Package leaflet: Information for the patient

Sonlax, 7.5 mg, coated tablets
Zopiclonum
Please read this leaflet carefully before taking this medicine, as it contains
important information for you.

Keep this leaflet, as you may need to read it again.
If you have any further questions, please consult your doctor or pharmacist.
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 as yours.
If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents of the leaflet:

What Sonlax is and what it is used for
Important information before taking Sonlax
How to take Sonlax
Possible side effects
How to store Sonlax
Contents of the pack and other information

1. What Sonlax is and what it is used for

Sonlax belongs to a group of sleeping medicines. The medicine contains zopiclone – a substance similar to benzodiazepines.
Sonlax is indicated for the short-term treatment of insomnia in adults – transient, short-term or chronic (including difficulty falling asleep, fragmented sleep, early morning awakening). The use of benzodiazepines and substances similar to benzodiazepines is indicated only in cases of severe disturbances, inability to function normally, or conditions causing significant exhaustion in the patient.

2. Important information before taking Sonlax
When not to take Sonlax:

if you are allergic to zopiclone or any of the other ingredients of this medicine (listed in section 6);
if you have myasthenia gravis – a disease characterized by muscle weakness;
if you have respiratory insufficiency;
if you have sleep apnoea syndrome (breathing disorders occurring during sleep);
if you have severe hepatic insufficiency;
in patients under 18 years of age.

Warnings and precautions
Before starting treatment with Sonlax, discuss it with your doctor or pharmacist.
Dependence
The use of benzodiazepines and other drugs similar to benzodiazepines may lead to physical and psychological dependence. The risk of dependence increases with higher doses and prolonged treatment duration. The risk is also higher in patients with a history of alcohol or drug abuse, and in patients with marked personality disorders.
In physical dependence, withdrawal symptoms may occur after abrupt discontinuation of the medicine: headache, muscle pain, severe anxiety, tension, restlessness, confusion (disorientation), and irritability. In severe cases, derealization (loss of reality perception), depersonalization (disturbance of self-identity), hyperacusis (increased sensitivity to sound), numbness and tingling of limbs, hypersensitivity to light, noise or touch, hallucinations, or seizures may occur.
Rebound insomnia
After stopping benzodiazepines or substances similar to benzodiazepines, the symptoms that led to treatment may temporarily worsen. Other reactions, including mood changes, anxiety, and restlessness, may accompany this rebound effect. Due to the risk of withdrawal or rebound symptoms, gradual dose reduction is recommended.
Duration of treatment
Treatment should be as short as possible and should not exceed 4 weeks, including the tapering-off period. Your doctor will inform you how long the medicine should be taken and how to reduce the dose.
Tolerance
The hypnotic effect of short-acting benzodiazepines and drugs with similar action may decrease after several weeks of use. However, this effect does not occur with zopiclone during treatment lasting up to 4 weeks.
Anterograde amnesia
Benzodiazepines and drugs with similar action may cause anterograde amnesia (affecting the period after taking the medicine), particularly within a few hours after intake. Patients should ensure uninterrupted sleep of 7–8 hours after taking the medicine to reduce the risk of these symptoms.
Psychological and paradoxical reactions
During treatment with benzodiazepines and similar drugs, reactions such as anxiety, agitation, irritability, aggression, delusions, rage attacks, nightmares, hallucinations, psychoses, inappropriate behavior, and other behavioral disturbances may occur. If such symptoms occur, contact your doctor immediately to discontinue zopiclone treatment. These adverse effects occur more frequently in children and elderly patients.
Somnambulism and similar behaviors
In patients taking zopiclone who do not fully awaken, the following disturbances may occur: sleepwalking and related behavioral disturbances such as driving while asleep, preparing and eating food, making phone calls during sleep, with no memory of these activities. It appears that consuming alcohol or taking other central nervous system depressants together with zopiclone increases the risk of such behaviors, as does using zopiclone at doses higher than the maximum recommended dose. Patients reporting such behaviors should discontinue zopiclone (see sections "Sonlax with other medicines" and "Possible side effects").
Special patient groups
Dosing in elderly patients is described in section 3, "How to take Sonlax".
In patients with chronic respiratory insufficiency, the doctor may recommend a lower dose.
Benzodiazepines and drugs similar to benzodiazepines are not suitable for treating patients with severe hepatic insufficiency.
In patients with psychoses, benzodiazepines and similar drugs are not recommended as first-line treatment.
In the treatment of depression or anxiety associated with depression, benzodiazepines and similar substances should not be used as the sole therapy.
In patients with a history of alcohol or drug abuse, medicines in this therapeutic group should be used with extreme caution.
Before starting zopiclone treatment, the doctor should determine the cause of insomnia. Discuss with your doctor, even if the above warnings relate to past conditions.

Sonlax with other medicines
Inform your doctor or pharmacist about all medicines you are currently taking, have recently taken, or plan to take.
Zopiclone may enhance the central nervous system depressant effects of medicines such as antipsychotics (neuroleptics), hypnotics, anxiolytics (anti-anxiety medicines)/sedatives, antidepressants, opioid analgesics, antiepileptics, general anesthetics, and sedating antihistamines.
Zopiclone may enhance the effect of muscle relaxants. Medicines such as ketoconazole, erythromycin, clarithromycin, itraconazole, ritonavir, and nefazodone, which inhibit zopiclone metabolism in the body, may enhance its effects.
Erythromycin accelerates zopiclone absorption and may enhance its hypnotic effect.
Blood concentrations of zopiclone may decrease when taken concomitantly with medicines such as rifampicin, carbamazepine, phenobarbital, phenytoin, and St John's wort (Hypericum perforatum). In such cases, your doctor may increase the dose of Sonlax.

Sonlax with food, drink, and alcohol
This medicine may be taken regardless of meals. Sonlax should always be taken immediately before going to bed.
Do not consume alcohol while taking Sonlax, as alcohol enhances the sedative effect of zopiclone.

Pregnancy, breastfeeding, and effects on fertility
If you are pregnant or breastfeeding, suspect you may be pregnant, or are planning to have a child, consult your doctor or pharmacist before using this medicine.
Do not use Sonlax during pregnancy. If you are planning pregnancy or suspect you are pregnant, contact your doctor immediately to discontinue zopiclone treatment.
If you have taken zopiclone during the last three months of pregnancy or before delivery, inform your doctor. Due to physical dependence, newborns of mothers who used zopiclone for a prolonged period during the last months of pregnancy may experience withdrawal symptoms.
Zopiclone passes into breast milk. Although the concentration of zopiclone in the breast milk of nursing mothers is very low, women who are breastfeeding should not take Sonlax.
Zopiclone crosses the placenta, and therefore in the newborn, hypothermia (lowered body temperature), reduced muscle tone, and breathing disorders may occur.

Driving and operating machinery
Zopiclone may affect psychomotor performance. Post-medication sedation, amnesia, concentration disturbances, and muscle function disorders may reduce the ability to drive vehicles or operate machinery. The risk is increased if the patient consumes alcohol or sleeps for too short a period.

Sonlax contains lactose monohydrate
If you have been previously diagnosed with intolerance to certain sugars, consult your doctor before taking this medicine.

Sonlax contains sodium
The medicine contains less than 1 mmol of sodium (23 mg) per coated tablet, meaning the medicine is considered "sodium-free".

3. How to use Sonlax

This medicine should always be used as directed by the physician. In case of doubt, consult a
physician or pharmacist.
Treatment with Sonlax should last as short as possible, and the duration of treatment should be determined by the physician. This medicine should be taken immediately before bedtime.
The usual duration of treatment ranges from several days to 2 weeks, up to a maximum of 4 weeks, including the dose reduction period. The physician may decide to extend the treatment duration after re-evaluating the patient.
Duration of treatment:
Transient insomnia: 2 to 5 days.
Short-term insomnia: 2 to 3 weeks.
The recommended dose for adult patients is 7.5 mg (one tablet). Do not take a higher dose.
For elderly patients, patients with hepatic impairment, or chronic respiratory insufficiency, treatment should be initiated at a dose of 3.75 mg, i.e. half a tablet.
For patients with renal impairment, treatment should be initiated at a dose of 3.75 mg.
Tablets can be divided as follows:

place the tablet on a flat surface,
press with the left and right thumbs or index fingers on both sides of the dividing groove.

Taking more Sonlax than recommended
If more than the recommended dose of the medicine is taken, contact a physician, hospital, or pharmacist immediately. Overdose may result in dizziness, lethargy, and ataxia (lack of voluntary coordination of muscle movements). Overdose of benzodiazepines or other similar medicines may cause drowsiness or coma.
Missing a dose of Sonlax
Take the next dose at the usual time the following day. The medicine should always be taken in the evening to help with falling asleep. Do not take a double dose to make up for a missed dose.
Stopping Sonlax treatment
Use of benzodiazepines and other medicines similar to benzodiazepines may lead to physical and psychological dependence.
In case of physical dependence, abrupt discontinuation of the medicine may lead to withdrawal symptoms: headache, muscle pain, severe anxiety, tension, restlessness, confusion, and irritability. In severe cases, the following may occur: derealization (loss of sense of reality), depersonalization (disturbance of self-identity), auditory hypersensitivity, numbness and tingling of extremities, hypersensitivity to light, noise, or touch, hallucinations, or seizures.
In case of any further doubts regarding the use of this medicine, consult a physician or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everybody will experience them.

Psychiatric disorders
Reduced sensitivity, confusion, change in libido, depression, anxiety, agitation, irritability, aggression, delusions, rage attacks, nightmares, hallucinations, psychosis, behavioural disturbances, dependence.

See also below: "Depression", "Paradoxical and psychiatric reactions" and "Dependence".

Nervous system disorders
Memory impairment, next-day drowsiness, reduced alertness, headache, dizziness, ataxia (mainly occurs at the beginning of treatment and usually resolves upon repeated administration).

5. How to store Sonlax

Store below 25°C. Keep in the original packaging to protect from light and moisture.
Keep Sonlax out of sight and reach of children.
Do not use Sonlax after the expiry date stated on the carton and blister pack after "Tw".
The expiry date refers to the last day of the stated month.
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 package and other information

What Sonlax contains

The active substance is zopiclone. Each tablet contains 7.5 mg of zopiclone.
The other ingredients are: calcium hydrogen phosphate anhydrous, potato starch, magnesium stearate, sodium carboxymethyl starch (type A), colloidal anhydrous silica, Opadry 33G28707 White (hypromellose, titanium dioxide (E 171), lactose monohydrate, polyethylene glycol 3000, triacetin)

What Sonlax looks like and contents of the pack
White, round, film-coated tablets, convex on one side and flat on the other, with a break line on one side, packed in blisters and cardboard boxes.
Pack sizes: 10 or 20 film-coated tablets.
Marketing Authorisation Holder and Manufacturer
AS GRINDEKS
Krustpils iela 53
Rīga, LV-1057
Latvia