Zopiclone 7.5 Mg Film Coated Tablets
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PACKAGE LEAFLET: INFORMATION FOR THE USER
Zopiclone 7.5 mg film-coated tablets
Zopiclone
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.
- Ifyou have any further questions, askyour doctor orpharmacist.
- 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.
- Ifyou 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. Whatyouneedto 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 is a sedative-hypnotic drug with zopiclone as active substance. Zopiclone induces sleep andhelps you to relax.
Zopiclone is used for the short-term treatment of sleeplessness which causes you extreme distress. The treatment can take a few days to 2 weeks and usually does not take longer than 4 weeks.
2. 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. “Further information” at the end of this leaflet)
• ifyou suffer from any of the following diseases:
- a serious muscle-weakness called myasthenia gravis (an autoimmune disease)
- severe respiratory insufficiency (a condition in which the gas exchange in the lungs is insufficient to meet the body's needs)
- sleep apnoea syndrome (a sleep disorder characterized by pauses in breathing during sleep)
- severe liver impairment
• ifyou are a child or adolescent under 18 years of age.
Warnings and precautions
Talk to your doctor or pharmacist before taking Zopiclone.
General
Before treatment with Zopiclone
- the cause ofthe sleep disturbances shouldbe clarified
- underlying diseases should be treated.
Please tell your doctor if you have or have had any medical conditions or illnesses, especially any ofthe following:
• chronic respiratory insufficiency (caused by breathing or heart problems). Your doctor will reduce the dose due to the risk of respiratory depression.
• impaired liver or kidney function. Your doctor will reduce the dose.
• psychoses (severe mental disorders characterized by disturbance of personality and loss of contact with reality)
• depression
• anxiety linked with depression
• history of alcohol or drug abuse.
• you have recentely taken Zopiclone or other similar medicines for more than four weeks.
• you do not feel you will ever be able to stop taking Zopiclone or other medicines used to treat sleep problems.
Your doctor will decide whether you should take Zopiclone or not. They will also monitor you closely during the treatment.
Dependence and withdrawal symptoms
The use of benzodiazepines and benzodiazepine-like substances can lead to physical and psychological dependence on these agents. The risk of dependence increases the higher the dose and the longer the period of treatment. This risk is also higher in patients with a history of alcohol or drug abuse and/or those who have marked personality disorders.
If physical dependence occurs, stopping the treatment suddenly may lead to withdrawal symptoms such as: headache, muscle pain, extreme anxiety, tension, restlessness, confusion and irritability. In severe cases following symptoms may occur: an alteration in the perception of the world so that it seems strange or unreal (derealisation), loss of your own personal identity followed by feelings of unreality and strangeness (depersonalization), oversensitivity to sound (hyperacusis), numbness and tingling of arms and legs, hypersensitivity to light, noise or physical contact, seeing, hearing or feeling things that don't really exist (hallucinations) and epileptic seizures.
Sleeplessness (Rebound insomnia)
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.
Tolerance
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, ifyou have the feeling that the effect of Zopilcon decreases after repeat use for a few weeks.
Short-term memory loss (Anterograde amnesia)
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.
Psychiatric and “paradoxical” reactions
During the use of benzodiazepines and benzodiazepine-like substances, the following reactions may occur:
• restlessness
• agitation
• irritability
• aggression
• false beliefs (delusions)
• outbursts ofrage
• nightmares
• seeing, hearing or feeling things that don't really exist (hallucination)
• severe mental disorders characterized by disturbance of personality and loss of contact withreality (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 associated behaviours
Sleep walking and other associated behaviours such as “sleep driving”, preparing and eating food, or making phone calls, with memory loss (amnesia) of 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.
Risk of fall
Due to the muscle relaxing effect of zopiclone, there is a risk of fall, especially in the elderly when they get up during the night.
Other medicines and Zopiclone
Tell your doctor or pharmacist ifyou are taking, have recently taken or might take any other medicines. This includes medicines, herbal remedies, health foods or supplements that you have obtained without a prescription.
