Zopiclone Baltiios Bitė

Leaflet accompanying the packaging: information for the user

Zopiclone Baltijos Bitė, 3.75 mg, coated tablets

Zopiclone Baltijos Bitė, 5 mg, coated tablets

Zopiclone Baltijos Bitė, 7.5 mg, coated tablets

Zopiclone

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

• Keep this leaflet, you may need to read it again.
• In case of any doubts, consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 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 packaging and other information

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

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

Zopiclone Baltijos Bitė will only be prescribed if the sleep problem is significant, there is a disability or a condition causing severe exhaustion in the patient.

2. Important information before taking Zopiclone Baltijos Bitė

When not to take Zopiclone Baltijos Bitė

• severe liver disease;
• sleep apnea syndrome (sleep disorders with temporary breathing pauses during sleep);
• significant muscle weakness called myasthenia (an autoimmune disease);
• significant breathing difficulties (severe respiratory failure).

Warnings and precautions

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

• liver or kidney problems;
• breathing problems;
• depression or anxiety related to depression;
• history of alcohol, drug, or medication abuse;
• if you have recently taken Zopiclone Baltijos Bitė or other similar medicines for a period longer than 4 weeks. Your doctor will decide whether you should take Zopiclone Baltijos Bitė or not, or adjust the dose. 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 of these medicines. 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 significant personality disorders.
If physical dependence occurs, sudden cessation of treatment 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:
change in perception of the world, so that it seems unusual or unreal, loss of one's own identity, and then a feeling of unreality and alienation, 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 actually exist (hallucinations), and seizures.
Rebound insomnia after stopping treatment (rebound insomnia)
If treatment is stopped suddenly after long-term use, it can sometimes 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. You should talk to your doctor if you feel that the effect of Zopiclone Baltijos Bitė is decreasing.
Short-term memory loss, so-called anterograde amnesia
Zopiclone Baltijos Bitė may cause short-term memory loss, especially a few hours after taking the tablet. To reduce this risk, Zopiclone Baltijos Bitė should be taken immediately before or after going to bed and ensuring uninterrupted sleep for 7-8 hours.
Psychological reactions and "paradoxical reactions"
During treatment with Zopiclone Baltijos Bitė, certain psychological reactions may occur, such as anxiety and anxiety, nightmares, irritability, aggression, inappropriate behavior, hallucinations (seeing and hearing things that are not true), confusion, and concentration difficulties.
Sleepwalking, somnambulism, and similar behaviors
In patients who have taken zopiclone and have not been fully awake, there have been reports of sleepwalking and other related behaviors, such as "sleep driving", preparing and eating food, or making phone calls while sleeping, with loss of memory of the event.
The risk of such behaviors increases if Zopiclone Baltijos Bitė is combined with alcohol or certain other specific medicines (e.g., painkillers from the opioid group, antipsychotic medicines, sleeping pills, or anxiolytic/sedative medicines).
The risk also increases if Zopiclone Baltijos Bitė is taken in doses higher than the maximum recommended dose.
In case of any of the above symptoms, you should contact your doctor immediately.
Depression/suicidal thoughts
This medicine is not intended for the treatment of depression. If depression occurs, the doctor will prescribe appropriate treatment. Untreated depression may worsen, become persistent, or increase the risk of suicide.
Some studies have shown an increased risk of suicidal thoughts, suicide attempts, and suicides in patients taking certain sedative and sleeping pills, including this medicine. However, it has not been established whether this is due to the effect of the medicine or other reasons. If you have suicidal thoughts, you should 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 patients who get up at night.

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 and other medicines

The effect of treatment may be affected by taking Zopiclone Baltijos Bitė at the same time as 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 currently taking or have recently taken, as well as any medicines you plan to take. In particular, any of the following medicines:

• medicines for certain mental disorders (antipsychotic/neuroleptic medicines);
• sleeping pills (sedatives);
• medicines used to treat anxiety (anxiolytics);
• medicines used to calm (sedatives);
• medicines used to treat depression (antidepressants);
• strong painkillers from the opioid group, such as morphine and morphine-like substances;
• medicines used in surgery (anesthetics);
• medicines used to treat allergies (antihistamines);
• certain 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);
• medicines containing St. John's Wort (herbal medicine).

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

Zopiclone Baltijos Bitė with food and alcohol

Avoid consuming 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 the ability to drive vehicles or operate machinery.
Avoid consuming grapefruits and 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 child, consult your doctor or pharmacist before using 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 child. Some studies have shown that there may be an increased risk of cleft lip and palate in the newborn.
Decreased 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 child may experience muscle weakness, low body temperature, feeding difficulties, and breathing problems (respiratory depression).
If the medicine is taken regularly in the late stages of pregnancy, the child 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 finished treatment with Zopiclone Baltijos Bitė or until it has been determined 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:

• fatigue and drowsiness the next day (residual sedation);
• dizziness;
• memory loss (anterograde amnesia);
• reduced ability to concentrate.

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

Zopiclone Baltijos Bitė contains Allura Red AC

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

Zopiclone Baltijos Bitė contains sodium

The medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means that the medicine is considered "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 patients 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 their absorption by the body may be slowed down. Ensure uninterrupted sleep for 7-8 hours. Swallow the tablet with a liquid (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 reduce the risk of withdrawal symptoms or recurring sleep problems 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 period of gradual dose reduction. If your symptoms do not improve within this period, consult your doctor.

Taking a higher dose of Zopiclone Baltijos Bitė than recommended

In case of taking too many tablets or, for example, accidental ingestion by a child, contact your doctor or the nearest hospital emergency department immediately for advice.
Overdose of zopiclone in combination with certain agents or medicines with a depressant effect on the central nervous system can be life-threatening. This also applies to alcohol.
Taking too high a dose of zopiclone may cause symptoms such as:

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

Missing a dose of Zopiclone Baltijos Bitė

Do not take a double dose to make up for a missed dose.
If you have the opportunity to sleep for 7-8 hours, you should take the dose immediately. If you do not have the opportunity to sleep all night, skip the missed dose and take a new dose only when you go to bed the next night.

Stopping treatment with Zopiclone Baltijos Bitė

In case of sudden cessation of treatment with Zopiclone Baltijos Bitė, sleep problems may return for a while. Withdrawal symptoms may also occur. Withdrawal symptoms include difficulty falling asleep, headaches, sweating, hallucinations, and rapid heartbeat. In severe cases, seizures may occur.
The risk of withdrawal symptoms increases with the dose and duration of treatment, so your doctor may provide information on gradual dose reduction.
In case of any further doubts about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
In case of 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 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 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):

• restlessness (agitation), nightmares;
• nausea (nausea), malaise, 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 (existing depression may be revealed during zopiclone treatment), short-term memory loss;
• change in sexual desire (libido disorders);
• 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):

• increase in some liver enzymes observed in blood tests.

Frequency not known (cannot be estimated from the available data)
anxiety,
delusions,
anger,
inappropriate
behavior
(probably
related
to amnesia), sleepwalking or other unusual behavior (such as driving, eating, making phone calls, or having sex, etc.) while not 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 actually true;
memory disorders, inability to concentrate, speech disorders;
difficulty coordinating some movements, numbness, or tingling in some parts of the body;
double vision;
shallow breathing or difficulty breathing;
nausea, vomiting;
muscle weakness.
If treatment is stopped suddenly after long-term treatment, so-called withdrawal symptoms may occur. Withdrawal symptoms are varied and include difficulty falling asleep, tremors, sweating, disorientation (confusion), headaches, rapid heartbeat, and accelerated heart rate, nightmares, and hallucinations. The patient may also feel anxiety, irritability, and agitation.
In very rare cases, seizures may occur.

Reporting side effects

If you experience any side effects, including any side effects not listed in this leaflet, tell your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products: Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl.
Side effects can also be reported to the marketing authorization holder.
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 the month.
There are no special precautions for storage.
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 packaging 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:
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)
Coating
5 mg tablets:
macrogol copolymer, polyvinyl alcohol (E 1209), talc (E 553b), titanium dioxide (E 171), monokaprylokaprynian glycerol (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, polyvinyl alcohol (E 1209), talc (E 553b), titanium dioxide (E 171), monokaprylokapronian glycerol (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, 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, 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, coated tablet, convex on one side and with a recess and a dividing line on the other side, 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 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
Tel. +370 37 204896
e-mail: 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:

Date of last revision of the leaflet: