a maximum of four weeks. In certain cases
treatment may last longer than four weeks, but only if your doctor believes this to be necessary. 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 than you should
If you (or someone else) swallow a lot of the tablets all together, or if you think a child has swallowed any of the tablets, contact your nearest hospital casualty department or your doctor immediately. An overdose is likely to cause drowsiness, 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, 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
If you forget to take a dose immediately before bed but remember during the night, only take the missed dose if you are still able to have 7-8 hours of uninterrupted sleep. If this is not the case, restart immediately before the next night. Do not take a double dose on the next day to make up for the previously missed dose.
If you stop taking Zopiclone
DO NOT stop taking your tablets without talking to your doctor first, even if you feel better.
DO NOT stop taking your tablets suddenly. When your doctor decides to stop your tablets, the dose will be reduced gradually over a period of time.
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.
Taking Zopiclone may lead to dependence. If dependence has developed, stopping your treatment abruptly will cause withdrawal effects. These may consist of headache, muscular pain, extreme anxiety, feelings of tension, restlessness, confusion, sleeping difficulties and irritability.
In severe cases the following symptoms may occur:
• a feeling of detachment from your surroundings
• a feeling of things being unreal
• sounds seeming to be louder than usual and which can sometimes be painful if the sound is loud
• numbness and tingling in the fingers and toes
• sensitivity to light, noise and physical contact
• seeing, hearing or feeling things that are not real (hallucinations)
• fits.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
POSSIBLE SIDE EFFECTS
Like all medicines, Zopiclone 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.
The following side effects have been observed in patients treated with Zopiclone:
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.
Common (in more than 1 in 100 users):
• a bitter (metallic) taste in the mouth
• drowsiness during the following day
• reduced alertness
• headache
• dizziness
• stomach upsets (including feeling or being sick).
Rare (in more than 1 in 10,000 users):
• 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
• amnesia (loss of memory)
• loss of co-ordination
• difficulty in controlling movements
• light-headedness
• problems with sight (double vision)
• skin rashes
• muscle weakness
• tiredness
• dry mouth.
Very rare (in less than 1 in 10,000 users):
• severe hypersensitivity reactions
• changes in sex drive.
Unknown (cannot be estimated from the available data)
• physical and mental dependence.
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.