ESOGNO 2 mg Tablets

Contents of the leaflet

1. Leaflet included in the packaging: patient information
2. Esogno, 1 mg, coated tablets
3. Esogno, 2 mg, coated tablets
4. Esogno, 3 mg, coated tablets
   1. It is essential to carefully read the contents of the leaflet before taking the medicine, as it contains important information for the patient.
   2. Table of contents of the leaflet
5. What is Esogno and what is it used for
6. Important information before taking Esogno
   1. When not to take Esogno:
   2. Warnings and precautions
   3. Esogno and other medicines
   4. Using Esogno with food, drink, and alcohol
   5. Pregnancy and breastfeeding
   6. Driving and operating machinery
   7. Esogno contains sodium
7. How to take Esogno
   1. Taking a higher dose of Esogno than recommended
   2. Missing a dose of Esogno
   3. Discontinuing Esogno
8. Possible side effects
   1. Reporting side effects
9. How to store Esogno
10. Contents of the packaging and other information
    1. What Esogno contains
    2. What Esogno looks like and contents of the packaging
    3. Marketing authorization holder and manufacturer
    4. To obtain more detailed information and information on the product name in other EEA member states, please contact the representative of the marketing authorization holder:
    5. Date of the last update of the leaflet:

Leaflet included in the packaging: patient information

Esogno, 1 mg, coated tablets

Esogno, 2 mg, coated tablets

Esogno, 3 mg, coated tablets

Eszopiclone
For use in adults

It is essential to carefully read the contents of the leaflet before taking the medicine, as it contains important information for the patient.

• The leaflet should be kept, so it can be re-read if necessary.
• In case of any doubts, the patient should consult a doctor or pharmacist.
• This medicine has been prescribed to a specific person. It should not be given to others. The medicine may harm another person, even if the symptoms of their illness are the same.
• If the patient experiences any side effects, including those not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is Esogno and what is it used for
• 2. Important information before taking Esogno
• 3. How to take Esogno
• 4. Possible side effects
• 5. How to store Esogno
• 6. Contents of the packaging and other information

1. What is Esogno and what is it used for

Esogno belongs to a group of medicines called hypnotics, which are used to facilitate sleep.
Esogno is used to treat insomnia, usually for a short period. Esogno is intended for use in adult patients, only in cases of severe sleep disorders, causing a deterioration in the quality of life or extreme suffering for the patient.

2. Important information before taking Esogno

When not to take Esogno:

Warnings and precautions

Before starting to take Esogno, the patient should discuss the following with their doctor or pharmacist:

• If the patient is 65 years of age or older (see section 3, "How to take Esogno").
• When taking sleeping aids like Esogno, there is a risk of dependence. This is more likely in patients who have been dependent on drugs, illegal substances, or alcohol in the past, or if they have been diagnosed with personality disorders. The patient should inform their doctor if they have been dependent on illegal substances, drugs, or alcohol in the past.
• If the patient has breathing disorders (see section 2, "When not to take Esogno").
• The patient should inform their doctor if they have anxiety or depression. The doctor may change the treatment.

During treatment with Esogno:

• Esogno should not be taken without the possibility of devoting 8 hours to sleep.
• Esogno may cause memory loss. To minimize this risk, the patient should ensure they have at least 8 hours of uninterrupted sleep.
• If the patient does not have the opportunity to sleep for 8 hours after taking Esogno, they may feel unsteady on their feet. In patients over 65 years of age, falls and bodily injuries are more likely.
• The patient should inform their doctor if, while taking Esogno, they start to behave in an unusual way, e.g., become more sociable or aggressive than usual, feel confused, excited, anxious, have nightmares, see or hear things that do not exist (hallucinations), experience worsening depression, or have suicidal thoughts or behaviors.
• There may be sleepwalking and other related behaviors. After taking Esogno, the patient may get out of bed while not fully awake and perform activities without knowing they are doing them. The next morning, the patient may not remember doing anything at night. These behaviors are more likely if the patient consumes alcohol or takes other sleeping aids at the same time as Esogno. Reported behaviors include sleep driving, preparing and eating food, talking on the phone, having sex, and sleepwalking.
• Next-day psychomotor impairment (see section 2, "Driving and operating machinery") - the day after taking Esogno, the risk of psychomotor impairment, including impaired driving ability, may increase:
• Esogno should be taken as a single dose immediately before bedtime. A second dose should not be taken on the same night.

