Package Leaflet: Information for the User

Coated Tablets 7.5 mg

zopiclona

Read this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, as 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 pass it on to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, talk to your doctor or pharmacist. See section 4.

1. What Limován is and what it is used for

2. What you need to know before you start taking Limován

3. How to take Limován

4. Possible side effects

5. Storage of Limován

6. Contents of the pack and additional information

Zopiclone is a sleep-inducing agent. It has been shown to shorten the time to onset of sleep and reduce the incidence of nocturnal awakenings, thereby increasing the quality of sleep and morning awakening.

Zopiclone is also a sedative medication with anxiolytic properties, capable of combating seizures and having muscle-relaxing effects.

Limován is used for the short-term treatment of insomnia inpatients over 18 years of age.

Do not take this medication for a long time. Treatment should be as short as possible, because the risk of dependence increases with the duration of treatment.

Do not take Limován

• If you are allergic to zopiclone, the benzodiazepine group in general, or any of the other components of this medication (listed in section 6).
• If you suffer from muscle weakness caused by your own immune system (myasthenia gravis).
• If you suffer from respiratory problems (respiratory insufficiency).
• If you suffer from sleep-related breathing difficulties (severe sleep apnea syndrome).
• If you suffer from severe liver problems (severe hepatic insufficiency).
• As long-term treatment. The treatment should be as short as possible, as the risk of dependence increases with the duration of treatment.
• If you have experienced somnambulism or any other unusual behavior (such as driving, eating, calling, or having sex, etc.) without being fully awake after taking Limován.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Limován.

Before starting treatment, make sure your doctor knows if you:

• have any liver or kidney disorders
• suffer from muscle weakness
• have other diseases
• have allergies

• If you experience respiratory problems, take special precautions, as this medication has the ability to depress respiratory function.

• Impaired psychomotor function: like other sedative/hypnotic drugs, zopiclone has depressant effects on the central nervous system.

The risk of psychomotor problems, including impaired ability to drive, increases if:

• you take zopiclone within 12 hours of performing activities that require mental alertness,
• if you take a higher dose than recommended or
• if you take it with other central nervous system depressants, alcohol, or other medications that increase zopiclone levels in the blood.

Be aware of this risk if you plan to perform hazardous tasks such as operating machinery or driving vehicles, which require complete mental alertness or motor coordination after taking this medication and especially within 12 hours after taking it.

• Do not take Limován at the same time as opioids (medications used to relieve intense pain, such as morphine or codeine) unless your doctor prescribes it, due to the possible risk of sedation, respiratory depression, coma, or even death (see “Use of Limován with other medications”).
• The use of zopiclone can lead to dependence or abuse. This occurs mainly after taking the medication continuously for a long time. To minimize the risk of dependence, follow these precautions:

• Take zopiclone only under medical prescription (never because it has worked for other patients) and never recommend it to others,
• Do not increase the prescribed dose or prolong treatment longer than recommended,
• Consult your doctor regularly to decide if you should continue treatment.

• If you have a history of mental disorders or problems with substance abuse or alcohol.

The use of zopiclone can lead to physical and psychological dependence. The risk of dependence increases with the dose and duration of treatment and is higher 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 substance abuse.

If you are dependent on substances or alcohol, do not take Limován unless your doctor tells you to. If you have any doubts, consult your doctor.

• When stopping treatment, withdrawal symptoms may occur (see the section “If treatment with Limován is interrupted”).

• In some cases, a transient syndrome may occur in which symptoms that led to starting treatment appear in increased form. It may be accompanied by other reactions such as mood changes, anxiety, sleep disorders, and restlessness. It is essential to be aware of the possibility of this rebound effect to minimize the anxiety it may cause when these effects appear after stopping treatment.

• Treatment should be discontinued if you experience reactions such as restlessness, agitation, irritability, delirium, anger attacks, nightmares, hallucinations, psychosis, abnormal behavior, and other effects on behavior. Inform your doctor if these symptoms appear. This type of reaction is more likely in older patients.

• If you have a history of somnambulism or other unusual behaviors (such as driving in a somnambulistic state, eating, calling, or having sex, etc.) without being fully awake after taking Limován.

