ZOPICLONE ARISTO 7.5 MG FILM-COATED TABLETS - patient leaflet, side effects, dosage

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 Aristo is and what it is used for

• 2. What you need to know before you take Zopiclone Aristo

• 3. How to take Zopiclone Aristo

• 4. Possible side effects

• 5. How to store Zopiclone Aristo

• 6. Contents of the pack and other information

1. what zopiclone aristo is and what it is used for

The name of your medicine is Zopiclone Aristo. Zopiclone Aristo contains a medicine called zopiclone. This belongs to a group of medicines called hypnotics. It works by acting on your brain to help you sleep.

Zopiclone Aristo is used to treat sleep problems in adults.

Zopiclone Aristo is used for short-term treatment of insomnia in adults.

Do not use long-term. Treatment should be as short as possible because the risk of dependence increases with the duration of the treatment.

Ask your doctor for advice if you are unsure.

2. what you need to know before you take zopiclone aristo you are allergic to zopiclone or 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 have a problem that causes severe muscle weakness (myasthenia gravis);
• your lungs do not work properly (respiratory failure);
• you have a problem where you stop breathing for short periods at night (sleep apnoea);
• you have severe liver problems;
• you are under the age of 18. The safety and efficacy of Zopiclone Aristo 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 Aristo.

Warnings and precautions

Talk to your doctor or pharmacist before taking Zopiclone Aristo if:

• you have any liver problems (see also ‘Do not take Zopiclone Aristo if:’). Your doctor may

need to give you a lower dose of Zopiclone Aristo;

• you have any kidney problems. Your doctor may need to give you a lower dose of Zopiclone

Aristo;

• you suffer from mild breathing problems. Your doctor will decide if you should receive

Zopiclone Aristo (see also ‘Do not take Zopiclone Aristo if:’);

• 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 Aristo or other similar medicines for more than four weeks;
• you do not feel you will ever be able to stop taking Zopiclone Aristo or other medicines used to

treat sleep problems.

Some studies have shown an increased risk of suicidal ideation, suicide attempt and suicide in patients taking certain sedatives and hypnotics, including this medicine. However, it has not been established whether this is caused by the medicine or if there may be other reasons. If you have suicidal thoughts, contact your doctor as soon as possible for futher medical advice.

Before taking Zopiclone Aristo, it is important to make sure that you can have at least 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 Aristo.

Use of Zopiclone Aristo may lead to the development of abuse and/or physical and psychological dependence. The risk of dependence increases with dose and duration of treatment and is greater when Zopiclone Aristo is used for longer than 4 weeks, and in patients with a history of mental disorders and/or alcohol, illicit substance or drug abuse. Tell your healthcare provider if you have ever had a mental disorder, or have abused or have been dependent on alcohol, substances or drugs.

Other medicines and Zopiclone Aristo

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 Aristo can affect the way some other medicines work. Also some medicines can affect the way Zopiclone Aristo works.

Tell your doctor if you are taking any of the following medicines.

Zopiclone Aristo may increase the effect of the following medicines:

• Medicines for mental problems (antipsychotics)
• Medicines for depression
• Medicines for epilepsy (anticonvulsants)
• Medicines used in surgery (anaesthetics)
• Medicines to calm or reduce anxiety or for sleep problems (hypnotics)
• Medicines for hay fever, rashes or other allergies that can make you sleepy (sedative

antihistamines) such as chlorphenamine or promethazine

• Some medicines for moderate to severe pain (narcotic analgesics) such as codeine, methadone,

morphine, oxycodone, pethidine or tramadol.

The following medicines can increase the chance of you getting side effects when taken with Zopiclone Aristo. To make this less likely, your doctor may decide to lower your dose of Zopiclone Aristo:

• Some antibiotics such as clarithromycin or erythromycin
• Some medicines for fungal infections such as ketaconazole and itraconazole
• Ritonavir (a protease inhibitor) – for HIV infections
• Concomitant use of Zopiclone Aristo and opioids (strong pain killers, medicines for substitution

therapy and some cough medicines) increases the risk of drowsiness, difficulties breathing (respiratory depression), coma and may be life-threatenong. Because of this, concomitant use should only be considered when other treatment options are not possible. However if your doctor does prescribe Zopiclone Aristo 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.

The following medicines can make Zopiclone Aristo 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

Zopiclone Aristo with alcohol

Do not drink alcohol while you are taking Zopiclone Aristo. Alcohol can increase the effects of Zopiclone Aristo and make you sleep very deeply so that you do not breathe properly or have difficulty waking.

Pregnancy and breast-feeding

Pregnancy

Use of Zopiclone Aristo is not recommended during pregnancy.

If you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

If used during pregnancy, there is a risk that the baby is affected. Some studies have shown that there may be an increased risk of cleft lip and palate (sometimes called “harelip”) in the newborn baby. Reduced foetal movement and foetal heart rate variability may occur after taking Zopiclone Aristo during the second and/or third trimester of pregnancy.

If Zopiclone Aristo 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.

Breast-feeding

Do not take Zopiclone Aristo if you are breast-feeding or planning to breast-feed. 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 Aristo 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 Aristo within 12 hours of performing activities that require mental alertness;
• you take higher than the recommended dose of Zopiclone Aristo;
• You take Zopiclone Aristo while already taking another central nervous system depressant or

another medicine that increases levels of Zopiclone Aristo 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 Aristo , 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 Aristo contains lactose

Each 3.75 mg film-coated tablet contains 14.96 mg lactose (as lactose monohydrate).

Each 7.5 mg film-coated tablet contains 29.93 mg lactose (as lactose monohydrate).

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 aristo

Treatment should be as short as possible and should not exceed four weeks including a period of tapering off. Your doctor will give you the lowest effective dose.

Always take this medicine exactly as your doctor 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 usual dose is one 7.5 mg film-coated tablet just before bedtime.

Elderly

The usual starting dose is one 3.75 mg film-coated tablet just before bedtime.

Your doctor may decide to increase your dose to one 7.5 mg film-coated tablet if needed.

Use in children and adolescents

Zopiclone Aristo should not be used in children and adolescents less than 18 years.

The safety and efficacy of Zopiclone Aristo in children and adolescents aged less than 18 years have not been established.

Patients with liver, respiratory or kidney problems

The usual starting dose is one 3.75 mg film-coated tablet just before bedtime.

Blood Tests

• Zopiclone Aristo 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 Aristo.

The 7.5 mg tablet can be divided into equal doses.

If you take more Zopiclone Aristo than you should

If you take more Zopiclone Aristo than you should, tell a doctor or go to a hospital casualty department straight away. Take the medicine pack with you. This is so the doctor knows what you have taken.

Taking too much Zopiclone Aristo 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 Aristo

Zopiclone Aristo 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 a double dose to make up for a forgotten tablet.

If you stop taking Zopiclone Aristo

Keep taking Zopiclone Aristo until your doctor tells you to stop. Do not stop taking Zopiclone Aristo 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 Aristo 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 Aristo 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):

• Poor memory since taking Zopiclone Aristo (amnesia). By having 7–8 hours of uninterrupted

sleep after taking Zopiclone Aristo, 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 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 or a dry 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 or sleepy
• 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 Aristo
• 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: 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 aristo

This medicinal product does not require any special storage conditions

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 expiry date. The expiry date refers to the last day of that month.

Do not throw away any medicines via wastewater. 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 the active substance is zopiclone.

Each 3.75 mg film-coated tablet contains 3.75 mg zopiclone.

Each 7.5 mg film-coated tablet contains 7.5 mg zopiclone.

• The other ingredients are calcium hydrogen phosphate dihydrate, hydroxy propyl cellulose,

What Zopiclone Aristo looks like and contents of the pack

Zopiclone Aristo 3.75 mg film-coated tablets are white to off white, round, biconvex film-coated tablets.

Zopiclone Aristo 7.5 mg film-coated tablets are white to off white, oval, biconvex film-coated tablets with a breakline on one side.

Zopiclone Aristo is packaged within clear PVC/aluminium foil blister packs containing 20 or 28 film-coated tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Aristo Pharma GmbH

Wallenroder StraBe 8–10

13435 Berlin

Germany

This leaflet was last revised in May 2021.

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