Zopiclone Baltiios Bitė

Package Leaflet: Information for the User

Zopiclone Baltijos Bitė, 3.75 mg, film-coated tablets

Zopiclone Baltijos Bitė, 5 mg, film-coated tablets

Zopiclone Baltijos Bitė, 7.5 mg, film-coated tablets

Zopiclone

Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this package 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 symptoms are the same as yours.
• If you experience any side effects, including those not listed in this package leaflet, please inform your doctor or pharmacist. See section 4.

Package Leaflet Contents

• 1. What is Zopiclone Baltijos Bitė and what is it used for
• 2. Important information before taking Zopiclone Baltijos Bitė
• 3. How to take Zopiclone Baltijos Bitė
• 4. Possible side effects
• 5. How to store Zopiclone Baltijos Bitė
• 6. Contents of the pack and other information

1. What is Zopiclone Baltijos Bitė and what is it used for

Zopiclone Baltijos Bitė is a sleeping tablet containing the active substance zopiclone. It is used in adults as a sleeping aid for various sleep disorders, such as difficulty falling asleep, waking up too early, or having too many awakenings during the night. Zopiclone Baltijos Bitė is used for the short-term treatment of sleep disorders.

Zopiclone Baltijos Bitė will only be prescribed if the sleep disorder is severe, causes significant distress, or impairs normal daily functioning, or if the patient is exhausted.

2. Important information before taking Zopiclone Baltijos Bitė

When not to take Zopiclone Baltijos Bitė

• 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 (sleep disorder with temporary breathing pauses during sleep);
• myasthenia gravis (a chronic autoimmune disease that causes muscle weakness);
• severe breathing difficulties (severe respiratory failure).
• if you have ever experienced sleepwalking or other unusual behavior (such as driving, eating, talking on the phone, or having sex, etc.) while taking zopiclone and not being fully awake.

Warnings and precautions

General
Before taking Zopiclone Baltijos Bitė, discuss it with your doctor or pharmacist.
Before starting treatment with Zopiclone Baltijos Bitė, the cause of the sleep disorder should be investigated and treated if possible.
Tell your doctor if you have or have had any medical condition or disease, especially if you have any of the following symptoms:

• liver or kidney problems;
• breathing difficulties;
• depression or anxiety disorders;
• a history of alcohol, drug, or medication abuse;
• if you have taken Zopiclone Baltijos Bitė or similar medicines for more than 4 weeks. Your doctor will decide whether you should take Zopiclone Baltijos Bitė and adjust the dose if necessary. You will also be closely monitored during treatment.

Dependence and withdrawal symptoms
Taking medicines like Zopiclone Baltijos Bitė can lead to physical or psychological dependence or abuse. The risk of dependence increases with the dose and duration of treatment. This risk is also higher in patients who have abused alcohol, drugs, or medications in the past and (or) have personality disorders.
If physical dependence occurs, sudden withdrawal of the medicine may lead to withdrawal symptoms, such as insomnia, headache, muscle pain, extreme anxiety, tension, restlessness, disorientation, and irritability. In severe cases, the following symptoms may occur:
changed perception of the world, making it seem unusual or unreal, loss of identity, and then a feeling of unreality and strangeness, hypersensitivity to sound, numbness and tingling of hands and feet, hypersensitivity to light, noise, or physical contact, seeing, hearing, or feeling things that do not exist (hallucinations), and seizures.
Rebound insomnia after withdrawal of treatment (rebound insomnia)
If treatment is stopped suddenly after long-term use, it may lead to insomnia for several nights. This is a temporary syndrome called "rebound insomnia". To avoid withdrawal problems after long-term treatment, it is recommended to gradually reduce the dose. See also the section on side effects.
Tolerance
The effect of Zopiclone Baltijos Bitė may decrease if the medicine is taken repeatedly for several weeks. This phenomenon is called tolerance. If you feel that the effect of Zopiclone Baltijos Bitė is decreasing, talk to your doctor.
Anterograde amnesia (short-term memory loss)
Zopiclone Baltijos Bitė may cause short-term memory loss, especially a few hours after taking the tablet. To minimize this risk, take Zopiclone Baltijos Bitė immediately before or after going to bed and make sure you have 7-8 hours of uninterrupted sleep.
Psychological reactions and "paradoxical reactions"
During treatment with Zopiclone Baltijos Bitė, certain psychological reactions may occur, such as anxiety and agitation, nightmares, irritability, aggression, inappropriate behavior, hallucinations (seeing and hearing things that are not real), confusion, and concentration difficulties.
Somnambulism (sleepwalking) and similar behaviors
In patients taking zopiclone and not being fully awake, there have been reports of sleepwalking and other related behaviors, such as "sleep-driving", preparing and eating food, or talking on the phone while asleep, with no memory of the event.
The risk of such behaviors increases if Zopiclone Baltijos Bitė is taken with alcohol or certain other specific medicines (e.g., opioid painkillers, antipsychotics, sedatives, or anxiolytics).
The risk also increases if Zopiclone Baltijos Bitė is taken in higher doses than the recommended maximum dose.
If you experience any of the above symptoms, contact your doctor immediately.
Depression/suicidal thoughts
This medicine is not intended for the treatment of depression. If you experience depression, your doctor will prescribe appropriate treatment. Untreated depression can worsen, become persistent, or increase the risk of suicide.
Some studies have shown an increased risk of suicidal thoughts, attempted suicide, and suicide in patients taking certain sedatives and sleeping pills, including this medicine. However, it is not established whether this is due to the medicine or other factors. If you experience suicidal thoughts, contact your doctor as soon as possible for medical advice.

Children and adolescents

Zopiclone Baltijos Bitė 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.

Zopiclone Baltijos Bitė with other medicines

The effect of treatment may be influenced by taking Zopiclone Baltijos Bitė with certain other medicines, which means that the dose of Zopiclone Baltijos Bitė may need to be adjusted.
Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or might take. In particular, any of the following medicines:

• medicines for certain mental disorders (antipsychotics/neuroleptics);
• sleeping pills (sedatives);
• medicines for anxiety (anxiolytics);
• medicines for depression (antidepressants);
• strong opioid painkillers, such as morphine and morphine-like substances;
• medicines used in surgery (anesthetics);
• medicines for allergies (antihistamines);
• certain medicines for bacterial and fungal infections, such as erythromycin or itraconazole;
• medicines for HIV infection;
• medicines for epilepsy, such as phenytoin, phenobarbital, and carbamazepine;
• medicines for tuberculosis (e.g., rifampicin);
• medicines containing St. John's Wort (traditional herbal medicine).

Taking Zopiclone Baltijos Bitė with opioids (strong painkillers, substitution therapy, and some cough medicines) increases the risk of drowsiness, breathing difficulties (respiratory depression), coma, and can be life-threatening. Therefore, concurrent use should only be considered if other treatment options are not possible.
If your doctor prescribes Zopiclone Baltijos Bitė with opioids, the dose and duration of concurrent treatment should be limited by your doctor.
Tell your doctor about all opioid medicines you are taking and follow your doctor's dosage instructions carefully. It may be helpful to inform friends or relatives to be aware of the signs and symptoms mentioned above. If such symptoms occur, contact your doctor.

Zopiclone Baltijos Bitė with food and alcohol

Avoid drinking alcohol while taking Zopiclone Baltijos Bitė, as alcohol may enhance the effect of Zopiclone Baltijos Bitė. This effect may last until the next morning, which may adversely affect your ability to drive or operate machinery.
Avoid drinking grapefruit juice while taking Zopiclone Baltijos Bitė. Grapefruit may enhance the effect of Zopiclone Baltijos Bitė.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
Zopiclone Baltijos Bitė should not be used during pregnancy, as it passes through the placenta.
If used during pregnancy, there is a risk of disorders in the baby. Some studies have shown that there may be an increased risk of cleft lip and palate in the newborn.
Reduced fetal movement and fetal heart rate variability may occur after taking Zopiclone Baltijos Bitė in the second and/or third trimester of pregnancy.
If Zopiclone Baltijos Bitė is taken at the end of pregnancy or during childbirth, the baby may experience muscle weakness, low body temperature, feeding difficulties, and breathing problems (respiratory depression).
If Zopiclone Baltijos Bitė is taken regularly in late pregnancy, the baby may develop physical dependence and may be at risk of withdrawal symptoms, such as agitation or tremors. In such cases, the newborn should be closely monitored in the postnatal period.
Breastfeeding
Zopiclone passes into breast milk. You should not take Zopiclone Baltijos Bitė if you are breastfeeding.

Driving and using machines

Do not drive or operate machinery until you have stopped taking Zopiclone Baltijos Bitė or until your doctor has confirmed that your ability to drive is not impaired. The effect may also last until the next day.
The side effects of Zopiclone Baltijos Bitė that may affect your ability to drive include:

• next-day drowsiness (residual sedation);
• dizziness;
• memory loss (anterograde amnesia);
• reduced concentration.

The risk of these side effects is higher if you drink alcohol and do not get enough sleep.

Zopiclone Baltijos Bitė contains Allura Red AC

The 5 mg film-coated tablet contains Allura Red AC (E 124), which may cause allergic reactions.

Zopiclone Baltijos Bitė contains sodium

This medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means it is essentially 'sodium-free'.

3. How to take Zopiclone Baltijos Bitė

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.
The recommended initial dose for adults is one 5 mg or 7.5 mg tablet taken before bedtime.
In some patients, such as the elderly or those with kidney, liver, or breathing problems, a lower initial dose of 3.75 mg may be used. Your doctor may later increase the dose to 5 mg, and if necessary, to 7.5 mg.
The maximum daily dose is 7.5 mg per day.
How to take Zopiclone Baltijos Bitė
Take Zopiclone Baltijos Bitė immediately before going to bed. Do not take the tablets while lying down, as this may slow down their absorption. Ensure you have 7-8 hours of uninterrupted sleep. Swallow the tablet with a drink of water (e.g., a glass of water).
Duration of treatment
Treatment with Zopiclone Baltijos Bitė should be as short as possible (from a few days to 2 weeks). To minimize the risk of withdrawal symptoms or rebound insomnia after stopping treatment, your doctor will explain how to gradually reduce the dose at the end of treatment (so-called dose tapering). Do not take Zopiclone Baltijos Bitė for longer than 4 weeks, including the dose tapering period. If your symptoms do not improve within this period, consult your doctor.

If you take more Zopiclone Baltijos Bitė than you should

If you have taken too many tablets or, for example, a child has accidentally swallowed some, contact your doctor or the nearest hospital emergency department immediately for advice.
Overdose of zopiclone combined with certain substances or medicines that have a depressant effect on the central nervous system may be life-threatening. This includes alcohol.
Taking too much zopiclone may cause symptoms such as:

• drowsiness, disorientation, deep sleep, and possible coma;
• muscle weakness;
• dizziness, drowsiness, or fainting. These effects are caused by low blood pressure;
• stumbling or loss of balance;
• shallow breathing or difficulty breathing (respiratory depression).

If you forget to take Zopiclone Baltijos Bitė

Do not take a double dose to make up for a forgotten dose.
If you can sleep for 7-8 hours, take the dose as soon as you remember. If you cannot sleep for a full night, skip the missed dose and take the next dose at bedtime as usual.

Stopping treatment with Zopiclone Baltijos Bitė

If you stop taking Zopiclone Baltijos Bitė suddenly, your sleep problems may return for a while. You may also experience withdrawal symptoms. Withdrawal symptoms include difficulty sleeping, tremors, sweating, hallucinations, and rapid heartbeat. You may also feel anxious, agitated, or irritable (agitation).
In rare cases, seizures may occur.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Zopiclone Baltijos Bitė can cause side effects, although not everybody gets them.
If you experience any of the following symptoms (very rare, may affect up to 1 in 10,000 people), stop taking Zopiclone Baltijos Bitė and contact your doctor or go to the nearest hospital emergency department immediately:

• swelling of the face, tongue, or throat; difficulty swallowing; hives and difficulty breathing (angioedema).
• symptoms of a severe allergic reaction: itching rash, swelling of the mouth, which can cause breathing or swallowing difficulties, 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):

• restlessness (agitation), nightmares;
• nausea (vomiting), malaise, stomach 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 (existing depression may be revealed during zopiclone treatment), short-term memory loss;
• change in libido (sexual desire);
• breathing difficulties;
• allergic skin reactions (including rash, itching, hives);
• falls (mainly in elderly patients).

