Zopiclone Aristo

Package leaflet: Information for the patient

Zopiclone Aristo 3.75 mg film-coated tablets, 7.5 mg film-coated tablets

Generic medicine
Please read this leaflet carefully before taking this medicine because it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if they have the same symptoms as yours, because it could be harmful.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

1. What Zopiclone Aristo is and what it is used for
2. What you need to know before taking 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 the medicine is Zopiclone Aristo. Zopiclone Aristo contains a substance called
zopiclone. It belongs to a class of medicines known as hypnotics. It acts on the brain to help you sleep.
Zopiclone Aristo is used for the treatment of sleep disorders in adults.
Zopiclone Aristo is indicated for short-term treatment of insomnia in adults.
It should not be used for long periods. Treatment should be as short as possible, since the risk of dependence increases with the duration of treatment.
Ask your doctor for advice if you are unsure.

2. What you should know before taking Zopiclone Aristo

Do not take Zopiclone Aristo 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: rash, difficulty swallowing or breathing, swelling of the lips, face, throat or tongue.
• you have a condition causing severe muscle weakness (myasthenia gravis);
• your lungs do not work properly (respiratory failure);
• you have a disorder characterized by breathing pauses during sleep (sleep apnoea);
• you have severe liver problems;
• you are under 18 years of age. The safety and efficacy of Zopiclone Aristo in children and adolescents under 18 years of age have not been established.

Do not take this medicine if any of the above conditions apply to you. If you are unsure,
consult your doctor or pharmacist before taking Zopiclone Aristo.
Warnings and precautions
Talk to your doctor or pharmacist before taking Zopiclone Aristo if:

• you suffer from liver disorders (see also “Do not take Zopiclone Aristo if:”). Your doctor may advise you to take a lower dose of Zopiclone Aristo.
• you suffer from kidney problems. Your doctor may advise you to take a lower dose of Zopiclone Aristo.
• you suffer from mild respiratory problems. Your doctor will decide whether to prescribe Zopiclone Aristo (see also “Do not take Zopiclone Aristo if:”).
• you have a history of alcohol or drug abuse;
• you have been diagnosed by your doctor with a personality disorder;
• you have recently taken Zopiclone Aristo or similar medicines for more than four weeks;
• you feel unable to stop taking Zopiclone Aristo or other medicines used to treat sleep disorders.

Some studies have shown an increased risk of suicidal thoughts, suicide attempts and
suicide in patients taking certain sedatives and hypnotics, including this medicine.
However, it is not known whether this is caused by the medicine or whether there may be another reason. If you have suicidal thoughts, contact your doctor as soon as possible for further advice.
Before taking Zopiclone Aristo, make sure you are able to have an uninterrupted sleep of at least 7–8 hours to reduce the risk of developing certain side effects (see section 4).
If you are unsure whether any of the conditions listed above apply to you, consult your doctor or pharmacist before taking Zopiclone Aristo.
The 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 higher when Zopiclone Aristo is used for more than 4 weeks, and in patients with a history of mental disorders and/or alcohol, illicit substances or drug abuse. Inform your doctor if you have ever had a mental disorder, or have abused or 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 not requiring a prescription, including herbal medicines. This is because Zopiclone Aristo can affect how other medicines work.
Likewise, some medicines can affect how Zopiclone Aristo works.
Inform your doctor if you are taking any of the following medicines.
Zopiclone Aristo can enhance the effect of the following medicines:

• medicines used to treat mental disorders (antipsychotics)
• medicines used to treat depression
• medicines used to treat epilepsy (anticonvulsants)
• medicines used in surgery (anaesthetics)
• medicines used to calm or reduce anxiety or for sleep disorders (hypnotics)
• medicines used to treat hay fever, skin rashes or other allergies, which may cause drowsiness (sedating antihistamines) such as chlorphenamine or promethazine
• certain medicines used to relieve moderate to severe pain (narcotic analgesics) such as codeine, methadone, morphine, oxycodone, pethidine or tramadol.

The following medicines may increase the likelihood of experiencing side effects if taken together with Zopiclone Aristo. To reduce the chance of this happening, your doctor may decide to reduce the dose of Zopiclone Aristo:

• certain antibiotics, such as clarithromycin or erythromycin
• certain medicines used to treat fungal infections, such as ketoconazole and itraconazole
• ritonavir (a protease inhibitor), used to treat HIV infection
• concomitant use of Zopiclone Aristo with opioids (strong painkillers, medicines for addiction therapy and some cough medicines) increases the risk of drowsiness, breathing difficulties (respiratory depression), coma and can be life-threatening. For this reason, concomitant use should only be considered when no other treatment options are available.

However, if your doctor prescribes Zopiclone Aristo together with opioids, your doctor will reduce the dose and duration of concomitant treatment.
Inform your doctor about all opioid medicines you are taking and carefully follow the dose recommended by your doctor. It may be helpful to inform your friends and family to watch for the symptoms and signs listed above. Contact your doctor if such symptoms occur.

The following medicines may reduce the effects of Zopiclone Aristo:

• certain medicines used to treat epilepsy, such as carbamazepine, phenobarbital or phenytoin
• rifampicin (an antibiotic), used to treat infections
• St John’s Wort (a herbal preparation), used to treat mood swings and depression

Zopiclone Aristo and alcohol
You must not drink alcoholic beverages while being treated with Zopiclone Aristo. Alcohol can enhance the effects of Zopiclone Aristo and cause you to fall into a deep sleep, potentially leading to breathing problems or difficulty waking up.
Pregnancy and breastfeeding
Pregnancy
The use of Zopiclone Aristo is not recommended during pregnancy.
If you are pregnant, suspect you may be pregnant, or are planning to become pregnant, ask your doctor or pharmacist for advice before taking this medicine.
If used during pregnancy, there is a risk to the unborn child. Some studies have shown that the risk of developing cleft lip and/or palate (sometimes called “hare lip”) in the newborn may be increased.
Reduced fetal movement and decreased variability in fetal heart rate may occur after taking Zopiclone Aristo during the second and/or third trimester of pregnancy.
If Zopiclone Aristo is taken in the late stages of pregnancy or during labour, the baby may show muscle weakness, low body temperature, feeding difficulties and breathing problems (respiratory depression).
If this medicine is taken regularly in the late stages of pregnancy, your baby may develop physical dependence and may be at risk of developing withdrawal symptoms such as agitation or tremors. In this case, the newborn should be closely monitored during the postnatal period.
Breastfeeding
Do not use Zopiclone Aristo if you are breastfeeding or planning to breastfeed.
This is because small amounts of the medicine may pass into breast milk. If you are breastfeeding or planning to breastfeed, consult your doctor or pharmacist before taking any medicine.
Driving and using machines
Like other medicines used to treat sleep disorders, Zopiclone Aristo can cause slowing of 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 before performing activities requiring mental alertness;
• you take more than the recommended dose of Zopiclone Aristo;
• you take Zopiclone Aristo while already being treated with another central nervous system depressant, or another medicine that increases the levels of Zopiclone Aristo in the blood, or while drinking alcohol.

After taking Zopiclone Aristo, do not engage in hazardous activities requiring full mental alertness, such as driving or operating machinery, particularly within the 12 hours following administration of the medicine.
For further information on possible side effects that may affect driving, see section 4 of this Patient Information Leaflet.

Zopiclone Aristo contains lactose

Each 3.75 mg film-coated tablet of Zopiclone Aristo contains 14.96 mg of lactose (as lactose monohydrate).
Each 7.5 mg film-coated tablet of Zopiclone Aristo contains 29.93 mg of lactose (as lactose monohydrate).
If your doctor has diagnosed you with an intolerance to certain sugars, please contact him or her before taking this
medicinal product.

3. How to take Zopiclone Aristo

The duration of treatment with Zopiclone Aristo should be as short as possible and must
not exceed four weeks, including the period of gradual reduction. Your doctor will
prescribe the lowest effective dose.
Take this medicine exactly as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
How to take this medicine

• take this medicine orally
• swallow the tablet with a glass of water
• do not crush or chew the tablets
• take the tablet shortly before going to bed, in a single dose, and do not take it again during the same night
• the usual duration of treatment ranges from 2 days to 3 weeks

Adults
The usual dose is one 7.5 mg film-coated tablet of Zopiclone Aristo taken shortly before bedtime.
Elderly
The usual starting dose is one 3.75 mg film-coated tablet of Zopiclone Aristo taken shortly before bedtime. If necessary, your doctor may decide to increase the dose to one 7.5 mg film-coated tablet of Zopiclone Aristo.
Use in children and adolescents
Zopiclone Aristo must not be used in children and adolescents under 18 years of age.
The safety and efficacy of Zopiclone Aristo have not been established in children and adolescents under 18 years of age.
Patients with liver, respiratory or kidney problems
The usual starting dose is one 3.75 mg film-coated tablet of Zopiclone Aristo taken shortly before bedtime.
Blood tests

• Zopiclone Aristo may alter the levels of liver enzymes detected in blood tests. This may indicate that your liver is not functioning properly.
• If you are due to have a blood test, it is important to inform your doctor that you are taking Zopiclone Aristo.

The 7.5 mg tablet may be divided into equal doses.
If you take more Zopiclone Aristo than you should
If you take more Zopiclone Aristo than you should, contact a doctor immediately or go to the nearest hospital emergency department. Take the medicine pack with you so that the doctor knows what you have taken.
Taking an excessive dose of Zopiclone Aristo can be very dangerous. The following adverse effects may occur:

• feeling drowsy, confused, deeply sedated or possibly progressing to coma
• floppy muscles (hypotonia)
• dizziness, lightheadedness or weakness. These effects are due to low blood pressure
• falls or loss of balance (ataxia)
• shallow breathing or difficulty breathing (respiratory depression)

If you forget to take Zopiclone Aristo
Zopiclone Aristo should only be taken before going to bed. If you forget to take the tablet before bedtime, do not take it at any other time, otherwise you may feel sleepy, dizzy or confused during the day.
Do not take a double dose to make up for a forgotten tablet.
If you stop taking Zopiclone Aristo
Continue taking Zopiclone Aristo for as long as your doctor tells you to.
Do not stop taking Zopiclone Aristo suddenly, but inform your doctor first if you wish to discontinue treatment. Your doctor will advise you to gradually reduce the dose and then stop taking the tablets for a period of time.
If you stop taking Zopiclone Aristo suddenly, your insomnia symptoms may return and you may experience "withdrawal symptoms". If this happens, you may experience some of the following effects:
Contact your doctor immediately if you notice any of the following:

• anxiety, tremors, irritability, agitation, confusion or panic attacks
• sweating
• headache
• rapid or irregular heartbeat (palpitations)
• reduced level of awareness and problems with focus or concentration
• nightmares, seeing or hearing things that are not real (hallucinations)
• increased sensitivity to light, noise and physical touch
• a relaxed perception of reality
• numbness and tingling in hands and feet
• muscle pain
• stomach disturbances Rarely, seizures (fits) may also occur.

If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
Stop taking Zopiclone Aristo and contact a doctor immediately or go to hospital if you:

• experience an allergic reaction. Signs may include: rash, difficulty swallowing or breathing, swelling of the lips, face, throat or tongue

Tell your doctor as soon as possible if you get any of the following side effects:
Rare: (may affect up to 1 in 1,000 people)

• memory problems after taking Zopiclone Aristo (amnesia). Ensuring 7–8 hours of uninterrupted sleep after taking Zopiclone Aristo makes this condition less likely to occur.
• seeing or hearing things that are not real (hallucinations)
• falls, especially in elderly people

Not known: (frequency cannot be estimated from the available data)

• thinking things that are not true (delusions)
• feeling of sadness or depression (depressed mood)

Tell your doctor or pharmacist if any of the following side effects become severe or last longer than a few days:
Common: (may affect up to 1 in 10 people)

• a slightly bitter or metallic taste in the mouth or dry mouth

• feeling drowsy or sleepiness

• dry mouth
  Uncommon: (may affect up to 1 in 100 people)

• feeling unwell (nausea) or being unwell (vomiting)

• feeling dizzy or drowsy

• headache

• nightmares

• feeling of physical or mental tiredness

• restlessness
  Rare: (may affect up to 1 in 1,000 people)

• feeling confused

• itching, raised itchy rash (urticaria)

• feeling irritable or aggressive

• reduced sex drive

• difficulty breathing or shortness of breath
  Not known: (frequency cannot be estimated from the available data)

• feeling restless or angry

• feeling of emptiness in the head or coordination problems

• double vision

• moving in an unsteady or concerning way

• muscle weakness

• indigestion

• dependence on Zopiclone Aristo

• slowed breathing (respiratory depression)

• unusual skin sensations such as numbness, tingling, itching, burning, or crawling on the skin (paraesthesia)

• mental problems such as poor memory

• difficulty concentrating

• disruption of normal speech

Sleep-driving and other unusual behaviours
There have been reports of people carrying out activities while asleep after taking a sleeping medicine, which they do not remember upon waking.
These include sleep-driving and sleepwalking. Alcohol and certain medicines for depression or anxiety may increase the likelihood of this serious effect occurring.

Reporting of side effects
If you get any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Zopiclone Aristo

This medicine 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 stated on the blister and on the carton after the word "Exp". The expiry date refers to the last day of that month.
Do not dispose of any medicine via wastewater. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Zopiclone Aristo contains

• The active substance is zopiclone. Each 3.75 mg film-coated tablet of Zopiclone Aristo contains 3.75 mg of zopiclone. Each 7.5 mg film-coated tablet of Zopiclone Aristo contains 7.5 mg of zopiclone.
• The other components are calcium hydrogen phosphate dihydrate, hydroxypropylcellulose, lactose monohydrate, maize starch, magnesium stearate, pregelatinized starch, Opadry White (composed of hypromellose, macrogol, titanium dioxide (E171)).

Description of the appearance of Zopiclone Aristo and contents of the pack
Zopiclone Aristo 3.75 mg film-coated tablets are white to off-white, round, biconvex tablets.
Zopiclone Aristo 7.5 mg film-coated tablets are white to off-white, oval, biconvex tablets with a break line on one side.
Zopiclone Aristo is packed in transparent PVC/aluminum blisters containing 20 or 28 film-coated tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer
Aristo Pharma GmbH
Wallenroder Straße 8-10
13435 Berlin
Germany

Selling Licensee
Aristo Pharma Italy S.r.l.
[email protected]

This medicinal product is authorized in the Member States of the European Economic Area under the following names:
Italy: Zopiclone Aristo
United Kingdom: Zopiclone Aristo 3.75 mg film-coated tablets
Zopiclone Aristo 7.5 mg film-coated tablets