Limován can cause somnambulism or other unusual behavior (such as driving, eating, calling, or having sex, etc.) without being fully awake. The next morning, you may not remember anything you did during the night. These activities can occur whether or not you take Limován with alcohol or other medications that cause drowsiness. If you experience any of the above symptoms, stop treatment with Limován immediately and contact your doctor or healthcare professional.

• Use with extreme caution if you have suicidal tendencies and depression.

Some studies have shown an increased risk of suicidal ideation, suicide attempts, and suicide in patients taking certain sedatives and hypnotics, including this medication. However, it has not been established whether this is caused by the medication or if there may be other reasons. If you have suicidal thoughts, contact your doctor as soon as possible for additional medical advice.

Consult your doctor before using this medication, as it maymaskthe symptoms of depression.

• Zopiclone administration can induce anterograde amnesia. This occurs more frequently several hours after taking it, so take the tablet just before going to bed and make sure you can rest without being woken up for 7-8 hours (a full night's sleep).

• After prolonged use of hypnotics, their effectiveness may decrease. Inform your doctor if you feel that the effect of this medication has decreased after repeated use.

• If you are an older patient, your doctor may prescribe a lower dose and monitor your response to treatment. Please follow your doctor's instructions carefully.

• If you have any kidney or liver problems, chronic respiratory problems, or muscle weakness, your doctor will decide whether you should take a lower dose of Limován or not take it at all.

Pediatric population

Zopiclone should not be used in children and adolescents under 18 years old. The safety and efficacy of zopiclone have not been established in children and adolescents under 18 years old.

Use of Limován with other medications

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication.

This is extremely important because taking multiple medications at the same time can increase or decrease their effect.Therefore, do not use other medications at the same time as Limován unless your doctor is informed and approves it in advance.

Not recommended associations:

• Alcohol (see the section “Use of Limován with food, drinks, and alcohol”).

Associations to be considered:

• The administration of Limován with central nervous system depressants such as sleep-inducing medications, medications for mental health disorders (antidepressants, antipsychotics), for anxiety treatment (anxiolytics, sedatives), pain-relieving medications (anesthetics), medications for seizure/epileptic attacks (antiepileptic medications), sedating antihistamines, may increase central nervous system depression.

In the case of using narcotic analgesics, there may be an increase in the feeling of euphoria, which may increase psychological dependence.

• The concomitant administration of erythromycin, clarithromycin, ketoconazole, itraconazole, ritonavir (infection medications) and Limován may increase the effect of the latter.
• Conversely, the concomitant administration of rifampicin (infection medication), carbamazepine, phenobarbital, phenytoin (epilepsy medication) and St. John's Wort with Limován may decrease the effect of the latter.
• Opioid medications: the use of Limován at the same time as opioids (powerful pain-relieving medications, medications for substitution therapy, and some cough medications) increases the risk of drowsiness, difficulty breathing (respiratory depression), coma, and may be potentially fatal.Due to this, concomitant use should only be considered when other treatment options are not possible.

However, if your doctor prescribes Limován with opioids, the dose and duration of concomitant treatment should be limited by your doctor.

Inform your doctor about all opioid medications you are taking and follow your doctor's dosage recommendation closely. It may be helpful to inform friends or family members so they are aware of the signs and symptoms mentioned above. Contact your doctor when you experience these symptoms.

Use of Limován with food, drinks, and alcohol

Avoid drinking alcoholic beverages during treatment. The effect of alcohol may enhance sedation, and this may affect your ability to drive or operate machinery. If you need additional information on this point, consult your doctor.

Pregnancy, lactation, and fertility

If you are pregnant or breastfeeding, or if you think you may be pregnant, consult your doctor or pharmacist before using any medication.

Pregnancy

It is not recommended to use Limován during pregnancy.

If you are pregnant, think you may be pregnant, or plan to become pregnant, consult your doctor.

If used during pregnancy, there is a risk that the baby may be affected. Some studies have shown an increased risk of cleft lip and palate (sometimes called “hare lip”) in newborns.

Fetal movement reduction and fetal heart rate variability may occur after taking Limován during the second and/or third trimester of pregnancy.

If Limován is taken at the end of pregnancy or during delivery, your baby may experience muscle weakness, decreased body temperature, difficulty feeding, and respiratory problems (respiratory depression).

If you take this medication regularly at the end of pregnancy, your 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.

Lactation

Zopiclone passes into breast milk, so Limován should not be used during lactation.

