Zopiclone Olpha

Patient Information Leaflet

Zopiclone Olpha 7.5 mg film-coated tablets

Zopiclone
Generic medicine
Please read all of this leaflet carefully before you take 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, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not give it to other people, even if they have the same symptoms as you, because it may be harmful.
• If you experience any adverse reaction, including those not listed in this leaflet, contact your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet:

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

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

Zopiclone Olpha contains a substance called zopiclone, which belongs to a class of medicines known as hypnotics and sedatives, benzodiazepines and related medicines.
Zopiclone Olpha is indicated for the short-term treatment of insomnia in adults.
It works by increasing sleep duration and reducing the number of awakenings during the night.
Zopiclone Olpha is prescribed only if the sleep problem is severe, disabling or causing extreme distress.

2. What you need to know before taking Zopiclone Olpha

Do not take Zopiclone Olpha if:

• you are allergic to zopiclone or to any of the other ingredients of this medicine (listed in section 6).
• you have severe breathing difficulties (severe respiratory insufficiency).
• you suffer from sleep apnoea syndrome (a disorder characterized by breathing pauses during sleep).
• you have severe liver disease.
• you have a severe muscle weakness condition called myasthenia gravis (an autoimmune disease).
• you have experienced sleepwalking or other unusual behaviors (such as driving, eating, making phone calls, or having sexual intercourse, etc.) without being fully awake after taking Zopiclone Olpha or other medicines containing zopiclone.

Warnings and precautions
General
Talk to your doctor or pharmacist before taking Zopiclone Olpha.
Before starting treatment with Zopiclone Olpha, the cause of your sleep problems should be investigated and any underlying medical conditions treated.
Inform your doctor if you currently have or have previously had any medical conditions, especially if you have any of the following:

• liver or kidney problems
• breathing difficulties
• general poor health
• you are elderly (in elderly people, medicines remain in the body longer)
• depression or anxiety related to depression
• history of alcohol, drug, or medicine abuse
• you have recently taken Zopiclone Olpha or similar medicines for more than 4 weeks.

Your doctor will decide whether you should take Zopiclone Olpha and whether the dose needs to be adjusted. You will also be closely monitored during treatment.
Dependence and withdrawal symptoms
Medicines such as Zopiclone Olpha may lead to physical or psychological dependence or abuse. The risk of dependence increases with higher doses and longer duration of treatment. The risk is also higher in patients with a history of alcohol, drug, or medicine abuse and/or those with marked personality disorders.
If physical dependence occurs, abruptly stopping treatment may cause withdrawal symptoms such as: insomnia, headache, muscle pain, extreme anxiety, tension, restlessness, confusion, and irritability.
In more severe cases, the following symptoms may occur: altered perception making the world seem strange or unreal, loss of personal identity followed by feelings of unreality and strangeness, hypersensitivity to sounds, numbness and tingling in arms and legs, hypersensitivity to light, noise, or physical touch, seeing, hearing, or sensing things that are not real (hallucinations), and epileptic seizures.
Recurrent insomnia after stopping treatment (rebound insomnia)
If treatment is stopped abruptly after prolonged use, insomnia may occur for several nights.
This is a temporary condition called "rebound insomnia". To avoid problems when stopping long-term treatment, it is recommended to gradually reduce the dose. See also section on side effects.
Tolerance
The effect of Zopiclone Olpha may decrease if the medicine is used repeatedly for several weeks. This phenomenon is called tolerance. Talk to your doctor if you feel that the effect of Zopiclone Olpha is diminishing.
Short-term memory loss, so-called anterograde amnesia
Zopiclone Olpha may cause short-term memory loss, especially a few hours after taking the tablet. To reduce this risk, take Zopiclone Olpha shortly before or after going to bed and ensure you can have an uninterrupted sleep of 7–8 hours.
Psychiatric and paradoxical reactions
When taking Zopiclone Olpha, mental reactions such as restlessness and anxiety, nightmares, irritability, aggression, inappropriate behavior, hallucinations (seeing or hearing unreal things), confusion, and difficulty concentrating may occur.
Sleepwalking, so-called sleepwalking, and associated behaviors
Sleepwalking and other associated behaviors such as "sleep-driving", cooking and eating, or making phone calls during sleep, with subsequent memory loss of the event, have been reported in patients taking zopiclone who were not fully awake.
The risk of such behaviors increases if Zopiclone Olpha is taken together with alcohol or certain specific medicines (e.g., opioid painkillers, antipsychotics, hypnotics, or anxiolytics/sedatives).
The risk also increases if Zopiclone Olpha is taken at doses higher than the maximum recommended dose.
Contact your doctor immediately if any of the symptoms described above occur.
Depression/suicidal thoughts
This medicine is not intended for the treatment of depression. If you have depression, your doctor will prescribe appropriate treatment. If depression is not treated, it 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 sedatives and hypnotics, including this medicine. However, it has not been 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.
Fall risk
Due to the muscle-relaxing effect of zopiclone, there is a risk of falling, especially in elderly people when getting up during the night.
Children and adolescents
Zopiclone Olpha must not be used in 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 Olpha
The effect of treatment may be affected if Zopiclone Olpha is taken together with other medicines, meaning that the dose of Zopiclone Olpha may need to be adjusted.
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
In particular, if you are taking any of the following medicines:

• medicines for certain mental disorders (antipsychotics/neuroleptics)
• medicines for sleep disorders (hypnotics)
• medicines for treating anxiety (anxiolytics)
• medicines used to calm down (sedatives)
• medicines for treating depression (antidepressants)
• strong opioid painkillers, such as morphine and morphine-like substances
• medicines used in surgery (anaesthetics)
• medicines used for treating allergies (antihistamines)
• certain medicines used for treating bacterial and fungal infections, such as erythromycin or itraconazole
• medicines used for treating HIV infection
• medicines used for treating epilepsy such as phenytoin, phenobarbital, and carbamazepine
• medicines used for treating tuberculosis (e.g., rifampicin)
• products containing St. John’s wort (herbal medicinal product).

Concomitant use of Zopiclone Olpha and opioids (strong painkillers, substitution therapy medicines, and some cough medicines) increases the risk of drowsiness, breathing difficulties (respiratory depression), coma, and can be life-threatening. Therefore, concomitant use should only be considered when no other therapeutic options are possible.
However, if your doctor prescribes Zopiclone Olpha together with opioids, the dose and duration of concomitant treatment must be limited by your doctor.
Inform your doctor about all opioid medicines you are taking and strictly follow the dose recommended by your doctor. It may be helpful to inform friends or family members to be aware of the signs and symptoms described above. If such symptoms occur, contact your doctor.
Zopiclone Olpha with drinks and alcohol
Alcohol must be avoided while taking Zopiclone Olpha, as alcohol can increase the effects of Zopiclone Olpha.
Grapefruit and grapefruit juice must be avoided while taking Zopiclone Olpha. Grapefruit may increase the effect of Zopiclone Olpha.
Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, or are planning to become pregnant, ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
The use of Zopiclone Olpha is not recommended during pregnancy, as it crosses the placenta.
If used during pregnancy, there is a risk that the baby may be affected. Some studies have shown an increased risk of cleft lip and palate in newborns.
Reduced fetal movement and variability in fetal heart rate may occur after taking Zopiclone Olpha during the second and/or third trimester of pregnancy.
If Zopiclone Olpha is taken in the late stages of pregnancy or during labor, 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.
If your baby shows one or more of these symptoms at birth or after birth, contact your doctor and/or midwife.
Breastfeeding
This medicine is excreted in breast milk; therefore, do not use Zopiclone Olpha if you are breastfeeding.
Driving and using machines
Zopiclone can significantly affect your ability to drive and use machines.
Like other hypnotics, zopiclone can cause drowsiness, prolonged reaction times, dizziness, stupor (lack of responsiveness), blurred or double vision, reduced alertness, and impaired driving performance, especially within the first 12 hours after taking zopiclone (see section 4. “Possible side effects”).
Impaired driving ability and behaviors such as falling asleep at the wheel may occur even when zopiclone is used alone at therapeutic doses.
You must not drive or operate machinery until after treatment with Zopiclone is completed, or until it is established that your abilities are not impaired. The effect may persist into the next day.
Do not consume alcohol or other central nervous system depressants (tranquillisers, sleeping pills, some cough medicines, etc.) together with Zopiclone Olpha, as they may worsen side effects (see section 2 “Warnings and precautions”, “Other medicines and Zopiclone Olpha”).
Zopiclone Olpha contains lactose
If you have been diagnosed with an intolerance to certain sugars, consult your doctor before taking this medicine.
Zopiclone Olpha contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per tablet, i.e., it is essentially “sodium-free”.

3. How to take Zopiclone Olpha

Dosage
Take this medicine exactly as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
In any case, your doctor will aim to find the lowest effective dose.
Do not take another dose during the same night.

The recommended dose for adults under 65 years of age is 7.5 mg once daily, taken at bedtime.
The recommended dose for patients aged 65 years and over is 3.75 mg once daily, taken at bedtime.
In cases of chronic respiratory insufficiency, or hepatic or renal impairment, the recommended dose is 3.75 mg once daily, taken at bedtime.

If the effect of the medicine decreases over time, do not increase the dose yourself; consult your doctor.

Use in children and adolescents
The use of Zopiclone Olpha is not recommended in children and adolescents under 18 years of age, as the safety and efficacy of Zopiclone Olpha have not been established in this population.

Method of administration
Take this medicine by mouth.
Swallow the tablet with a glass of water.
The tablets are divisible, meaning they can be split into two equal doses if necessary.

Frequency of administration
Take the medicine as a single dose shortly before going to bed or lying down.
Ensure you are able to have an uninterrupted sleep of 7–8 hours. This will help limit the risk of memory loss (amnesia) and difficulty coordinating movements (impaired psychomotor function).

Duration of treatment
Treatment duration should be as short as possible and must not exceed 4 weeks, including any period of gradual dose reduction.
If insomnia persists, consult your doctor.

If you take more Zopiclone Olpha than you should
If you take more Zopiclone Olpha than prescribed, contact a doctor, pharmacist, or go to the Emergency Department immediately, as overdose can be dangerous.
Symptoms of overdose may include:

• drowsiness, confusion, lethargy
• falls or loss of balance (ataxia)
• muscle weakness (hypotonia)
• dizziness, lightheadedness or fainting (due to low blood pressure)
• shallow and slowed breathing (respiratory depression)
• coma

If you forget to take Zopiclone Olpha
If you still have time to sleep for 7–8 hours, take the missed dose immediately.
If there is less time available, skip the missed dose and take the next dose only the following day at your usual time before going to sleep, as needed. Do not take a double dose to make up for a forgotten dose.

If you stop taking Zopiclone Olpha
If you stop taking Zopiclone Olpha abruptly, sleep problems may return temporarily. Withdrawal symptoms may also occur. These may include difficulty sleeping, headache, sweating, hallucinations, and increased heart rate. In more severe and very rare cases, epileptic seizures may occur.
The risk of withdrawal symptoms increases with higher doses and longer treatment duration; therefore, your doctor may provide guidance on gradually reducing the dose.

If you have any further questions 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.
These effects may vary depending on the dose used and individual sensitivity.
Stop taking Zopiclone Olpha and consult a doctor immediately or go to hospital 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 a severe allergic reaction: itchy rash, swelling of the mouth which may cause breathing and swallowing difficulties, shortness of breath (anaphylactic reaction).

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

• Reduced alertness or drowsiness (particularly in elderly people)
• Bitter taste in the mouth or other disturbances of taste
• Dry mouth

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

• Restlessness, nightmares
• Dizziness, headache
• Nausea
• Fatigue

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

• Altered state of consciousness, disturbances in libido, irritability, aggression, aggressive behaviour, hallucinations
• Memory loss for events occurring during treatment (anterograde amnesia). This effect may occur at doses prescribed by the doctor. The risk increases proportionally with the dose.
• Dyspnea (difficulty breathing)
• Skin rash, itching, itchy red patches on the skin (urticaria)
• Falls (particularly in elderly people)

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

• Increased liver enzymes (transaminases and/or alkaline phosphatase in the blood), liver disease (hepatitis).

Not known (frequency cannot be estimated from the available data):

• Behavioural disturbances
• Delirium (a sudden and severe change in mental state causing confusion, disorientation and/or inattention), delirium
• Excessive anger, nervousness
• Sleepwalking or other unusual behaviours during sleep (such as driving, eating, making phone calls or having sex, etc.) while not fully awake (see section 2 “Warnings and precautions”)
• Physical and psychological dependence even at doses recommended by the doctor, with withdrawal syndrome or rebound insomnia upon discontinuation of treatment (see section 2 “Dependence and withdrawal symptoms” and “Rebound insomnia after stopping treatment (rebound insomnia)”)
• Confusion, insomnia, tension
• Depression
• Inability to coordinate muscle movements (ataxia), numbness or tingling of the extremities (paraesthesia), cognitive disturbances such as memory problems, attention disturbances, language disturbances
• Respiratory depression (slow and shallow breathing)
• Double vision
• Indigestion, vomiting
• Reduced muscle strength (hypotonia)

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist.
You can also report side effects directly via the national reporting system at 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 Zopiclone Olpha

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the blister and on the carton after
the word 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 any medicine via wastewater. 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 Olpha contains

• The active substance is zopiclone. Each film-coated tablet contains 7.5 mg of zopiclone.
• The other components are:
  • Tablet core: calcium hydrogen phosphate, dihydrate; lactose monohydrate (see section 2 “Zopiclone Olpha contains lactose”); sodium starch glycolate (see section 2 “Zopiclone Olpha contains sodium”); maize starch; magnesium stearate.
  • Coating: blue Opadry [(contains: hypromellose (E464); talc (E553b); titanium dioxide (E171); propylene glycol (E1520); brilliant blue FCF aluminium lake (E133)].

Description of the appearance of Zopiclone Olpha and pack contents
The film-coated tablets are blue to sky-blue, oval, biconvex, with the inscription “Z” on one side of the break line and “1” on the other side of the break line, smooth on the reverse side.
The tablet can be divided into equal doses.
Aluminum - PVC/PVDC blisters containing 10 film-coated tablets.
10, 20 or 30 film-coated tablets (1, 2 or 3 blisters) with a package leaflet in a cardboard box.
Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer
Olpha AS,
Rupnicu iela 5,
Olaine, Olaines novads, LV-2114,
Latvia

This medicinal product is authorized in the European Economic Area countries under the following names:
Italy, Czech Republic, Estonia,
Slovakia, Denmark, Sweden, Norway: Zopiclone Olpha
Germany: Zopiclon Olpha
Lithuania: Zopiclone Olpha 7,5 mg plėvele dengtos tabletės
Latvia: Zopiclone Olpha 7,5 mg apvalkotās tabletes
Poland: Sonrest

Patient information leaflet

Zopiclone Olpha 3.75 mg film-coated tablets

Zopiclone
Generic medicine
Please read 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 questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not give it to others, even if they have the same symptoms as you, because it could be harmful.
• If you experience any side effects, including those not listed in this leaflet, contact your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet:

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

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

Zopiclone Olpha contains a substance called zopiclone, which belongs to a class of medicines known as hypnotics and sedatives, benzodiazepines and related medicines.
Zopiclone Olpha is indicated for the short-term treatment of insomnia in adults.
It works by increasing sleep duration and reducing the number of awakenings during the night.
Zopiclone Olpha is prescribed only if the sleep problem is severe, disabling or causing extreme distress.

2. What you should know before taking Zopiclone Olpha

Do not take Zopiclone Olpha if:

• you are allergic to zopiclone or to any of the other ingredients of this medicine (listed in section 6).
• you have severe breathing difficulties (severe respiratory insufficiency).
• you suffer from sleep apnoea syndrome (a disorder characterized by pauses in breathing during sleep).
• you have severe liver disease.
• you have a severe muscle weakness called myasthenia gravis (an autoimmune disease).
• you have experienced sleepwalking or other unusual behaviours (such as driving, eating, making phone calls or having sexual intercourse, etc.) without being fully awake after taking Zopiclone Olpha or other medicines containing zopiclone.

Warnings and precautions
General
Talk to your doctor or pharmacist before taking Zopiclone Olpha.
Before starting treatment with Zopiclone Olpha, the cause of your sleep problems should be investigated and any underlying medical conditions treated.
Inform your doctor if you currently have or have previously had any medical conditions, especially if you suffer from any of the following:

• liver or kidney problems
• breathing problems
• general poor health
• you are elderly (in elderly people, medicines remain in the body longer)
• depression or anxiety related to depression
• history of alcohol, drug or medicine abuse
• you have recently taken Zopiclone Olpha or similar medicines for more than 4 weeks.

Your doctor will decide whether you should take Zopiclone Olpha or whether your dose needs to be adjusted. You will also be closely monitored during treatment.
Dependence and withdrawal symptoms
Medicines such as Zopiclone Olpha may lead to physical or psychological dependence or abuse of these medicines. The risk of dependence increases with higher doses and longer duration of treatment. The risk is also higher in patients with a history of alcohol, drug or medicine abuse and/or in those who have marked personality disorders.
If physical dependence occurs, abruptly stopping treatment may cause withdrawal symptoms such as: insomnia, headache, muscle pain, extreme anxiety, tension, restlessness, confusion and irritability.
In more severe cases, the following symptoms may occur: altered perception of the world making it seem strange or unreal, loss of personal identity followed by feelings of unreality and strangeness, hypersensitivity to sounds, numbness and tingling in arms and legs, hypersensitivity to light, noise or physical touch, seeing, hearing or sensing things that are not really there (hallucinations), and epileptic seizures.
Recurrent insomnia after stopping treatment (rebound insomnia)
If treatment is stopped abruptly after prolonged use, insomnia may occur for several nights.
This is a temporary condition called "rebound insomnia". To avoid problems when stopping long-term treatment, it is recommended to gradually reduce the dose. See also the section on side effects.
Tolerance
The effect of Zopiclone Olpha may decrease if the medicine is used repeatedly for several weeks.
This phenomenon is called tolerance. Speak to your doctor if you feel that the effect of Zopiclone Olpha is decreasing.
Short-term memory loss, so-called anterograde amnesia
Zopiclone Olpha may cause short-term memory loss, especially a few hours after taking the tablet. To reduce this risk, take Zopiclone Olpha shortly before or after going to bed and ensure that you can have an uninterrupted sleep of 7–8 hours.
Psychiatric and paradoxical reactions
When taking Zopiclone Olpha, mental reactions such as restlessness and anxiety, nightmares, irritability, aggression, inappropriate behaviour, hallucinations (seeing or hearing things that are not real), confusion and difficulty concentrating may occur.
Sleepwalking, so-called sleepwalking, and associated behaviours
Sleepwalking and other associated behaviours, such as "sleep-driving", cooking and eating, or making phone calls while asleep, with subsequent memory loss of the event, have been reported in patients taking zopiclone who were not fully awake.
The risk of these behaviours increases if Zopiclone Olpha is taken together with alcohol or certain specific medicines (e.g., opioid painkillers, antipsychotics, hypnotics or anxiolytics/sedatives).
The risk also increases if Zopiclone Olpha is taken at doses higher than the maximum recommended dose.
Contact your doctor immediately if any of the above symptoms occur.
Depression/suicidal thoughts
This medicine is not intended for the treatment of depression. If you have depression, your doctor will prescribe appropriate treatment. If depression is not treated, it may worsen, become persistent or increase the risk of suicide.
Some studies have shown an increased risk of suicidal thoughts, suicide attempts and suicide in patients taking certain sedatives and hypnotics, including this medicine. However, it has not been established whether this is due to the medicine or other factors. If you have suicidal thoughts, contact your doctor as soon as possible for medical advice.
Risk of falls
Due to the muscle-relaxing effect of zopiclone, there is a risk of falling, especially in elderly people when getting up during the night.
Children and adolescents
Zopiclone Olpha must not be used in 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 Olpha
The effect of treatment may be affected if Zopiclone Olpha is taken at the same time as other medicines, which means that the dose of Zopiclone Olpha may need to be adjusted.
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, especially if you are taking any of the following:

• medicines used to treat certain mental disorders (antipsychotics/neuroleptics)
• medicines for sleep disorders (hypnotics)
• medicines used to treat anxiety (anxiolytics)
• medicines used to calm down (sedatives)
• medicines used to treat depression (antidepressants)
• strong opioid painkillers, such as 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)
• products containing St. John’s wort (a traditional herbal medicine).

Concomitant use of Zopiclone Olpha and opioids (strong painkillers, medicines for substitution therapy and some cough medicines) increases the risk of drowsiness, breathing difficulties (respiratory depression), coma and can be life-threatening. For this reason, concomitant use should only be considered when no other therapeutic options are possible.
However, if your doctor prescribes Zopiclone Olpha together with opioids, the dose and duration of concomitant treatment must be limited by your doctor.
Inform your doctor about all opioid medicines you are taking and strictly follow the dose recommended by your doctor. It may be helpful to inform friends or family members to be aware of the signs and symptoms described above. If such symptoms occur, contact your doctor.
Zopiclone Olpha with drinks and alcohol
Alcohol must be avoided while taking Zopiclone Olpha, as alcohol can increase the effects of Zopiclone Olpha.
Grapefruit and grapefruit juice must be avoided while taking Zopiclone Olpha. Grapefruit may increase the effect of Zopiclone Olpha.
Pregnancy and breastfeeding
If you are pregnant, think you might be pregnant or are planning to become pregnant, consult your doctor or pharmacist before taking this medicine.
Pregnancy
The use of Zopiclone Olpha is not recommended during pregnancy, as it crosses the placenta.
If used during pregnancy, there is a risk that the baby will be affected. Some studies have shown that the risk of developing cleft lip and palate in the newborn may increase.
Reduced fetal movement and variability in fetal heart rate may occur after taking Zopiclone Olpha during the second and/or third trimester of pregnancy.
If Zopiclone Olpha is taken in the late stages of pregnancy or during labour, the baby may show muscle weakness, low 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.
If your baby shows one or more of these symptoms at birth or after birth, contact your doctor and/or midwife.
Breastfeeding
This medicine is excreted in breast milk; therefore, do not use Zopiclone Olpha if you are breastfeeding.
Driving and using machines
Zopiclone may significantly affect your ability to drive and use machines.
Like other hypnotics, zopiclone can cause drowsiness, prolonged reaction times, dizziness, stupor (lack of responsiveness), blurred or double vision, reduced alertness and reduced driving performance, especially within the first 12 hours after taking zopiclone (see section 4. “Possible side effects”).
Impaired driving ability and behaviours such as falling asleep at the wheel may occur even when zopiclone is used alone at therapeutic doses.
You must not drive or operate machinery until after the end of treatment with Zopiclone Olpha, or until it is established that your abilities are not impaired. The effect may last into the next day.
Do not consume alcohol or other central nervous system depressants (tranquillisers, sleeping pills, some cough medicines, etc.) together with Zopiclone Olpha, as they may worsen side effects (see section 2 “Warnings and precautions”, “Other medicines and Zopiclone Olpha”).
Zopiclone Olpha contains lactose
If you have been diagnosed with an intolerance to certain sugars, consult your doctor before taking this medicine.
Zopiclone Olpha contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per tablet, i.e. it is essentially “sodium-free”.

3. How to take Zopiclone Olpha

Dosage
Take this medicine exactly as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
In any case, your doctor will aim to find the lowest effective dose.
Do not take another dose during the same night.

The recommended dose for adults under 65 years of age is 7.5 mg once daily, taken at bedtime.
The recommended dose for patients aged 65 years and over is 3.75 mg once daily, taken at bedtime.
In patients with chronic respiratory insufficiency, or with hepatic or renal impairment, the recommended dose is 3.75 mg once daily, taken at bedtime.

If the effect of the medicine decreases over time, do not increase the dose yourself; consult your doctor.

Use in children and adolescents
The use of Zopiclone Olpha is not recommended in children and adolescents under 18 years of age, as the safety and efficacy of Zopiclone Olpha have not been established in this population.

Method of administration
Take this medicine by mouth.
Swallow the tablet with a glass of water.

Frequency of administration
Take the medicine as a single dose shortly before going to bed or when getting into bed.
Ensure that you are able to have an uninterrupted sleep of 7–8 hours. This will help limit the risk of memory loss (amnesia) and difficulty coordinating movements (impaired psychomotor function).

Duration of treatment
Treatment duration should be as short as possible and must not exceed 4 weeks, including the period of gradual dose reduction.
If insomnia persists, consult your doctor.

If you take more Zopiclone Olpha than you should
If you take more Zopiclone Olpha than you should, contact a doctor, pharmacist, or go to the Emergency Room immediately, as overdose can be dangerous.
Symptoms of overdose may include:

• drowsiness, confusion, lethargy
• falling or loss of balance (ataxia)
• muscle weakness (hypotonia)
• dizziness, lightheadedness or fainting (due to low blood pressure)
• shallow and slowed breathing (respiratory depression)
• coma

If you forget to take Zopiclone Olpha
If you still have time to sleep for 7–8 hours, take the missed dose immediately.
If there is less time available, skip the missed dose and take the next dose only the following day at your usual time before going to sleep, as needed. Do not take a double dose to make up for a forgotten dose.

If you stop taking Zopiclone Olpha
If you stop taking Zopiclone Olpha abruptly, sleep problems may return temporarily. Withdrawal symptoms may also occur. Withdrawal symptoms may include difficulty sleeping, headache, sweating, hallucinations, and increased heart rate. In more severe and very rare cases, epileptic seizures may occur. The risk of withdrawal symptoms increases with the dose and duration of treatment; therefore, your doctor may provide guidance on gradually reducing the dose.

If you have any further questions 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 everyone experiences them.
These effects may vary depending on the amount used and individual sensitivity.
Stop taking Zopiclone Olpha and consult a doctor immediately or go to hospital if any of the following symptoms occur (very rare, may affect up to 1 in 10,000 people):

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

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

• Decreased alertness or drowsiness (particularly in elderly people)
• Bitter taste in the mouth or other disturbances in taste
• Dry mouth

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

• Restlessness, nightmares
• Dizziness, headache
• Nausea
• Fatigue

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

• Altered state of consciousness, disturbances in libido, irritability, aggression, aggressive behaviour, hallucinations
• Memory loss for events occurring during treatment (anterograde amnesia). This effect may occur at doses prescribed by the doctor. The risk increases proportionally with the dose.
• Dyspnoea (difficulty breathing)
• Skin rash, itching, red itchy patches on the skin (urticaria)
• Falls (particularly in elderly people)

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

• Increased liver enzymes (transaminases and/or alkaline phosphatase in blood), liver disease (hepatitis).

Not known (frequency cannot be estimated from the available data):

• Behavioural disturbances
• Delirium (a sudden and severe change in mental state causing confusion, disorientation and/or inattention), delirium
• Excessive anger, nervousness
• Sleepwalking or other unusual behaviours during sleep (such as driving, eating, making phone calls or having sex, etc.) while not fully awake (see section 2 "Warnings and precautions")
• Physical and psychological dependence even at doses recommended by the doctor, with withdrawal syndrome or rebound insomnia upon discontinuation of treatment (see section 2 "Dependence and withdrawal symptoms" and "Rebound insomnia after stopping treatment")
• Confusion, insomnia, tension
• Depression
• Inability to coordinate muscle movements (ataxia), numbness or tingling of the extremities (paraesthesia), cognitive disturbances such as memory impairment, attention deficits, language disorders
• Respiratory depression (slow and shallow breathing)
• Double vision
• Indigestion, vomiting
• Reduced muscle strength (hypotonia)

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, please inform your doctor or pharmacist. You may also report side effects directly via the national reporting system at 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 Zopiclone Olpha

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the blister and carton, following the word "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 any medicine via waste water. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Package contents and other information

What Zopiclone Olpha contains

• The active substance is zopiclone. Each film-coated tablet contains 3.75 mg of zopiclone.
• The other components are:
  • Tablet core: calcium hydrogen phosphate dihydrate; lactose monohydrate (see section 2 “Zopiclone Olpha contains lactose”); sodium starch glycolate (see section 2 “Zopiclone Olpha contains sodium”); maize starch; magnesium stearate.
  • Coating: orange Opadry [(contains: talc (E553b); hypromellose (E464); titanium dioxide (E171); propylene glycol (E1520); yellow iron oxide (E172); red iron oxide (E172)].

Description of the appearance of Zopiclone Olpha and package contents
The film-coated tablets are light orange to orange in colour, round and biconvex,
with the inscription “Z2” in relief on one side and smooth on the other.
Aluminum - PVC/PVDC blisters containing 10 film-coated tablets.
20 film-coated tablets (2 blisters) together with a leaflet in a cardboard box.
Marketing Authorization Holder and Manufacturer
Olpha AS,
Rupnicu iela 5,
Olaine, Olaines novads, LV-2114,
Latvia
This medicinal product is authorized in the European Economic Area member states under the following names:
Italy, Czech Republic, Estonia,
Slovakia, Denmark, Sweden, Norway: Zopiclone Olpha
Germany: Zopiclon Olpha
Lithuania: Zopiclone Olpha 3,75 mg plėvele dengtos tabletės
Latvia: Zopiclone Olpha 3,75 mg apvalkotās tabletes
Poland: Sonrest