Esogno and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.
Esogno may affect the action of other medicines or other medicines may affect its action, e.g.,

• over-the-counter medicines, including herbal medicines;
• CYP3A4 inhibitors, such as antibiotics (medicines used to treat bacterial infections), antifungal medications (medicines used to treat fungal infections, e.g., ketoconazole), or grapefruit juice. It may be necessary to reduce the dose or discontinue Esogno (see section 3, "How to take Esogno");
• 3. "How to take Esogno");
• cytochrome P450 enzyme inducers, such as carbamazepine, phenytoin, or St. John's Wort;
• medicines used to treat mood or behavioral disorders, e.g., medicines used to treat depression and anxiety (antipsychotic, sedative, anti-anxiety, or antidepressant medicines);
• strong painkillers (narcotic painkillers);
• medicines used to treat seizures or epilepsy (antiepileptic medicines);
• anesthetics;
• medicines used to treat allergies (antihistamines that can cause drowsiness). Combination with these medicines may increase the risk of side effects. The patient should inform their doctor if they are taking any of the above medicines. The doctor may need to adjust the dose of Esogno. Concomitant use of Esogno with opioids (strong painkillers, substitution therapy medicines, and some cough medicines) increases the risk of drowsiness, breathing difficulties (respiratory depression), sleepiness, and may be life-threatening. Therefore, concomitant use of these medicines may only be considered if other treatment options are not possible. If the doctor prescribes Esogno to be taken with an opioid medicine, they should limit the dose and duration of concomitant use.

The patient should inform their doctor about all opioid medicines they are taking and strictly follow their doctor's instructions regarding dosing. It may be helpful to inform family members or friends to be aware of the above symptoms. If the patient experiences such symptoms, they should contact their doctor.

Using Esogno with food, drink, and alcohol

Esogno may start to work later if taken with or immediately after a high-fat or heavy meal.
During treatment with Esogno, the patient should not consume alcohol, as it may increase the side effects of the medicine.
The patient should avoid consuming grapefruit juice, as it affects the action of Esogno.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor before taking this medicine.
Esogno is not recommended for use during pregnancy.
Esogno is not recommended if the patient is breastfeeding, as it may pass into breast milk. The doctor may advise the patient to stop taking Esogno.

Driving and operating machinery

The patient should not drive vehicles, operate machinery, or work at heights for 12 hours after taking Esogno.
Drowsiness, blurred vision, and concentration, memory, and coordination disorders may impair the ability to perform such activities.
If the patient experiences such disorders the next morning after taking Esogno, they should not drive vehicles, operate machinery, or work at heights.

Esogno contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per tablet and can be considered "sodium-free".

3. How to take Esogno

This medicine should always be taken as directed by the doctor. In case of doubts, the patient should consult their doctor or pharmacist.
Adults
The recommended initial dose of eszopiclone is 1 mg per night. If necessary, the dose may be increased to 2 or 3 mg.
Esogno should be taken as a single dose immediately before bedtime. The patient should not take more than one dose in the same night.
Elderly patients 65 years of age and older
The recommended initial dose of eszopiclone is 1 mg per night. If necessary, the dose may be increased to 2 mg.
Patients with severe renal impairment
The maximum recommended dose of eszopiclone is 2 mg per night.
Patients taking CYP3A4 inhibitors, such as certain antibiotics or antifungal medications
The maximum recommended dose of eszopiclone is 2 mg per night. In patients over 65 years of age, Esogno should not be taken concomitantly with CYP3A4 inhibitors.
Esogno is intended for oral use. The tablets should be swallowed whole. The tablets should not be crushed or broken, as the active substance has a bitter taste.
Duration of treatment
The duration of treatment should be as short as possible and should not exceed four weeks, including the tapering-off period (see "Discontinuing Esogno").
In some cases, it may be necessary to take Esogno for more than 4 weeks. In such cases, the doctor will determine how long the patient should take the medicine.

Taking a higher dose of Esogno than recommended

If the patient has taken too many Esogno tablets, they should immediately seek medical attention. If possible, they should show the doctor the packaging of the medicine.
If the patient has taken too high a dose of Esogno, they may become very sleepy or fall into a coma.

Missing a dose of Esogno

The patient should not take a double dose to make up for a missed dose.
The patient should take the next dose at the usual time.
The patient should not take more than one dose in the same night.

Discontinuing Esogno

The patient should not suddenly stop taking Esogno but should inform their doctor of their intention to stop treatment. The doctor will advise the patient on how and for how long to taper off the dose. After stopping Esogno, it is possible that insomnia may recur for one or two nights.
Occasionally, after discontinuing Esogno, side effects such as stomach pain, headache, and increased appetite may occur. In rare cases, after discontinuing medicines like Esogno, seizures may occur. The patient should inform their doctor if they experience any of these symptoms.
In case of any further doubts related to the use of this medicine, the patient should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Esogno can cause side effects, although not everybody gets them.
Very common(affects more than 1 in 10 people)

