ZOPICLONE GRINDEKS 5 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Zopiclona Grindeks 3.75mg film-coated tablets EFG

Zopiclona Grindeks 5mg film-coated tablets EFG

Zopiclona Grindeks 7.5mg film-coated tablets EFG

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

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

1. What is Zopiclona Grindeks and what is it used for
2. What you need to know before you take Zopiclona Grindeks
3. How to take Zopiclona Grindeks
4. Possible side effects
5. Storage of Zopiclona Grindeks
6. Contents of the pack and other information

1. What is Zopiclona Grindeks and what is it used for

Zopiclone is a sedative that contains the active substance zopiclone. It is used in adults as a sedative for various types of sleep disorders, such as difficulty falling asleep, waking up too early, or waking up many times during the night. Zopiclone is used for short-term sleep disorders.

Zopiclone will only be prescribed if your sleep problem is severe, disabling, or causing you considerable distress.

2. What you need to know before you take Zopiclona Grindeks

Do not take Zopiclona Grindeks

• if you are allergic to zopiclone or any of the other ingredients of this medicine (listed in section 6).
• if you have any of the following conditions:
• • severe liver disease;
  • sleep apnea syndrome (a sleep disorder with temporary pauses in breathing during sleep);
  • myasthenia gravis (a severe muscle weakness);
  • severe breathing difficulties (severe respiratory insufficiency).
• if you have ever had somnambulism (sleepwalking) or other unusual behavior (such as driving, eating, making a phone call, or having sex, etc.) while not fully awake after taking zopiclone.

Warnings and precautions

General

Consult your doctor or pharmacist before starting to take this medicine.

Before starting treatment with zopiclone, the cause of your sleep problems should be investigated, as well as any underlying illness being treated.

If you have or have had any disease or other medical condition, talk to your doctor, especially if you have:

• liver or kidney problems;
• breathing problems;
• general impairment;
• are an elderly person (in elderly people, medicines stay in the body for longer);
• depression or anxiety related to depression;
• a history of alcohol, drug, or medicine abuse;
• have taken zopiclone recently or other similar medicines for more than 4 weeks.

Your doctor will decide whether you should take zopiclone or adjust the dose. They will also closely monitor you during treatment.

Dependence and withdrawal symptoms

Taking medicines like zopiclone can lead to physical or mental dependence or abuse of these medicines. The risk of dependence increases with higher doses and longer treatment. The risk is also higher in patients with a history of alcohol, drug, or medicine abuse and/or those who suffer from marked personality disorders.

If physical dependence occurs, sudden withdrawal of treatment may cause withdrawal symptoms such as insomnia, headache, muscle pain, severe anxiety, tension, agitation, confusion, and irritability. In severe cases, the following symptoms may occur: altered perception of the world, so that it seems strange or unreal, loss of personal identity, followed by feelings of unreality and strangeness, hypersensitivity to sounds, numbness and tingling of the legs and arms; hypersensitivity to light, noise, or physical contact, seeing, hearing, or feeling things that do not really exist (hallucinations), and epileptic seizures.

Rebound insomnia

If treatment is stopped suddenly after prolonged use, it may sometimes cause insomnia for a few nights. This is a temporary syndrome called "rebound insomnia". To avoid having any problems when stopping treatment after prolonged treatment, it is recommended to gradually reduce the dose. See also the section on side effects.

Tolerance

The effect of zopiclone may decrease if the medicine is used repeatedly for several weeks. This is known as tolerance. Consult your doctor if you feel that the effect of zopiclone has decreased.

Short-term memory loss, also known as anterograde amnesia

Zopiclone may cause short-term memory loss, especially a few hours after taking the tablet. To reduce this risk, take zopiclone just before or after going to bed and make sure you have an uninterrupted sleep of 7-8 hours.

Psychiatric and paradoxical reactions

When using zopiclone, certain mental reactions may occur, such as restlessness and anxiety, nightmares, irritability, aggression, inappropriate behavior, hallucinations (seeing and hearing things that are not real), confusion, and difficulty concentrating.

Sleepwalking, and related behaviors

Cases of sleepwalking and other related behaviors, such as "sleep-driving", cooking, and eating or making phone calls while asleep and not remembering what happened, have been reported in patients who had taken zopiclone and had not woken up enough.

The risk of this behavior increases if zopiclone is combined with alcohol or other specific medicines (e.g., opioid analgesics, antipsychotics, hypnotics, or anxiolytics/sedatives). The risk also increases if zopiclone is taken with higher doses than the highest recommended dose.

Contact your doctor immediately if you experience any of the symptoms mentioned above.

Depression/suicidal ideation

This medicine is not indicated for the treatment of depression. If you also suffer from depression, your doctor will prescribe the appropriate treatment. If depression is not treated, it may worsen, become persistent, or increase the possible risk of suicide.

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 reasons. If you have suicidal thoughts, contact your doctor as soon as possible for medical advice.

Risk of falls

Due to the muscle relaxant effect of zopiclone, there is a risk of falls, especially in elderly people when getting up at night.

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.

Other medicines and Zopiclona Grindeks

The therapeutic effect may be affected if zopiclone is taken at the same time as certain medicines; i.e., it may be necessary to adjust the dose of zopiclone.

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. In particular, any of the following:

• Medicines for certain mental disorders (antipsychotics/neuroleptics)
• Sedatives (hypnotics)
• Medicines used to treat anxiety (anxiolytics)
• Medicines to calm nerves (sedatives)
• Treatment of depression (antidepressants)
• Potent opioid analgesics, such as morphine and morphine-like medicines
• Medicines used in surgery (anesthetics)
• Medicines used to treat allergies (antihistamines)
• Some medicines used to treat bacterial and fungal infections, such as erythromycin or itraconazole
• Medicines used to treat HIV infection
• Medicines used to treat epilepsy, such as phenytoin, phenobarbital, and carbamazepine
• Medicines used to treat tuberculosis (e.g., rifampicin)
• Products containing St. John's Wort (a plant used in natural medicine)

Taking zopiclone and opioids (potent analgesics, substitution treatments, and some cough medicines) at the same time increases the risk of drowsiness, breathing difficulties (respiratory depression), coma, and can be fatal. As a result, concurrent use should only be considered when other therapeutic options are not possible.

However, if your doctor prescribes zopiclone with opioids, they will restrict the dose and duration of concurrent treatment.

Tell your doctor about all opioid medicines you are taking and strictly follow the dosage recommendation given by your doctor. It may be helpful to inform your friends or family to be aware of the signs and symptoms described above. Contact your doctor if you experience these symptoms.

Taking Zopiclona Grindeks with drinks and alcohol

When taking zopiclone, you should avoid drinking alcohol, as alcohol increases the effects of zopiclone. The effect may persist until the next morning, which can negatively affect your ability to drive or use machines.

During treatment with zopiclone, you should avoid consuming grapefruit and grapefruit juice, as grapefruit can increase the effect of zopiclone.

Pregnancy and breastfeeding

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 this medicine.

Pregnancy

Zopiclone should not be used during pregnancy, as it crosses the placenta.

If used during pregnancy, there is a risk that the newborn may be affected. Some studies have shown that there may be an increased risk of cleft lip and cleft palate in the newborn.

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

If zopiclone is taken at the end of pregnancy or during delivery, the newborn may show muscle weakness, a drop in body temperature, feeding difficulties, and breathing problems (respiratory depression).

If this medicine is taken periodically in the late stage of pregnancy, the newborn may develop physical dependence and be at risk of experiencing withdrawal symptoms, such as agitation or tremors. In this case, the newborn should be closely monitored during the postnatal period.

Breastfeeding

Zopiclone is excreted in breast milk. Do not use zopiclone during breastfeeding.

Driving and using machines

You should not drive or use machines until you have finished treatment with zopiclone or until it has been determined that your ability is not affected. The effect may also persist until the next day.

The side effects of zopiclone that may affect your ability to drive are:

• Fatigue and drowsiness the next day (residual somnolence)
• Dizziness
• Memory loss (anterograde amnesia)
• Decreased ability to concentrate.

The risk of experiencing the above side effects is higher if you have drunk alcohol and if you have not slept enough.

Zopiclona Grindeks containscochineal red A

The 5 mg film-coated tablets contain cochineal red A (E124), which may cause allergic reactions.

Zopiclona Grindeks contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per tablet; i.e., it is essentially "sodium-free".

3. How to take Zopiclona Grindeks

Follow exactly the administration instructions of this medicine given by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist again.

The recommended initial dose in adults is one 5 mg or 7.5 mg tablet, taken at bedtime.

In some patients, such as elderly patients or those with kidney, liver, or respiratory problems, a lower starting dose of 3.75 mg may be used. Your doctor may then increase the dose to 5 mg and, if necessary, up to 7.5 mg.

The maximum daily dose is 7.5 mg per day.

How to take Zopiclona Grindeks

Take zopiclone just before going to bed. Do not take the tablets while lying down, as this may delay absorption in the body. Make sure you can sleep for a full night with 7-8 hours of sleep. Swallow the tablet with liquid (e.g., half a glass of water).

Duration of treatment

Your treatment with zopiclone should be as short as possible (a few days to 2 weeks). To reduce the risk of withdrawal symptoms or the return of sleep problems when treatment is stopped, your doctor will explain how to gradually reduce the dose at the end of treatment, which is called tapering. You should not take zopiclone for more than 4 weeks, including the tapering phase. Consult your doctor for advice if your symptoms do not improve during this time.

If you take more Zopiclona Grindeksthan you should

If you have taken too many tablets or if, for example, a child has taken the medicine by mistake, contact your doctor or the nearest hospital emergency department immediately for advice.

Overdose of zopiclone with certain substances or medicines that have a central nervous system depressant effect can be life-threatening, including alcohol.

Taking too much zopiclone may cause symptoms such as:

• drowsiness, confusion, deep sleep, and possibly coma
• muscle hypotonia
• dizziness, lightheadedness, or fainting. These effects are due to low blood pressure
• falls or loss of balance
• shallow breathing or difficulty breathing (respiratory depression)

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone 915 620 420, indicating the medicine and the amount taken.

If you forget to take Zopiclona Grindeks

Do not take a double dose to make up for forgotten doses.

If you still have time to sleep for 7-8 hours, you should take the dose immediately. If you do not have the opportunity for a full night's sleep, skip the missed dose and do not take a new dose until you go to bed the next night.

If you stop taking Zopiclona Grindeks

If you stop taking zopiclone suddenly, your sleep problems may return for a while. You may also experience withdrawal symptoms. Withdrawal symptoms include difficulty sleeping, headaches, sweating, hallucinations, and increased heart rate. In more severe and rare cases, seizures may also occur.

The risk of withdrawal symptoms increases with the dose and duration of treatment. Therefore, your doctor will give you information on how to gradually reduce the dose.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible Adverse Effects

Like all medicines, this medicine can cause adverse effects, although not all people suffer from them.

Stopusing zopiclone and contact a doctor or go to your nearest emergency service immediatelyif you experience any of the following symptoms (very rare, may affect up to 1 in 10,000 people):

• Swelling of the face, tongue, or throat; difficulty swallowing; urticarial hives and difficulty breathing (angioedema).
• Symptoms of a severe allergic reaction: pruritic rash, swelling of the mouth, which can cause difficulty breathing and swallowing, wheezing (anaphylactic reaction).

Other Adverse Effects

Frequent (may affect up to 1 in 10people):

• drowsiness
• bitter or metallic taste in the mouth
• dry mouth

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

• nervous excitement (agitation), nightmares
• feeling of dizziness (nausea), general malaise, abdominal pain
• decreased alertness, headache, dizziness
• difficulty getting out of bed in the morning, fatigue (asthenia)

Rare (may affect up to 1 in 1000people):

• feeling of confusion, irritability, aggression, hallucinations, depression (during treatment with zopiclone, a pre-existing depression may manifest itself), short-term memory loss
• change in sexual desire (libido disorders)
• difficulty breathing
• cutaneous allergic reactions (including rash, pruritus, urticaria)
• falls (mainly in elderly patients)

Very Rare (may affect up to 1 in 10000people):

• increase in concentrations of certain liver enzymes observed in blood tests

Frequency Not Known (frequency cannot be estimated from available data)

• restlessness, false beliefs, anger, abnormal behavior (possibly associated with memory loss), sleepwalking or other unusual behavior during sleep (such as driving, eating, calling, or having sex, etc.) while still not fully awake
• physical and psychological dependence, withdrawal syndrome, or rebound insomnia after discontinuation of zopiclone treatment
• loss of contact with reality (psychosis); this may involve seeing or hearing things that cannot be seen or heard and believing things that are not actually true
• memory impairment, inability to concentrate, speech disorder
• difficulty coordinating certain movements, numbness or tingling in some parts of the body
• double vision
• shallow breathing or difficulty breathing
• indigestion, vomiting
• muscle weakness

If treatment is stopped abruptly after long-term treatment, what are called withdrawal symptoms may occur. Withdrawal symptoms vary and include difficulty sleeping, tremors, sweating, confusion (delirium), headaches, palpitations, and increased heart rate, nightmares, and hallucinations. You may also feel anxious, irritated, and disgusted (agitation). Very rare cases of crisis have occurred.

Reporting of Adverse Effects

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

5. Conservation of Zopiclone Grindeks

Keep this medicine out of sight and reach of children.

Do not use this medicine after the expiration date that appears on the box after "CAD". The expiration date is the last day of the month indicated.

This medicine does not require special storage conditions.

Medicines should not be thrown away through wastewater or household waste. Deposit the containers and medicines you no longer need at the SIGRE point in the pharmacy or in any other system for collecting medicinal waste. In case of doubt, ask your pharmacist how to dispose of the containers and medicines you no longer need. This way, you will help protect the environment.

6. Package Contents and Additional Information

Composition of Zopiclone Grindeks

The active ingredient of this medicine is zopiclone. Each tablet contains 3.75 mg, 5 mg, or 7.5 mg of zopiclone, respectively.

The other components (excipients) are:

Core of the tablet: Cornstarch, hypromellose (type 2910) (E-464), calcium hydrogen phosphate (E-341), sodium carboxymethyl starch (type A) (potato), microcrystalline cellulose (E-460), magnesium stearate (E-572).

Coating material

5 mg tablets:

Graft copolymer of macrogol and poly(vinyl alcohol) (E-1209), talc (E-553b), titanium dioxide (E-171), glycerol monocaprylocaprate (E-471), poly(vinyl alcohol) (E-1203), indigo carmine (E-132), cochineal red A (E-124), quinoline yellow (E-104).

3.75 mg and 7.5 mg tablets:

Graft copolymer of macrogol and poly(vinyl alcohol) (E-1209), talc (E-553b), titanium dioxide (E-171), glycerol monocaprylocaprate (E-471), poly(vinyl alcohol) (E-1203).

Appearance of the Product and Package Contents

Zopiclone Grindeks 3.75 mg are white, round, biconvex, film-coated tablets with smooth surfaces. The approximate diameter of the tablet is 5 mm.

Zopiclone Grindeks 5 mg are blue, round, biconvex, film-coated tablets with smooth surfaces. The approximate diameter of the tablet is 6 mm.

Zopiclone Grindeks 7.5 mg are white, round, convex on one side and with a score line on the other, film-coated tablets with smooth surfaces. The approximate diameter of the tablet is 7 mm. The tablet can be divided into equal doses.

Zopiclone Grindeks is available in PVC/PVDC//Al blisters containing 10, 20, 30, or 100 film-coated tablets.

Only some pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

AS GRINDEKS

Krustpils iela 53,

Riga, LV‑1057,

Latvia

Phone: (+371) 67083205

e-mail: [email protected]

You can request more information about this medicine by contacting the local representative of the marketing authorization holder

Grindeks Kalceks España, S.L.

C/ José Abascal, 58 – 2º Dcha.

Madrid, 28003, Spain

This medicine is authorized in the Member States of the European Economic Area under the following names:

Date of the Last Revision of this Prospectus: 08/2024

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