Zopiclone Grindex

Package leaflet: Information for the user

Zopiclone Grindeks 3.75 mg film-coated tablets, 5 mg film-coated tablets, 7.5 mg film-coated tablets

zopiclone
Generic medicine
Read this entire 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 or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful to them.
• If you experience any side effects, including those not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Contents of this leaflet

1. What Zopiclone Grindeks is and what it is used for
2. What you need to know before taking 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

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

Zopiclone Grindeks is a hypnotic medicine containing the active substance zopiclone. It is used in adults as a sleeping aid for various sleep disorders, e.g. difficulty falling asleep, waking up too early, or frequent night-time awakenings. Zopiclone Grindeks is used for short-term treatment of sleep disorders.
Zopiclone Grindeks will be prescribed to you only if your insomnia is severe, disabling or causing you extreme distress.

2. What you should know before taking Zopiclone Grindeks

Do not take Zopiclone Grindeks:

• If you are allergic to zopiclone or to any of the other ingredients of this medicine (listed in section 6).
• If you suffer from any of the following conditions:
• severe liver disease;
• sleep apnoea syndrome (a sleep disorder characterized by temporary pauses in breathing during sleep);
• severe muscle weakness called myasthenia gravis (an autoimmune disease);
• severe breathing difficulties (severe respiratory insufficiency);
• If you have experienced sleepwalking or other unusual behaviours (such as driving, eating, making phone calls or having sexual intercourse, etc.) while not fully awake after taking zopiclone.

Warnings and precautions
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 underlying medical conditions should be treated.
Inform your doctor if you have or have previously had any other medical condition, especially any of the following:

• liver or kidney problems;
• respiratory problems;
• general malaise;
• if you are elderly (in elderly patients, medicines remain in the body for longer);
• depression or anxiety associated with depression;
• history of alcohol, illicit substance or medicine abuse;
• if you have recently taken Zopiclone Grindeks or similar medicines for more than 4 weeks. Your doctor will decide whether you should take Zopiclone Grindeks or may adjust the dose. You will also be closely monitored during treatment.

Dependence and withdrawal symptoms
Medicines such as Zopiclone Grindeks may lead to physical or psychological dependence or abuse. The risk of dependence increases with dose and duration of treatment. The risk is also higher in patients with a history of alcohol, illicit substance or drug abuse and/or in those with personality disorders.
If physical dependence occurs, abrupt discontinuation of treatment may lead to withdrawal symptoms such as: insomnia, headache, muscle pain, extreme anxiety, tension, restlessness, confusion and irritability. In severe cases, the following symptoms may occur: altered perception of the world, which seems strange or unreal, loss of personal identity followed by sensations of illusion, strangeness, hypersensitivity to sound, numbness and tingling in arms and legs, hypersensitivity to light, noise or physical contact, seeing, hearing or perceiving things that are not actually present (hallucinations), and epileptic seizures.
Rebound insomnia after stopping treatment (rebound insomnia)
If treatment is stopped abruptly after prolonged use, it may sometimes cause insomnia for several nights. This is a temporary syndrome known as "rebound insomnia". To avoid problems when stopping after prolonged treatment, it is recommended to gradually reduce the dose.
See also the section on undesirable effects.
Tolerance
The effect of Zopiclone Grindeks may be reduced if the medicine is used repeatedly for several weeks. This phenomenon is called tolerance. Inform your doctor if you feel that the effect of Zopiclone Grindeks is decreasing.
Short-term memory loss, known as anterograde amnesia
Zopiclone Grindeks may cause short-term memory loss, especially a few hours after taking the tablet. To reduce this risk, take Zopiclone Grindeks immediately before or after going to bed, and ensure you can have an uninterrupted sleep of 7–8 hours.
Psychiatric reactions and "paradoxical" reactions
When using Zopiclone Grindeks, some mental reactions may occur, such as restlessness and anxiety, nightmares, irritability, aggression, inappropriate behaviour, hallucinations (seeing and hearing things that are not real), confusion and difficulty concentrating.
Sleepwalking and associated behaviours
In patients who have taken zopiclone and were not fully awake, episodes of sleepwalking and other associated behaviours have been reported, such as driving, cooking, eating or making phone calls while asleep, with loss of memory of the event.
The risk of such behaviour increases if Zopiclone Grindeks is taken together with alcohol or certain other medicines (e.g. opioid painkillers, antipsychotics, hypnotics or anxiolytics/sedatives). The risk also increases if Zopiclone Grindeks is taken at doses higher than the maximum recommended dose.
Contact a doctor immediately if you experience any of the above symptoms.
Depression/suicidal thoughts
This medicine is not intended for the treatment of depression. If you also suffer from depression, your doctor will prescribe appropriate treatment. If depression is not treated, it may worsen, become chronic 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 if there are other reasons. If you have suicidal thoughts, contact your doctor as soon as possible for advice.
Fall risk
Due to the muscle-relaxant effect of zopiclone, there is a risk of falling, especially in elderly patients when getting up during the night.
Children and adolescents
Zopiclone Grindeks must not be taken by children and adolescents under 18 years of age. The safety and efficacy in children and adolescents under 18 years of age have not been established.
Other medicines and Zopiclone Grindeks
Treatment may be affected if Zopiclone Grindeks is taken together with certain other medicines, meaning that the dose of Zopiclone Grindeks may need to be adjusted.
Inform your doctor or pharmacist if you are taking, have recently taken or might take any other medicine. In particular, any of the following medicines:

• Medicines for the treatment of certain mental disorders (antipsychotics/neuroleptics)
• Sleeping pills (hypnotics)
• Medicines used to treat anxiety (anxiolytics)
• Sedatives
• Medicines used for the treatment of depression (antidepressants)
• Strong opioid painkillers, e.g. morphine or morphine-like substances
• Medicines used in surgery (anaesthetics)
• Medicines used to treat allergies (antihistamines)
• Certain medicines used to treat bacterial or fungal infections such as erythromycin and 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)
• St John’s wort products (traditional herbal medicine).

Concomitant use of Zopiclone Grindeks and opioids (strong painkillers, substitution therapy medicines and some cough medicines) increases the risk of drowsiness, breathing difficulties (respiratory depression), coma and may be potentially fatal. Therefore, concomitant use should only be considered when no other treatment options are possible.
However, if your doctor prescribes Zopiclone Grindeks together with opioids, your doctor should limit the dose and duration of concomitant treatment.
Inform your doctor about all opioids you are taking, and carefully follow your doctor’s recommendations regarding dosage. It may be helpful to inform friends or relatives to be alert for the signs and symptoms listed above.
If you experience such symptoms, contact your doctor.
Zopiclone Grindeks with food, drinks and alcohol
You should avoid drinking alcohol while taking Zopiclone Grindeks, as alcohol may increase its effects. The effect may persist into the next morning, and this may unintentionally affect your ability to drive or operate machinery.
Grapefruit and grapefruit juice should be avoided while taking Zopiclone Grindeks. Grapefruit may increase the effect of Zopiclone Grindeks.
Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, are planning to become pregnant or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Pregnancy
The use of Zopiclone Grindeks is not recommended during pregnancy as it crosses the placenta.
If used during pregnancy, there is a risk to the unborn child. Some studies have shown that the risk of cleft lip and palate (cleft lip) in the newborn may increase.
After taking Zopiclone Grindeks during the second and/or third trimester of pregnancy, reduced fetal movement and variability in fetal heart rate may occur.
If Zopiclone Grindeks is taken in the late stages of pregnancy or during labour, the baby may show muscle weakness, lowered body temperature, feeding difficulties and breathing problems (respiratory depression).
If this medicine is taken regularly in the late stages 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 must be closely monitored during the postnatal period.
Breastfeeding
Zopiclone passes into breast milk. Do not use Zopiclone Grindeks if you are breastfeeding.
Driving and using machines
You must not drive or operate machinery until the end of treatment with Zopiclone Grindeks, or until it has been established that your ability is not impaired. The effect may also persist into the following day.
The undesirable effects of Zopiclone Grindeks that may affect your ability to drive are:

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

The risk of experiencing one of these effects is higher if you have consumed alcohol or have not slept enough.
Zopiclone Grindeks contains Carmoisine A (Red cochineal A)
The 5 mg film-coated tablet contains carmoisine A (E124), which may cause allergic reactions.
Zopiclone Grindeks contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per tablet, i.e. essentially 'sodium-free'.

3. How to take Zopiclone Grindeks

Take this medicine exactly as directed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
The recommended starting dose for adults is one 5 mg or 7.5 mg tablet taken at bedtime.
For certain patients, such as elderly patients, or if you have kidney, liver or respiratory problems, a lower starting dose of 3.75 mg will be used. If necessary, your doctor may subsequently increase the dose to 5 mg and, if needed, up to 7.5 mg.
The maximum daily dose is 7.5 mg per day.

How to take Zopiclone Grindeks
Take Zopiclone Grindeks immediately before going to bed. Do not take the tablets while lying down, as absorption may be delayed. Make sure you are able to sleep uninterrupted for 7–8 hours.
Swallow the tablet with liquid (e.g. half a glass of water).

Duration of treatment
Treatment with Zopiclone Grindeks should be as short as possible (from a few days to 2 weeks). To reduce the risk of withdrawal symptoms or recurrence of sleep problems when treatment is stopped, your doctor will explain how to gradually reduce the dose at the end of treatment. You must not take Zopiclone Grindeks for more than 4 weeks, including the gradual reduction phase. Consult your doctor if symptoms do not improve within this period.

If you take more Zopiclone Grindeks than you should
If you have taken too many tablets or if, for example, a child has accidentally ingested the medicine, contact your doctor or the nearest emergency department immediately for advice.
Overdose of zopiclone, especially when combined with other agents or medicines that have a calming effect on the central nervous system, can be potentially fatal. This includes alcohol.
Taking too much zopiclone may cause symptoms such as:

• feeling drowsy, confused, or deeply asleep, possibly progressing to coma
• floppy muscles
• dizziness, lightheadedness or weakness due to low blood pressure
• falls or loss of balance
• shallow breathing or difficulty breathing (respiratory depression)

If you forget to take Zopiclone Grindeks
Do not take a double dose to make up for the missed dose.
If you still have time to sleep for 7–8 hours, you should take the dose immediately. If you are unable to sleep through the entire night, skip the missed dose and do not take the next dose until you go to bed the following night.

If you stop taking Zopiclone Grindeks
If you stop taking Zopiclone Grindeks suddenly, your insomnia problems may temporarily return. You may also experience withdrawal symptoms. Withdrawal symptoms include difficulty sleeping, headache, sweating, hallucinations and rapid heartbeat. In more severe and very rare cases, seizures may occur.
The risk of withdrawal symptoms increases with the dose and duration of treatment; therefore, your doctor may provide you with information on how to gradually reduce the 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 everyone gets them.
Stop taking Zopiclone Grindeks and contact your doctor immediately or go to the nearest emergency room if 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; hives and breathing difficulties (angioedema).
• Symptoms of severe allergic reaction: skin rash with itching, swelling of the mouth which may cause difficulty breathing and swallowing, wheezing (anaphylactic reaction).

Other side effects
Common (may affect up to 1 in 10 people):

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

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

• nervous excitement (agitation), nightmares
• feeling unwell (nausea), general discomfort, abdominal pain
• reduced alertness, headache, dizziness
• difficulty getting up in the morning, fatigue (asthenia).

Rare (may affect up to 1 in 1,000 people):

• confusion, irritability, aggression, hallucinations, depression (depression may emerge during treatment with zopiclone), short-term memory loss
• altered sexual desire (libido disorders)
• difficulty breathing
• allergic skin reactions (including skin rash, itching, hives)
• falls (especially in elderly patients).

Very rare (may affect up to 1 in 10,000 people):

• increase in certain liver enzymes observed in blood tests.

Frequency not known (frequency cannot be estimated from the available data):
restlessness, false beliefs, rage, abnormal behaviour (possibly associated with memory loss), sleepwalking or other unusual sleep-related behaviours (such as driving, eating, making a phone call or having sexual intercourse, etc.) while not fully awake
physical and psychological dependence, withdrawal syndrome or rebound insomnia when zopiclone is discontinued
loss of touch with reality (psychosis); this may include seeing or hearing things that are not there and believing things that are not actually true
memory impairment, inability to concentrate, speech disorders
difficulty coordinating certain movements, numbness or tingling in parts of the body
double vision
shallow breathing or difficulty breathing
indigestion, vomiting
muscle weakness

If treatment is stopped abruptly after long-term use, so-called withdrawal symptoms may occur. Withdrawal symptoms may vary and include difficulty sleeping, tremor, sweating, confusion (delirium), headache, palpitations and increased heart rate, nightmares and hallucinations. You may also feel anxious, irritable and disturbed (agitation). In very rare cases, seizures have also occurred.

Reporting of side effects
If you get any side effects, including ones not listed in this leaflet, talk to your doctor, pharmacist or nurse. You can also report side effects directly via the national reporting system: 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 [Brand name]

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.
This medicine does not require any special storage conditions.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Zopiclone Grindeks contains
The active substance in Zopiclone Grindeks is zopiclone. Each tablet contains
3.75 mg, 5 mg or 7.5 mg of zopiclone, respectively.
The other components are:
Tablet core: maize starch, hypromellose (type 2910) (E464), dibasic calcium phosphate (E341),
sodium carboxymethylstarch (type A), microcrystalline cellulose (E460), magnesium stearate (E572).
Film coating of the tablet
5 mg tablets:
Graft copolymer of poly(vinyl alcohol) and polyethylene glycol (E1209), talc (E553b), titanium dioxide (E171),
glycerol monocaprylocaprate (E471), polyvinyl alcohol (E1203), indigo carmine (E132), carmine red A (E124),
quinoline yellow (E104).
3.75 mg and 7.5 mg tablets:
Graft copolymer of poly(vinyl alcohol) and polyethylene glycol (E1209), talc (E553b), titanium dioxide (E171),
glycerol monocaprylocaprate (E471), polyvinyl alcohol (E1203).

Description of the appearance of Zopiclone Grindeks and pack sizes
Zopiclone Grindeks 3.75 mg are film-coated tablets, white, round, biconvex, with smooth surfaces, with a diameter of approximately 5 mm.
Zopiclone Grindeks 5 mg are film-coated tablets, blue, round, biconvex, with smooth surfaces, with a diameter of approximately 6 mm.
Zopiclone Grindeks 7.5 mg are film-coated tablets, white, round, convex on one side and with a score line on the other, with smooth surfaces, with a diameter of approximately 7 mm. The tablet can be divided into 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.

Marketing Authorisation Holder and Manufacturer
AS GRINDEKS
Krustpils iela 53,
Rīga, LV-1057,
Latvia
Telephone: +371 67083205
e-mail: [email protected]

This medicinal product is authorised in the European Economic Area countries under the following names:
Sweden Zopiclone Grindeks 3.75 mg, 5 mg, 7.5 mg film-coated tablets
Austria Zopiclon Grindeks 3.75 mg, 5 mg, 7.5 mg Filmtabletten
Belgium Zopiclone Grindeks 3.75 mg, 5 mg, 7.5 mg comprimés pelliculés
Bulgaria Зопиклон Гриндекс 3,75 mg, 5 mg, 7,5 mg филмирани таблетки
Zopiclone Grindeks 3.75 mg, 5 mg, 7.5 mg film-coated tablets
Croatia Zopiklon Grindeks 3.75 mg filmom obložene tablete
Zopiklon Grindeks 5 mg filmom obložene tablete
Zopiklon Grindeks 7.5 mg filmom obložene tablete
Czech Republic Zopiclone Grindeks
Denmark Somnols 3.75 mg, 5 mg, 7.5 mg filmovertrukne tabletter
Estonia Zopiclone Baltijos Bite
Finland Zopiclone Grindeks 3.75 mg, 5 mg, 7.5 mg tabletti, kalvopäällysteinen
France ZOPICLONE GRINDEKS 3.75 mg, comprimé pelliculé
ZOPICLONE GRINDEKS 5 mg, comprimé pelliculé
ZOPICLONE GRINDEKS 7.5 mg, comprimé pelliculé sécable
Germany Zopiclon Grindeks 3.75 mg, 5 mg, 7.5 mg Filmtabletten
Greece Zopiclone/Baltijos Bite 3.75 mg, 5 mg, 7.5 mg επικαλυμμένα με λεπτό υμένιο δισκία
Hungary Zopiclone Grindeks 3.75 mg, 5 mg, 7.5 mg filmtabletta
Ireland Zopiclone Grindeks 3.75 mg, 5 mg, 7.5 mg film-coated tablets
Italy Zopiclone Grindeks
Latvia Zopiclone Baltijos Bite 3.75 mg, 5 mg, 7.5 mg apvalkotās tabletes
Lithuania Zopiclone Baltijos Bite 3.75 mg plėvele dengtos tabletės
Zopiclone Baltijos Bite 5 mg plėvele dengtos tabletės
Zopiclone Baltijos Bite 7.5 mg plėvele dengtos tabletės
Luxembourg Zopiclone Grindeks 3.75 mg, 5 mg, 7.5 mg filmbeschichtete Pëllen
Netherlands Zopiclon Grindeks 3.75 mg filmomhulde tabletten
Zopiclon Grindeks 5 mg filmomhulde tabletten
Zopiclon Grindeks 7.5 mg filmomhulde tabletten
Norway Sonlax
Poland Zopiclone Baltijos Bite
Portugal Zopiclona Grindeks 3.75 mg, 5 mg, 7.5 mg comprimidos revestidos por película
Romania Zopiclonă Baltijos Bite 3.75 mg, 5 mg, 7.5 mg comprimate filmate
Slovakia Zopiclone Baltijos Bite 3.75 mg, 5 mg, 7.5 mg filmom obalené tablety
Slovenia Zopiklon Grindeks 3.75 mg, 5 mg, 7.5 mg filmsko obložene tablete
Spain Zopiclona Grindeks 3.75 mg, 5 mg, 7.5 mg comprimidos recubiertos con película EFG