Sonrest

Package leaflet: Information for the user

Sonrest, 3.75 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 individual. Do not pass it on to others. It may harm someone else, even if their symptoms are the same.
• If you experience any adverse effects, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Contents of the leaflet

1. What Sonrest is and what it is used for
2. Important information before taking Sonrest
3. How to take Sonrest
4. Possible side effects
5. How to store Sonrest
6. 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 only be prescribed in cases of severe sleep disturbances that impair
daily functioning or cause 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 severe 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 known as myasthenia gravis (an autoimmune disease);
• if the patient has experienced sleepwalking or other unusual behaviours (such as driving, eating, making phone calls or engaging in sexual activity, 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 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.

The doctor will decide whether the patient should take Sonrest, whether not, 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 (altered 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 actually present (hallucinations), and seizures.
Rebound insomnia after stopping treatment (rebound insomnia)
Abruptly stopping the medicine after prolonged treatment may cause insomnia lasting for several nights.
This is a transient condition known as "rebound insomnia". To avoid withdrawal-related 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 temporary memory loss, especially a few 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 restlessness, nightmares, irritability, aggression, inappropriate behaviour, hallucinations (seeing or hearing things that are not real), confusion, and difficulty concentrating.
Sleepwalking, so-called somnambulism and related behaviours
Sleepwalking and related behaviours such as "driving while asleep", preparing and eating food or making phone calls during sleep, with loss of 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 specific 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 depression remains untreated, it 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 hypnotic medicines, including this medicine. 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 the patient plans to take. Especially 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. For this reason, concomitant use should only be considered when other treatment options are not possible.
However, 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 mentioned above. If such symptoms occur, contact your doctor.
Sonrest, food and alcohol
Do not consume alcohol while taking Sonrest, as alcohol may enhance the effect of Sonrest.
While taking Sonrest, avoid eating grapefruit or drinking grapefruit juice. Grapefruit may enhance the effect of Sonrest.
Pregnancy and breastfeeding
If the patient is pregnant, 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 disturbances 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, feeding difficulties and breathing problems (respiratory depression).
If the patient regularly takes Sonrest during late 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 during 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 who are 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 when zopiclone is used as a single medicine at the 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 intolerance to certain sugars, the patient 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 use Sonrest

Dosage
This medicine should always be taken exactly 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.
The recommended dose for adults and patients under 65 years of age 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 instead.

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.

Frequency of administration
Take a single dose of the medicine 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 in coordinating movements (psychomotor impairment).

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

Use of a higher than recommended dose of Sonrest
If a higher than recommended dose of Sonrest is taken, contact a doctor, pharmacist, or go to a
hospital emergency department immediately, 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 lightheaded (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 should
not be taken until the next day at the usual time before bedtime, if needed. Never take a double dose
to make up for a missed tablet.

Stopping Sonrest
Suddenly stopping Sonrest may lead to transient sleep disturbances. Withdrawal symptoms may also
occur, including: difficulty falling asleep, headache, excessive sweating, hallucinations, and
increased heart rate. 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 effects

Like any medicine, this medicine may cause adverse effects, although not everyone will experience them.
These may vary depending on the dose used and the individual sensitivity of the patient.
You must stop taking Sonrest and seek medical advice immediately 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 a severe allergic reaction: itchy rash, swelling of the mouth cavity which may cause difficulty breathing and swallowing, wheezing (anaphylactic reaction).

Other adverse effects:
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 having sex, etc.) while the patient is not fully awake (see section 2 “Warnings and precautions”)
• physical and psychological dependence, even at doses recommended 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 (paresthesia), cognitive disorders such as memory impairment, attention disorders, speech disorders
• respiratory depression (slow and shallow breathing)
• double vision
• indigestion, vomiting
• decreased muscle strength (hypotonia)

Reporting of adverse effects
If any adverse effects occur, including any adverse effects not listed
in this leaflet, inform your doctor or pharmacist. Adverse effects 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 effects can also be reported to the marketing authorisation holder or its representative
in Poland. Reporting adverse effects helps to collect more information on the safety of the medicine.

5. How to store Sonrest

Keep this medicine out of the 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 conditions are required 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 pack and other information

What Sonrest contains

• The active substance is zopiclone. Each coated tablet contains 3.75 mg of zopiclone.
• Other ingredients:
  Tablet core: calcium hydrogen phosphate dihydrate; lactose monohydrate (see section 2, "Sonrest contains lactose"); sodium carboxymethyl starch (type A) (see section 2, "Sonrest contains sodium"); corn starch; magnesium stearate.
  Coating: colourant "Opadry Orange": talc (E553b); hypromellose 2910 (E464); titanium dioxide (E171); propylene glycol (E1520); yellow iron oxide (E172); red iron oxide (E172).

What Sonrest looks like and contents of the pack
Light orange to orange, round, biconvex coated tablets,
coated tablets with an embossed mark “Z2” on one side and smooth on the other side.
Aluminium/PVC/PVDC blister pack containing 10 coated tablets.
20 or 30 coated tablets (2 or 3 blisters) with a patient leaflet in a cardboard box.

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 countries under the following names:
Czech Republic, Denmark, Estonia, Italy, Norway, Sweden, Slovakia: Zopiclone Olpha
Lithuania: Zopiclone Olpha 3.75 mg plėvele dengtos tabletės
Latvia: Zopiclone Olpha 3.75 mg apvalkotās tabletes
Poland: Sonrest
Germany: Zopiclon Olpha