Zopiclone 3.75mg Film-Coated Tablets
PACKAGE LEAFLET: INFORMATION FOR THE USER
ZOPICLONE 3.75mg and 7.5mg 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.
- 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 Tablets are and what they are used for
2. What you need to know before you take Zopiclone Tablets
3. How to take Zopiclone Tablets
4. Possible side effects
5. How to store Zopiclone Tablets
6. Contents of the pack and other information_
1. What Zopiclone Tablets are and what they are used for
The name of your medicine is Zopiclone 3.75mg and 7.5mg film-coated Tablets (referred to as Zopiclone Tablets in this leaflet). This belongs to a group of medicines called hypnotics. It works by acting on your brain to help you sleep.
In Adults:
Zopiclone, the active substance in Zopiclone Tablets is used to treat sleep problems such as:
• Difficulty falling asleep
• Waking in the middle of the night
• Waking too early
• Severe or upsetting sleep problems that are caused by your mood or mental health problems
Zopiclone can be used for both temporary and longer lasting sleep problems. However, Zopiclone is not meant to be used every day for long periods of time or to treat depression. Ask your doctor for advice if you are unsure.
2. What you need to know before you take Zopiclone Tablets
DO NOT take Zopiclone Tablets if:
• You are allergic (hypersensitive) to zopiclone or to any of the other ingredients of Zopiclone Tablets (listed in section 6.).
Signs of an allergic reaction include: a rash, swallowing or breathing problems, swelling of your lips, face, throat or tongue.
• You 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 problems
• You are a child or adolescent under 18 years of age. The safety and efficacy of Zopiclone in children and adolescents aged less than 18 years have not been established.
Do not take this medicine if any of the above applies to you. If you are not sure, talk to your doctor or pharmacist before taking Zopiclone.
Warnings and Precautions
Talk to your doctor or pharmacist before taking Zopiclone Tablets.
• You have any liver problems (see also 'Do not take this medicine and tell your doctor if:' section above). Your doctor may need to give you a lower dose of Zopiclone
• You have any kidney problems. Your doctor may need to give you a lower dose of Zopiclone
• You suffer from mild breathing problems, your doctor will decide if you should receive Zopiclone (see also 'Do not take this medicine and tell your doctor if: section above).
• You have a history of alcohol or drug abuse
• You have been told by a doctor that you have a personality disorder
• You have recently taken Zopiclone or other similar medicines for more than four weeks
• You do not feel you will ever be able to stop taking Zopiclone tablets or other medicines used to treat sleep problems
Before taking Zopiclone, it is important to make sure that you can have atleast 7 to 8 hours of uninterrupted sleep to help reduce the risk of some side effects (see section 4)
If you are not sure if any of the above applies to you, talk to your doctor or pharmacist before taking Zopiclone.
Other considerations Habituation
If after a few weeks you notice that the tablets are not working as well as they did when first starting treatment, you should go and see your doctor as an adjustment to your dosage may be required.
Dependence
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.
Withdrawal
Treatment should be gradually withdrawn. A transient syndrome whereby the symptoms that led to treatment with Zopiclone tablets recur in an enhances form, may occur on withdrawal. It may be accompanied by other reactions including mood changes, anxiety and restlessness.
Short-term memory loss (Anterograde amnesia)
Zopiclone Tablets 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.
Other medicines and Zopiclone Tablets
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines. This includes medicines you buy without a prescription, including herbal medicines. This is because Zopiclone can affect the way some other medicines work. Also some medicines can affect the way Zopiclone works.
Tell your doctor if you are taking any of the following medicines.
The following medicines may increase the effect of Zopiclone:
• Medicines for mental problems (antipsychotics)
• Medicines for epilepsy (anticonvulsants)
• Medicines to calm or reduce anxiety or sleep problems (hypnotics)
• Medicines for depression
• Some medicines for moderate to severe pain (narcotic analgesics) such as codeine, methadone, morphine, oxycodone, pethidine or tramadol
• Medicines used in surgery (anaesthetics)
• Medicines for hay fever, rashes or other allergies that can make you sleepy (sedative antihistamines) such as chlorphenamine or promethazine
The following medicines can increase the chance of you getting side effects when taken with Zopiclone Tablets. To make this less likely, your doctor may decide to lower your dose of Zopiclone:
• Some antibiotics such as clarithromycin or erythromycin
• Some medicines for fungal infections such as ketoconazole and itraconazole
• Ritonavir a protease inhibitor (used to treat AIDS).
The following medicines may reduce the effect of Zopiclone:
• Some medicines for epilepsy such as carbamazepine, phenobarbital and phenytoin
• rifampicin (an antibiotic) - for infections
• products containing St. John's wort (herb used to treat depression and mood swings).
Zopiclone Tablets 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
Talk to your doctor before taking this medicine if you are pregnant, might become pregnant, or think you may be pregnant
Do not take Zopiclone Tablets during the last 3 months of pregnancy or during labour because it may be harmful to your baby
Do not breast-feed if you are taking Zopiclone Tablets. This is because small amounts may pass into mother's milk. If you are breast-feeding or planning to breast-feed, talk to your doctor or pharmacist before taking any medicine.
Ask your doctor or pharmacist for advice before taking any medicine if you are pregnant or breast-feeding.
Driving and using machines
Like other medicines used for sleep problems, Zopiclone can cause slowing of your normal brain function (central nervous system depression). The risk of psychomotor impairment including driving ability, is increased if:
• You take Zopiclone within 12 hours of performing activities that require mental alertness
• You take higher than the recommended dose of Zopiclone
• You take Zopiclone while already taking another central nervous system depressant or another medicine that increases levels of Zopiclone in your blood, or while drinking alcohol.
Do not engage in hazardous activities requiring complete mental alertness such as driving or operating machinery after taking Zopiclone, and in particular during the 12 hours after taking your medicine.
For more information about possible side effects which could affect your driving see section 4 of this leaflet.
Zopiclone Tablets contain Lactose
Zopiclone Tablets contains milk sugar (lactose). If you have been told by your doctor that you have intolerance to some sugars, contact your doctor before taking this medicine.
3. How to take Zopiclone
Treatment should be as short as possible and should not exceed four weeks including period of tapering off.
Always take Zopiclone Tablets exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure. h
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Taking this medicine
• Take this medicine by mouth
• Swallow the tablet with a drink of water
• Do not crush or chew your tablets
• Take just before bedtime in a single intake and do not take again during the same night
• The usual length of treatment is 2 days to 3 weeks Adults
The recommended starting dose is 7.5 mg zopiclonejust before bedtime (two tablets of 3.75 mg or one tablet of 7.5mg). This dose should not be exceeded.
Elderly
The usual starting is one Zopiclone tablet (3.75mg) just before bed time. Your doctor may decide to increase your dose to one Zopiclone Tablet (7.5 mg) if needed. Patients with liver, respiratory or kidney problems The usual starting dose is one Zopiclone Tablet (3.75mg) just before bedtime. Children and adolescents: Zopiclone should not be used 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.
Blood Tests
• Zopiclone Tablets 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 Tablets
If you take more Zopiclone Tablets than you should
If you have taken too many tablets, contact your doctor or nearest hospital casualty department immediately for advice. Take the medicine pack with you. This is so the doctor knows what you have taken.
Zopiclone overdosage can be very dangerous 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 losing your balance (ataxia)
• Shallow breathing or difficulty breathing (respiratory depression)
If you forget to take Zopiclone Tablets
Zopiclone must only be taken at bedtime. If you forget to take your tablet at bedtime, then you should not take it at any other time, otherwise you may feel drowsy, dizzy and confused during the day. Do not take the double dose to make up for a forgotten dose.
If you stop taking Zopiclone Tablets
Keep taking Zopiclone until your doctor tells you to stop. Do not stop taking
Zopiclone suddenly, but tell your doctor if you want to stop. Your doctor will need to lower your dose and stop your tablets over a period of time If you stop taking Zopiclone suddenly, your sleep problems may come back and you may get a 'withdrawal effect'. If this happens you may get some of the effects listed below. See a doctor straight away if you get any of the following effects:
• Feeling anxious, shaky, irritable, agitated, confused or having panic attacks
• Sweating
• Headache
• Faster heartbeat or uneven heartbeat (palpitations)
• A lower level of awareness and problems with focusing or concentrating
• Nightmares, seeing or hearing things that are not real (hallucinations)
• Being more sensitive to light, noise and touch than normal
• Relaxed grip on reality
• Numbness and tingling in your hands and feet
• Aching muscles
• Stomach problems
In rare cases fits (seizures) may also occur.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, Zopiclone Tablets can cause side effects, although not everybody gets them.
Stop taking Zopiclone and see a doctor or go to a hospital straight away if:
You have an allergic reaction. The signs may include: a rash, swallowing or breathing
problems, swelling of your lips, face, throat or tongue
Tell your doctor as soon as possible if you have any of the following side
effects:
Rare (may affect up to 1 in 1,000 people)
Tell your doctor as soon as possible if you have any of the following side effects:
• Poor memory since taking Zopiclone (amnesia). By having 7-8 hours of uninterrupted sleep after taking Zopiclone, this is less likely to cause you a problem.
• Seeing or hearing things that are not real (hallucinations)
• Falling, especially in the elderly
Not Known (frequency cannot be estimated from the available data)
• Thinking things that are not true (delusions)
• Feeling low or sad (depressed mood)
Tell your doctor or pharmacist if any of the following side effects get serious or lasts longer than a few days:
Common (may affect up to 1 in 10 people)
• A mild bitter or metallic taste in your mouth
• Feeling drowsy or sleepy
• Dry mouth
Uncommon (may affect up to 1 in 100 people)
• Feeling sick (nausea) or being sick (vomiting)
• Feeling dizzy
• Headache
• Nightmares
• Feeling physically or mentally tired
• Agitation
Rare (may affect up to 1 in 1,000 people)
• Feeling confused
• Itchy, lumpy rash (urticaria)
• Feeling irritable or aggressive
• Reduced sex drive
• Difficulty breathing or being short of breath
Not known (frequency cannot be estimated from available data)
• Feeling restless or angry
• Feeling light headed or having problems with your coordination
• Double vision
• Moving unsteadily or staggering
• Muscular weakness
• Indigestion
• Becoming dependent on Zopiclone
• Slower breathing (respiratory depression)
• Unusual skin sensations such as numbness, tingling, pricking, burning or creeping on the skin (paraesthesia)
• Mental problems such as poor memory, Difficulty paying attention, Disrupted normal speech
Sleep-Driving and other strange behaviour
There have been some reports of people doing things while asleep that they do not remember when waking up after taking a sleep medicine. This includes sleep-driving and sleep walking. Alcohol and some medicines for depression or anxiety can increase the chance that this serious effect will happen.
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.
5. How to store Zopiclone
• Keep out of the reach and sight of children.
• Do not store above 250C. Store in the original package in order to protect from light.
• Do not use this medicine after the expiry date (EXP.) which is stated on the carton. The expiry date refers to the last day of that month.
• Do not throw away any medicines via wastewater or house hold waste. Ask your pharmacist how to throw away any medicines you no longer use. These measures will help protect the environment.
6. Contents of the pack and other information
What Zopiclone Tablets contain
The active substance is zopiclone.
Each Zopiclone Tablet contains 3.75mg or 7.5 mg of zopiclone.
The other ingredients are:
• Lactose monohydrate, Calcium hydrogen phosphate dihydrate, Sodium Starch Glycolate, Povidone, Maize Starch, Colloidal Anhydrous Silica, Magnesium Stearate, Hypromellose, Titanium Dioxide (E171), Talc, Macrogol 6000
• Zopiclone 3.75mg tablet in addition to the above also contains indigo carmine lake (E132).
What Zopiclone Tablets look like and contents of the pack
Zopiclone Tablets 3.75 mg tablets are blue, round, biconvex film-coated tablets plain on both sides.
Zopiclone Tablets 7.5 mg tablets are white to off white, round biconvex film-coated tablets, with 'BL' embossing on one side and plain on the other side.
Zopiclone Tablets are available in packs containing 10, 20 or 28 tablets in PVC/PVDC Al blisters. Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer Bristol Laboratories Ltd,
Unit 3, Canalside, Northbridge Road, Berkhamsted, Herts, HP4 1EG, UK Telephone: 0044(0)1442 200922
Fax: 0044(0)1442 873717
Email: info@bristol-labs.co.uk
This medicine is authorised in the Member States of the EEA under the following names:
DE: Zopiclon axcount 3,75mg and 7,5mg filmtabletten Zopiclone 3.75mg Film-coated Tablets; PL 17907/0122 Zopiclone 7.5mg Film-coated Tablets; PL 17907/0051 This leaflet was last revised in November 2015
To request a copy of this leaflet in Braille, large print or audio format, contact the licence holder at the address (or telephone, fax, email) above.
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