Zopiclone EG

Package leaflet: Information for the user

ZOPICLONE EG 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 may be harmful.
• If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet

1. What Zopiclone EG is and what it is used for
2. What you need to know before taking Zopiclone EG
3. How to take Zopiclone EG
4. Possible side effects
5. How to store Zopiclone EG
6. Contents of the pack and other information

1. What Zopiclone EG is and what it is used for

Zopiclone belongs to a class of medicines called cyclopyrrolones. It has properties similar to benzodiazepines. Benzodiazepines or substances similar to benzodiazepines should be used only if you suffer from severe sleep disorders causing extreme distress.
Zopiclone, the active substance in Zopiclone EG, is a hypnotic sedative (sleeping aid). It induces sleep and is therefore used for the short-term treatment of insomnia.

2. What you should know before taking Zopiclone EG

Do NOT take Zopiclone EG
if you are allergic to zopiclone or to any of the other ingredients of this medicine (listed in
section 6).
if you have any of the following conditions:
severe muscle weakness called myasthenia gravis (an autoimmune disease)
severe respiratory insufficiency (a condition in which 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 hepatic impairment
if you are a child or adolescent under 18 years of age

Warnings and precautions
Talk to your doctor or pharmacist before taking Zopiclone EG.

General recommendations
Before treatment with Zopiclone EG
the causes of sleep disturbances should be clarified
pre-existing diseases must be treated.

Inform your doctor if you have or have had any illness or medical condition, especially the following:
chronic respiratory insufficiency (caused by heart or lung problems). Your doctor will reduce the dose
due to the risk of respiratory depression.
impaired liver function. Your doctor will reduce the dose.
psychosis (severe mental disorders characterized by personality disturbances and loss of contact with reality)
depression
anxiety states related to depression
alcohol or drug abuse.

Your doctor will decide whether or not you should take Zopiclone EG. You will also be closely monitored
during treatment.

Dependence and withdrawal symptoms
The use of benzodiazepines and benzodiazepine-like substances may lead to physical and psychological dependence on
these medicines. The risk of dependence increases with higher doses and longer duration of
treatment. The risk is also greater in patients with a history of alcohol or drug abuse and/or in those
with marked personality disorders.

If physical dependence occurs, abruptly stopping treatment may lead to withdrawal symptoms
(see section 3 “How to take Zopiclone EG”).

Insomnia (Rebound insomnia)
After stopping treatment with a benzodiazepine or a benzodiazepine-like substance, a temporary condition called rebound insomnia may occur. Insomnia may recur in a more severe form. Other symptoms may include mood swings, anxiety and restlessness. The risk of rebound or withdrawal symptoms is higher if you stop treatment suddenly. Therefore, your doctor will advise you to gradually reduce the dose of Zopiclone EG.

Tolerance
The effect of some benzodiazepines or benzodiazepine-like substances may decrease after repeated use over
several weeks. This process is called tolerance. Consult your doctor if you feel that
the effect of Zopiclone EG diminishes after repeated use over a few weeks.

Short-term memory loss (anterograde amnesia)
Benzodiazepines and benzodiazepine-like substances may cause short-term memory loss (anterograde amnesia). This typically occurs a few hours after taking the medicine. To reduce the risk, ensure you are able to have an uninterrupted sleep of 7–8 hours.

Psychiatric reactions and "paradoxical" reactions
During the use of benzodiazepines and benzodiazepine-like substances, the following reactions may occur:
restlessness
agitation
irritability
aggressive states
false beliefs (delusions)
outbursts of anger
nightmares
hearing, seeing or perceiving things that do not exist (hallucinations)
severe mental disorders characterized by personality disturbances and loss of contact with reality (psychosis)
inappropriate behaviour
other behavioural disturbances.

The risk of these reactions is higher in elderly patients. If you experience any of the symptoms listed above,
you must stop taking Zopiclone EG. Consult your doctor.

Sleepwalking and associated behaviours
Sleepwalking and other behaviours such as "driving while asleep", preparing and eating food, or making phone calls with loss of memory of the event (amnesia) have been reported in patients who took
zopiclone and were not fully awake.

The risk of such behaviours is higher
if alcohol or certain other medicines (such as narcotic analgesics, antipsychotic agents, hypnotics or sedative anxiolytics) are consumed during treatment with zopiclone
if zopiclone is used at doses exceeding the maximum recommended dose.

If you develop such behaviours, consult your doctor immediately. Your doctor may discontinue
treatment with zopiclone.

Risk of falls
Due to the muscle-relaxant effect of zopiclone, there is a risk of falling, particularly in elderly patients who get up during the night.

Other medicines and Zopiclone EG
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other
medicine.

The following medicines may enhance the effects of Zopiclone EG:
antipsychotics/neuroleptics (used to treat psychosis)
hypnotics (used to treat insomnia)
anxiolytics (used to treat anxiety)
sedatives/tranquillisers (used to calm and reduce anxiety)
antidepressants (used to treat depression)
narcotic analgesics/opioid painkillers, such as morphine and morphine-like substances (used to relieve pain). These may also cause an abnormal feeling of happiness (euphoria), which may promote psychological dependence.
The concomitant use of Zopiclone EG and opioids (strong painkillers, medicines for substitution therapy and some cough medicines) increases the risk of drowsiness, breathing difficulties (respiratory depression), coma and may be life-threatening. For this reason, concomitant use should only be considered when no other treatment options are possible.
However, if your doctor prescribes Zopiclone EG together with opioids, the dose and duration of concomitant therapy must be limited by your doctor.
Inform your doctor about all opioid medicines you are taking and follow your doctor’s dosage recommendations carefully. It may be helpful to inform friends or relatives so they are aware of the signs and symptoms listed above. Contact your doctor if such symptoms occur.
antiepileptics/anticonvulsants (used to prevent epileptic seizures)
anaesthetics (used to block pain perception, e.g. during surgery)
sedating antihistamines (used to treat allergic reactions).

The combination of Zopiclone EG with muscle relaxants may enhance the muscle-relaxant effect.

The following medicines may enhance the effects of Zopiclone EG. Therefore, it may be necessary to reduce the amount of zopiclone you take:
macrolide antibiotics (used to treat bacterial infections), e.g. erythromycin
azole antifungals (used to treat fungal infections)
HIV protease inhibitors (used to treat AIDS).

The following medicines may reduce the effects of Zopiclone EG:
phenobarbital and phenytoin (used to treat epileptic seizures)
carbamazepine (used to treat epileptic seizures and mood disorders)
rifampicin (an antibiotic)
St John's wort preparations (herbal remedy used to treat depression and anxiety)

Zopiclone EG with food, drinks and alcohol
You must not drink alcoholic beverages while being treated with zopiclone. Alcohol may enhance the effect of the medicine. This may particularly affect your ability to drive and use machinery.
Avoid drinking grapefruit juice during treatment. Grapefruit may enhance the effect of zopiclone.

Pregnancy, breastfeeding and fertility
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.
The safety of zopiclone during pregnancy and breastfeeding has not yet been established.

Pregnancy
You must not take Zopiclone EG if you are pregnant. If zopiclone is taken during the last three months of pregnancy or during labour, the newborn may be affected. These effects include low body temperature (hypothermia), low blood pressure (hypotension), reduced muscle tone (hypotonia), shortness of breath and very slow breathing (respiratory depression), and reduced sucking reflex (floppy infant syndrome).
Withdrawal symptoms may occur in newborns. This has been observed in infants whose mothers took zopiclone for prolonged periods during the last months of pregnancy.
Your doctor will prescribe Zopiclone EG only after evaluating the benefit-risk ratio.

Breastfeeding
Do not take Zopiclone EG if you are breastfeeding. Zopiclone is excreted in breast milk.

Driving and using machines
Do not drive or operate machinery until your treatment is complete or until it has been established that your abilities are not impaired.
Zopiclone EG may cause adverse effects that may impair your ability to drive and operate machinery. These include, for example:
drowsiness (sedation)
memory loss (amnesia)
impaired concentration
impaired muscle function.
The risk of these effects increases with alcohol consumption and is even greater if sleep duration is insufficient. Symptoms may also affect you the following morning.

