Zopiclone 3.75mg Tablets
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PACKAGE LEAFLET: INFORMATION FORTHE USER
ZOPICLONE 3.75 mg TABLETS
(zopiclone)
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 gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
In this leaflet:
1. What Zopiclone is and what it is used for.
2. Before you take Zopiclone.
3. Flow to take Zopiclone.
4. Possible side effects.
5. How to store Zopiclone.
6. Further information.
1. WHAT ZOPICLONE IS AND WHAT IT IS USED FOR
Zopiclone tablets are sleeping pills (hypnotics) which work by acting on the brain to cause sleepiness.
Zopiclone may be used for the short term treatment of difficulty in sleeping which is severe, disabling or causing great distress.
2. BEFORE YOU TAKE ZOPICLON E Do not take Zopiclone if you:
• are allergic (hypersensitive) to zopiclone or any of the other ingredients of this medicine.
• suffer from a disease of the muscles causing drooping eyelids, double vision, difficulty speaking and swallowing and sometimes muscle weakness in the arms and legs (myasthenia gravis)
• have severe liver problems
• suffer from irregular breathing while asleep (sleep apnoea syndrome)
• have severe breathing problems
• are under the age of 18.
Take special care with Zopiclone - You should tell your doctor before taking this medicine if you:
• are elderly or at risk of getting confused. Taking Zopiclone may mean an increased risk of falling resulting in injuries
• suffer from liver problems
• have a history of breathing problems.Taking Zopiclone may reduce the force of your breathing
• suffer from or have a history of depression, anxiety or psychotic illness. Zopiclone may cause these symptoms to reappear or worsen
• have ever had a history of alcohol or drug abuse.
Other considerations when taking Zopiclone are:
• Tolerance - if after a few weeks you notice that the tablets are not working as well as they did when you first started taking them, you should see your doctor, as an adjustment of your dosage may be required.
• Dependence - when taking this type of medicine there is a risk that you may develop some dependence. This risk increases with the length of time you have been taking Zopiclone and your dosage. There is also a greater risk in those patients who have history of alcohol or drug abuse.
• Withdrawal - when you stop taking Zopiclone, treatment should be gradually withdrawn. After you stop taking the tablets you may notice that you have difficulty sleeping. This may be accompanied by other reactions such as nervousness, headaches, muscle pain, tension, confusion, restlessness and irritability.
• Amnesia - you may have memory loss soon after taking Zopiclone. Ensure that you go to bed as soon as you have taken your tablets and that you will be able to have uninterrupted sleep.
• Psychiatric and 'paradoxical' reactions - Zopiclone can cause restlessness, agitation, irritability, aggression, delusion, outbursts of rage, nightmares, hallucinations, psychoses, unsuitable behaviour and other behavioural disturbances.
If you experience any of these symptoms you should stop taking Zopiclone and see your doctor.
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, or the following:
• medicines used to treat certain mental and emotional conditions (antipsychotics)
• sedatives
• other sleeping pills
• medicines used to treat depression (antidepressants)
• strong medicines used to relieve pain (narcotic analgesics), such as codeine and morphine.The sensation of feeling high (euphoric) may increase, which in turn can lead to dependency
• medicines that reduce liver function, such as erythromycin, clarithromycin, ketoconazole, itraconazole and ritonavir. Ask your doctor or pharmacist which medicines have this affect
• medicines that increase liver function, such as rifampicin, nefazode, phenobarbital, phenytoin and St. Johns wort Ask your doctor or pharmacist which medicines have this affect
• medicines used to treat epilepsy.
Taking Zopiclone with food and drink-You should not drink alcohol while taking this medicine, because this may increase the effects of Zopiclone. This may persist to the following morning and affect your ability to drive.
Pregnancy and breast-feeding - Ask your doctor or pharmacist for advice before taking any medicine. Tell your doctor if you are pregnant or planning to become pregnant. Zopiclone should not be taken in the last three months of pregnancy as it can affect the growth of your unborn baby and may also affect your labour. Do not breast-feed your baby, as small amounts of Zopiclone can pass into breast milk.
Driving and using machines - Do not drive or operate machinery if you feel dizzy or drowsy, or you have eyesight problems while taking this medicine. Zopiclone may make you feel drowsy, cause loss of concentration or muscle weakness.
Important information about some of the ingredients of Zopiclone - This medicine contains lactose. If your doctor has told you that you have an intolerance to some sugars, such as lactose, contact your doctor before taking this medicine.
This medicine also contains ponceau 4R aluminium lake
(El 24) which may cause allergic reactions.
LT1291 AD
LT1291 AD 10002814
3. 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 taken with a glass of water, immediately before going to bed. The usual dose is:
Adults - 2 tablets immediately before going to bed. This dose should not be exceeded.
Elderly, frail or patients with reduced kidney, liver or lung function - a starting dose of 3.75 mg is recommended in these patients; the tablets being taken immediately before going to bed. This dosage may be increased with care if considered necessary by your doctor.
Children and Adolescents - Zopiclone should not be given to children or adolecents under the age of 18 years.
How long should you take Zopiclone for - The duration of treatment with Zopiclone should be as short as possible. Generally treatment should last from between a few days to up to two weeks. Treatment should not exceed 4 weeks, including a period of tapering off.
If you take more Zopiclone than you should - Contact your doctor or nearest hospital emergency department immediately, do not go unaccompanied to seek medical help. If you have taken an overdose you may become increasingly drowsy very quickly. Take the container and any remaining tablets with you. Symptoms of overdose can range from extreme drowsiness to coma. These symptoms can be magnified when combined with alcohol.
If you forget to take Zopiclone - If you forget to take a dose immediately before going to bed but remember during the night, only take the missed dose if you are still able to have 7-8 hours uninterrupted sleep. If this is not possible, take the next dose before bed time the next night. Do not take a double dose to make up for a forgotten dose.
If you stop taking Zopiclone - Treatment of Zopiclone should be gradually withdrawn, as the symptoms that Zopiclone was used to treat will return with a higher intensity (rebound insomnia). Other such withdrawal symptoms could include anxiety, restlessness and mood changes, these will however disappear with time.
If you have become physically dependent on Zopiclone, sudden withdrawal of treatment could lead to symptoms such as headaches, tension, muscle pain, confusion, anxiety, restlessness and irritability. In severe cases symptoms may also include hypersensitivity to light, noise and physical contact, hallucinations, epileptic seizures, personality disturbances, numbness of the extremities and the feeling that the world around you is not real (derealisation).
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Zopiclone can cause side effects, although not everybody gets them.
If any of the following happen, stop taking Zopiclone and tell your doctor immediately or go to your nearest hospital emergency department;
• serious allergic reaction causing difficulty breathing or dizziness (anaphylaxis)
• serious allergic reaction which causes swelling of the face or the throat (angioedema)
• serious skin reactions.
Other side effects may include;
• drowsiness the following day
• numbed emotions
• reduced alertness
• confusion
• fatigue
• headache
• dizziness
• muscle weakness
• uncontrollable movements
• double vision
• gastrointestinal disturbances
• changes in sexual drive (libido)
• loss of memory (amnesia)
• unmasking of pre-existing depression
• restlessness
• agitation
• irritability
• aggressiveness
• fixed irrational ideas, not shared by others (delusions)
• hallucinations
• nightmares
• inappropriate behaviour
• psychoses
• dependence.
If any side effect gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
5. HOWTO STORE ZOPICLONE
Keep out of the reach and sight of children. Do not use Zopiclone after the expiry date which is stated on the carton after 'EXP'. The expiry date refers to the last day of that month. Zopiclone should be stored below 25°C in the original package. 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. FURTHER INFORMATION
What Zopiclone contains - The active substance is zopiclone. The other ingredients are: lactose anhydrous, calcium hydrogen phosphate anhydrous, maize starch, povidone, magnesium stearate and hypromellose. The printing ink and tablet coating contains titanium dioxide (El 71), indigo carmine, aluminium lake (El 32), ponceau 4R aluminium lake (El 24), quinoline yellow aluminium lake (El 04) and macrogol 400.
What Zopiclone looks like and contents of the pack - Your medicine is a blue film coated round tablet with 'ZE3' printed on one side and 'G' in the reverse. Zopiclone is available in blister packs of 5,7,10,14,20,21,28,30,56,60,84,90 and 100 tablets. Zopiclone is also available in a bulk pack of 100 tablets in a polypropylene container. Not all pack sizes may be marketed.
Marketing Authorisation Holder - Mylan, Potters Bar, Hertfordshire, EN6 1TL, U.K.
Manufacturer - McDermott Laboratories Ltd,t/a Gerard Laboratories, Baldoyle Industrial Estate, Grange Road, Dublin 13, Ireland.
Date of revision: July 2010