Zopiclone Grindeks 5 mg film-coated tablets

• 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 ate the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This also includes any possible side effects not listed in this leaflet. See section 4.

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

• 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 diseases:
  • a severe liver disease;
  • sleep apnoea syndrome (sleep disturbance with temporary pauses in breathing during sleep);
  • a serious muscle-weakness called myasthenia gravis (an autoimmune disease);
  • severe difficulty breathing (severe respiratory failure).
• You have ever experienced sleepwalking or other unusual behavior (such as driving, eating, making a phone call or having sex etc.) while not being fully awake after taking zopiclone.

General

Talk to your doctor or pharmacist before taking Zopiclone Grindeks.

Before starting treatment with Zopiclone Grindeks, the cause of your sleep problems should be investigated, and any other underlying disease treated.

Tell your doctor if you have or have had any illness or any other medical condition, especially if you have any of the following:

• liver or kidney problems;
• breathing problems;
• impaired general condition;
• is elderly (in older people, medicines stay longer in the body);
• depression or anxiety linked with depression;
• history of abuse of alcohol, drug, or medicines;
• you have recently taken Zopiclone Grindeks or other similar medicines for more than 4 weeks.

Your doctor will decide whether you should take Zopiclone Grindeks or not or adjusts your dose. You will be also monitored closely during the treatment.

Dependence and withdrawal symptoms

The use of medicines like Zopiclone Grindeks may lead to a physical or mental dependence or abuse of these medicines. The risk of dependence increases the higher the dose and the longer the period of treatment. The risk is also higher in patients with a history of alcohol, drug or medicine abuse and/or those who have marked personality disorders.

If physical dependence occurs, stopping the treatment suddenly may lead to withdrawal symptoms such as: insomnia, headache, muscle pain, extreme anxiety, tension, restlessness, confusion and irritability. In severe cases following symptoms may occur: an alteration in the perception of the world so that it seems strange or unreal, loss of your own personal identity followed by feelings of unreality and strangeness, oversensitivity to sound, numbness and tingling of arms and legs, hypersensitivity to light, noise or physical contact, seeing, hearing or feeling things that don’t really exist (hallucinations) and epileptic seizures.

Sleeplessness recurring after stopping the treatment (rebound insomnia)

If treatment is stopped abruptly after prolonged use, it sometimes leads sleeplessness for a few nights. This is a temporary syndrome called "rebound insomnia". To avoid any problems with discontinuation after long-term treatment, it is recommended to gradually reduce the dose. See also the section on side effects.

Tolerance

The effect of Zopiclone Grindeks may be reduced if the medicine is used repeatedly for a few weeks. This is called tolerance. Talk to your doctor if you have the feeling that the effect of Zopiclone Grindeks decreases.

Short-term memory loss, so-called anterograde amnesia

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

Psychiatric and "paradoxical reactions"

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

Sleepwalking, so-called somnambulism, and associated behaviours

Sleepwalking and other associated behaviours such as ‘sleep driving’, cooking and eating or making phone calls in your sleep, with memory loss of the event, have been reported in patients who have taken zopiclone and were not fully awake.

The risk of such behaviour increases if Zopiclone Grindeks is combined with alcohol or certain other specific medications (e.g., opioid-class painkillers, antipsychotics, hypnotics or anti-anxiety / sedatives). The risk also increases if Zopiclone Grindeks is taken in higher doses than the highest recommended dose.

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

Depression/suicidal thoughts

This medicine is not intended to treat depression. If you also have a depression, your doctor will prescribe appropriate treatment. If depression is left untreated, it can worsen, become persistent or increase 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 if this is due to the medicine or if there are other reasons. If you have suicidal thoughts, contact your doctor as soon as possible for medical advice.

Risk of fall

Due to the muscle relaxing effect of zopiclone, there is a risk of fall, especially in the elderly when they get up during the night.

Zopiclone Grindeks should not be used by children and adolescents under 18 years of age. Safety and efficacy in children and adolescents under 18 years of age have not been established.

The treatment effect can be affected if Zopiclone Grindeks is taken at the same time as certain other medicines, which means that the dose of Zopiclone Grindeks may need to be adjusted.

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:

• Medicines for certain mental disorders (antipsychotics/neuroleptics)
• Sleeping pills (hypnotics)
• Medicines used to treat anxiety (anxiolytics)
• Medicines used to calm (sedatives)
• Treatment of depression (antidepressants)
• Strong opioid class painkillers, e.g., morphine and morphine-like substances
• Medicines used in surgery (anaesthetics)
• Medicines used to treat allergy (antihistamines)
• Some medicines used to treat bacterial and fungal infections such as erythromycin or itraconazole
• Medicines used to treat HIV infections
• 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 (traditional herbal medicine).

Concomitant use of Zopiclone Grindeks and opioids (strong pain killers, medicines for substitution therapy and some cough medicines) increases the risk of drowsiness, difficulties in breathing (respiratory depression), coma and may be life-threatening. Because of this, concomitant use should only be considered when other treatment options are not possible.

However, if your doctor does prescribe Zopiclone Grindeks together with opioids, the dose and duration of concomitant treatment should be limited by your doctor.

Please tell your doctor about all opioid medicines you are taking and follow your doctor’s dose recommendation closely. It could be helpful to inform friends or relatives to be aware of the signs and symptoms stated above. Contact your doctor when experiencing such symptoms.

Alcohol should be avoided when taking Zopiclone Grindeks as alcohol may increase the effects of Zopiclone Grindeks. The effect may persist until the next morning, which may adversely affect your ability to drive or use machines.

Grapefruit and grapefruit juice should be avoided while taking Zopiclone Grindeks. Grapefruit can increase the effect of Zopiclone Grindeks.

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy

Use of Zopiclone Grindeks is not recommended during pregnancy since it crosses the placenta.

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

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

If Zopiclone Grindeks is taken at the end of pregnancy or during labour, your baby may show muscle weakness, a drop in body temperature, difficulty feeding and breathing problems (respiratory depression).

If this medicine is taken regularly in late pregnancy, your baby may develop physical dependence and may be at risk of developing withdrawal symptoms such as agitation or shaking. In this case the newborn should be closely monitored during the postnatal period.

Breast-feeding

Zopiclone passes into breast milk. Do not use Zopiclone Grindeks if you are breast-feeding.

You should not drive or use machines until your treatment with Zopiclone Grindeks has ended, or until it has been established that your ability is not impaired. The effect can also persist until the next day.

Side effects of Zopiclone Grindeks that may affect your ability to drive are:

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

The risk of suffering from the above side effects is greater if you have drunk alcohol and if you have not had enough sleep.

5 mg film-coated tablet contains Cochineal red A (E124) that may cause allergic reactions.

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

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

Zopiclone overdosage together with certain agents or medicines which have a suppressive effect on the central nervous system might be life-threatening. This also includes alcohol.

Taking too much zopiclone may cause symptoms such as:

• feeling drowsy, confused, sleeping deeply and possibly falling into a coma
• floppy muscles
• feeling dizzy, lightheaded, or faint. These effects are due to low blood pressure
• falling over or losing your balance
• shallow breathing or difficulty breathing (respiratory depression).

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

If you still have time to sleep for 7 to 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 next night.

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

The risk of withdrawal symptoms increases with the dose and the duration of treatment and therefore the doctor may give you information on how to gradually reduce the dose.

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via Yellow Card Scheme at www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

By reporting side effects you can help provide more information on the safety of this medicine.

The active substance in Zopiclone Grindeks is zopiclone. Each tablet contains 3.75 mg, 5 mg or 7.5 mg zopiclone, respectively.

The other ingredients are:

Tablet core: maize starch, hypromellose (type 2910) (E464), calcium hydrogen phosphate (E341), sodium starch glycolate (type A), cellulose, microcrystalline (E460), magnesium stearate (E572).

Tablet film-coating

5 mg tablets:

Macrogol poly(vinyl alcohol) grafted copolymer (E1209); talc (E553b); titanium dioxide (E171); glycerol monocaprylocaprate (E471); poly(vinyl alcohol) (E1203); indigo carmine (E132); cochineal red A (E124); quinoline yellow (E104).

3.75 mg and 7.5 mg tablets:

Macrogol poly(vinyl alcohol) grafted copolymer (E1209); talc (E553b); titanium dioxide (E171); glycerol monocaprylocaprate (E471); poly(vinyl alcohol) (E1203).

Zopiclone Grindeks 3.75 mg are white round biconvex film-coated tablets with plain surfaces; size of tablet is approximately 5 mm in diameter.

Zopiclone Grindeks 5 mg are blue round biconvex film-coated tablets with plain surfaces; size of tablet is approximately 6 mm in diameter.

Zopiclone Grindeks 7.5 mg are white round film-coated tablets, convex on one side and dimple with break-line on other with plain surfaces; size of tablet is approximately 7 mm in diameter. Tablet can be divided in equal doses.

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

Not all pack sizes may be marketed.