The following medicines may increase the effect of Zopiclone:
• antipsychotics/neuroleptics (used to treat psychoses)
• hypnotics (used to treat sleeplessness)
• anxiolytics (used to treat anxiety)
• sedatives/tranquilizers (used to induce calmness and reduce anxiety)
• antidepressants (used to treat depression)
• narcotic analgesics/painkillers ofthe opioid class, such as morphine and morphine-like substances (used to relieve pain). They may additionally cause an abnormal feeling of happiness (euphoria). This may promote psychological dependence
• antiepileptics/anticonvulsants (used to prevent epileptic seizures)
• anaesthetics (used to block pain sensation, for example during surgeries)
• calming antihistamines (used to treat allergic reactions)
• grapefruitjuice
• alcohol
The following medicines can increase the change of you getting side effects when taken with Zopiclone. To make this less likely, your doctor may decide to lower your dose of Zopiclone:
• antibiotics ofthe macrolide class (usedto treat bacterial infections), e.g. erythromycin
• antimycotics of the azole group (used to treat fungal infections)
• HIV protease inhibitors (used to treatAIDS)
The combination of Zopiclone with muscle relaxants may enhance the muscle relaxing effect.
The following medicines may reduce the effect of Zopiclone:
• 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).
Taking Zopiclone with food and drink
• Do not drink alcohol while you are taking Zopiclone. Alcohol can increase the effects of Zopiclone and make you sleep very deeply so that you do not breathe properly or have difficulty waking.
Pregnancy, breast-feeding and fertility
Ask your doctor or pharmacist for advice before taking any 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.
Pregnancy
The use of Zopiclone is not recommended during pregnancy.
If zopiclone is used during the last three months of pregnancy or during labour, some effects on the newborn child may arise. These include low body temperature (hypothermia), and low blood pressure (hypotension), decreased muscle tone (hypotonia), very slow or shallow breathing (respiratory depression) and decreased suckling reflex (“floppy infant syndrome”).
Withdrawal symptoms may occur in newborns. This has been observed in children of mothers who have used zopiclone for long periods during the last months of pregnancy.
Breast-feeding
You should not take Zopiclone if you are breast-feeding. Zopiclone is excreted in breast milk in a small amount.
Driving and using machines
You should not drive or operate machines until the treatment has finished or it has been established that your performance is not impaired.
Zopiclone may cause side effects which affect your ability to drive and use machines. These are, for example:
• feeling numb (sedation)
• loss of memory (amnesia)
• impaired concentration
• impaired muscle function.
The risk of these effects increases with alcohol intake and is even higher when the sleep duration is insufficient (7-8 hours). The symptoms may affect you also in the next morning.
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.
3. How to take Zopiclone
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
The recommended dose is:
Use in adults
The recommended dose is 7,5 mg zopiclone. This dose shouldnot be exceeded.
Use in children
You must not take Zopiclone if you are under 18 years of age.
Elderly, also patients with impaired liver or kidney function or chronic respiratory insufficiency (a condition in which the gas exchange in the lungs is insufficient to meet the body's needs)
You should start the treatment at a dosage of 3.75 mg zopiclone.
Maximum dose
Adailydoseof 1 film-coated tablet ofZopiclone shouldnot be exceeded.
You can break the tablet as follows:
• lay the tablet on a desk
• take the left and right thumb or forefinger and press on both sides of the scoring line.
Take Zopiclone just before going to bed. Make sure you will be able to have an uninterrupted sleep of 7-8 hours. Swallow the tablet with liquid (e.g. 1 glass of water), however not with grapefruit juice.
Please talk to your doctor if you think that the effect ofZopiclone is too weak or too strong. Duration of the treatment
Your treatment with Zopiclone should be as short as possible. In general, it should last between a few days to 2 weeks. Your doctor will explain to you how to reduce the dose of Zopiclone gradually at the end of the treatment (tapering off). This measure lowers the risk of withdrawal or rebound symptoms (see section 2. “Take special care with Zopiclon”).
You should not take Zopiclone for longer than 4 weeks including the tapering off phase. Ask your doctor for advice if your symptoms don't improve within this period.
Blood tests
• Zopiclone 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.
If you take more Zopiclone than you should
If you have taken too many tablets, contact your doctor or nearest hospital casualty department immediately for advice.
Zopiclone overdosage together with certain agents might be life-threatening. These agents are drugs which have a suppressive effect on the central nervous system, including alcohol.
Overdosage of benzodiazepines or benzodiazipines-like substances usually causes depression of the central nervous system which ranges from drowsiness to coma. The following effects may happen:
• Feeling drowsy, confused, sleeping deeply and possibly falling in to a coma.
• Floppy muscles (hypotonia).