Zopiclone EG contains sugar (lactose)
If your doctor has diagnosed you with an intolerance to certain sugars, contact him before taking this medicine.

Zopiclone EG contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially 'sodium-free'.

3. How to take Zopiclone EG

Take this medicine exactly as your doctor has told you. If you are unsure, consult your doctor or pharmacist.

Recommended dose
Adults
The recommended dose is 7.5 mg of zopiclone. This dose must not be exceeded.

Use in children
Zopiclone EG must not be taken by anyone under 18 years of age.

Elderly patients, including those with impaired liver or kidney function or chronic respiratory insufficiency
(a condition in which gas exchange in the lungs is insufficient to meet the body's needs)
Treatment should be started at a dose of 3.75 mg of zopiclone.

Maximum dose
Do not exceed a daily dose of 1 film-coated tablet of Zopiclone EG.

You may break the tablet as follows:
Place the tablet on a flat surface.
Use your right and left thumbs or index fingers to press on both sides of the score line.
The tablet can be divided into equal doses.

Take Zopiclone EG just before going to bed. Make sure you are able to have an uninterrupted sleep of 7–8 hours. Swallow the tablet with liquid (e.g. a glass of water), but not with grapefruit juice.

Duration of treatment
Treatment with Zopiclone EG should be as short as possible. In general, it should last from a few days to 2 weeks. Your doctor will explain how to gradually reduce the dose of Zopiclone EG at the end of treatment (gradual tapering). This helps reduce the risk of withdrawal and rebound symptoms (see section 2 Warnings and precautions).

Do not take Zopiclone EG for longer than 4 weeks, including the tapering-off period. Inform your doctor if your symptoms do not improve within this time.

If you take more Zopiclone EG than you should
If you take too many tablets, contact your doctor immediately or go to the nearest Emergency Department.
An overdose of zopiclone, especially when combined with certain other substances, may be life-threatening. These substances include medicines that depress the central nervous system, including alcohol.

Overdose with benzodiazepines or benzodiazepine-like substances usually causes central nervous system depression, ranging from drowsiness to coma. The most common symptoms are dizziness, lack of energy (lethargy), and difficulty coordinating muscle movements (ataxia).

If you forget to take Zopiclone EG
If you still have time to sleep for 7–8 hours, take the missed dose immediately.
If there is little time left, skip the missed dose and do not take another dose until the next evening before going to sleep. Never take a double dose, as this is worse than missing a dose.

If you stop taking Zopiclone EG
Stopping treatment suddenly may cause withdrawal or rebound symptoms. Withdrawal symptoms may include:
headache
muscle pain
extreme anxiety
tension
restlessness
confusion
irritability.

In severe cases, the following withdrawal symptoms may occur:
altered perception of the world, making it seem strange or unreal (derealisation)
loss of personal identity followed by feelings of unreality and detachment (depersonalisation)
increased sensitivity to sound (hyperacusis)
numbness and tingling in arms and legs
increased sensitivity to light, noise, or physical contact
hallucinations (hearing, seeing, or sensing things that are not real)
seizures.

The risk of developing these symptoms increases with higher doses and longer duration of treatment. Therefore, your doctor will advise you on how to gradually reduce the dose.

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 everybody gets them.
The most common adverse reaction with zopiclone is a bitter taste or metallic aftertaste.
The following side effects have been observed in patients treated with zopiclone.
Very common (may affect more than 1 in 10 people):
bitter or metallic taste (dysgeusia)
Common (may affect up to 1 in 10 people):
drowsiness during the following day
reduced alertness
headache
dizziness
gastrointestinal problems, including feeling unwell (nausea) and vomiting.
Rare (may affect up to 1 in 1,000 people):
mild to moderate increase in certain liver enzymes (serum transaminases and/or alkaline phosphatase)
memory loss (amnesia)
inco-ordination
difficulty in coordinating muscular movements (ataxia), which mainly occurs at the beginning of treatment and disappears after repeated use.
feeling of light-headedness
diplopia (double vision), which mainly occurs at the beginning of treatment and disappears after repeated use.
dry mouth
skin reactions, including urticaria
muscle weakness
risk of falling, especially in the elderly (see also section 2 Warnings and precautions)
fatigue
numbness
confusion
depression
so-called paradoxical reactions such as
restlessness
agitation
irritability
aggressive states
delusions
outbursts of anger
nightmares
hearing, seeing or perceiving things that are not real (hallucinations)
severe mental disturbances characterised by personality disturbances and loss of contact with reality (psychosis)
inappropriate behaviour and other behavioural disturbances.
Very rare (may affect up to 1 in 10,000 people):
swelling of the face, lips or tongue with breathing or swallowing difficulties (angioedema)
severe allergic reactions (anaphylactic reactions)
severe skin reactions (Stevens-Johnson syndrome, toxic epidermal necrolysis/Lyell’s syndrome, erythema multiforme).
changes in libido (reduced libido).
Not known (frequency cannot be estimated from the available data):
physical and psychological dependence
sleepwalking (walking during sleep and associated behaviour, see also section 2 Warnings and precautions).
Even when taken as directed, short-term memory loss may occur, sometimes associated with inappropriate behaviour. The risk of this increases with higher doses.
During treatment with Zopiclone EG, pre-existing depression may become apparent.
The use of Zopiclone EG may lead to physical or psychological dependence, potentially resulting in withdrawal reactions or rebound insomnia upon discontinuation of treatment. Please also consult section 2 Warnings and precautions.

Reporting of side effects
If you experience 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 EG

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the blister after the wording EXP. The expiry date refers to the last day of that month.
Do not store above 25°C.
Do not dispose of any medicine via wastewater or household waste. 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 EG contains
The active substance is zopiclone.
Each Zopiclone EG 7.5 mg tablet contains 7.5 mg of zopiclone.
The other components are:
monohydrate lactose
dibasic calcium phosphate dihydrate
maize starch
sodium croscarmellose
magnesium stearate
titanium dioxide (E171)
hypromellose
Description of the appearance of Zopiclone EG tablets and pack contents
Zopiclone EG 7.5 mg tablets are white, round, biconvex film-coated tablets, with “ZOC 7.5” engraved in relief on one side and a notch on both sides.
Zopiclone EG is available in packs containing 5, 10, 14, 18, 20, 28, 30, 50, 56, 60, 90, 100, 150, 200, 250, 300, 400, 500 or 1000 tablets in PVC/PVDC/Al blisters, packs in PP containers containing 100, 250 or 1000 tablets, or HDPE bottles containing 250 tablets.
Not all pack sizes may be marketed.
Marketing Authorization Holder
EG S.p.A. Via Pavia, 6 - 20136 Milano
Manufacturer
STADA Arzneimittel AG, Stadastraße 2-18, 61118 Bad Vilbel (Germany)
Centrafarm Services B.V., Van de Reijtstraat 31-E, 4814 NE Breda (The Netherlands)
Sanico n.v., Industriezone IV Veedijk, 59 - B-2300 Turnhout (Belgium)
Synthon BV, Microweg 22 – 6503 GN Nijmegen (The Netherlands)
Synthon Hispania S.L., C/Castelló 1, Polígono Las Salinas, 08830 San Boi de Llobregat, Barcelona (Spain)
This medicinal product is authorized in the European Economic Area countries under the following names:
AT: Somnal 7.5 mg – Filmtabletten
BE: Zopiclone EG 7.5mg omhulde tabletten
DE: Zopistad 7.5 mg
DK: Zopiclon Stada
FR: Zopiclone EG 7.5 mg, comprimé pelliculé sécable
IE: Zopicalm tablets 7.5mg
IT: Zopiclone EG 7.5 mg Compresse rivestite con film
LU: Zopiclone EG
NL: Zopiclone CF 7.5 mg, tabletten
PL: Dobroson
SE: Zopiclon Stada