LIMOVAN 7.5 mg FILM-COATED TABLETS

2. What you need to know before you take Limován

Do not take Limován

• If you are allergic to zopiclone, to the group of benzodiazepines in general, or to any of the other components of this medication (listed in section 6).
• If you suffer from muscle weakness caused by your immune system (myasthenia gravis).
• If you have respiratory problems (respiratory failure).
• If you have breathing difficulties related to sleep (severe sleep apnea syndrome).
• If you have severe liver problems (severe liver failure).
• As long-term treatment. The treatment should be as short as possible, because the risk of dependence increases with the duration of treatment.
• If you have experienced sleepwalking or any other unusual behavior (such as driving, eating, making phone calls, 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 disorder
• suffer from muscle weakness
• have other illnesses
• have allergies.

• If you have respiratory problems, special precautions should be taken, as this medication has the ability to depress respiratory function.

• Psychomotor impairment: like other sedative/hypnotic drugs, zopiclone has depressive effects on the central nervous system.

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

• you take zopiclone in the 12 hours prior to performing activities that require being mentally alert,
• if you take a higher dose than the recommended dose or
• if it is administered in conjunction with other central nervous system depressants, alcohol, or other medications that increase zopiclone levels in the blood.

You should be aware of this risk if you are going to perform hazardous tasks such as operating machinery or driving vehicles that require complete mental alertness or motor coordination after taking this medication, especially during the 12 hours following it.

• Do not take Limován at the same time as opioids (powerful pain relievers, medication for replacement therapy, and some cough medications) 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 may lead to dependence or abuse. This occurs mainly after uninterrupted use of the medication for a long time. To minimize the risk of dependence, the following precautions should be taken:

• the use of zopiclone will only be done under medical prescription (never because it has worked for other patients) and will never be recommended to other people,
• do not increase the prescribed doses by the doctor, nor prolong the treatment for longer than recommended,
• consult your doctor regularly so that he can decide if you should continue treatment.

• If you have ever had any mental disorder or problems of abuse or dependence on alcohol or drugs.

The use of zopiclone may lead to the development of abuse and/or physical and psychological dependence. The risk of dependence increases with the dose and duration of treatment and is greater when zopiclone is used for more than 4 weeks. The risk of abuse and dependence is greater in patients with a history of mental disorders and/or abuse of alcohol, illicit substances, or drugs.

If you are addicted to drugs or alcohol, do not take Limován unless your doctor formally indicates it. If you have any doubts, consult your doctor.

• When stopping the administration of this medication, withdrawal symptoms may appear (see the section "If treatment with Limován is interrupted").

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

• Treatment should be discontinued in the event of reactions such as restlessness, agitation, irritability, delirium, fits of rage, 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 elderly patients.

• If you have a history of sleepwalking or other unusual behaviors (such as driving, eating, making phone calls, or having sex, etc.) without being fully awake after taking Limován.

Limován may cause sleepwalking or other unusual behavior (such as driving, eating, making phone calls, 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 if you have taken or not taken 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.

• It should be used with extreme caution if you have suicidal tendencies and depression.

Some studies have shown an increased risk of suicidal ideation, suicide attempt, 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 may mask the symptoms of depression.

• The administration of zopiclone may induce anterograde amnesia. This occurs more frequently several hours after intake, so you should take the tablet just before going to bed at night and it is convenient to ensure that you can rest without being awakened during 7-8 hours (full night's sleep).

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

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

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

Pediatric Population

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.

Taking Limován with Other Medications

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medications.

This is extremely important because the simultaneous use of more than one medication can increase or decrease its effect. Therefore, you should not use other medications at the same time as Limován unless your doctor is informed and approves it beforehand.

Non-recommended associations:

• Alcohol (see the section "Taking Limován with food, drinks, and alcohol").

Associations to be taken into account:

• The administration of Limován with central nervous system depressant medications such as sleep-inducing medications, medications for the treatment of mental illnesses (antidepressants, antipsychotics), for the treatment of anxiety (anxiolytics, sedatives), medications used to relieve strong pain (anesthetics), medications used for the treatment of convulsions/epileptic seizures (antiepileptic medications), sedating antihistamines, may increase the central depressant effect.

In the case of using narcotic analgesics, an increase in the sensation of euphoria may occur, which can 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 relievers, replacement therapy medications, and some cough medications) increases the risk of drowsiness, difficulty breathing (respiratory depression), coma, and can 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 along with opioids, the dose and duration of concomitant treatment should be limited by your doctor.

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

Taking Limován with Food, Drinks, and Alcohol

During treatment, avoid alcoholic beverages. The effect of alcohol can potentiate sedation, and this can affect the ability to drive or operate machinery. If you need additional information on this point, consult your doctor.

Pregnancy, Breastfeeding, and Fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking any medication.

Pregnancy

The use of Limován is not recommended during pregnancy.

If you are pregnant, think you may be pregnant, or are planning to have a baby, 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 "harelip") in newborns.

Reduced fetal movement 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 childbirth, your baby may show muscle weakness, a decrease in body temperature, difficulty feeding, and breathing problems (respiratory depression).

If you take this medication regularly at the end of pregnancy, your baby may develop symptoms of 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

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

Driving and Using Machines

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

Like other sedative/hypnotic drugs, zopiclone has depressive effects on the central nervous system.