• Unpleasant taste Common(affects 1 to 10 in 100 people)
• Anxiety, depression, fear
• Headache, migraine, drowsiness, dizziness, abnormal dreams, memory loss or disorders, abnormal thinking
• Blurred vision (mainly in patients over 65 years of age)
• Sore throat
• Dry mouth, diarrhea, nausea, vomiting, indigestion, stomach pain
• Rash
• Back pain, muscle pain
• Weakness, pain Uncommon(affects 1 to 10 in 1,000 people)
• Infections, viral infections
• Changes in red blood cell color, anemia, decreased white blood cell count, increased white blood cell count
• Allergic reactions
• Hyperthyroidism
• Swelling of the feet, ankles, or fingers, anorexia, increased appetite, low potassium levels in the blood
• Emotional instability, decreased libido, confusion, excitement, anxiety, seeing or hearing things that do not exist (hallucinations), insomnia, apathy, euphoria
• Dizziness, coordination and walking disorders, movement disorders or restrictions, tingling, numbness, tremors
• Dry eyes
• Tinnitus, ear pain
• High blood pressure, fainting
• Breathing difficulties, runny nose, hiccups
• Shortness of breath, mouth ulcers, pharyngitis, influenza-like illness, tongue swelling
• Sensitivity to light, sweating, flushing, dry skin, rash
• Leg cramps, muscle twitching, muscle weakness, joint problems
• Frequent urination, urinary tract infections, uncontrolled or involuntary urination, kidney pain, kidney stones, presence of albumin in the urine
• Painful, irregular, or scarce menstruation, breast pain, impotence
• Fever, fatigue
• Weight gain, weight loss Rare(affects 1 to 10 in 10,000 people)
• Angioedema (face, lip, tongue, or throat swelling), anaphylactic reaction (rapid, allergic reaction with rash, swelling, and breathing difficulties)
• Emotional disorders, aggression, irritability, anxiety, thinking about things that are not true (delusions), abnormal behavior, memory disorders from the time of taking eszopiclone (amnesia), sleepwalking, sleep driving, and other strange behaviors
• Itching (often in patients over 65 years of age)
• Falls (mainly in patients over 65 years of age) Very rare(affects less than 1 in 10,000 people)
• Mild to moderate increase in aminotransferase and/or alkaline phosphatase activity in the blood Side effects with unknown frequency(frequency cannot be estimated from available data)
• Dependence, withdrawal symptoms, emotional suppression
• Loss of appetite, attention disorders, prolonged reaction time
• Double vision
• Slow breathing (respiratory depression)
• Muscle weakness

Elderly patients
The following side effects occurred exclusively in patients over 65 years of age:
Common(affects 1 to 10 in 100 people)

• Blurred vision

Reporting side effects

If the patient experiences any side effects, including those not listed in the leaflet, they should inform their doctor or pharmacist. Side effects can be reported directly to the Department of Post-Marketing Surveillance of Adverse Reactions of Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181 C
02-222 Warsaw, Poland
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Email: [email protected]
Side effects can also be reported to the marketing authorization holder.
Reporting side effects helps to gather more information on the safety of the medicine.

5. How to store Esogno

The medicine should be stored out of sight and reach of children.
The medicine should not be used after the expiration date stated on the packaging and blister after: EXP.
The expiration date refers to the last day of the given month.
For 1 mg packaged in PVC/PCTFE/Aluminum and OPA/Aluminum/PVC/Aluminum blisters, and 2 mg and 3 mg packaged in PVC/PCTFE/Aluminum, OPA/Aluminum/PVC/Aluminum, and PVC/PVdC/PVC/Aluminum blisters
There are no special storage instructions for the medicine.
For 1 mg packaged in PVC/PVdC/PVC/Aluminum blisters
The medicine should not be stored at temperatures above 30°C.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Esogno contains

• The active substance of Esogno is eszopiclone. Esogno, 1 mg, coated tabletsEach coated tablet contains 1 mg of eszopiclone.

Esogno, 2 mg, coated tablets
Each coated tablet contains 2 mg of eszopiclone.
Esogno, 3 mg, coated tablets
Each coated tablet contains 3 mg of eszopiclone.

• Other ingredients are: Tablet core:microcrystalline cellulose, calcium hydrogen phosphate, sodium croscarmellose, colloidal anhydrous silica, magnesium stearate.

Coating:hypromellose, talc, titanium dioxide (E 171), macrogol 3350.
The 1 mg and 3 mg tablets also contain indigo carmine (E 132), aluminum lake.

What Esogno looks like and contents of the packaging

Esogno, 1 mg, coated tablets are light blue, round, biconvex, coated tablets with the imprint "1" on one side.
Esogno, 2 mg, coated tablets are white, round, biconvex, coated tablets with the imprint "2" on one side.
Esogno, 3 mg, coated tablets are blue, round, biconvex, coated tablets with the imprint "3" on one side.
Esogno is available in blisters containing 7, 10, 14, 20, 28, 30, 50, 56, 98, or 100 coated tablets.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

G.L. Pharma GmbH
Schloβplatz 1
8502 Lannach
Austria

To obtain more detailed information and information on the product name in other EEA member states, please contact the representative of the marketing authorization holder:

G.L. PHARMA POLAND Sp. z o.o.
Al. Jana Pawła II 61/313
01-031 Warsaw, Poland
Phone: 022/636 52 23; 636 53 02
[email protected]

Date of the last update of the leaflet: