ZOPICLONE 3.75 MG FILM-COATED TABLETS - patient leaflet, side effects, dosage

Patient leaflet - ZOPICLONE 3.75 MG FILM-COATED TABLETS

1. what zopiclone is and what it is 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

Do not take Zopiclone

– if you are allergic to Zopiclone or to any of the other ingredients of this medicine (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 have ever experienced sleepwalking or other unusual behavior (such as driving, eating, making a phone call or having sex etc.) while not being fully awake after taking Zopiclone.

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.

– 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 8 hours of uninterrupted sleep to help reduce the risk of some side effects (see section 4)

Zopiclone may cause sleepwalking or other unusual behaviour (such as driving, eating, making a phone call, or having sex etc.) while not being fully awake. The next morning, you may not remember that you did anything during the night. These activities may occur whether or not you drink alcohol or take other medicines that make you drowsy with Zopiclone.

If you are not sure if any of the above applies to you, talk to your doctor or pharmacist before taking Zopiclone.

This medicine does not treat depression. If you also have depression, your doctor will tell you prescribe appropriate treatment. If the depression is not treated, it can get worse with persistence or a possible increase in suicidal risk.

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.

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.

Suicidality

Risk of suicides and suicide attempts may be increased in patients treated with benzodiazepines or hypnotics, including zopiclone. If you develop thoughts of harming or killing yourself at any time, contact your doctor or go to a hospital straight away.

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 shortterm 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 8 hours.

Other medicines and Zopiclone

Tell your doctor or pharmacist if you are taking, have recently taken or might take 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. 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).

Concomitant use of Zopiclone and opioids (strong pain killers, medicines for substitution therapy and some cough medicines) increases the risk of drowsiness, difficulties in breathing (respiratory depression), coma and may be life-threatening. Because of this, concomitant use should only be considered when other treatment options are not possible.

However if your doctor does prescribe Zopiclone together with opioids the dose and duration of concomitant treatment should be limited by your doctor.

Please tell your doctor about all opioid medicines you are taking, and follow your doctor’s dose recommendation closely. It could be helpful to inform friends or relatives to be aware of the signs and symptoms stated above. Contact your doctor when experiencing such symptoms.

Zopiclone with food, drink and alcohol

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

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.

Do not take Zopiclone tablets during the last 3 months of pregnancy or during labour because it may be harmful to your baby.

Some studies have shown that there may be an increased risk of cleft lip and palate (sometimes called “harelip”) in the newborn baby.

Reduced fetal movement and fetal heart rate variability may occur after taking Zopiclone during the second and/or third trimester of pregnancy.

If Zopiclone is taken at the end of pregnancy or during labour, your baby may show muscle weakness, a drop in body temperature, difficulty feeding and breathing problems (respiratory depression).

If this medicine is taken regularly in late pregnancy, your baby may develop physical dependence and may be at risk of developing withdrawal symptoms such as agitation or shaking. In this case the newborn should be closely monitored during the postnatal period.

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.

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 contain Lactose: If you have been told by your doctor that you have intolerance to some sugars, contact your doctor before taking this medicine.

Zopiclone contain Sodium: This medicine contains less than 1 mmol sodium (23 mg) per 3.75 mg/ 7.5 mg film-coated tablets, that is to say essentially ‘sodium-free’.

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 this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

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 zopiclone just 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.

Use in 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 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 into 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

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

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 medicine, ask your doctor or pharmacist.

4. possible side effects

Like all medicines, this medicine 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

– Diarrhoea

Very rare (may affect up to 1 in 10,000 people)

– Severe and life-threatening skin rashes (Stevens-Johnson Syndrome/ toxic epidermal necrolysis)
– Skin rash with irregular red spots (erythema multiforme)

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 national reporting system listed in Yellow Card Scheme Website: or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.

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 or carton after EXP. The expiry date refers to the last day of that month.

This medicine does not require any special storage conditions.

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 film-coated tablet contains 3.75 mg zopiclone.

Each film-coated tablet contains 7.5 mg zopiclone.

– The other ingredients are:

What Zopiclone looks like and contents of the pack

Film-coated tablet.

Zopiclone 3.75 mg film-coated tablets: White, round, biconvex film coated tablets debossed with ‘Z1’ on one side and plain on the other side.

Zopiclone 7.5 mg film-coated tablets: White, round, biconvex film coated tablets debossed with ‘Z & 2’ separated with break line on one side and break line on the other side. The tablet can be divided into equal doses.

Zopiclone film-coated tablets are available in blister packs.

Pack sizes:

Blister packs: 5, 10, 14, 20, 28, 30, 50, 60 and 90 film-coated tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

APL Swift Services (Malta) Limited HF26, Hal Far Industrial Estate, Hal Far, Birzebbugia, BBG 3000, Malta

Milpharm Limited

Ares Block, Odyssey Business Park West End Road

Ruislip HA4 6QD

United Kingdom

Generis Farmaceutica, S.A.

Rua Joao de Deus, 19, Amadora, 2700487, Portugal

This leaflet was last revised in 09/2020