Driving and operating machinery

Limován is a sleep-inducing medication. Do not drive or operate machinery if you feel drowsy or if you notice that your attention and reaction time are reduced. Pay special attention to the start of treatment or if the dose is increased.

Like other sedative/hypnotic medications, zopiclone has depressant effects on the central nervous system.

The risk of psychomotor problems, including impaired ability to drive, increases if:

• you take zopiclone within 12 hours of performing activities that require mental alertness,
• if you take a higher dose than recommended or
• if you take it with other central nervous system depressants, alcohol, or other medications that increase zopiclone levels in the blood.

Be aware of this risk if you plan to perform hazardous tasks such as operating machinery or driving vehicles, which require complete mental alertness or motor coordination after taking this medication and especially within 12 hours after taking it.

This risk may increase with the consumption of alcoholic beverages.

Limován contains gluten

This medication contains very low levels of gluten (from wheat starch) and it is highly unlikely to cause problems if you have celiac disease.

A tablet contains no more than 6 micrograms of gluten.

If you are allergic to wheat (other than celiac disease), do not take this medication.

Limován contains lactose

This medication contains lactose. If your doctor has told you that you have a certain sugar intolerance, consult with them before taking this medication.

This medication contains less than 1 mmol of sodium (23 mg) per tablet; it is essentially “sodium-free”.

Follow exactly the administration instructions for Limován indicated by your doctor.

In case of doubt, consult your doctor or pharmacist.

Depending on the nature of your illness, your age and weight, your doctor will prescribe the appropriate dose. In most cases, only a short-term treatment with Limován is needed (usually not exceeding two weeks). The maximum duration of treatment is four weeks if the gradual withdrawal of the medication is included. Prolonging treatment will not be done without a reevaluation of the patient's condition, as the risk of abuse and dependence increases with the duration of treatment (see section 2).

Treatment should begin with the lowest dose. Do not exceed the maximum dose.

The most effective dose should be used.

It should be taken in a single dose and not taken again during the same night.

Each individual dose should not exceed the indicated limits, and the total daily dose should not either, unless your doctor prescribes a higher dose.

The recommended doses are as follows:

• In adults: 1 tablet (7.5 mg of zopiclone),

• In elderly patients, and patients with liver or kidney disease, or chronic respiratory insufficiency, treatment will begin with half a tablet (3.75 mg of zopiclone), increasing to 1 tablet if necessary.
• Pediatric population: zopiclone should not be used in children and adolescents under 18 years old. The safety and efficacy of zopiclone have not been established in children and adolescents under 18 years old.

Never change the dose prescribed by your doctor yourself.

It should only be administered orally. Take Limován just before going to bedand swallow the tablet wholewith water or another non-alcoholic beverage.

The tablet can be divided into equal doses.

Under normal conditions, it will not take more than 20 minutes to fall asleep after taking Limován, and it is advisable to ensure that you can rest without being woken up for at least 7-8 hours. Otherwise, although this happens in rare cases, it is possible that you will not remember what happened while you were awake.

To avoid withdrawal symptoms, do not stop treatment with Limován abruptly, especially if you have been taking it for a long time.

If you estimate that the effect of Limován is too strong or too weak, inform your doctor or pharmacist.

If you take more Limován than you should

Zopiclone overdose is generally manifested by different degrees of central nervous system depression, ranging from drowsiness to coma, depending on the amount ingested. In moderate cases, symptoms include drowsiness, confusion, and lethargy; in more severe cases, discoordination in movement, hypotonia, hypotension, elevated metahemoglobin levels in blood, respiratory depression, and coma may appear. Overdose does not represent a life-threatening risk unless combined with other central depressant medications (including alcohol).

Other risk factors may be the presence of diseases and the patient's weakness, which can increase the severity of symptoms and rarely may have a fatal outcome.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

If you forgot to take Limován

Do not take a double dose to compensate for the missed doses. Continue with the normal dose.

If you stop treatment with Limován

Upon cessation of administration, restlessness, anxiety, rebound insomnia, tremors, sweating, palpitations, tachycardia, tension, confusion, irritability, unease, agitation, delirium, nightmares, headache, or muscle pain may appear.

In severe cases, the following symptoms may occur: loss of sense of reality, depersonalization,
reduced tolerance to usual sounds, numbness and tingling in the extremities, hypersensitivity to light, noise, and physical contact, hallucinations, and in very rare cases, seizures.

