Zopiclone baltijos bite

Package leaflet: 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
Zopiclonum
Please read all of this 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 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 any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of the leaflet

1. What Zopiclone Baltijos Bitė is and what it is used for
2. Before you take 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 Zopiclone Baltijos Bitė is and what it is used for

Zopiclone Baltijos Bitė is a sleeping tablet containing the active substance zopiclone. It is used
in adults as a sleeping medicine for various sleep problems, such as difficulty falling asleep, waking
up too early, or excessive number of awakenings during the night. Zopiclone Baltijos Bitė is used
to treat short-term sleep disorders.
Zopiclone Baltijos Bitė will be prescribed only when the sleep problem is significant, causing
inability to function properly or resulting in severe exhaustion of the patient.

2. Before you take 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 apnoea syndrome (sleep disorder with temporary breathing interruptions during sleep);
  • significant muscle weakness called myasthenia (autoimmune disease);
  • significant breathing difficulties (severe respiratory insufficiency);
• if you have ever experienced sleepwalking or other unusual behaviour (such as driving, eating, making phone calls or having sexual intercourse, etc.) while not fully awake after taking zopiclone.

Warnings and precautions
General
Before starting to take Zopiclone Baltijos Bitė, discuss this with your doctor or
pharmacist.
Before starting treatment with Zopiclone Baltijos Bitė, the cause of sleep problems should be investigated and any underlying medical conditions treated.
Inform your doctor if you have or have had any illness or medical condition, especially if you have any of the following:

• liver or kidney problems;
• breathing problems;
• worsening of general well-being;
• are elderly (medicines stay in the body longer in older people);
• depression or anxiety states related to depression;
• history of alcohol, drug or medicine abuse;
• have recently taken Zopiclone Baltijos Bitė or other similar medicines for 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
Medicines such as Zopiclone Baltijos Bitė may lead to physical or psychological dependence or misuse. The risk of dependence increases with higher doses and longer duration of treatment. This risk is also higher in patients with a history of alcohol, drug or medicine abuse and (or) in patients with marked personality disorders.
If physical dependence occurs, abruptly stopping treatment may lead to withdrawal symptoms such as: insomnia, headache, muscle pain, extreme anxiety, tension, motor restlessness, disorientation and irritability. In severe cases, the following symptoms may occur: altered perception of the world, making it seem unusual or unreal, loss of personal identity, followed by feelings of unreality and detachment, hypersensitivity to sound, numbness and tingling in hands and feet, hypersensitivity to light, noise or physical contact, seeing, hearing or feeling things that are not real (hallucinations), and seizures.

Rebound insomnia after stopping treatment (rebound insomnia)
If treatment is stopped abruptly after prolonged use, it may sometimes lead to insomnia for several nights. This is a temporary condition called "rebound insomnia". To avoid problems related to stopping the medicine after long-term treatment, gradual dose reduction is recommended. 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. 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, take Zopiclone Baltijos Bitė just before or after going to bed and ensure that uninterrupted sleep lasts 7–8 hours.

Psychiatric reactions and "paradoxical reactions"
While taking Zopiclone Baltijos Bitė, certain psychiatric reactions may occur, such as anxiety and restlessness, nightmares, irritability, aggression, inappropriate behaviour, hallucinations (seeing and hearing things that are not real), confusion and difficulty concentrating.

Sleepwalking, so-called somnambulism and similar behaviours
Cases of sleepwalking and other related behaviours have been reported in patients taking zopiclone who were not fully awake, such as "driving while asleep", preparing and eating food or making phone calls during sleep, with loss of memory of the event.
The risk of such behaviours increases if Zopiclone Baltijos Bitė is taken together with alcohol or certain other specific medicines (e.g. opioid painkillers, antipsychotics, sleeping or anxiolytic/sedative medicines).
The risk also increases if Zopiclone Baltijos Bitė is taken at doses higher than the maximum recommended dose.
If any of the above symptoms occur, contact your doctor immediately.

Depression/suicidal thoughts
This medicine is not intended for the treatment of depression. If depression occurs, your 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 medicines, including this medicine. However, it has not been established whether this is due to the effect of the medicine or other causes. If you have suicidal thoughts, contact your doctor as soon as possible for medical advice.

Fall risk
Due to the muscle-relaxing effect of zopiclone, there is a risk of falling, especially in elderly people who get up at night.

Children and adolescents
Zopiclone Baltijos Bitė must not be used in children and adolescents under 18 years of age. The safety and efficacy of zopiclone have not been established in children and adolescents under 18 years of age.

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 may mean that the dose of Zopiclone Baltijos Bitė needs 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, mention any of the following medicines:

• medicines for certain mental disorders (antipsychotics/neuroleptics);
• sleeping tablets (sleeping medicines);
• medicines used to treat anxiety (anxiolytics);
• medicines used to calm (sedatives);
• medicines used to treat depression (antidepressants);
• strong opioid painkillers, e.g. morphine and morphine-like substances;
• medicines used in surgery (anaesthetics);
• 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 (traditional herbal medicine).

Concomitant use of Zopiclone Baltijos Bitė and opioids (strong painkillers, medicines used in substitution treatment and some antitussive medicines) increases the risk of drowsiness, breathing difficulties (respiratory depression), coma and may be life-threatening. Therefore, concomitant use should only be considered when other treatment options are not possible.
If your doctor prescribes Zopiclone Baltijos Bitė together with opioids, the dose and duration of concomitant treatment should be limited by your doctor.
Inform your doctor about all opioid medicines you are taking and strictly follow your doctor's dosing instructions. It may be helpful to inform friends or relatives about the signs and symptoms listed above. Contact your doctor if such symptoms occur.

Zopiclone Baltijos Bitė with food and alcohol
Avoid drinking alcohol while taking Zopiclone Baltijos Bitė, as alcohol may intensify 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 eating grapefruit or drinking grapefruit juice while taking Zopiclone Baltijos Bitė. Grapefruit may intensify the effect of Zopiclone Baltijos Bitė.

Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a child, you should consult your doctor or pharmacist before using this medicine.

Pregnancy
Use of Zopiclone Baltijos Bitė during pregnancy is not recommended, as it crosses the placenta.
When 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.
Reduced fetal movements and changes in fetal heart rate may occur after taking Zopiclone Baltijos Bitė in the second and (or) third trimester of pregnancy.
If Zopiclone Baltijos Bitė is taken towards the end of pregnancy or during delivery, the child may experience muscle weakness, low body temperature, feeding difficulties and breathing problems (respiratory depression).
If the medicine is taken regularly in late pregnancy, the child may develop physical dependence and may experience withdrawal symptoms such as agitation or tremors. In such cases, the newborn should be closely monitored in the postnatal period.

Breastfeeding
Zopiclone passes into human milk. Do not use Zopiclone Baltijos Bitė if you are breastfeeding.

Driving and using machines
Do not drive or operate machinery until your treatment with Zopiclone Baltijos Bitė is completed or until you have determined that your ability to drive is not impaired. The effect may also persist into the next day.
Adverse effects of Zopiclone Baltijos Bitė that may affect your ability to drive include:

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

The risk of these adverse effects is higher if alcohol is consumed or if sleep duration is insufficient.

Zopiclone Baltijos Bitė contains Carmoisine A
The 5 mg coated tablet contains Carmoisine A (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, meaning the medicine is considered "sodium-free".

3. How to take Zopiclone Baltijos Bitė

This medicine should always be taken exactly as directed by your doctor or pharmacist.
If in doubt, consult your doctor or pharmacist.
The recommended starting dose for adults is one 5 mg or 7.5 mg tablet taken before
sleep.
In certain patients, such as elderly patients or those with kidney, liver or respiratory
problems, a lower starting dose of 3.75 mg will 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 just before going to bed. Do not take the tablets while lying down, as absorption may be delayed. Ensure an uninterrupted sleep of 7–8 hours. Swallow the tablet whole with 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 recurrence of sleep problems after stopping treatment, your doctor will explain how to gradually reduce the dose towards 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 symptoms do not improve within this time, consult your doctor.

Taking more than the recommended dose of Zopiclone Baltijos Bitė
If too many tablets have been taken, or if the medicine has been accidentally swallowed by a child, contact your doctor or the nearest hospital emergency department immediately for advice.
Overdose of zopiclone in combination with certain other drugs or medicines that depress the central nervous system may 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, lightheadedness or fainting. These effects are due to 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 the patient has the opportunity to sleep for 7 to 8 hours, the missed dose should be taken immediately. If there is no possibility of sleeping through the night, the missed dose should be skipped and the next dose taken only when going to bed the following night.

Stopping Zopiclone Baltijos Bitė
If Zopiclone Baltijos Bitė is stopped abruptly, sleep problems may return temporarily. Withdrawal symptoms may also occur. Withdrawal symptoms include difficulty falling asleep, 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 instructions on gradually reducing the dose.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like any medicine, this medicine can cause adverse reactions, although they do not occur in everyone.
If any of the following symptoms occur (very rare, may affect up to
1 in 10,000 people), discontinue use of Zopiclone Baltijos Bitė and immediately
contact a doctor or go to the nearest emergency department:

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

Other adverse reactions
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 agitation (agitation), nightmares;
• 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 become apparent during treatment with zopiclone), short-term memory loss;
• change in sexual desire (libido disorders);
• breathing difficulties;
• allergic skin reactions (including rash, itching, urticaria);
• falls (mainly in elderly patients).

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

• increased levels of certain liver enzymes observed in blood tests.

Frequency unknown (cannot be estimated from available data)
anxiety, delusions, anger, inappropriate behaviour (possibly related to memory loss),
sleepwalking or other unusual behaviours (such as driving, eating,
making phone calls or having sexual intercourse, etc.) while the patient is not fully awake;
physical and psychological dependence, withdrawal syndrome or rebound insomnia after discontinuation
of 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 in reality;
memory disturbances, inability to concentrate, speech disorders;
difficulty coordinating certain movements, numbness or tingling in certain parts of
the body;
double vision;
shallow breathing or breathing difficulties;
indigestion, vomiting;
muscle weakness.
If treatment is suddenly stopped after long-term use, so-called withdrawal symptoms may occur. Withdrawal symptoms vary and include difficulty sleeping, tremor, sweating, disorientation (delirium), headache, palpitations and increased heart rate, nightmares and hallucinations. The patient may also experience anxiety, irritability and agitation.
In very rare cases, seizures may occur.
Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed
in this leaflet, tell your doctor, pharmacist or nurse. Adverse reactions
can be reported directly to the Department of Monitoring Adverse Drug Reactions 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.
Adverse reactions can also be reported to the responsible entity.
By reporting adverse reactions, additional information on the safety of the medicine can be collected.

5. How to store the medicine Zopiclone Baltijos Bite

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the pack after "EXP". The expiry date refers to the last day of the mentioned month.
There are no special storage instructions for this medicine.
Medicines must 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 in Zopiclone Baltijos Bitė is zopiclone. Each tablet contains 3.75 mg, 5 mg, or 7.5 mg of zopiclone, respectively.
The other ingredients are:
Tablet core:
Corn starch, 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:
Polyglycol graft copolymer 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), carmine red A (E 124), quinoline yellow (E 104)
3.75 mg and 7.5 mg tablets:
Polyglycol graft copolymer poly(vinyl alcohol) (E 1209), talc (E 553b), titanium dioxide (E 171), glycerol monocaprylocaprate (E 471), poly(vinyl alcohol) (E 1203)

What Zopiclone Baltijos Bitė looks like and contents of the pack
Zopiclone Baltijos Bitė 3.75 mg are white, round, biconvex film-coated tablets with a smooth surface; the tablet diameter is approximately 5 mm.
Zopiclone Baltijos Bitė 5 mg are blue, round, biconvex film-coated tablets with a smooth surface; the tablet diameter is approximately 6 mm.
Zopiclone Baltijos Bitė 7.5 mg are white, round, film-coated tablets, convex on one side and with a score line on the other side, with a smooth surface; the tablet diameter is approximately 7 mm. The tablet can be divided into equal doses.
Zopiclone Baltijos Bitė is available in PVC/PVDC/Aluminium foil 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
Tel.: +371 67083205
E-mail: [email protected]

This medicinal product is authorised in the European Economic Area under the following names: