Imovane

Leaflet accompanying the packaging: information for the user

IMOVANE, 7.5 mg, coated tablets

Zopiclone

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• In case of any doubts, consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. 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 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, shallow sleep, early morning awakening
).
Do not take continuously. Treatment should be 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;
• if the patient has experienced sleepwalking or other atypical behaviors (such as driving, eating, making phone calls or having sex, etc.) while not fully awake after taking Imovane.

Warnings and precautions

In each case, before the doctor prescribes a sedative, it should be determined, if possible, the causes of insomnia and, if possible, eliminate the factors causing 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 is taken than recommended, 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, one should avoid engaging in activities that require significant concentration or motor coordination, such as operating machines and driving vehicles, after taking zopiclone and, in particular, 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 the doctor in patients for whom alternative treatment options are not sufficient.
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 patient should inform the doctor before taking Imovane if they have ever had mental disorders, abused or been dependent on alcohol, illicit substances, or medicines.
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 a history of mental disorders and/or abuse of alcohol, illicit substances, or medicines.
In cases where physical dependence has developed, sudden cessation of treatment will be accompanied by withdrawal symptoms. These may include headache and muscle pain, increased anxiety and tension, restlessness, confusion, 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, with Imovane, no significant tolerance phenomenon has been observed during treatment lasting up to 4 weeks.
Anterograde 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 ensure:

• taking the tablet immediately before going to bed,
• having 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, inappropriate 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
The patient should inform the doctor before taking Imovane if they have experienced sleepwalking or other atypical behaviors (such as driving, eating, making phone calls, or having sex, etc.) while not fully awake after taking Imovane.
Imovane may cause sleepwalking or other atypical behaviors (such as driving while asleep, eating, making phone calls, or having sex, etc.) while the patient is not fully awake. The next morning, the patient may not remember doing anything at night. These behaviors may occur regardless of whether the patient drinks alcohol or takes other medicines that cause drowsiness in combination with Imovane. However, it seems that consuming 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 does taking zopiclone in doses exceeding the maximum recommended dose. Treatment should be discontinued immediately and the doctor consulted if the patient experiences any of the above symptoms.
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 caused by taking the medicine or if there are other causes. 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 taking 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 central nervous system depressant effect:
The enhancement of the central nervous system depressant effect may occur when zopiclone is taken concomitantly with 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.
When concomitantly taking medicines such as erythromycin, clarithromycin, ketoconazole, itraconazole, and ritonavir, the concentration of zopiclone in the blood may increase, and the sedative effect of Imovane may be enhanced. Medicines such as rifampicin, carbamazepine, phenobarbital, phenytoin, and St. John's wort preparations may decrease the concentration of zopiclone in the blood. When concomitantly taking 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 enhanced depressant effect on the central nervous system.

Imovane with food and drink

The medicine should be taken immediately before going to bed or in 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 taken 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 childbirth, 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, the child may develop physical dependence, and withdrawal symptoms may occur, such as agitation or seizures.
In such a case, 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 taken 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 case of:

• taking Imovane within 12 hours preceding activities that require attention
• taking a higher dose of the medicine than recommended
• concomitant administration with other medicines that have a central nervous system depressant effect, consuming 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, one should avoid engaging in activities that require significant concentration or motor coordination, such as operating machines and driving vehicles.

Imovane contains lactose

Imovane contains lactose. If the patient has been informed by their doctor that they have an intolerance to some sugars, the patient should consult their doctor before taking Imovane.

Imovane contains gluten

This medicine contains very small amounts of gluten (derived from wheat starch). It is therefore very unlikely to cause any problems in patients with celiac disease (celiac disease).
One tablet contains no more than 6 micrograms of gluten.
Patient with a wheat allergy (other than celiac disease) should not take this medicine.

Imovane contains sodium

The medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means 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 be 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, may recommend a longer treatment period.
The medicine should be taken immediately before 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 evening rest. This dose should not be exceeded.
Elderly patients:
Treatment should be started with a dose of 3.75 mg (1/2 tablet) in elderly patients.
The dose can be increased to 7.5 mg (1 tablet) only if necessary and if the patient tolerates the medicine well.
Patient with liver failure:
Treatment should be started with a dose of 3.75 mg (1/2 tablet) in patients with liver failure.
The dose can be increased to 7.5 mg (1 tablet).
Patient 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.
Patient with chronic respiratory failure:
Treatment should be started with a dose of 3.75 mg (1/2 tablet) in patients with chronic respiratory failure. 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.
If the patient feels that the effect of Imovane is too strong or too weak, they should consult their doctor.

Overdose of Imovane

The symptom of overdose is usually a varying degree of central nervous system depression, 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 central nervous system depressant effect, 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
It is recommended to use symptomatic and supportive treatment in the hospital. Attention should be paid to the function of the respiratory and cardiovascular systems. Gastric lavage is useful only if applied 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.

Missed 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 short intervals.
In case of any further doubts regarding 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 affect up to 1 in 10 people):

• taste disorders (bitter taste), drowsiness
• dry mouth

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

• nightmares, agitation
• headache, dizziness
• nausea
• fatigue

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

• confusion, libido disorders, irritability, aggression, hallucinations
• anterograde amnesia (memory disorders)
• shortness of breath
• rash, itching
• falls (mainly in elderly patients)

Very rare (may affect 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
• mild to moderate increase in liver enzyme activity in serum

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

• anxiety, delusions, anger, inappropriate behavior, somnambulism (sleepwalking), dependence, withdrawal symptoms
• delirium (sudden and severe change in mental state, which can cause a combination of confusion, disorientation, and/or attention deficit)
• ataxia (coordination disorders), paresthesia (tingling, numbness of the skin), cognitive function disorders, such as memory disorders, concentration disorders, speech disorders
• double vision
• respiratory disorders
• indigestion
• muscle weakness
• sleepwalking or other atypical behaviors (such as driving, eating, making phone calls, or having sex, etc.) while not fully awake

After discontinuation of Imovane, withdrawal symptoms have been reported (see section 2. Important information before taking Imovane). Withdrawal symptoms are varied and may include: insomnia, muscle pain, anxiety, tremors, sweating, agitation, confusion, disorientation, headache, palpitations, tachycardia, hallucinations, nightmares, 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. In very rare cases, seizures may occur.

Reporting side effects

If side effects occur, including any not listed in this 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, Tel: +48 22 49 21 301, Fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder or its representative in Poland. By reporting side effects, more information can be collected on the safety of the medicine.

5. How to store Imovane

No special requirements.
The medicine should be stored in a place inaccessible and invisible to children.
Do not use the medicine after the expiry date stated on the packaging.

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, calcium hydrogen phosphate dihydrate, wheat starch, sodium carboxymethyl starch (type A), magnesium stearate; coating: hypromellose, titanium dioxide (E171), macrogol 6000.

What Imovane looks like and contents of the pack

The pack contains 5, 14, or 20 coated tablets.

Marketing authorization holder and manufacturer

Marketing authorization holder:
Sanofi Winthrop Industrie
82, Avenue Raspail
94250 Gentilly
France
Manufacturer:
Opella Healthcare International SAS
56, route de Choisy
60200 Compiegne
France
To obtain more detailed information, please contact the local representative of the marketing authorization holder:
Sanofi Sp. z o.o.
ul. Marcina Kasprzaka 6
01-211 Warsaw

Date of last revision of the leaflet: