Imovane

Leaflet attached to the packaging: information for the user

Warning! Keep the leaflet! Information on the immediate packaging in a foreign language.

Imovane,7.5 mg, coated tablets
Zopiclone

You should carefully read the contents of the leaflet before using the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if necessary.
• In case of any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed to you specifically. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet:

• 1. What is Imovane and what is it used for
• 2. Important information before taking Imovane
• 3. How to take Imovane
• 4. Possible side effects
• 5. How to store Imovane
• 6. Contents of the pack and other information

1. What is Imovane and what is it used for

Imovane is available in the form of coated tablets and contains the active substance zopiclone.
Zopiclone belongs to a group of sedative medicines.
Imovane facilitates falling asleep, reduces the number of nocturnal awakenings, prolongs the duration of sleep
and improves both the quality of sleep and the feeling after waking up.
Imovane is indicated for short-term treatment of insomnia in adults - transient, short-term or chronic (including difficulty falling asleep, sleep fragmentation, early morning awakening
).
Do not use for a long time. Treatment should last as short as possible, as the risk of dependence increases with the duration of treatment.

2. Important information before taking Imovane

When not to take 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 (muscle weakness);
• in case of respiratory failure;
• in severe sleep apnea syndrome;
• in severe liver failure.

Warnings and precautions

In each case, before the doctor prescribes a sedative, it should be determined, if possible, what causes insomnia and, if possible, eliminate the factors that cause it.
Since sedatives have the ability to suppress the respiratory center, caution should be exercised when prescribing zopiclone to patients with respiratory system disorders.
Psychomotor disorders
Like other sedatives, zopiclone has a central nervous system depressant effect.
The risk of psychomotor disorders, including impaired ability to drive vehicles, increases if: zopiclone is taken within 12 hours preceding activities that require attention, a higher dose of the medicine than recommended is taken, or if zopiclone is taken with other medicines that have a depressant effect on the central nervous system, with alcohol, or with other medicines that increase the concentration of zopiclone in the blood. During the use of Imovane, you should avoid engaging in activities that require significant attention or motor coordination, such as operating machines and driving vehicles, after taking zopiclone and especially within 12 hours after taking it.
Risk associated with concomitant use of opioids
Concomitant use of opioids with benzodiazepines or other sedative or hypnotic medicines, including zopiclone, may cause sedation, respiratory depression, coma, and death. Due to these risks, concomitant prescription of opioids and benzodiazepines will be made by a doctor in patients for whom alternative treatment options are insufficient.
If the decision is made to prescribe zopiclone concomitantly with opioids, the medicines will be prescribed in the smallest effective dose and for the shortest possible duration of concomitant use.
Dependence
Taking Imovane may lead to the development of abuse and/or psychological or physical dependence.
The risk of dependence increases with the size of the dose and the duration of treatment and is greater when Imovane is used for longer than 4 weeks. The risk of dependence is greater in patients with mental disorders and/or a history of alcohol, illicit substance, or drug abuse. If the patient has ever had mental disorders, abused or been dependent on alcohol, illicit substances, or drugs, they should tell their doctor.
In cases where physical dependence has developed, sudden discontinuation of treatment will be accompanied by withdrawal symptoms. These may include headaches and muscle pain, increased anxiety and tension, restlessness, and irritability. In severe cases, symptoms such as derealization, depersonalization, increased hearing acuity, numbness and tingling of limbs, hypersensitivity to light, noise, and touch, hallucinations, and seizures may occur. Withdrawal symptoms may develop within a few days after discontinuation of zopiclone. During regular use of the medicine, withdrawal symptoms may occur between doses, especially if the dose was large.
Rebound insomnia
After discontinuation of zopiclone, transient rebound insomnia may occur, which is an exacerbation of the symptoms that led the doctor to prescribe a sedative. Other symptoms may also occur: mood changes, anxiety, and agitation.
Due to the fact that the risk of rebound insomnia is greater after sudden discontinuation of Imovane, especially after prolonged use or use of high doses, it is recommended to gradually reduce the dose.
Tolerance
With repeated use of sedatives, their effect may decrease.
However, in the case of Imovane, no significant tolerance phenomenon has been observed during treatment lasting up to 4 weeks.
Amnesia
Anterograde amnesia may occur, especially if sleep is interrupted or the patient does not go to bed immediately after taking the medicine.
To reduce the risk of anterograde amnesia, patients should make sure to:

• take the tablet immediately before going to bed,
• have the opportunity to sleep uninterrupted throughout the night.

Psychological and paradoxical reactions
The use of sedatives and hypnotics, such as zopiclone, may be accompanied by reactions such as: anxiety, agitation, irritability, aggression, delusions, anger, nightmares, hallucinations, inadequate behavior, and other behavioral disorders. In such cases, treatment should be discontinued. The occurrence of such reactions is more likely in elderly patients (see section 4. Possible side effects).
Somnambulism and similar behaviors
In patients who have taken zopiclone and have not fully awakened, the following disorders may occur: sleepwalking and related behavioral disorders, such as driving while asleep, preparing and eating food, and making phone calls while asleep with no memory of the activities performed. It seems that the consumption of alcohol or taking other medicines with a depressant effect on the central nervous system, in combination with zopiclone, increases the risk of such behaviors, as well as the use of zopiclone in doses exceeding the maximum recommended dose. In patients who report such behaviors, such as driving while asleep, it is recommended to discontinue the use of zopiclone, due to the risk to themselves and others (see section: Imovane and other medicinesand 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 suicides in patients taking certain sedatives and hypnotics, including this medicine. However, it has not been established whether this is due to the medicine or other factors. If the patient has suicidal thoughts, they should contact their doctor as soon as possible for medical advice.
As with other sedatives or hypnotics, caution should be exercised when using Imovane in patients with symptoms of depression. Such patients may exhibit suicidal tendencies, so the doctor will prescribe the smallest dose of Imovane to prevent intentional overdose. During the use of Imovane, existing depression may be revealed in the patient. Insomnia can be a symptom of depression, so if insomnia persists, the doctor should re-examine 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 in children and adolescents under 18 years of age have not been established.

Imovane and other medicines

The patient should tell their doctor about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.
Contraindicated combinations
Alcohol should not be consumed concomitantly. During concomitant alcohol consumption, the sedative effect of Imovane may be enhanced. This may affect the ability to drive vehicles and operate machinery.
Combinations to be considered
Medicines with a depressant effect on the central nervous system:
The enhancement of the depressant effect on the central nervous system may occur during concomitant use of zopiclone and antipsychotic medicines (neuroleptics), other sedatives, anxiolytics, antidepressants, opioid analgesics, antiepileptics, general anesthetics, and antihistamines with a sedative effect.
In the case of opioid analgesics, the enhancement of euphoria may occur, which may lead to increased psychological dependence.
In the event of concomitant use of medicines such as erythromycin, clarithromycin, ketoconazole, itraconazole, and ritonavir, an increase in the concentration of zopiclone in the blood and an enhancement of the sedative effect of Imovane may occur. Medicines such as rifampicin, carbamazepine, phenobarbital, phenytoin, and St. John's wort preparations may decrease the concentration of zopiclone in the blood. During concomitant use with these medicines, the doctor may increase the dose of zopiclone.
Concomitant use of benzodiazepines and other sedative or hypnotic medicines, including zopiclone and opioids, increases the risk of sedation, respiratory depression, coma, and death due to the enhancement of the depressant effect on the central nervous system.

Imovane with food and drink

The medicine should be taken immediately before going to bed, regardless of the meal.

Pregnancy and breastfeeding

Pregnancy
Imovane is not recommended during pregnancy. If the patient is pregnant, thinks she may be pregnant, or plans to have a child, she should consult her doctor before taking this medicine.
The medicine used during pregnancy may affect the child.
Some studies have shown an increased risk of cleft lip and palate (sometimes called "harelip") in newborns.
Decreased fetal movement and variable fetal heart rate may occur if the mother takes Imovane in the second and/or third trimester of pregnancy.
If the patient takes Imovane in late pregnancy or during delivery, her child may exhibit muscle weakness (floppy infant syndrome), decreased body temperature, difficulty sucking, and respiratory depression (respiratory depression).
If the patient regularly takes Imovane in late pregnancy, physical dependence may develop in the child, and withdrawal symptoms may occur, 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 using machines

Due to its effect on the central nervous system, Imovane may have a negative impact on the ability to drive vehicles and operate machinery. The risk is increased in the following cases:

• use of Imovane within 12 hours preceding activities that require attention
• use of a higher dose of the medicine than recommended
• concomitant administration with other medicines that have a depressant effect on the central nervous system, consumption of alcohol, or concomitant use of medicines that increase the concentration of zopiclone in the blood (see section: Warnings and precautions).

During the use of Imovane, you should avoid engaging in activities that require significant attention or motor coordination, such as operating machines and driving vehicles.

Imovane contains lactose monohydrate

If the patient has previously been diagnosed with intolerance to some sugars, they should consult their doctor before taking the medicine.

Imovane contains wheat starch (contains gluten)

This medicine contains very small amounts of gluten (derived from wheat starch). Therefore, it is very unlikely to cause problems in patients with celiac disease.
One tablet contains no more than 6.0 micrograms of gluten.
The medicine should not be used by patients with an allergy to wheat (other than celiac disease).

The medicine contains sodium

The medicine contains less than 1 mmol (23 mg) of sodium per dose, which means that the medicine is considered "sodium-free".

3. How to take Imovane

Imovane should be taken as directed by the doctor. In case of doubts, the patient should consult their doctor again.
General information
The patient should take the smallest effective dose. Imovane should be taken in a single dose; the medicine should not be taken again during the same night.
Treatment should last as short as possible, not longer than 4 weeks, including the period of gradual dose reduction. Only the doctor, after a thorough assessment of the patient's condition, can recommend a longer treatment period.
The medicine should be taken immediately before the evening rest.
Duration of treatment:
Transient insomnia: 2-5 days.
Short-term insomnia: 2-3 weeks.
Adults:
The recommended dose of the medicine is 7.5 mg, taken orally before the evening rest. This dose should not be exceeded.
Elderly patients:
Treatment should be started with a dose of 3.75 mg (1/2 tablet). The dose can be increased to 7.5 mg (1 tablet) only if necessary and if the patient tolerates the medicine well.
Patients with liver failure:
Treatment should be started with a dose of 3.75 mg (1/2 tablet). The dose can be increased to 7.5 mg (1 tablet).
Patients with renal failure:
Although zopiclone does not accumulate in the body in renal failure, it is recommended to start treatment with a dose of 3.75 mg (1/2 tablet) per day.
Patients with chronic respiratory failure:
Treatment should be started with a dose of 3.75 mg (1/2 tablet). The dose can 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 in children and adolescents under 18 years of age have not been established.
In case of a feeling that the effect of Imovane is too strong or too weak, the patient should consult their doctor.

Use of a higher dose of Imovane than recommended

A symptom of overdose is usually a varying degree of suppression of the central nervous system, from drowsiness to coma, depending on the amount of medicine taken. In mild cases, symptoms include: drowsiness, confusion, and lethargy; in more severe cases, symptoms may include: impaired motor function, decreased muscle tone, decreased blood pressure, respiratory disorders, and coma. Usually, overdose is not life-threatening. Exceptions are cases of concomitant consumption of other substances with a depressant effect on the central nervous system, including alcohol. Other risk factors, such as the presence of concomitant disease or poor general condition of the patient, may contribute to the severity of symptoms. Very rarely, they can lead to death.
Treatment
Symptomatic and supportive treatment is recommended in a hospital. Attention should be paid to the function of the respiratory and cardiovascular systems. Gastric lavage is useful only if performed immediately after taking the medicine. Hemodialysis is not effective. Flumazenil may be a useful antidote.
In case of taking a higher dose of Imovane than recommended, the patient should immediately consult their doctor or pharmacist.

Missing a dose of Imovane

The patient should take the medicine the next day at the usual time. The patient should not take two doses of the medicine at the same time or at a short interval.
In case of any further doubts related to the use of this medicine, the patient should consult their doctor.

4. Possible side effects

Like all medicines, Imovane can cause side effects, although not everybody gets them.
The following side effects may occur:
Common (may occur in up to 1 in 10 people):
‐ taste disorders (bitter taste), drowsiness
‐ dry mouth.
Uncommon (may occur in up to 1 in 100 people):
‐ nightmares, agitation
‐ headache, dizziness
‐ nausea
‐ fatigue.
Rare (may occur in up to 1 in 1,000 people):
‐ confusion, libido disorders, irritability, aggression, hallucinations
‐ anterograde amnesia (memory disorders)
‐ dyspnea
‐ rash, itching
‐ falls (mainly in elderly patients).
Very rare (may occur in up to 1 in 10,000 people):
‐ skin or mucous membrane edema called angioedema, allergic reactions of the immediate type, occurring after re-exposure to the allergen, called anaphylactic reactions
‐ slight to moderate increase in liver enzyme activity in serum.
Frequency not known (frequency cannot be estimated from the available data):
‐ anxiety, delusions, anger, inadequate behavior, somnambulism (sleepwalking), dependence, withdrawal symptoms
‐ ataxia (coordination disorders), paresthesia (tingling, numbness of the skin), cognitive function disorders, such as memory disorders, attention disorders, speech disorders
‐ double vision
‐ respiratory disorders
‐ dyspepsia
‐ muscle weakness.
After discontinuation of Imovane, withdrawal symptoms have been reported (see section 2. Important information before taking Imovane). Withdrawal symptoms are diverse and may include: insomnia, muscle pain, anxiety, tremors, sweating, agitation, confusion (disorientation), headache, palpitations, tachycardia, hallucinations, nightmares, irritability. In severe cases, the following may occur: derealization (change in the perception of the surrounding world), depersonalization (feeling of loss of one's own identity), hypersensitivity to sounds, light, and touch, numbness and tingling of limbs, hallucinations. In very rare cases, seizures may occur.

Reporting side effects

If side effects occur, including any side effects not listed in the leaflet, the patient should tell their doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring of 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.
By reporting side effects, more information can be collected on the safety of the medicine.

5. How to store Imovane

The medicine should be stored out of sight and reach of children.
Store in a temperature 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 given month.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Imovane contains

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

What Imovane looks like and contents of the pack

The pack contains 14 or 20 coated tablets.
For more detailed information, the patient should consult the marketing authorization holder or parallel importer.

Marketing authorization holder in Romania, the country of export:

Sanofi Romania SRL
Str. Gara Herăstrău, nr. 4, Clădirea B, etajele 8-9 Sector 2
Bucharest, Romania

Manufacturer:

Opella Healthcare International SAS
56, Route de Choisy
60200 Compiègne, France

Parallel importer:

InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw

Repackaged by:

InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Authorization number in Romania, the country of export:8632/2016/01
8632/2016/02
Parallel import authorization number:224/16

Date of leaflet approval: 27.06.2023

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