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

• you take zopiclone in the 12 hours prior to performing activities that require being mentally alert,
• if you take a higher dose than the recommended dose or
• if it is administered in conjunction with other central nervous system depressants, alcohol, or other medications that increase zopiclone levels in the blood.

You should be aware of this risk if you are going to perform hazardous tasks such as operating machinery or driving vehicles that require complete mental alertness or motor coordination after taking this medication, especially during the 12 hours following it.

This risk may be increased by the consumption of alcoholic beverages.

Limován Contains Gluten

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

One tablet does not contain more than 6 micrograms of gluten.

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

Limován Contains Lactose

This medication contains lactose. If your doctor has told you that you have an intolerance to some sugars, 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".

3. How to take Limován

Follow your doctor's instructions for taking Limován exactly.

If you are in 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 (generally not exceeding two weeks). The maximum duration of treatment is four weeks, including gradual withdrawal of the medication. Treatment extension will not be performed without re-evaluation of the patient's condition, as the risk of abuse and dependence increases with the duration of treatment (see section 2).

Treatment should be started with the lowest dose. Do not exceed the maximum dose.

The effective lowest dose should be used.

It should be taken in one intake and not repeated with a new dose 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 with chronic respiratory insufficiency, treatment will be started with half a tablet (3.75 mg of zopiclone), which may be increased, if necessary, to 1 tablet.
• Pediatric population: 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.

Never change the dose that has been prescribed for you.

It should be administered only orally. Take Limován just before bedtime and swallow the tablet without chewing, with water or another non-alcoholic beverage.

The tablet can be divided into equal doses.

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

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

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

If you take more Limován than you should

Overdose with zopiclone is generally characterized by various degrees of central nervous system depression, which can range from drowsiness to coma, depending on the amount ingested. In moderate cases, symptoms include drowsiness, confusion, and lethargy; in more severe cases, movement coordination disorders, hypotonia, hypotension, elevated methemoglobin levels in the blood, respiratory depression, and coma may appear. Overdose does not pose a threat to life unless it is combined with other central depressant medications (including alcohol).

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

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

If you forget to take Limován

Do not take a double dose to make up for forgotten doses. You should continue with the normal dose.

If you interrupt treatment with Limován

When stopping 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, decreased tolerance to usual sounds, numbness, and tingling in the extremities, hypersensitivity to light, noise, and physical contact, hallucinations, and, in very rare cases, convulsions.

It is not recommended to interrupt 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.

4. Possible adverse effects

Like all medications, this medication can cause adverse effects, although not all people experience them.

Most patients tolerate this medication well, but some, especially at the beginning of treatment, may feel somewhat tired or drowsy during the day.

Frequencies are defined as follows:

common: may affect up to 1 in 10 patients,

uncommon: may affect up to 1 in 100 patients,

rare: may affect up to 1 in 1,000 patients,

very rare: may affect up to 1 in 10,000 patients,

frequency not known: cannot be estimated from the available data.

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

Immune system disorders

Very rare: allergic inflammation that can be localized in feet, hands, throat, lips, and respiratory tract (angioedema), severe allergic reactions (anaphylactic reactions)

Psychiatric disorders

Uncommon: nightmares, agitation

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

Frequency not known: unease, delirium, fits of rage, changes in behavior (possibly associated with amnesia) and sleepwalking, dependence, and withdrawal syndrome when treatment is interrupted (see "Withdrawal syndrome" at the end of the "Possible adverse effects" section).

Limován may cause sleepwalking or other unusual behavior (such as driving, eating, making phone calls, or having sexual relations, etc.) without being 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, drowsiness during the day

Uncommon: dizziness, headache

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

Frequency not known: decreased ability to coordinate movements (ataxia), tingling sensation (paresthesia), cognitive disorders such as memory impairment, attention disorders, speech disorders.

Eye disorders

Frequency not known: double vision

Respiratory, thoracic, and mediastinal disorders

Rare: breathing difficulties (dyspnea)

Frequency not known: respiratory depression

Gastrointestinal disorders

Common: dry mouth

Uncommon: nausea

Frequency not known: stomach pain (dyspepsia)

Hepatobiliary disorders

Very rare: increased 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

Trauma, poisoning, and procedural complications

Rare: falls (mainly in elderly patients)

Dependence

Administration of the product may cause physical and psychological dependence. Cases of abuse of hypnotics, including zopiclone, have been reported.

Withdrawal syndrome

Stopping treatment may lead to the appearance of adverse effects after treatment is interrupted (see "If you interrupt treatment with Limován" section).

Depression

The use of the medication may reveal an existing depression. Since insomnia can be a symptom of depression, if insomnia persists, inform your doctor so that they can assess your situation.

Reporting adverse effects

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

5. Conservation of Limován

Keep this medication out of sight and reach of children.

No special storage conditions are required.

Expiration date

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

Medications should not be thrown down the drain or into the trash. Deposit the packaging and medications you no longer need at the SIGRE point in the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This way, you will help protect the environment.

6. Package contents and additional information

Composition of Limován

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

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

Appearance of the product and package contents

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

Limován is available in packages of 28 tablets.

Marketing authorization holder and manufacturer

Holder

sanofi-aventis, S.A.

C/ Roselló i Porcel, 21

08016 Barcelona

Spain

Manufacturer

Opella Healthcare International SAS

56 route de Choisy

60200 Compiègne

France

Date of the last revision of this prospectus: October 2022

Detailed information about this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/