It is not recommended, in general, to stop medication abruptly, but rather to gradually reduce the dose according to the doctor's instructions.

If you have any other doubts about the use of this medication, ask your doctor or pharmacist.

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

Most patients tolerate this medicine well, but some, especially at the beginning of treatment, may feel a bit tired, drowsy during the day.

Frequencies are defined as follows:

Common: can affect up to 1 in 10 patients,

Uncommon: can affect up to 1 in 100 patients,

Rare: can affect up to 1 in 1,000 patients,

Very rare: can affect up to 1 in 10,000 patients,

Frequency not known: cannot be estimated from available data.

In patients treated with zopiclone, the following side effects have been observed:

Immune system disorders

Very rare: allergic inflammation that can occur infeet, hands, throat, lips, and respiratory passages (angioedema), severe allergic reactions (anaphylactic reactions)

Mental and behavioral disorders

Uncommon: nightmares, agitation

Rare: confusion, alterations in sexual desire, irritability, aggression, hallucinations

Frequency not known: restlessness, delirium, outbursts of anger, alterations in behavior (possibly associated with amnesia) and somnambulism, dependence, and withdrawal syndrome upon discontinuing treatment (see "Withdrawal syndrome" at the end of the "Possible side effects" section).

Limován may cause somnambulism or otherunusual behavior (such as driving, eating,calling, or engaging in sexual activity, etc.) while not fully awake.

Limován may cause delirium (a sudden and severe change in mental state that can cause a combination of confusion, disorientation, and/or attention deficit).

Nervous system disorders

Common: bitter taste,daytime somnolence

Uncommon: dizziness, headache

Rare: anterograde amnesia (does not remember what happened while awake after taking the medication, therefore, should ensure that they can rest for at least 7-8 hours without being disturbed)

Frequency not known: decreased ability to coordinate movements (ataxia), sensation of tingling (paresthesia), disorders of knowledge such as memory deficit, attention alteration, speech disorder.

Eye disorders

Frequency not known: double vision

Respiratory, thoracic, and mediastinal disorders

Rare: shortness of breath (dyspnea)

Frequency not known: respiratory depression

Gastrointestinal disorders

Common: dry mouth

Uncommon: nausea

Frequency not known: stomach pain (dyspepsia)

Hepatobiliary disorders

Very rare: increase in liver enzymes (transaminases) and/or blood (alkaline phosphatase)

Skin and subcutaneous tissue disorders

Rare: itching, skin rash

Musculoskeletal and connective tissue disorders

Frequency not known: muscle weakness

General disorders and administration site conditions

Uncommon: fatigue

Injury, poisoning, and procedural complications

Rare: falls (predominantly in elderly patients)

Dependence

The administration of the product may produce physical and psychological dependence. Cases of abuse of hypnotics, including zopiclone, have been reported.

Withdrawal syndrome

Discontinuing treatment may lead to the appearance of side effects after treatment discontinuation (see section "If you stop taking Limován").

Depression

The use of the medication may unmask an existing depression. Since insomnia can be a symptom of depression, if insomnia persists, inform your doctor to evaluate your situation.

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep this medication out of the sight and reach of children.

No special storage conditions are required.

Expiration Date

Do not use this medication after the expiration date that appears on the packaging, after CAD. The expiration date is the last day of the month indicated.

Do not dispose of medications through drains or trash. Deposit empty packaging and unused medications at the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medications. By doing so, you will help protect the environment.

Composition of limován

• The active principle is zopiclone. Each tablet contains 7.5 mg of zopiclone.
• The other components are wheat starch (contains gluten), lactose, calcium dihydrogen phosphate dihydrate, sodium carboxymethyl starch (type A) from potato, magnesium stearate.

Coating: hypromellose, titanium dioxide (E-171), macrogol 6000.

Appearance of the product and contents of the packaging

The tablets are film-coated, oblong, white, scored on one side.

Limován is presented in packs of 28 tablets.

Holder of the marketing authorization and responsible for manufacturing

Holder

sanofi-aventis, S.A.

C/ Roselló i Porcel, 21

08016 Barcelona

Spain

Responsible for manufacturing

Opella Healthcare International SAS

56 route de Choisy

60200 Compiègne

France

Last review date of this leaflet: October 2022

The detailed information of this medicine is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/