Package leaflet: Information for the user

Sonrest, 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, pharmacist, or nurse.
This medicine has been prescribed for a specific person only. Do not pass it on to others. The medicine may harm someone else, even if their symptoms are the same.
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

What Sonrest is and what it is used for
What you need to know before taking Sonrest
How to take Sonrest
Possible side effects
How to store Sonrest
Contents of the pack and other information

1. What Sonrest is and what it is used for

Sonrest contains the active substance zopiclone, which belongs to a group of medicines called
hypnotic and sedative medicines, drugs similar to benzodiazepines.
Sonrest is used for the short-term treatment of insomnia in adults.
It works by prolonging sleep duration and reducing the number of awakenings during the night.
Sonrest will be prescribed only in cases of severe sleep disturbances impairing daily functioning or causing significant patient exhaustion.

2. Important information before using Sonrest

When not to use Sonrest:

if the patient is allergic to zopiclone or any of the other ingredients of this medicine (listed in section 6);
if the patient has serious breathing difficulties (severe respiratory insufficiency);
if the patient suffers from sleep apnoea syndrome (a disorder characterised by breathing interruptions during sleep);
if the patient has severe liver disease;
if the patient has significant muscle weakness called myasthenia (an autoimmune disease);
if the patient has experienced sleepwalking or other unusual behaviours (such as driving, eating, making phone calls or having sexual intercourse, etc.) while not being fully awake after taking Sonrest or other medicines containing zopiclone.

Warnings and precautions
General
Before starting treatment with Sonrest, discuss this with your doctor or pharmacist.
Before beginning treatment with Sonrest, the cause of sleep problems should be investigated and any underlying medical conditions treated.
Inform your doctor if the patient has or has previously had any of the following conditions or diseases, especially:

liver or kidney function disorders;
breathing disorders;
worsening of general health;
the patient is elderly (in older people, medicines remain in the body longer);
depression or anxiety associated with depression;
history of alcohol, drug or medicine abuse;
the patient has recently taken Sonrest or other similar medicines for longer than 4 weeks.

Your doctor will decide whether or not the patient should take Sonrest, or whether the dose should be adjusted. During treatment, the patient should be closely monitored by the doctor.
Dependence and withdrawal symptoms
Medicines such as Sonrest may lead to physical or psychological dependence or abuse. The risk of dependence increases with higher doses and longer treatment duration. This risk is also higher in patients with a history of alcohol, drug or medicine abuse and/or in individuals with marked personality disorders.
If physical dependence occurs, abruptly stopping treatment may lead to withdrawal symptoms such as: insomnia, headache, muscle pain, increased anxiety, tension, restlessness, confusion (disorientation), and irritability.
In severe cases, the following symptoms may occur: derealisation (a change in perception of the world so that it seems strange or unreal), depersonalisation (loss of personal identity, followed by feelings of unreality and detachment), hypersensitivity to sound, numbness and tingling in the limbs, 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)
Abruptly stopping the medicine after prolonged use may cause insomnia lasting for several nights.
This is a temporary condition called "rebound insomnia". To avoid withdrawal symptoms after long-term treatment, it is recommended to gradually reduce the dose.
See also the section on undesirable effects.
Tolerance
The effect of Sonrest may decrease if the medicine is taken repeatedly for several weeks. This phenomenon is called tolerance. Consult your doctor if the patient feels that the effect of Sonrest is decreasing.
Short-term memory loss (so-called anterograde amnesia)
Sonrest may cause short-term memory loss, especially several hours after taking the tablet. To reduce the risk of this effect, patients should take Sonrest immediately before going to bed or while in bed, and ensure uninterrupted sleep for 7–8 hours.
Psychological reactions and "paradoxical" reactions
While taking Sonrest, the following psychological reactions may occur: anxiety and nervousness, nightmares, irritability, aggression, inappropriate behaviour, hallucinations (seeing or hearing things that are not real), confusion, and difficulty concentrating.
Sleepwalking (somnambulism) and related behaviours
Sleepwalking and related behaviours such as "driving while asleep", preparing and eating food, or making phone calls during sleep, with no memory of the activity, have been reported in patients taking zopiclone who were not fully awake.
The risk of such behaviour increases if Sonrest is taken together with alcohol or certain other medicines (e.g. opioid painkillers, antipsychotics, sleeping medicines, or anxiolytics/sedatives).
The risk also increases if Sonrest is taken at doses exceeding 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 recommend appropriate treatment. If left untreated, depression may worsen, become chronic, or increase the potential risk of suicide.
Some studies have shown an increased risk of suicidal thoughts, suicide attempts and suicides in patients taking certain sedative and sleep medicines, including this one. However, it has not been established whether this is due to the medicine's effect or other causes. If the patient has suicidal thoughts, they should contact their 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 patients who get up at night.
Children and adolescents
Sonrest should 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.
Sonrest and other medicines
Taking other medicines together with Sonrest may affect its action, and it may be necessary to adjust the dose of Sonrest.
Tell your doctor about all medicines the patient is currently taking or has recently taken, as well as any medicines they plan to take. In particular, mention if any of the following medicines are being taken:
medicines for certain mental disorders (antipsychotics/neuroleptics)
sleeping tablets (hypnotics)
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 antibiotics and antifungals, such as erythromycin or itraconazole
medicines used to treat HIV (human immunodeficiency virus)
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 (a traditional herbal remedy).
Concomitant use of Sonrest and opioids (strong painkillers, medicines used in substitution therapy, and some cough medicines) increases the risk of drowsiness, breathing difficulties (respiratory depression), coma, and may be life-threatening. Therefore, concomitant use should only be considered if no other treatment options are available.
If your doctor prescribes Sonrest together with opioids, the dose and duration of concomitant treatment should be limited by the doctor.
Inform your doctor about all opioid medicines the patient is taking and strictly follow the doctor's dosing instructions. It may be helpful to inform friends or family about the risks so they are aware of the signs and symptoms listed above. If such symptoms occur, contact your doctor.
Sonrest, drinking and alcohol
Do not consume alcohol while taking Sonrest, as alcohol may intensify the effect of Sonrest.
While taking Sonrest, avoid eating grapefruit or drinking grapefruit juice. Grapefruit may intensify the effect of Sonrest.
Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a baby, she should consult her doctor or pharmacist before using this medicine.
Pregnancy
Sonrest is not recommended during pregnancy as it crosses 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 newborns.
Reduced fetal movement and variable fetal heart rate may occur if the mother takes Sonrest during the second and/or third trimester of pregnancy.
If the patient takes Sonrest towards the end of pregnancy or during delivery, her baby may show muscle weakness, low body temperature, difficulty sucking, and breathing problems (respiratory depression).
If the patient regularly takes Sonrest late in pregnancy, the baby may develop physical dependence and withdrawal symptoms such as agitation or tremors may occur. In such cases, the newborn should be closely monitored in the postnatal period.
If one or more of the above symptoms occur in the newborn at birth or after birth, contact the doctor and/or midwife immediately.
Breastfeeding
This medicine passes into human milk. Sonrest should not be used by women during breastfeeding.
Driving and operating machinery
Zopiclone may significantly affect the ability to drive and operate machinery.
Like other sleeping medicines, zopiclone may cause drowsiness, prolonged reaction time, dizziness, drowsiness (lack of alertness), blurred or double vision, reduced concentration, and impaired ability to drive, especially within the first 12 hours after taking zopiclone (see section 4. "Possible side effects").
Impaired ability to drive and behaviours such as falling asleep at the wheel may occur even when zopiclone is used as a single medicine at recommended doses.
Do not drive or operate machinery until treatment with Sonrest is completed or until it is established that this ability is not impaired. These effects may persist into the next day.
Do not consume alcohol or other medicines that depress the central nervous system (sedatives, sleeping tablets, certain cough medicines, etc.) together with Sonrest, as this may worsen side effects (see section 2 "Warnings and precautions", "Sonrest and other medicines").
Sonrest contains lactose
If the patient has previously been diagnosed with an intolerance to certain sugars, they should consult their doctor before taking this medicine.
Sonrest contains sodium
The medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. the medicine is considered "sodium-free".

3. How to take Sonrest

Dosage
This medicine should always be taken as directed by a doctor or pharmacist. If in doubt, consult a doctor or pharmacist.
In all cases, the doctor will aim to find the lowest effective dose.
Do not take another dose during the same night.

For adults and patients under 65 years of age, the recommended dose is 7.5 mg once daily, taken before bedtime.
For patients aged 65 years or older, the recommended dose is 3.75 mg once daily, taken before bedtime.
For patients with chronic respiratory insufficiency, or with hepatic or renal impairment, the recommended dose is 3.75 mg once daily, taken before bedtime.

If you feel that the effectiveness of the medicine has decreased over time, do not increase the dose; consult your doctor.

Use in children and adolescents
Sonrest must not be used in children and adolescents under 18 years of age, as the safety and efficacy of Sonrest have not been established in this age group.

Method of administration
The medicine should be taken orally.
Swallow the tablet with a glass of water.
The break line on the tablet indicates that it may be divided into two equal doses if necessary.

Frequency of administration
Take a single dose immediately before going to bed or while in bed.
Ensure an uninterrupted sleep of 7–8 hours. This will reduce the risk of memory loss (amnesia) and difficulties with coordination of movement (psychomotor impairment).

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

Overdose of Sonrest
If more than the recommended dose of Sonrest has been taken, contact a doctor, pharmacist, or go immediately to a hospital emergency department, as overdose may be dangerous.
Symptoms of overdose may include:
drowsiness, disorientation, lethargy
falls or loss of balance (ataxia)
muscle weakness (hypotonia)
dizziness, feeling faint or fainting (due to low blood pressure)
shallow and slow breathing (respiratory depression)
coma.

Missed dose of Sonrest
If the patient forgets to take the medicine but can still sleep for 7 to 8 hours, the dose should be taken immediately.
If the time available for sleep is shorter, the missed dose should be skipped and the next dose taken the following day at the usual time before bedtime, if needed. Never take a double dose to make up for a missed tablet.

Stopping Sonrest
Abruptly stopping treatment with Sonrest may lead to transient sleep disturbances. Withdrawal symptoms may also occur, including: difficulty falling asleep, headache, excessive sweating, hallucinations, and rapid heartbeat. In severe and very rare cases, seizures (convulsions) may occur. The risk of withdrawal symptoms increases with higher doses and longer duration of treatment; therefore, the 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 all medicines, this medicine can cause adverse reactions, although not everybody will experience them.
These may vary depending on the dose used and the individual sensitivity of the patient.
You should stop taking the medicine Sonrest and seek medical advice immediately from a doctor or go to the
nearest emergency department if any of the following symptoms occur ( very rare, may occur
in no more than 1 in 10,000 people):

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 cavity which may cause difficulty in breathing and swallowing, wheezing (anaphylactic reaction).

Other adverse reactions:
Common (may occur in no more than 1 in 10 people):

reduced concentration or drowsiness (especially in elderly patients)
bitter taste in the mouth or other taste disturbances
dryness of the mouth

Uncommon (may occur in no more than 1 in 100 people):

restlessness, nightmares
dizziness, headache
nausea
fatigue

Rare (may occur in no more than 1 in 1,000 people):

confusion, libido disorders, irritability, aggression, hallucinations
loss of memory of events occurring during treatment (anterograde amnesia). This effect may occur at doses prescribed by a doctor. The risk increases proportionally with the dose.
shortness of breath (difficulty breathing)
rash, itching, itchy red skin patches (urticaria)
risk of falling (especially in elderly patients)

Very rare (may occur in no more than 1 in 10,000 people):

increased liver enzyme activity (aminotransferases and/or alkaline phosphatase in blood), liver disease (hepatitis)

Frequency not known (frequency cannot be estimated from available data):

behavioural disturbances
delirium (sudden and severe change in mental state, which may cause a combination of confusion, disorientation and/or attention deficit), false beliefs (delusions)
rage attacks, nervousness
sleepwalking or other unusual sleep-related behaviours (such as driving, eating, making phone calls or engaging in sexual activity) while the patient has not fully awakened (see section 2 “Warnings and precautions”)
physical and psychological dependence, even at doses prescribed by a doctor, with withdrawal syndrome or rebound insomnia after discontinuation of treatment (see section 2 “Dependence and withdrawal symptoms” and “Rebound insomnia after stopping treatment (rebound insomnia)”)
disorientation, insomnia, tension
depression
ataxia (impaired body movement coordination), numbness or tingling of limbs (paraesthesiae), cognitive disorders such as memory impairment, attention disturbances, speech disorders
respiratory depression (slow and shallow breathing)
double vision
indigestion, vomiting
reduced muscle strength (hypotonia)

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed
in this leaflet, you should inform your doctor or pharmacist. 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 marketing authorisation holder or the representative of the marketing authorisation holder in Poland. Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Sonrest

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the outer carton and
blister after "EXP". The expiry date refers to the last day of the stated month.
No special storage requirements 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. Such measures will help
protect the environment.

6. Contents of the pack and other information

What Sonrest contains

The active substance is zopiclone. Each coated tablet contains 7.5 mg of zopiclone.
Other ingredients:
Core: calcium hydrogen phosphate dihydrate; lactose monohydrate (see section 2 " Sonrest contains lactose "); sodium carboxymethyl starch (type A) (see section 2 " Sonrest contains sodium "); maize starch; magnesium stearate.
Coating: colouring agent " Opadry Blue ": hypromellose 2910 (E464); talc (E553b); titanium dioxide (E171); propylene glycol (E1520); brilliant blue FCF "aluminium lake" (E133).

What Sonrest looks like and contents of the pack
Light blue to blue, oval, biconvex coated tablets, with the imprint "Z" on one side of the division line and "1" on the other side of the division line on one side, and smooth on the other side.
The tablet can be divided into equal doses.
Aluminium/PVC/PVDC foil blister pack containing 10 coated tablets.
10, 20, 30 or 100 coated tablets (1, 2, 3 or 10 blisters) with a patient leaflet in a cardboard box.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Olpha AS,
Rupnicu iela 5,
Olaine, Olaines novads, LV-2114,
Latvia
E-mail: [email protected]
This medicinal product is authorised in the European Economic Area member states under the following names:
Czech Republic, Denmark, Estonia, Italy, Norway, Sweden, Slovakia: Zopiclone Olpha
Lithuania: Zopiclone Olpha 7,5 mg plėvele dengtos tabletės
Latvia: Zopiclone Olpha 7,5 mg apvalkotās tabletes
Poland: Sonrest
Germany: Zopiclon Olpha