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

• increased liver enzymes observed in blood tests.

Frequency not known (cannot be estimated from the available data)
anxiety,
delusions,
anger,
inappropriate
behavior
(possibly
related
to anterograde amnesia), sleepwalking or other unusual behavior (such as driving, eating, talking on the phone, or having sex, etc.) while not being fully awake;
physical and psychological dependence, withdrawal syndrome, or rebound insomnia after stopping zopiclone;
loss of contact with reality (psychosis); this may include seeing or hearing things that cannot be seen or heard and believing in things that are not true;
memory disorders, inability to concentrate, speech disorders;
difficulty coordinating certain movements, numbness or tingling in certain parts of the body;
double vision;
shallow breathing or difficulty breathing;
nausea, vomiting;
muscle weakness.
If treatment is stopped suddenly after long-term use, withdrawal symptoms may occur. Withdrawal symptoms are varied and include difficulty sleeping, tremors, sweating, hallucinations, and rapid heartbeat. You may also feel anxious, agitated, or irritable (agitation).
In very rare cases, seizures may occur.

Reporting side effects

If you experience any side effects, including those not listed in this package leaflet, please inform your doctor, pharmacist, or nurse. You can also report side effects directly to the Pharmacovigilance Department of the Medicinal Products Agency (contact details below). By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Zopiclone Baltijos Bitė

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton after "EXP". The expiry date refers to the last day of that month.
There are no special storage instructions for this medicine.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Zopiclone Baltijos Bitė contains

The active substance of Zopiclone Baltijos Bitė is zopiclone. Each tablet contains 3.75 mg, 5 mg, or 7.5 mg of zopiclone.
Other ingredients are:

Tablet core: cornstarch, hypromellose (type 2910) (E 464), calcium hydrogen phosphate (E 341), sodium starch glycolate (type A), microcrystalline cellulose (E 460), magnesium stearate (E 572)
Tablet coating

5 mg tablets:

Macrogol copolymer (type E 1209), talc (E 553b), titanium dioxide (E 171), glycerol monocaprylate (E 471), polyvinyl alcohol (E 1203), indigo carmine (E 132), Allura Red AC (E 124), quinoline yellow (E 104)

3.75 mg and 7.5 mg tablets:

Macrogol copolymer (type E 1209), talc (E 553b), titanium dioxide (E 171), glycerol monocaprylate (E 471), polyvinyl alcohol (E 1203)

What Zopiclone Baltijos Bitė looks like and contents of the pack

Zopiclone Baltijos Bitė 3.75 mg is a white, round, biconvex film-coated tablet with a smooth surface; the diameter of the tablet is about 5 mm.
Zopiclone Baltijos Bitė 5 mg is a blue, round, biconvex film-coated tablet with a smooth surface; the diameter of the tablet is about 6 mm.
Zopiclone Baltijos Bitė 7.5 mg is a white, round film-coated tablet, convex on one side and with a break line on the other, with a smooth surface; the diameter of the tablet is about 7 mm. The tablet can be divided into equal doses.
Zopiclone Baltijos Bitė is available in blisters of PVC/PVDC/Aluminum containing 10, 20, 30, or 100 film-coated tablets.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

UAB Baltijos Bitė
Ramybės g. 49,
Kaunas, LT-47163,
Lithuania
Phone: +370 37 204896
Email: bite@baltijosbite.com

Manufacturer

AS GRINDEKS
Krustpils iela 53,
Rīga, LV-1057,
Latvia

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

Data of last revision of the package leaflet: