Patient Information Leaflet: Read this leaflet carefully before using the medicine, as it contains important information for you.

Keep this leaflet! The label on the immediate packaging is in a foreign language.
Imovane, 7.5 mg, coated tablets
Zopiclone
Read the entire leaflet carefully before using this medicine, as it contains important information for you.

Keep this leaflet so that you can read it again if necessary.
If you have any questions, consult your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm others, even if their symptoms are the same as yours.
If you experience any adverse effects, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of Contents:

What Imovane is and what it is used for
Important information before taking Imovane
How to take Imovane
Possible side effects
How to store Imovane
Contents of the pack and other information

1. What Imovane is and what it is used for

Imovane is available as coated tablets and contains the active substance zopiclone.
Zopiclone belongs to a group of medicines known as hypnotics.
Imovane helps you fall asleep, reduces the number of nighttime awakenings, prolongs sleep duration,
and improves both sleep quality and the sense of well-being upon waking.
Imovane is indicated for the short-term treatment of insomnia in adults – transient, short-term, or chronic insomnia (including difficulty falling asleep, fragmented sleep, and early morning awakening).
Do not use for prolonged periods. Treatment should be as short as possible, since the risk of developing dependence increases with the duration of treatment.

2. Important information before using Imovane

When not to use Imovane:

if the patient is allergic to zopiclone or any of the other ingredients of this medicine (listed in section 6);
if the patient has myasthenia gravis (muscle weakness);
in case of respiratory insufficiency;
in severe forms of sleep apnoea syndrome;
in severe hepatic insufficiency.

Warnings and precautions
In every case, before prescribing a sleeping medicine, the doctor should determine, if possible, the causes of insomnia and eliminate, as far as possible, the factors causing it.
Since sleeping medicines may suppress the respiratory centre, caution should be exercised when prescribing zopiclone to patients with impaired respiratory function.
Psychomotor disturbances
Like other sleeping medicines, zopiclone has a central nervous system depressant effect.
The risk of psychomotor disturbances, including impaired ability to drive motor vehicles, increases if:
zopiclone is taken within 12 hours before performing activities requiring concentration, if a higher than recommended dose is used, or if zopiclone is taken together with other medicines that depress the central nervous system, with alcohol, or with other medicines that increase the blood concentration of zopiclone. During treatment with Imovane, patients should avoid engaging in activities requiring high concentration or motor coordination, such as operating machinery or driving motor vehicles, after taking zopiclone, and especially within 12 hours after administration.
Risk associated with concomitant use of opioids
Concomitant use of opioids with benzodiazepines or other sedative or hypnotic medicines, including zopiclone, may result in sedation, respiratory depression, coma, and death. Due to these risks, simultaneous prescription of opioids and benzodiazepines should only be considered by a physician when alternative treatment options are insufficient.
If a decision is made to prescribe zopiclone together with opioids, both medicines should be prescribed at the lowest effective dose and for the shortest duration possible.
Dependence
Use of Imovane may lead to the development of abuse and/or psychological and/or physical dependence.
The risk of dependence increases with the dose and duration of treatment and is greater when Imovane is used for longer than 4 weeks. The risk of dependence is higher in patients with psychiatric disorders and/or a history of alcohol, illicit substance, or medication abuse. If the patient has ever had psychiatric disorders or has abused or been dependent on alcohol, illicit substances, or medications, they should inform their doctor.
In cases where physical dependence has developed, abrupt discontinuation of treatment may lead to withdrawal symptoms. These may include headache and muscle pain, increased anxiety and tension, restlessness, confusion, and irritability. In severe cases, symptoms such as derealisation, depersonalisation, heightened auditory sensitivity, numbness and tingling in the limbs, hypersensitivity to light, noise, and touch, hallucinations, and seizures may occur.
Withdrawal symptoms may appear within a few days after stopping zopiclone. During regular use of the medicine, withdrawal symptoms may occur between doses, especially if the dose was high.
Rebound insomnia
After discontinuation of zopiclone, transient rebound insomnia may occur, characterised by a worsening of symptoms that initially prompted the use of the sleeping medicine. Other symptoms may also appear, such as mood changes, anxiety, and agitation.
Because the risk of rebound insomnia is greater after abrupt discontinuation of Imovane, especially after long-term use or high-dose treatment, gradual dose reduction is recommended.
Tolerance
With repeated use of sleeping medicines, a reduction in their effect may occur. However, with Imovane, no significant tolerance has been observed during treatment lasting up to 4 weeks.
Amnesia
Anterograde amnesia may occur, particularly if sleep is interrupted or if the patient does not go to bed immediately after taking the medicine.
To reduce the risk of anterograde amnesia, patients should ensure:

taking the tablet immediately before going to bed,
having the possibility of uninterrupted sleep throughout the night.

Psychiatric and paradoxical reactions
Use of sedative and hypnotic medicines such as zopiclone may be associated with reactions such as: anxiety, agitation, irritability, aggression, delusions, anger, nightmares, hallucinations, inappropriate behaviour, and other behavioural disturbances. In such cases, treatment should be discontinued. These reactions are more likely to occur in elderly patients (see section 4. Possible side effects).
Sleepwalking and similar behaviours
In patients taking zopiclone who do not fully awaken, the following disturbances may occur: sleepwalking and related behavioural disturbances such as driving while asleep, preparing and eating food, making phone calls during sleep, with no memory of these activities. Alcohol consumption or concomitant use of other central nervous system depressants with zopiclone appears to increase the risk of such behaviours, as does using zopiclone at doses exceeding the maximum recommended dose. Patients reporting such behaviours, such as driving while asleep, should discontinue Imovane due to the risk to themselves and others (see section: Imovane with other medicines and section 4. Possible side effects).
Suicidal thoughts, suicide attempts, suicide, and depression
Some studies have shown an increased risk of suicidal thoughts, suicide attempts, and suicide in patients taking certain sedative and hypnotic medicines, including this one. However, it is not known whether this is caused by the medicine or other factors. If a patient experiences suicidal thoughts, they should contact their doctor as soon as possible for medical advice.
As with other sedative or hypnotic medicines, caution should be exercised when using Imovane in patients with symptoms of depression. Such patients may have suicidal tendencies; therefore, the doctor should prescribe the lowest possible dose of Imovane to prevent intentional overdose. During treatment with Imovane, pre-existing depression may become apparent. Insomnia may be a symptom of depression; therefore, if insomnia persists, the doctor should re-evaluate the patient.
Children and adolescents
Zopiclone should not be used in children and adolescents under 18 years of age. The safety and efficacy of zopiclone have not been established in children and adolescents under 18 years of age.
Imovane with other medicines
Inform your doctor about all medicines currently used, recently used, or planned for use.
Combinations not recommended
Do not consume alcohol simultaneously. Alcohol may enhance the sedative effect of Imovane. This may affect the ability to drive motor vehicles and operate machinery.
Combinations that should be considered
Medicines with central nervous system depressant effects:
Enhanced central nervous system depression may occur when zopiclone is used concomitantly with antipsychotics (neuroleptics), other hypnotics, anxiolytics and sedatives, antidepressants, opioid analgesics, antiepileptic medicines, general anaesthetics, and sedating antihistamines.
With opioid analgesics, euphoria may be intensified, potentially increasing psychological dependence.
Concomitant use of medicines such as erythromycin, clarithromycin, ketoconazole, itraconazole, and ritonavir may increase zopiclone blood levels and intensify the hypnotic effect of Imovane.
Medicines such as rifampicin, carbamazepine, phenobarbital, phenytoin, and St John’s wort (Hypericum perforatum) preparations may decrease zopiclone blood levels. When used concomitantly with these medicines, the doctor may increase the zopiclone dose.
Concomitant use of benzodiazepines and other sedatives or hypnotics, including zopiclone, and opioids increases the risk of sedation, respiratory depression, coma, and death due to enhanced central nervous system depression.
Imovane with food and drink
The medicine should be taken immediately before going to bed or in bed, regardless of meals.
Pregnancy and breastfeeding
Pregnancy
Imovane is not recommended during pregnancy. If the patient is pregnant, suspects she may be pregnant, or is planning to become pregnant, she should consult her doctor before using this medicine.
The medicine may affect the unborn child if taken during pregnancy.
Some studies have shown an increased risk of cleft lip and palate (sometimes called "hare lip") in newborns.
Reduced fetal movement and variable fetal heart rate may occur if the mother uses Imovane during the second and/or third trimester of pregnancy.
If the patient uses Imovane late in pregnancy or during delivery, her newborn may exhibit muscle weakness (floppy infant syndrome), low body temperature, feeding difficulties, and breathing problems (respiratory depression).
If the patient regularly uses Imovane late in pregnancy, the newborn may develop physical dependence and withdrawal symptoms such as agitation or seizures. In such cases, the newborn should be closely monitored in the postnatal period.
Breastfeeding
Although zopiclone passes into breast milk in very small amounts, Imovane should not be used by breastfeeding women.
Driving and operating machinery
Due to its effect on the central nervous system, Imovane may impair the ability to drive motor vehicles and operate machinery. The risk is increased if:

Imovane is taken within 12 hours before performing activities requiring concentration,
a higher than recommended dose is used,
it is taken concomitantly with other central nervous system depressants, alcohol, or medicines that increase zopiclone blood levels (see section: Warnings and precautions).

During treatment with Imovane, patients should avoid engaging in activities requiring high concentration or motor coordination, such as operating machinery and driving motor vehicles.
Imovane contains lactose monohydrate
If the patient has previously been diagnosed with intolerance to certain sugars, they should consult their doctor before taking this medicine.
Imovane contains wheat starch (contains gluten)
This medicine contains very small amounts of gluten (from wheat starch). Therefore, it is very unlikely to cause problems in patients with coeliac disease.
One tablet contains no more than 6.0 micrograms of gluten.
Patients with wheat allergy (other than coeliac disease) should not take this medicine.
This medicine contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. it is considered "sodium-free".

3. How to use Imovane

Imovane should be used as directed by the physician. In case of any doubts, please contact your doctor again.
General information
Use the lowest effective dose. Imovane should be taken as a single dose; the medication should not be administered again during the same night.
Treatment should last as short as possible, no longer than 4 weeks, including the period of gradual dose reduction. Only a physician, after careful assessment of the patient's condition, may recommend a longer treatment duration.
The medication should be taken just before bedtime.
Duration of treatment:
Transient insomnia: 2–5 days.
Short-term insomnia: 2–3 weeks.
Adults:
The recommended dose is 7.5 mg, taken orally before bedtime. This dose should not be exceeded.
Elderly patients:
Treatment in elderly patients should be initiated at a dose of 3.75 mg (1/2 tablet). The dose may be increased to 7.5 mg (1 tablet) only if necessary and if the patient tolerates the medication well.
Patients with hepatic impairment:
In patients with hepatic impairment, treatment should be initiated at a dose of 3.75 mg (1/2 tablet). The dose may be increased to 7.5 mg (1 tablet).
Patients with renal impairment:
Although zopiclone does not accumulate in the body in renal impairment, it is recommended to initiate treatment at a dose of 3.75 mg (1/2 tablet) per day.
Patients with chronic respiratory insufficiency:
In patients with chronic respiratory insufficiency, treatment should be initiated at a dose of 3.75 mg (1/2 tablet). The dose may be increased to 7.5 mg (1 tablet).
Use in children and adolescents
Zopiclone should not be used in children and adolescents under 18 years of age. The safety and efficacy of zopiclone have not been established in children and adolescents under 18 years of age.
If you feel that the effect of Imovane is too strong or too weak, consult your doctor.
Taking more than the recommended dose of Imovane
Symptoms of overdose usually involve varying degrees of central nervous system depression, ranging from drowsiness to coma, depending on the amount ingested. In mild cases, symptoms include somnolence, confusion, and lethargy; in more severe cases, symptoms may include ataxia, decreased muscle tone, hypotension, respiratory depression, and coma. Overdose is generally not life-threatening. An exception is when other substances with central nervous system depressant effects, including alcohol, are taken concurrently. Other risk factors, such as concomitant illness or poor general health of the patient, may contribute to worsening of symptoms. Very rarely, these may lead to death.
Treatment
Supportive and symptomatic treatment in hospital is recommended. Close monitoring of respiratory and cardiovascular function is essential. Gastric lavage may be beneficial only if performed immediately after ingestion. Hemodialysis is ineffective. Flumazenil may be a useful antidote.
If more than the recommended dose of Imovane has been taken, seek immediate medical advice from a doctor or pharmacist.
Missed dose of Imovane
Take the next dose at the usual time the following day. Do not take two doses at the same time or in close succession.
If you have any further questions about the use of this medicine, consult your doctor.

4. Possible adverse reactions

Like any medicine, Imovane can cause adverse reactions, although not everyone experiences them.
The following adverse reactions may occur:

Common (may occur in up to 1 in 10 people):
- taste disturbances (bitter taste), drowsiness
- dry mouth.

Uncommon (may occur in up to 1 in 100 people):
- nightmares, restlessness
- headache, dizziness
- nausea
- fatigue.

Rare (may occur in up to 1 in 1,000 people):
- confusion, libido disorders, irritability, aggression, hallucinations
- memory impairment (amnesia)
- shortness of breath
- rash, itching
- falls (mainly in elderly patients).

Very rare (may occur in up to 1 in 10,000 people):
- skin or mucosal swelling known as angioedema, immediate-type allergic reactions occurring after re-exposure to an allergen, known as anaphylactic reactions
- mild to moderate increase in serum liver enzyme activity.

Frequency not known (frequency cannot be estimated from available data):
- anxiety, delusions, anger, inappropriate behaviour, somnambulism (sleepwalking), dependence, withdrawal symptoms
- ataxia (impaired body movement coordination), paraesthesia (tingling, numbness of the skin), cognitive disorders such as memory impairment, concentration difficulties, speech disorders
- double vision
- breathing disorders
- indigestion
- muscle weakness.

After discontinuation of Imovane, withdrawal symptoms have been reported (see section 2. Important information before taking Imovane). Withdrawal symptoms vary and may include: insomnia, muscle pain, anxiety, tremor, sweating, restlessness, confusion (disorientation), headache, palpitations, tachycardia, delirium, nightmares, irritability. In severe cases, derealisation (altered perception of the surrounding world), depersonalisation (feeling of loss of one's own identity), hypersensitivity to sound, light and touch, numbness and tingling of limbs, delusions may occur. In very rare cases, seizures may occur.

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, phone: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl.
Reporting adverse reactions helps to provide more information on the safety of this medicine.

5. How to store the medicine Imovane

Keep the medicine out of the sight and reach of children.
Store below 25°C, in the original packaging.
Do not use the medicine after the expiry date stated on the packaging.
The expiry date refers to the last day of the stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the packaging and other information

What Imovane contains
1 film-coated tablet contains the active substance: zopiclone 7.5 mg
and the following excipients: monohydrate lactose, calcium hydrogen phosphate dihydrate, wheat starch,
sodium carboxymethyl starch (type A), magnesium stearate; coating composition: hypromellose,
titanium dioxide (E 171), macrogol 6000.

What Imovane looks like and contents of the packaging
The packaging contains 14 or 20 film-coated tablets.
For more detailed information, please contact the marketing authorisation holder or the parallel importer.

Marketing authorisation holder in Romania, country of export:
Sanofi Romania SRL
Str. Gara Herăstrău No. 4, Building B, 8th-9th floors, Sector 2
Bucharest, Romania

Manufacturer:
Opella Healthcare International SAS
56, Route de Choisy
60200 Compègne, France

Parallel importer:
InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw, Poland

Repackaged in:
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw, Poland

Marketing authorisation numbers in Romania, country of export: 8632/2016/01
8632/2016/02

Parallel import authorisation number: 224/16