Esnoxiben

Patient Information Leaflet: Information for the Patient

ESNOXIBEN 1 mg film-coated tablets, 2 mg film-coated tablets, 3 mg film-coated tablets

eszopiclone
For use in adults
Please read 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 questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if they have the same symptoms as you, because it could be harmful.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet

1. What ESNOXIBEN is and what it is used for
2. What you need to know before taking ESNOXIBEN
3. How to take ESNOXIBEN
4. Possible side effects
5. How to store ESNOXIBEN
6. Contents of the pack and other information

1. What ESNOXIBEN is and what it is used for

ESNOXIBEN belongs to a class of medicines called "hypnotics", which are used to help sleep.
ESNOXIBEN is used for the treatment of insomnia, usually for a short period of time.
ESNOXIBEN is indicated in adults only when the condition is severe, disabling, or causing significant distress to the patient.

2. What you should know before taking ESNOXIBEN

Do not take ESNOXIBEN:

• If you are allergic to eszopiclone, zopiclone, or any of the other ingredients of this medicine (listed in section 6).
• If you suffer from severe myasthenia gravis (a condition in which muscles become easily fatigued and weak).
• If you have severe respiratory problems.
• If you have severe sleep apnea (a condition in which you stop breathing for short periods during sleep).
• If you have severe liver impairment.
• If you are aged 65 years or older or are taking CYP3A4 inhibitors such as certain antibiotics or antifungals (e.g., ketoconazole). In this case, consult your doctor or pharmacist.
• If you are under 18 years of age.

Warnings and precautions
Talk to your doctor or pharmacist before taking ESNOXIBEN:

• If you are aged 65 years or older (see section 3, “How to take ESNOXIBEN”).

• If you are taking medicines to help you sleep, such as ESNOXIBEN, there is a possibility that you may become dependent on them. This is more likely if you have previously been dependent on medicines, illicit substances, or alcohol, or if you have been diagnosed with a personality disorder. Inform your doctor if you have had a history of dependence on illicit substances, medicines, or alcohol.

• If you have respiratory problems (see section 2, “Do not take ESNOXIBEN”).

• Inform your doctor if you feel anxious or depressed. Your doctor may need to review your treatment.

During treatment with ESNOXIBEN:

• Do not take ESNOXIBEN if you do not have the opportunity to get at least 8 hours of sleep.
• ESNOXIBEN may cause memory loss. To reduce this risk, ensure you are able to have at least 8 hours of uninterrupted sleep.
• If you have not had 8 hours of sleep after taking ESNOXIBEN, you may feel unsteady when standing. If you are aged 65 years or older, you may be more likely to fall and injure yourself.
• Inform your doctor if you start behaving in an unusual way, for example, if you become more extroverted or aggressive than normal, confused, agitated, restless, have nightmares, or if you see or hear things that are not real (hallucinations), or if your depression worsens, or if you have suicidal thoughts or actions while taking ESNOXIBEN.
• Episodes of sleepwalking or similar behaviors may occur. After taking ESNOXIBEN, you may get out of bed while not fully awake and perform activities without being aware of them. The next morning, you may not remember what you did during the night. Your risk of performing these activities may be higher if you consume alcohol or take other medicines that cause drowsiness together with ESNOXIBEN. Reported activities include: driving a car (“sleep-driving”), cooking and eating, talking on the phone, having sex, sleepwalking.
• Psychomotor impairment the following day (see section “Driving and use of machines”). The day after taking ESNOXIBEN, the risk of psychomotor impairment, including impaired ability to drive, may increase:
  • if you take the medicine less than 12 hours before performing activities requiring your attention
  • if you take a higher dose than the recommended dose
  • if you take ESNOXIBEN while already taking another central nervous system depressant or other medicines that increase ESNOXIBEN levels in the blood, while consuming alcohol or using illicit substances.
• Take the single dose immediately before going to bed. Do not take additional doses during the same night.

Other medicines and ESNOXIBEN
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
ESNOXIBEN may affect or be affected by certain medicines, such as:

• Medicines you have purchased without a prescription, including herbal products.
• CYP3A4 inhibitors such as antibiotics (medicines used to treat bacterial infections), antifungals (medicines used to treat fungal infections, e.g., ketoconazole) or grapefruit juice. The dose of ESNOXIBEN may need to be reduced or discontinued (see section 3, “How to take ESNOXIBEN”).
• Cytochrome P-450 enzyme inducers such as carbamazepine, phenytoin, and St. John’s wort (hypericum).
• Medicines used to treat mood or behavior (how you feel or act), e.g., medicines for depression or anxiety (antipsychotics, hypnotics, anxiolytics/sedatives, antidepressants).
• Medicines used to relieve pain (narcotic analgesics).
• Medicines used to treat seizures or epileptic fits (antiepileptic drugs).
• Anesthetics.
• Medicines used to treat allergies (antihistamines that may cause drowsiness).

Combining ESNOXIBEN with the medicines listed above may increase the risk of adverse events. Inform your doctor if you are taking any of the medicines listed above. Your doctor may need to adjust the dose of ESNOXIBEN.
Concomitant use of ESNOXIBEN and opioids (strong painkillers, medicines for 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 when no other treatment options are available.
However, if your doctor prescribes ESNOXIBEN together with other opioids, your doctor must reduce the dose and duration of concomitant treatment.
Inform your doctor about all opioid-containing medicines you are taking, and carefully follow the dose recommended by your doctor. It is advisable to inform your friends or family members to watch for the signs and symptoms described above. Contact your doctor if these symptoms occur.

ESNOXIBEN with food, drinks, and alcohol
ESNOXIBEN may take longer to work if taken with or immediately after heavy or high-fat meals.
Do not drink alcohol while taking ESNOXIBEN, as alcohol may increase the undesirable effects of ESNOXIBEN.
Consumption of grapefruit juice should be avoided, as it affects the action of ESNOXIBEN.

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, planning to become pregnant, or breastfeeding, consult your doctor before taking this medicine.
ESNOXIBEN is not recommended during pregnancy.
ESNOXIBEN is not recommended if you are breastfeeding, as it may pass into breast milk. Your doctor may advise you to stop taking ESNOXIBEN.

Driving and use of machines
Do not drive, operate machinery, or work at heights for 12 hours after taking ESNOXIBEN.
Drowsiness, blurred vision, and difficulty concentrating, memory problems, and impaired coordination may affect your ability to perform these activities. If you experience these problems the morning after taking ESNOXIBEN, do not drive, operate machinery, or work at heights.

ESNOXIBEN contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per tablet, which means the medicine is “sodium-free”.

3. How to take ESNOXIBEN

Take this medicine exactly as your doctor has told you. If you are unsure, consult your doctor or pharmacist.

Adults
The recommended initial dose of eszopiclone is 1 mg once nightly. The dose may be increased to 2 or 3 mg if necessary.
Take a single dose of ESNOXIBEN immediately before going to bed. Do not take more than one dose in a single night.

Elderly patients aged 65 years and older
The recommended initial dose of eszopiclone is 1 mg once nightly. The dose may be increased to 2 mg if necessary.

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 antifungals
The maximum recommended dose of eszopiclone is 2 mg per night. If you are aged 65 years or older, you must not take ESNOXIBEN together with CYP3A4 inhibitors.

ESNOXIBEN is for oral use. Swallow the tablets whole. Do not crush or divide the tablet, as the active substance has a bitter taste.

Treatment duration
Treatment duration should be as short as possible and must not exceed 4 weeks, including the phase of gradual withdrawal (see section “If you stop taking ESNOXIBEN”).
In some cases, it may be necessary to take ESNOXIBEN for longer than 4 weeks. In such cases, your doctor will advise you on how long you should continue treatment.

If you take more ESNOXIBEN than you should
If you take more tablets than prescribed, contact a doctor immediately. If possible, show the doctor the ESNOXIBEN packaging.
If you take too much ESNOXIBEN, you may experience profound drowsiness or fall into a coma.

If you forget to take ESNOXIBEN
Do not take a double dose to make up for the missed dose.
Take the next tablet at your usual time. Do not take more than one dose in one night.

If you stop taking ESNOXIBEN
Do not stop taking ESNOXIBEN suddenly, but inform your doctor that you wish to discontinue treatment. Your doctor will gradually reduce your dose and stop treatment over a period of time.
Your sleep difficulties may return for one or two nights after stopping ESNOXIBEN.
Occasionally, unpleasant effects such as stomach pain, headache, and increased appetite may occur after discontinuation of ESNOXIBEN. In rare cases, seizures may occur after stopping medicines like ESNOXIBEN. Inform your doctor if you experience any of these conditions.

If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.

Very common side effects (may affect more than 1 in 10 people):

• Unpleasant taste

Common side effects (may affect more than 1 in 100 people):

• Nervousness, depression, anxiety
• Headache, migraine, drowsiness, dizziness, abnormal dreams, loss or difficulty with memory, abnormal thinking
• Blurred vision (mainly in patients aged 65 years or older)
• Sore throat
• Dry mouth, diarrhoea, feeling unwell (nausea), malaise (vomiting), indigestion, stomach pain
• Rash
• Back pain, muscle pain
• Weakness, pain

Uncommon side effects (may affect from 1 to 10 in 1,000 people):

• Infections, viral infections
• Change in colour of red blood cells, anaemia, decrease in white blood cells, increase in white blood cells
• Allergic reaction
• Hyperthyroidism
• Swelling of the ankles, feet or fingers, anorexia, thirst, increased appetite, decrease in blood potassium
• Emotional instability, decreased sexual desire, confusion, agitation, perceiving or hearing things that are not real (hallucinations), particularly when falling asleep, insomnia, apathy, euphoria
• Vertigo, difficulty with coordination and walking, disturbed or reduced body movements, tingling, stupor, tremor
• Dry eyes
• Ringing in the ears, ear pain
• High blood pressure, fainting
• Difficulty breathing, runny nose, hiccup
• Bad breath, mouth ulcers, inflammation of the colon, gastroenteritis, swelling of the tongue
• Skin sensitivity to light, sweating, acne, dry skin, eczema
• Leg cramps, muscle spasms, muscle weakness, joint problems
• Need to urinate frequently, urinary tract infection, involuntary and uncontrollable urination, kidney pain, kidney stones, presence of albumin protein in urine
• Painful, irregular or light menstrual cycles, breast pain, impotence
• Fever, fatigue
• Weight gain, weight loss

Rare side effects (may affect from 1 to 10 in 10,000 people):

• Angioedema (swelling of the face, lips, tongue and throat), anaphylactic reaction (rapid allergic reaction with rash, difficulty swallowing or breathing)
• Emotional disturbance, aggression, anger, restlessness, thinking things that are not true (delusions), abnormal behaviour, poor memory after taking eszopiclone (amnesia), sleepwalking or driving while asleep, or other unusual behaviours

Very rare side effects (may affect less than 1 in 10,000 people):

• Mild to moderate increase in transaminases and/or alkaline phosphatase in blood

Side effects with unknown frequency (frequency cannot be estimated from available data):

• Dependence, withdrawal symptoms, blunted emotions
• Loss of smell, attention disorder, delayed reaction time
• Double vision
• Slowed breathing (respiratory depression)
• Muscle fatigue

Elderly The following side effects occurred only in patients aged 65 years or older:

Common side effects (may affect from 1 to 10 in 100 people):

• Blurred vision

Reporting of side effects
If you get any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist.
You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store ESNOXIBEN

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister after EXP. The expiry date refers to the last day of that month.
[For the 1 mg pack in PVC/PCTFE-aluminium and OPA/Alu/PVC-aluminium blisters and for the 2 mg and 3 mg packs in PVC/PCTFE-aluminium, OPA/Alu/PVC-aluminium and PVC/PVdC/PVC-aluminium blisters]
This medicine does not require any special storage conditions.
[For the 1 mg pack in PVC/PVdC/PVC-aluminium blisters]
Do not store above 30°C.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What ESNOXIBEN contains

• The active substance is eszopiclone.
  ESNOXIBEN 1 mg film-coated tablets: Each film-coated tablet contains 1 mg of eszopiclone.
  ESNOXIBEN 2 mg film-coated tablets: Each film-coated tablet contains 2 mg of eszopiclone.
  ESNOXIBEN 3 mg film-coated tablets: Each film-coated tablet contains 3 mg of eszopiclone.

• Other components are:
  Tablet core: microcrystalline cellulose, calcium hydrogen phosphate, sodium croscarmellose, anhydrous colloidal silica, magnesium stearate.
  Film coating: hypromellose, talc, titanium dioxide (E171), macrogol 3350.
  The 1 mg and 3 mg tablets also contain indigo carmine aluminium lake (E132).

Description of the appearance of ESNOXIBEN and package contents
ESNOXIBEN 1 mg film-coated tablets are blue, round, biconvex tablets marked with “1” on one side.
ESNOXIBEN 2 mg film-coated tablets are white, round, biconvex tablets marked with “2” on one side.
ESNOXIBEN 3 mg film-coated tablets are blue, round, biconvex tablets marked with “3” on one side.
ESNOXIBEN is available in blisters; packages containing 10, 20 or 30 film-coated tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
Bruno Farmaceutici S.p.A. – Via delle Ande, 15 – 00144 Rome – Italy
Manufacturer
G.L. Pharma GmbH - Schlossplatz 1 – 8502 Lannach – Austria
HENNIG ARZNEIMITTEL GmbH & Co. KG - Liebigstrasse 1-2 - 65439 Flörsheim am Main - Germany

This medicinal product is authorized in the EEA Member States under the following names:
Germany: Lunivia 1 mg Filmtabletten
Lunivia 2 mg Filmtabletten
Lunivia 3 mg Filmtabletten
Belgium: Esnoxiben 1 mg filmomhulde tabletten
Esnoxiben 2 mg filmomhulde tabletten
Esnoxiben 3 mg filmomhulde tabletten
Finland: Lunivia 1 mg Tabletti, kalvopäällysteinen
Lunivia 2 mg Tabletti, kalvopäällysteinen
Lunivia 3 mg Tabletti, kalvopäällysteinen
France: LUNIVIA 1 mg comprimé pelliculé
LUNIVIA 2 mg comprimé pelliculé
LUNIVIA 3 mg comprimé pelliculé
Italy: Esnoxiben
Luxembourg: Lunivia 1 mg comprimé pelliculé
Lunivia 2 mg comprimé pelliculé
Lunivia 3 mg comprimé pelliculé
Norway: Lunivia