Imovane

Package leaflet: Information for the patient

Imovane 7.5 mg film-coated tablets

zopiclone
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, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not give it to other people, even if they have the same symptoms as you, because it could be harmful.
• If you experience any side effects, including those not listed in this leaflet, talk to your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet:

1. What Imovane is and what it is used for
2. What you need to know 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 Imovane is and what it is used for

Imovane contains zopiclone, which belongs to a class of medicines called "hypnotic agents similar to benzodiazepines".
Imovane is indicated for the short-term treatment of sleep disorders (insomnia) in adults, and only in cases where the sleep disturbances are severe, disabling or causing marked distress.
It must not be used for long periods. Treatment should be as short as possible, since the risk of dependence increases with the duration of treatment.

2. What you need to know before taking Imovane

Do not take Imovane

• if you are allergic to the active substance or to any of the other ingredients of this medicine (listed in section 6),
• if you suffer from a disease causing severe muscle weakness (myasthenia gravis),
• if you have breathing difficulties (severe respiratory insufficiency),
• if you suffer from severe liver damage (severe hepatic insufficiency),
• if you suffer from brief episodes of breathing cessation during sleep (sleep apnoea syndrome),
• if you have experienced or have previously experienced episodes of sleepwalking or other unusual behaviours during sleep (such as driving, eating, making a phone call, or having sexual intercourse) while not fully awake, after starting treatment with Imovane (see section Warnings and precautions).

Imovane must not be taken by children and adolescents under 18 years of age.
Warnings and precautions
Talk to your doctor or pharmacist before taking Imovane.
Before prescribing Imovane, your doctor should try to identify and treat the underlying causes of sleep disturbances.
Tolerance
After repeated use for several weeks, a certain reduction in the effect of this medicine may occur.
However, with Imovane, absence of severe tolerance has been observed in treatments lasting up to 4 weeks.
Dependence
The use of Imovane may lead to abuse and/or physical and psychological dependence (need to continue taking the medicine). Inform your doctor before taking Imovane if you have ever had mental disorders, or have abused or been dependent on alcohol, substances, or medicines.
The risk of dependence increases with dose and duration of treatment and is greater when zopiclone is used for more than 4 weeks. The risk of abuse and dependence is higher in patients with a history of mental disorders and/or alcohol, illicit substances, or medicine abuse.
If you have developed physical dependence, abruptly stopping treatment may cause withdrawal symptoms such as:

• headache (cephalalgia),
• muscle pain,
• extreme anxiety,
• tension,
• agitation (restlessness),
• confusion,
• irritability.

In severe cases, the following symptoms may occur:

• feeling detached from reality (derealization),
• feeling detached from one's own body (depersonalization),
• hearing disturbances (hyperacusis),
• numbness and tingling in the extremities,
• hypersensitivity to light, noise, and physical contact,
• hallucinations,
• epileptic seizures.

Rebound insomnia and anxiety
When stopping the medicine, a transient syndrome may occur, consisting of a return, in an intensified form, of the symptoms that led to treatment with the medicine. This may be accompanied by other reactions such as mood changes, anxiety, agitation, or sleep disturbances.
This syndrome is more likely to occur if treatment is stopped abruptly; therefore, discontinue Imovane treatment gradually.
It is important that you are aware of the possibility of such disturbances occurring, so that you can reduce your anxiety.
Duration of treatment
The treatment duration should be as short as possible (see also “How to take Imovane”) and should not exceed four weeks, including the tapering-off phase of the medicine. The treatment duration should not be extended beyond this period without your doctor re-evaluating your condition.
At the beginning, your doctor will explain to you that this treatment will be of limited duration and how you should gradually reduce the dose.
Memory disturbances (amnesia)
Imovane may cause memory disturbances (anterograde amnesia), which may occur especially when sleep is abruptly interrupted or when you delay going to bed after taking the tablets.
This effect most often occurs several hours after taking the medicine.
To reduce the risk, ensure you can sleep uninterrupted for 8 hours (see “Possible side effects”).
Psychiatric and paradoxical reactions
During the use of benzodiazepines or medicines similar to Imovane, the following may occur:

• restlessness,
• agitation,
• irritability,
• aggressiveness,
• disappointment,
• anger,
• nightmares,
• hallucinations,
• psychosis,
• behavioural changes.

If these disturbances occur, contact your doctor and stop using Imovane.
The occurrence of these reactions is more likely in elderly patients.
Sleep disorders (sleepwalking) and associated behaviours:
Inform your doctor before taking Imovane if you have previously experienced episodes of sleepwalking or other unusual behaviours during sleep (such as driving, eating, making a phone call, or having sexual intercourse) while not fully awake.
Imovane may cause episodes of sleepwalking or other unusual behaviours (such as driving, eating, making a phone call, or having sexual intercourse) in patients who are not fully awake; subsequently, you may not remember the event.
These activities may occur more frequently if you take Imovane together with alcoholic beverages, take an excessive dose of Imovane, or take it concomitantly with other medicines called “Central Nervous System depressants”.
If you experience any of these behaviours, immediately discontinue treatment with Imovane and contact your doctor.
Psychomotor disturbances
Imovane, like other sedative/hypnotic medicines, has a depressant effect on the Central Nervous System. The risk of behavioural disturbances (psychomotor impairment), such as the ability to drive vehicles or operate machinery, increases if you take Imovane less than 12 hours before performing activities requiring alertness, if you take a higher dose than recommended, or if you take Imovane with other medicines that depress the Central Nervous System (e.g. barbiturates, anxiolytics, hypnotics, anaesthetics, antihistamines, opioid analgesics), with alcohol, or with other medicines that increase the blood levels of Imovane (see “Other medicines and Imovane”). Avoid performing activities requiring alertness or motor coordination, such as driving vehicles or operating machinery, after taking Imovane, and especially within the 12 hours following administration. (See “Driving and use of machinery”).
Risks associated with concomitant use of opioids and benzodiazepines
See “Other medicines and Imovane”.
Elderly patients :
If you are an elderly patient, you will receive a lower dose (see “How to take Imovane”).
Patients with respiratory problems
If you suffer from severe respiratory problems (chronic respiratory insufficiency), Imovane will be prescribed with caution because it may depress respiratory function (see “Possible side effects”).
Patients with liver problems
If you suffer from severe liver problems (severe hepatic insufficiency), Imovane is not indicated for you because it may worsen brain damage (encephalopathy).
Patients with psychotic disorders
Imovane is not recommended as primary treatment for certain mental illnesses (psychotic disorders).
Patients with history of alcohol or drug abuse
Imovane should be used with caution if you have previously abused alcohol or drugs.
Suicidal tendencies and patients with depression or anxiety associated with depression
Imovane should not be used alone to treat depression or anxiety associated with depression; any suicidal ideation may be facilitated.
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 has not been established 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 evaluation.
As with other sedatives/hypnotics, Imovane should be used with caution if you have depression.
Since suicidal tendencies may occur, your doctor will prescribe the smallest possible quantity of Imovane. Pre-existing depression may be unmasked during treatment with Imovane.
Since insomnia may be a symptom of depression, medical advice should be sought if insomnia persists.
Children and adolescents
Imovane must not be used in children and adolescents under 18 years of age, as the safety and efficacy of Imovane in children and adolescents under 18 years of age have not been established.
Other medicines and Imovane
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
The depressant effect may be increased when used concomitantly with:

• medicines for certain mental health problems (neuroleptic antipsychotics),
• medicines for sleep problems (hypnotics),
• medicines to calm or reduce anxiety (anxiolytics/sedatives),
• medicines for depression (antidepressants),
• medicines for moderate to severe pain (narcotic analgesics),
• medicines for epilepsy (antiepileptics),
• medicines used for anaesthesia (anaesthetics),
• medicines for allergies that may cause drowsiness (sedative antihistamines).

The effects of Imovane may also be influenced by or influence the following medicines:

• highly effective painkillers (narcotic analgesics), as an increased sense of euphoria may occur, potentially leading to increased dependence (need to continue taking the medicine);
• inhibitors of a protein in the blood (cytochrome CYP450), such as erythromycin, clarithromycin (antibiotics), ketoconazole, itraconazole (medicines for fungal infections), ritonavir (used for AIDS), as substances inhibiting this protein may increase the activity of benzodiazepines or similar substances, such as Imovane. If you take these medicines together with Imovane, your doctor may decide to reduce the dose of Imovane;
• activators of a protein in the blood (cytochrome CYP3A4), such as rifampicin (antibiotic), carbamazepine, phenobarbital, phenytoin (used for seizures), and St. John’s wort (used for depression), as they may decrease blood levels of Imovane. If you take these medicines together with Imovane, your doctor may decide to increase the dose of Imovane;
• the concomitant use of Imovane with opioids (strong painkillers, medicines for substitution therapy, and some cough medicines) increases the risk of drowsiness, breathing difficulties (respiratory depression), coma, and potential life-threatening risk. Therefore, concomitant use should only be considered when other treatment options are not possible. However, if your doctor prescribes Imovane 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 strictly follow the recommended dose. It may be helpful to inform your friends and family to watch for the symptoms and signs mentioned above. Contact your doctor if these symptoms occur.

Imovane with alcohol
Do not take Imovane with alcohol.
The calming (sedative) effect may be increased if the medicine is taken with alcohol, and your ability to drive vehicles or operate machinery may be impaired.
Pregnancy and breastfeeding
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.
Pregnancy
The use of Imovane is not recommended during pregnancy.
If you are pregnant, think you may be pregnant, or are planning to become pregnant, consult your doctor.
If used during pregnancy, there is a risk that the baby may be affected. Some studies have shown that in the newborn, there may be an increased risk of developing cleft lip and palate (sometimes called "hare lip").
Reduced fetal movement and variability in fetal heart rate may occur after taking Imovane during the second and/or third trimester of pregnancy.
If Imovane is taken during the late stages of pregnancy or during childbirth, the baby may show:

• muscle weakness,
• lowered body temperature,
• feeding difficulties,
• breathing problems (respiratory depression).

If this medicine is taken regularly in the late stages of pregnancy, the 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
Imovane passes into breast milk; do not take this medicine if you are breastfeeding.
Driving and use of machinery
Imovane impairs the ability to drive vehicles and operate machinery because it may cause:

• sedation,
• memory loss (amnesia),
• impaired concentration,
• altered muscle function. The likelihood that alertness and physical activity (motor functions) are impaired increases if:
  • you take Imovane less than 12 hours before performing activities requiring alertness;
  • you take a higher dose than recommended;
  • you take Imovane with other medicines acting on the CNS (e.g. barbiturates, anxiolytics, hypnotics, anaesthetics, antihistamines, opioid analgesics), with alcohol, or with other medicines that increase the blood levels of Imovane. Avoid performing activities requiring alertness or motor coordination, such as driving vehicles or operating machinery, after taking Imovane, and especially within the 12 hours following administration.

Do not drink alcohol while taking Imovane, as the risk of impaired ability to drive vehicles and operate machinery is increased. If sleep duration has been insufficient, the likelihood that alertness is impaired may be increased.
Imovane contains lactose
If your doctor has diagnosed you with an intolerance to certain sugars, consult him before taking this medicine.
Imovane contains gluten
This medicine contains only a very small amount of gluten (from wheat starch) and it is very unlikely to cause problems if you have coeliac disease.
One tablet contains no more than 6.0 micrograms of gluten.
If you are allergic to wheat (a condition different from coeliac disease), do not take this medicine.
Imovane contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially “sodium-free”.

3. How to take Imovane

Take this medicine exactly as directed by your doctor or pharmacist. If
you have any doubts, consult your doctor or pharmacist.
The duration of treatment should be as short as possible.
Generally, treatment lasts from a few days to two weeks, up to a maximum of
four weeks including the phase of discontinuing the medicine. Sometimes your doctor may extend
the maximum treatment period; in such case, follow your doctor's instructions carefully.
Take Imovane at the lowest effective dose that achieves the desired effect.
Take a single dose of Imovane just before going to bed and do not take an additional dose
during the night. Do not take Imovane less than 12 hours before performing activities requiring alertness
(see "Warnings and precautions" and "Driving and use of machines").
Treatment should be initiated with the lowest recommended dose.
The recommended dose for adults is:
one tablet (7.5 mg).
Do not exceed this dose.
Use in elderly patients
The recommended dose is:
half a tablet (3.75 mg).
Use in patients with liver problems (impaired hepatic function), respiratory problems (chronic respiratory insufficiency), or kidney problems (renal insufficiency)
Your doctor will start your treatment with a dose of half a tablet (3.75 mg).
Use in children and adolescents
Imovane must not be used in children and adolescents under 18 years of age, as the safety and efficacy of Imovane in children and adolescents under 18 years have not been established.
If you take more Imovane than you should
In case of accidental ingestion/overdose of Imovane, contact your doctor immediately or go to the nearest hospital.
In cases of overdose (overdosing) of Imovane, the following have been reported:

• reduced level of consciousness up to coma,
• drowsiness, confusion, and profound fatigue (lethargy),
• loss of muscle coordination (ataxia),
• reduced organ activity (hypotonia),
• low blood pressure (hypotension),
• a blood disorder called "methaemoglobinaemia",
• respiratory depression,
• coma (rarely).

Other risk factors such as the presence of other diseases, a state of weakness, or taking
Imovane together with other medicines or substances that depress the activity of the Central Nervous
System (including alcohol) may contribute to the severity of symptoms and may very rarely lead
to death.
If you forget to take Imovane
Do not take a double dose to make up for the forgotten 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 experiences them.
The most common side effect observed with Imovane is bitter taste.
Other reported side effects include:

• daytime drowsiness,
• reduced emotions,
• decreased alertness,
• confusion,
• fatigue,
• headache (cephalalgia),
• dizziness,
• muscle weakness,
• loss of muscle coordination (ataxia),
• altered sensation in limbs (paraesthesia),
• double vision.
  These phenomena occur mainly at the beginning of treatment and usually disappear with subsequent doses.

Other side effects have been occasionally reported, including:

• stomach and intestinal (gastrointestinal) disorders such as: difficulty digesting (dyspepsia), nausea, dry mouth,
• changes in sexual desire,
• allergic skin reactions with itching and redness (rash).

Very rarely reported:

• swelling of the face, hands and feet, lips, tongue or throat (angioedema) and/or allergic (anaphylactic) reactions,
• changes in certain blood test values (moderate increase in transaminases and/or serum alkaline phosphatase).

Cases of falls have also been reported, mainly in elderly patients.
Other side effects:

• memory loss (anterograde amnesia), especially at higher doses, which may be associated with inappropriate behaviour (see "Warnings and precautions"),

• depression,

• psychiatric and paradoxical reactions, which may be quite severe and more likely in elderly patients:

• restlessness,

• agitation,

• irritability,

• aggression,

• delusion,

• anger,

• nightmares,

• confusion,

• hallucinations,

• mental disorders (psychosis),

• behavioural changes associated with memory loss (amnesia) and sleep-walking (somnambulism) or other unusual sleep-related behaviours (such as driving, eating, making phone calls or having sexual intercourse) while not fully awake (see "Warnings and precautions"),

• delirium (a sudden and severe change in mental status that may cause a combination of confusion, disorientation and/or attention deficit),

• physical and psychological dependence: stopping treatment may lead to rebound or withdrawal symptoms (see "Warnings and precautions"). Withdrawal symptoms may vary and include: rebound insomnia, anxiety, tremors, sweating, agitation, confusion, headache (cephalalgia), palpitations, increased heart rate (tachycardia), delirium, nightmares, hallucinations and irritability. In very rare cases, seizures may occur,

• abuse (excessive use of the medicine),

• disorders affecting the respiratory system and chest (respiratory, thoracic and mediastinal disorders),

• rarely: difficulty breathing (dyspnoea) (see "Warnings and precautions"),

• frequency not known: respiratory depression (see "Warnings and precautions"), cognitive learning disorders such as: impaired memory (memory deficit), disturbances in attention and language.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, please inform 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 Imovane

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after "Exp". The expiry date refers to the last day of that month.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Imovane contains

• The active substance is zopiclone. One film-coated scored tablet contains 7.5 mg of zopiclone.
• The other components are: wheat starch; calcium hydrogen phosphate dihydrate; lactose monohydrate; sodium carboxymethyl starch; magnesium stearate; hypromellose; titanium dioxide; macrogol 6000.

Description of the appearance of Imovane and contents of the pack
Imovane is available as
Film-coated scored tablets.

• Box of 14 tablets in PVC/AL blisters.
• Box of 20 tablets in PVC/AL blisters. Not all pack sizes may be marketed.

Marketing Authorization Holder
Sanofi S.r.l.
Viale L. Bodio, 37/B – 20158 Milan
Manufacturer
Opella Healthcare International SAS
56, Route de Choisy
60200 Compiègne (France)
SANOFI WINTHROP INDUSTRIE
30-36 Avenue Gustave Eiffel,
37100 Tours
France