Zopiclone 7.5 Mg Film-Coated Tablets
PACKAGE LEAFLET: INFORMATION FOR THE USER
Zopiclone 7.5mg Film-coated Tablets
Please 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. Do not pass it on to others. It may harm them, even if their symptoms 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
Zopiclone Tablets are benzodiazepine-like hypnotics, which work by acting on the brain to cause sleepiness. They may be used for short term treatment of difficulty in sleeping which is severe, disabling or causing great distress.
2. What you need to know before you take Zopiclone Tablets Do not take Zopiclone Tablets and tell your doctor if you:
• are allergic (hypersensitive) to zopiclone or any of the other ingredients in the tablet (see section 6). An allergic reaction may include a rash, itching, difficulty breathing or swelling of the face, lips, throat or tongue
• are allergic to any other benzodiazepines or benzodiazepine-like hypnotics, such as nitrazepam or diazepam
• have severe liver problems. In patients with severe liver problems encephalopathy (a brain disorder) may develop
• suffer from breathing problems whilst sleeping (sleep apnoea)
• suffer from severe muscle weakness (myasthenia gravis)
• have severe breathing problems or your lungs do not work properly
• are under the age of 18 years
Warnings and precautions
Check with your doctor or pharmacist before taking Zopiclone Tablets 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 any kidney problems
• have mild or moderate liver problems
• have breathing difficulties
• suffer from or have a history of depression or anxiety (as suicidal thoughts may occur)
• have psychiatric problems or mental illness (including personality disorders)
• have recently taken Zopiclone or other similar medicines for more than 4 weeks
• do not feel you will ever be able to stop taking Zopiclone Tablets or other medicines used to treat sleep problems.
Please tell your doctor if you have any of the conditions listed above.
Other considerations:
• Dependence (a need to keep taking the medicine) - when taking this type of medicine there is a risk of dependence, which increases with dose and length of treatment. 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. There is a greater risk in patients with a history of alcohol or drug abuse, of suffer from a personality disorder..
• Withdrawal - treatment should be withdrawn gradually. Withdrawal effects are unlikely when duration of treatment is limited to 4 weeks. Withdrawal effects may also occur between doses, especially if you are taking a high dose of Zopiclone. See Section 3, If you stop taking Zopiclone.
• Amnesia - Zopiclone Tablets can cause memory loss. To reduce this risk you should ensure that you are able to have 7-8 hours uninterrupted sleep.
• Behavioural effects may occur while taking Zopiclone (see Section 4, Possible side effects). Blood test
• 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.
Zopiclone and Other medicines
Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. Zopiclone Tablets may influence the effect and/or side effects of other medicines. If you see another doctor or go into hospital, particularly if you are having an operation under anaesthesia tell the doctor which medicines you use.
The following medicine may increase the sedating effects of Zopiclone Tablets:
• medicines to treat mental illness (antipsychotics)
• medicines to treat depression e.g. amitriptyline, fluoxetine, and those known as monoamine oxidase inhibitors (MAOIs) e.g. phenelzine
• other benzodiazepines or benzodiazepine-like hypnotics used to treat insomnia or anxiety e.g. nitrazepam, diazepam
• other tranquillizers e.g. chlorpromazine
• some medicines for moderate to severe pain (narcotic analgesics) such as codeine, methadone, morphine, oxycodone, pethidine, tramadol and morphine. Feelings of excitement (euphoria) may increase, which in turn increase the chance of physical or mental dependence
• medicines used to treat epilepsy e.g. carbamazepine
• anaesthetics (used during surgery)
• antihistamine medicines which cause sleepiness e.g. alimemazine, chlorphenamine
• erythromycin (an antibiotic)
• medicines for hay fever, rashes or other allergies that can make you sleepy (sedative antihistamines) such as chlorphenamine or promethazine
The following medicines may increase the risk of you getting side effects when taken with Zopiclone. To make this less likely, your doctor may lower your dose Zopiclone:
• Some medicines for fungal infections such as ketoconazole and itraconazole
• Some antibiotics including erythromycin and clarithromycin
• Ritonavir (a protease inhibitor) used to treat HIV infections
The following medicines can make Zopiclone work less well:
• Some medicines for epilepsy such as carbamazepine, phenobarbital or phenytoin
• Rifampicin (an antibiotic) - for infections
• St John’s Wort (a herbal medicine) - for mood swings and depression
The effect of the following medicines is increased when taken with Zopiclone:
• muscle relaxants e.g. baclofen
Zopiclone with food and drink
DO NOT drink grapefruit juice whilst taking Zopiclone, as the sedating effect may be increased.
Zopiclone with alcohol
DO NOT drink alcohol when taking Zopiclone Tablets, as the sedating effect may be increased. Alcohol increase the effect of Zopiclone tablets and make you sleep very deeply so that you do not breath properly or have difficulty waking.
Pregnancy and breast-feeding
• 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 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. This is because small amounts may pass into mother’s milk. If you are breast-feeding or plan to breast-feed, talk to your doctor or pharmacist before taking Zopiclone.
Ask your doctor or pharmacist for advice before taking any medicine if you are pregnant or breast-feeding.
Driving and using machines
• Zopiclone may make you feel drowsy, cause loss of concentration or muscle weakness. DO NOT drive or operate machinery after taking a dose of Zopiclone.
• DO NOT drive or operate machinery the day after taking Zopiclone until you are sure that you are not affected by Zopiclone
• If Zopiclone is taken with alcohol, the effects of Zopiclone may be increased the next morning. DO NOT drive or operate machinery until you are sure that you are not affected.
Zopiclone contains Lactose
If you have been told that you have an intolerance to some sugars, tell your doctor or pharmacist before taking Zopiclone Tablets as this medicine contains lactose (See section 6).
3. How to take Zopiclone Tablets
Always take Zopiclone Tablets exactly as your doctor has told you. You should check with your doctor or pharmacist when you are not sure. The tablets should be taken together with liquid immediately before going to bed. The tablet should be swallowed whole. DO NOT break, chew, or suck the tablet.
The usual dose is:
• Adults: 7.5mg immediately before going to bed. DO NOT take more than one 7.5 mg tablet a day.
• Elderly patients, or those with liver or kidney problems, or breathing difficulties: a lower dose of 3.75mg at night may be used. This dose may be increased to 7.5mg by your doctor
• Children and adolescents under 18: Zopiclone tablets are not intended for patients under 18 years of age
How long should you take Zopiclone Tablets?
Treatment with Zopiclone usually lasts from a few days to two weeks, up to a maximum of four weeks, as directed by your doctor. 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 Tablets than you should
If you, (or someone else) swallow a lot of the tablets at the same time, or if you think a child has swallowed any of the tablets, contact your nearest hospital casualty department or your doctor immediately. Do not go unaccompanied to seek medical help.
An overdose is likely to cause drowsiness, sleeping deeply, 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, falling over or losing your balance, 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 Tablets
If you forget to take a dose immediately before going to bed but remember during the night, only take the missed dose if you will still be able to have 7-8 hours of uninterrupted sleep. If this is not possible, take the next dose at the usual time the next night.
Do not take a double dose to make up for a forgotten dose. If you are worried ask your pharmacist or doctor for advice.
If you stop taking Zopiclone Tablets
When your doctor decides to stop your tablets, the dose will be reduced gradually over a period of time. DO NOT stop taking your tablets suddenly.
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.
These effects will disappear in time.
If you have become physically dependent on Zopiclone Tablets, sudden withdrawal of treatment will lead to side effects such as headaches, tremor, sweating, agitation, fast heart beat (palpitations), uneven heartbeat (tachycardia), relaxed grip on reality, panic attacks, stomach problems, muscle pain, tension, restlessness, confusion, sleeping difficulties, nightmares, a lower level of awareness and problems with focusing or concentrating and irritability.
In severe cases other effects may appear, such as:
• hypersensitivity to light, noise and physical contact
• sounds seeming louder than usual, and painful sensitivity to sound
• hallucinations
• numbness and tingling in the fingers and toes
• derealisation (feeling the world around you is not real)
• a feeling of detachment from your surroundings
• depersonalisation (feeling your mind is becoming separated from your body)
• epileptic seizures (violent fitting or shaking).
These symptoms may also be experienced between doses, especially if the dose is high.
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. Side effects are most common at the beginning of treatment, during the first hour after taking your tablet.
The following side effects of Zopiclone should disappear after a few days. Tell your doctor or pharmacist if any of the following side effects last more than a few days or become serious:
Very common (affects more than 1 in 10 patients taking the medicine)
• a bitter (metallic) taste in the mouth
Common (affects less than 1 in 10 patients taking the medicine):
• stomach upsets (including feeling sick (nausea) or being sick)
• drowsiness (during the following day)
• reduced alertness
• headache
• dizziness.
Rare (affecting affects less than 1 in 1000 patients taking the medicine):
• confusion
• depression
• tiredness
• numbed emotions
• hallucinations (seeing or hearing things that are not real)
• depressed mood (feeling low or sad)
• restlessness, agitation or irritability
• aggressiveness or anger
• nightmares
• psychiatric problems
• unsuitable behaviour or any other change in behaviour.
• poor memory (amnesia)
• dry mouth
• light-headedness
• loss of co-ordination
• difficulty in controlling movements
• muscle weakness
• skin rashes
• abnormal blood test results for liver function.
Very rare (affects less than 1 in 10000 patients taking the medicine):
If you experience any of the following rare, but very serious side effects, stop taking Zopiclone Tablets and tell your doctor immediately or contact the casualty department at your nearest hospital:
• reduced sex drive
• serious allergic reactions; includes skin rash, swelling of the face, lips, tongue or throat, or difficulty breathing or swallowing.
• rapid swelling (edema) of the dermis, subcutaneous tissue, mucosa and submucosal tissues.
This is a very serious but very rare side effect. You may need urgent medical attention or hospitalisation.
Not known (frequency cannot be estimated from the available data):
• physical and mental dependence
• sleep walking
• problems with sight (double vision)
Sleep-walking and other strange behaviours
There have been some reports of people (when asleep) performing tasks that they do not remember on waking up after taking a sleep medicine. This includes sleep-driving, eating and sleep walking. Alcohol and some medicines for depression or anxiety can increase the likelihood of this serious effect happening. If you are concerned this side effect may have happened to you after taking Zopiclone, tell your doctor as soon as possible.
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 Tablets
Keep out of the sight and reach of children.
Do not store above 25°C. Store in the original packaging.
Do not use Zopiclone Tablets after the expiry date which is stated on the product 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 how to dispose of medicines no longer required. These measures will help to protect the environment.
6. Contents of the pack and other information What Zopiclone Tablets contain
The active substance is zopiclone. Each tablet contains 7.5mg of the active ingredient.
The other ingredients are: calcium hydrogen phosphate dihydrate, lactose monohydrate, maize starch, sodium starch glycollate type A, magnesium stearate, hydroxypropylmethylcellulose, propylene glycol, titanium dioxide, talc.
What Zopiclone Tablets look like and contents of the pack
Zopiclone Tablets are white, round with a score line on one side. The tablets are packed in blisters inserted into a carton.
Pack size: 28
Marketing Authorisation Holder
TEVA UK Limited, Eastbourne, BN22 9AG
Manufacturer
PSI Supply nv Axxes Business Park Guldensporenpark 22 - Block C 9820 Merelbeke Belgium
Date of last revision: June 2015
PL 00289/1478