• Feeling dizzy, light headed or faint. These effects are due to low blood pressure.
• Falling over or losingyour balance (ataxia).
• Shallow breathing or difficulty breathing (respiratory depression).
If you forget to take Zopiclone
If you still have time to sleep for 7 to 8 hours, you should take the dose immediately.
If there is less time, ignore the forgotten dose and do not take another dose until the following day before going to sleep.
Do not take a double dose to make up for a forgotten tablet.
If you stop taking Zopiclone
Stopping the treatment suddenly may lead to withdrawal or rebound symptoms. See section 2.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
The most commonly reported adverse effects are: sleeplessness during the day, a bitter taste, a dry mouth and areduced alertness. These affect 1 to 10 users in 100.
Coordination problems or double vision occurs in 1 to 10 users in 10,000, especially at the beginning of the treatment. These symptoms usually disappear spontaneously so that the treatment doesn't need to be stopped.
Stop using Zopiclone and contact your doctor immediately if you develop one or more of following symptoms:
• swelling ofthe face, lips ortongue
• difficultybreathing
• sudden high fever
• joint pain
• blistering ofthe skin
These symptoms can be signs of severe allergic reactions which can be life-threathening. Other severe adverse effects which rarely occur are:
• loss of memory (amnesia) (sometimes in combination with inappropriate behaviour)
• risk of fall (particularly in the elderly)
The risk for memory loss is greater when high doses are used.
The following side effects have been observed in patients treated with zopiclone.
Uncommon (1 to 10 users in 1,000)
• nightmares
• agitation
• headache
• dizziness
• gastro-intestinal problems, including feeling sick (nausea) and vomiting
• tiredness.
Rare (1 to 10 users in 10,000):
• slight to moderate increases of certain liver enzymes (serumtransaminases and/or alkaline phosphatase)
• allergic reactions including itching and skin reactions
• dulling of sensitivity
• confusion
• depression
• restlessness
• irritability
• aggression
• false beliefs (delusions)
• outbursts ofrage
• seeing, hearing or feeling things that don't really exist (hallucinations)
• severe mental disorders characterized by disturbance of personality and loss of contact with reality (psychoses)
• inappropriate behaviour and other behavioral disturbances.
• change in sexual desire (decreased libido).
• sleepwalking
• physical andpsychological dependence
• dreaming more frequently
• difficulties inconcentrating
• dyspepsia
• withdrawal symptoms like: o anxiety
o tremor o palpitations o tension
o lossoffeelingwhoandwhereyouare o oversensitivity to sound o numb feeling and tingling in arms and legs o hypersensitivity to light, noise and physical contact o hearing or feeling things that don't really exist o epileptic seizures
Very rare (less than 1 user in 10,000):
• skin rash with irregular red spots (erythema multiforme)
• seizures
During treatment with Zopiclon pre-existing depression can be unmasked.
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 national reporting system listed in www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on the safety of this medicine.
If you get any side effects, talk to your doctor or pharmacist. This includes any side effects not listed in this leaflet.
5. How to store Zopiclone
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the blister and carton after EXP. The expiry date refers to the last day of that month.
Do not store above 25°C.
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 protect the environment.
6. Contents of the pack and other information
What Zopiclone contains
The active substance is zopiclone.
Each Zopiclone 7.5 mg tablet contains 7,5 mg of zopiclone.
The other ingredients are:
- calcium hydrogen phosphate dihydrate
- lactose monohydrate
- maize starch
- sodium starch glycolate
- magnesium stearate (E470b)
- hypromellose (E464)
- propylene glycol (E1520)
- titanium dioxide (E171)
- talc (E553B)
What Zopiclone tablets look like and contents of the pack
- Zopiclone 7.5 mg tablets are white, round, biconvex film-coated tablets, scored on one side and divisible.
The tablet can be divided in equal doses.
- Zopiclone is available in packs containing 10, 20, 28, 30 or 100 film-coated tablets in PVC/PVDC/Al blisters.
Not all pack sizes will be marketed.
Marketing Authorisation Holder and Manufacturer Marketing authorisation holder Manufacturer
Jubilant Pharmaceuticals nv PSI supply nv
Axxes Business Park Axxes Business Park
Guldensporenpark 22 - Block C Guldensporenpark 22 - Block C
9820 Merelbeke 9820 Merelbeke
Belgium Belgium
This leaflet was last revised in 10/2013