Sonlax

Package Leaflet: Information for the Patient

Sonlax, 7.5 mg, Film-Coated Tablets

Zopiclone

Read the Package Leaflet Carefully Before Taking the Medication, as it Contains Important Information for the Patient.

• Keep this Package Leaflet, You May Need to Read it Again.
• In Case of Any Doubts, Consult a Doctor or Pharmacist.
• This Medication has been Prescribed Specifically for You. Do Not Pass it on to Others. The Medication may Harm Others, Even if their Symptoms are the Same.
• If the Patient Experiences any Undesirable Effects, Including any Undesirable Effects not Listed in this Package Leaflet, Inform a Doctor or Pharmacist. See Section 4.

Package Leaflet Contents:

• 1. What is Sonlax and What is it Used for
• 2. Important Information Before Taking Sonlax
• 3. How to Take Sonlax
• 4. Possible Undesirable Effects
• 5. How to Store Sonlax
• 6. Package Contents and Other Information

1. What is Sonlax and What is it Used for

Sonlax Belongs to a Group of Sedative Medications. The Medication Contains Zopiclone - a Substance Similar to Benzodiazepines.
Sonlax is Indicated for Short-Term Treatment of Insomnia in Adults - Transient, Short-Term, or Chronic (Including Difficulty Falling Asleep, Sleep Fragmentation, Early Morning Awakening). The Use of Benzodiazepines and Benzodiazepine-Like Substances is Indicated Only in Cases of Severe Disorders, Inability to Function Normally, or a Condition Causing Severe Exhaustion in the Patient.

2. Important Information Before Taking Sonlax

When Not to Take Sonlax:

• If the Patient is Allergic to Zopiclone or any Other Component of this Medication (Listed in Section 6);
• If the Patient has Myasthenia Gravis - a Disease Characterized by Muscle Weakness;
• If the Patient has Respiratory Failure;
• If the Patient has Sleep Apnea Syndrome (Breathing Disorders Occurring During Sleep);
• If the Patient has Severe Liver Failure;
• In Patients Under 18 Years of Age.

Warnings and Precautions

Before Starting to Take Sonlax, Discuss it with a Doctor or Pharmacist.
Dependence
Taking Benzodiazepines and Other Medications Similar to Benzodiazepines may Cause Physical and Psychological Dependence. The Risk of Dependence Increases if the Medication Dose is High and the Treatment Duration is Long. Additionally, the Risk is Higher in Patients who have Previously Abused Alcohol or Medications and in Patients with Significant Personality Disorders.
In Physical Dependence, After Sudden Discontinuation of the Medication, Withdrawal Symptoms may Occur: Headaches, Muscle Pain, Severe Anxiety, Tension, Restlessness, Confusion, and Irritability. In Severe Cases, the Following may Occur: Depersonalization (Disorder of Identity), Derealization (Lack of Sense of Reality), Hyperacusis, Numbness and Tingling of the Limbs, Increased Sensitivity to Light, Noise, or Touch, Hallucinations, or Seizures.
Rebound Insomnia
After Discontinuation of Benzodiazepines or Benzodiazepine-Like Substances, the Symptoms that were the Reason for Treatment with Benzodiazepines or Benzodiazepine-Like Substances may Temporarily Worsen. After Sudden Discontinuation of the Medication, these Symptoms may be Accompanied by Other Reactions, Including Mood Changes, Anxiety, and Restlessness. Due to the Risk of Withdrawal Symptoms or Rebound Effects, it is Recommended to Gradually Reduce the Dose.
Treatment Duration
Treatment should Last as Short as Possible, not Longer than 4 Weeks, Including the Period of Gradual Dose Reduction. The Doctor will Inform the Patient how Long the Medication will be Taken and how to Reduce the Dose.
Tolerance
The Sedative Effect of Short-Acting Benzodiazepines and Benzodiazepine-Like Substances may Decrease after Several Weeks of Treatment. In the Case of Zopiclone, this Effect does not Occur During Treatment Lasting up to 4 Weeks.
Anterograde Amnesia
Benzodiazepines and Benzodiazepine-Like Substances may Cause Anterograde Amnesia (Regarding the Time After Taking the Medication), Especially a Few Hours After Administration. It is Necessary to Ensure the Patient has Uninterrupted Sleep for 7-8 Hours After Taking the Medication to Reduce the Risk of these Symptoms.
Psychological and Paradoxical Reactions
During Treatment with Benzodiazepines and Similar Medications, the Following may Occur: Restlessness, Excitement, Irritability, Aggression, Delusions, Outbursts of Anger, Nightmares, Hallucinations, Psychosis, Inappropriate Behavior, and Other Behavioral Disorders. If these Symptoms Occur, the Patient should Immediately Contact a Doctor to Discontinue Zopiclone Treatment. These Undesirable Effects are More Common in Children and the Elderly.
Somnambulism and Similar Behavioral Disorders
In Patients who have Taken Zopiclone and have not Woken up Completely, the Following Disorders may Occur: Sleepwalking and Related Behavioral Disorders, such as Driving a Vehicle while Asleep, Preparing and Consuming Food, Making Phone Calls while Asleep with No Memory of the Actions Performed. It seems that Consuming Alcohol or Taking Other Medications with a Depressant Effect on the Central Nervous System Along with Zopiclone Increases the Risk of such Behavior, as well as Taking Zopiclone in Doses Higher than the Maximum Recommended Dose. Patients Reporting such Behavior are Advised to Discontinue Zopiclone (See "Sonlax and Other Medications" and "Possible Undesirable Effects").
Special Patient Groups
Dosing of the Medication in the Elderly is Described in Section 3 "How to Take Sonlax".
In Patients with Chronic Respiratory Failure, the Doctor will Recommend a Lower Dose of the Medication.
Benzodiazepines and Benzodiazepine-Like Substances are not Suitable for Treating Patients with Severe Liver Failure.
In Patients with Psychosis, it is not Recommended to Use Benzodiazepines and Similar Medications as First-Line Treatments.
In the Treatment of Depression or Anxiety Associated with Depression, Benzodiazepines and Similar Substances should not be Used as the Only Medications.
In Patients who Abuse Alcohol or Other Medications, Medications from this Therapeutic Group should be Used with Great Caution.
Before Starting Zopiclone Treatment, the Doctor will Determine the Cause of Insomnia. It is Necessary to Consult a Doctor, even if the Above Warnings Refer to Situations that Occurred in the Past.

Sonlax and Other Medications

Inform a Doctor or Pharmacist about all Medications Currently Being Taken or Recently Taken, as well as Medications Planned to be Taken.
Zopiclone may Enhance the Inhibitory Effect on the Central Nervous System of Medications such as Antipsychotics (Neuroleptics), Sedatives, Anxiolytics (Anti-Anxiety Medications)/Sedatives, Antidepressants, Opioid Analgesics, Anticonvulsants, General Anesthetics, and Antihistamines with a Sedative Effect.
Zopiclone may Enhance the Effect of Muscle Relaxants. Medications such as Ketoconazole, Erythromycin, Clarithromycin, Itraconazole, Ritonavir, and Nefazodone, which Inhibit Zopiclone Metabolism in the Body, may Enhance its Effect.
Erythromycin Accelerates Zopiclone Absorption and may Enhance its Sedative Effect.
Zopiclone Concentrations in the Blood may Decrease During Concurrent Use of Medications such as Rifampicin, Carbamazepine, Phenobarbital, Phenytoin, and St. John's Wort (Hypericum perforatum). In this Case, the Doctor may Increase the Sonlax Dose.

Sonlax with Food, Drink, and Alcohol

The Medication can be Taken Independently of Meals. Sonlax should Always be Taken Immediately Before Sleep.
During Sonlax Treatment, do not Consume Alcohol, as Alcohol Enhances the Sedative Effect of Zopiclone.

Pregnancy, Breastfeeding, and Fertility

If the Patient is Pregnant or Breastfeeding, or Thinks they may be Pregnant or Plans to have a Child, they should Consult a Doctor or Pharmacist Before Taking this Medication.
Sonlax should not be Used in Pregnant Women. If the Patient Plans to Become Pregnant or Suspects they are Pregnant, they should Immediately Contact a Doctor to Discontinue Zopiclone Treatment.
If the Patient has Taken Zopiclone in the Last Three Months of Pregnancy or Before Delivery, they should Inform the Doctor. Due to the Risk of Physical Dependence, Newborns Born to Mothers who have Taken Zopiclone for a Long Time in the Last Months of Pregnancy may Experience Withdrawal Symptoms.
Zopiclone Passes into Breast Milk. Although the Concentration of Zopiclone in Breast Milk is Very Low, Women who are Breastfeeding should not Take Sonlax.
Zopiclone Passes Through the Placenta and may Cause Hypothermia (Low Body Temperature), Reduced Muscle Tone, and Breathing Disorders in the Newborn.

Driving and Operating Machinery

Zopiclone may Affect Psychophysical Abilities. Medication-Induced Sedation, Amnesia, Concentration Disorders, and Muscle Function Disorders may Occur, which Reduce the Ability to Drive Vehicles or Operate Machinery. The Risk Increases if the Patient also Consumes Alcohol or Sleeps for Too Short a Time.

Sonlax Contains Lactose Monohydrate

If the Patient has Previously been Diagnosed with Intolerance to Some Sugars, they should Consult a Doctor Before Taking the Medication.

Sonlax Contains Sodium

The Medication Contains Less than 1 mmol of Sodium (23 mg) per Film-Coated Tablet, which means the Medication is Considered "Sodium-Free".

3. How to Take Sonlax

This Medication should Always be Taken as Directed by a Doctor. In Case of Doubts, Consult a Doctor or Pharmacist.
Sonlax Treatment should Last as Short as Possible, and the Treatment Duration will be Determined by a Doctor. The Medication should be Taken Immediately Before Sleep.
Treatment Duration is Usually Several Days to 2 Weeks, Maximum 4 Weeks, Including the Period of Dose Reduction. The Doctor may Decide to Extend the Treatment Duration After Re-Examining the Patient.
Treatment Duration:
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 Exceed this Dose.
In Elderly Patients, those with Liver Failure, or those with Chronic Respiratory Failure, Treatment should be Started with a Dose of 3.75 mg, i.e., Half a Tablet.
In Patients with Renal Failure, Treatment should be Started with a Dose of 3.75 mg.
Tablets can be Divided as Follows:

• Place the Tablet on a Table,
• Press the Left and Right Thumbs or Index Finger on Both Sides of the Dividing Groove.

Taking a Higher than Recommended Dose of Sonlax

In Case of Taking a Higher than Recommended Dose of the Medication, Immediately Contact a Doctor, Hospital, or Pharmacist. After Overdose, Dizziness, Lethargy, and Ataxia (Loss of Coordination) may Occur. Overdose of Benzodiazepines or Other Similar Medications may Cause Drowsiness or Coma.

Missing a Dose of Sonlax

Take the Next Dose at the Usual Time the Next Day. The Medication should Always be Taken in the Evening to Facilitate Falling Asleep. Do not Take a Double Dose to Make up for a Missed Dose.

Discontinuing Sonlax

Taking Benzodiazepines and Other Medications Similar to Benzodiazepines may Cause Physical and Psychological Dependence on these Medications.
In Case of Physical Dependence, After Sudden Discontinuation of the Medication, Withdrawal Symptoms may Occur: Headaches, Muscle Pain, Severe Anxiety, Tension, Restlessness, Confusion, and Irritability. In Severe Cases, the Following may Occur: Depersonalization (Disorder of Identity), Derealization (Lack of Sense of Reality), Hyperacusis, Numbness and Tingling of the Limbs, Increased Sensitivity to Light, Noise, or Touch, Hallucinations, or Seizures.
In Case of Any Further Doubts Regarding the Use of this Medication, Consult a Doctor or Pharmacist.

4. Possible Undesirable Effects

Like all Medications, this Medication can Cause Undesirable Effects, although they do not Occur in Everyone.
Psychological Disorders
Decreased Sensitivity, Confusion, Changes in Libido, Depression, Anxiety, Restlessness, Irritability, Aggression, Delusions, Outbursts of Anger, Nightmares, Hallucinations, Psychosis, Behavioral Disorders, Dependence.
See also Below: "Depression", "Psychological and Paradoxical Reactions", and "Dependence".
Nervous System Disorders
Amnesia, Next-Day Sedation, Decreased Alertness, Headaches, Dizziness, Ataxia (Mainly Occurs at the Beginning of Treatment and Usually Disappears After Repeated Administration).
See also Below "Amnesia".
Eye Disorders
Double Vision (Mainly Occurs at the Beginning of Treatment and Usually Disappears After Repeated Administration).
Gastrointestinal Disorders
Gastrointestinal Symptoms (Including Nausea and Vomiting, Dry Mouth). Bitter Taste or Metallic Aftertaste.
Skin and Subcutaneous Tissue Disorders
Skin Reactions and Allergic Reactions (Including Urticaria).
Musculoskeletal and Connective Tissue Disorders
Muscle Weakness.
General Disorders and Administration Site Conditions
Fatigue.
Immune System Disorders
Very Rarely, Angioedema and/or Anaphylactic Reactions have been Reported.
In Some Patients During Sonlax Treatment, the Following may Occur:

• Anterograde Amnesia (Regarding the Time After Taking the Medication) - the Risk of this Symptom Increases with the Size of the Dose. In Addition to Amnesia, Inappropriate Behavior may Occur;
• Depression - not Present Before Sonlax Treatment;
• Psychological and Paradoxical Reactions - such as Anxiety, Restlessness, Irritability, Aggression, Delusions, Outbursts of Anger, Nightmares, Hallucinations, Psychosis, Sleepwalking, Inappropriate Behavior, and Other Behavioral Disorders. Sometimes these Reactions can be Quite Severe. The Risk of these Reactions is Higher in Children and the Elderly;
• Dependence - Taking the Medication can Cause Physical Dependence even when Therapeutic Doses are Used: Discontinuation of the Medication can Lead to Withdrawal Symptoms and Rebound Effects, i.e., Recurrence of Insomnia. Additionally, Psychological Dependence may also Occur.

In Case of any Undesirable Effects, Inform a Doctor, Pharmacist, or Nurse. Undesirable Effects can be Reported Directly to the Department of Monitoring of Undesirable Effects of Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products: Al. Jerozolimskie 181 C, 02-222 Warsaw, Tel.: +48 22 49-21-301, Fax: +48 22 49-21-309, Website: https://smz.ezdrowie.gov.pl
Undesirable Effects can also be Reported to the Marketing Authorization Holder.
Reporting Undesirable Effects will Allow for More Information to be Collected on the Safety of the Medication.

5. How to Store Sonlax

Store in a Temperature Below 25°C. Store in the Original Packaging to Protect from Light and Moisture.
The Medication should be Stored in a Place that is Inaccessible to Children.
Do not Use Sonlax After the Expiration Date Stated on the Box and Blister Pack.
The Expiration Date Refers to the Last Day of the Specified Month.
Medications should not be Disposed of in Sewers or Household Waste Containers. Ask a Pharmacist how to Dispose of Unused Medications. This will Help Protect the Environment.

6. Package Contents and Other Information

What Sonlax Contains

• The Active Substance of the Medication is Zopiclone. One Tablet Contains 7.5 mg of Zopiclone.
• Other Ingredients are: Calcium Phosphate Anhydrous, Potato Starch, Magnesium Stearate, Sodium Carboxymethylcellulose (Type A), Colloidal Silica Anhydrous, Opadry 33G28707 White (Hypromellose, Titanium Dioxide (E 171), Lactose Monohydrate, Macrogol 3000, Triacetin)

What Sonlax Looks Like and What the Package Contains

White, Round, Uncoated Film-Coated Tablets with a Dividing Line on the Other Side, Packaged in Blisters and Cardboard Boxes.
The Package Contains 10 or 20 Film-Coated Tablets.

Marketing Authorization Holder and Manufacturer

AS GRINDEKS
Krustpils iela 53
Rīga, LV-1057
Latvia

Date of the Last Update of the Package Leaflet: