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What Esogno is and what it is used for
Esogno belongs to a group of medicines called hypnotics, which are used to help you fall asleep. Esogno is used for the short-term treatment of insomnia. It is intended for use in adults only when the disease is severe, incapacitated or causing great suffering to the patient.
2. What you need to know before you take Esogno
Do not take Esogno:
If you are allergic to eszopiclone, zopiclone or any of the other ingredients of this medicine (listed in section 6).
If you have myasthenia gravis (a condition in which the muscles get tired easily and become weak).
If you have severe breathing problems.
If you have severe sleep apnea (a condition in which you stop breathing for short periods while you sleep).
If you have severe liver problems.
If you are over 65 and taking CYP3A4 inhibitors, such as some antibiotics or antifungals (such as ketoconazole). Talk to your doctor or pharmacist.
If you are under 18 years old.
Warnings and precautions
Talk to your doctor or pharmacist before taking Esogno:
If you are 65 or older (see section 3, "How to take Esogno").
If you are taking medicines that help you fall asleep, such as Esogno, you are likely to become addicted to them. It is more likely to occur if you have ever been addicted to drugs, narcotics or alcohol or if you have been diagnosed with a personality disorder. Tell your doctor if you have ever been addicted to drugs, narcotics or alcohol.
If you have trouble breathing (see section 2, "Do not take Esogno").
Tell your doctor if you feel anxious or depressed. Your doctor may need to reconsider your therapy.
During treatment with Esogno:
Do not take Esogno unless you have at least 8 hours of sleep.
Esogno can cause memory loss. To reduce this risk, you need to make sure that you can have at least 8 hours of uninterrupted sleep.
If you do not get at least 8 hours of sleep after taking Esogno, you may feel unstable on your feet. If you are 65 or older, you are more likely to fall and injure yourself.
Tell your doctor if you start acting in a way that is unusual for you, for example, more abrupt or aggressive behavior than normal, confusion, anxiety, irritability, anxiety, nightmares, if you feel or hear things that are not there (hallucinations), worsening of depression and suicidal thoughts or actions while taking Esogno.
Conditions such as sleepwalking and other related behaviors can occur. After taking Esogno, you can get out of bed until you are fully awake and perform activities you do not know you are doing. The next morning you may not remember doing anything at night. Alcohol and some medicines used to treat depression and anxiety, or the use of Esogno in doses above the maximum recommended dose, may increase the risk of these side effects. This includes going to sleep, driving in your sleep, preparing and eating food, making phone calls or having sex.
Psychomotor disorder the next day (see section 2, "Driving and using machines") - The effects of a psychomotor disorder the next day may be increased, including impaired ability to drive while taking Esogno:
If you take this medicine less than 12 hours before performing activities that require caution
If you take more than the recommended dose
If you have taken Esogno while you are already taking other medicines that suppress the central nervous system or other medicines that increase the level of Esogno in your blood, or while you are drinking alcohol or while you are taking illicit substances.
Take once, just before bedtime. Do not take another dose during the same night.
Other drugs and Esogno
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Esogno may affect or be affected by some medicines, for example:
Over-the-counter medications, including herbal remedies.
CYP3A4 inhibitors such as antibiotics (medicines used to treat bacterial infections), antifungals (medicines used to treat fungal infections, such as ketoconazole) or grapefruit juice. The dose of Esogno may need to be reduced or treatment stopped. (See section 3, how to take Esogno)
Inducers of cytochrome P450 enzymes such as carbamazepine, phenytoin and St. John's wort.
Medicines used to treat your mood or behavior (how you feel or act), e.g. medicines for depression or anxiety (antipsychotics, hypnotics, anxiolytics / sedatives, antidepressants)
Medicines used for severe pain relief (narcotic analgesics)
Medicines used to treat seizures or convulsions (antiepileptic medicines)
How to take Esogno
Always take this medicine exactly as your doctor has told you. If you are not sure, talk to your doctor or pharmacist.
The recommended starting dose of eszopiclone is 1 mg at night. The dose can be increased to 2 or 3 mg if needed.
Take Esogno as a single dose just before bedtime. Do not take more than one dose overnight.
Elderly patients 65 years of age or older
The recommended starting dose of eszopiclone is 1 mg at night. The dose can be increased to 2 mg if necessary.
Patients with severe kidney problems
The maximum recommended dose of eszopiclone is 2 mg every night.
Patients taking CYP3A4 inhibitors, such as certain antibiotics or antifungal drugs
The maximum recommended dose of eszopiclone is 2 mg every night. If you are 65 years of age or older, you should not take Esogno with CYP3A4 inhibitors.
Esogno is for oral use. Swallow the tablets whole. Do not crush or break the tablet, 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 gradual withdrawal (see section "If you stop taking Esogno").
In some cases, you may need to take Esogno for more than 4 weeks. In this case, your doctor will tell you how long you should take Esogno.
If you take more Esogno than you should
If you take more than the required dose, you should seek medical attention immediately. If possible, show the Esogno pack to a healthcare professional. If you take more Esogno than you should, you may become very drowsy or may fall into a coma.
If you forget to take Esogno
Do not take a double dose to make up for a forgotten dose.
Just take your next tablet at the usual time. Do not take more than one dose in the same night.
If you stop taking Esogno
Do not stop taking Esogno suddenly, but tell your doctor if you want to stop. Your doctor will need to reduce your dose and stop the tablets gradually. It is possible that your sleep difficulties will return in one or two nights when you stop taking Esogno. Occasionally, unpleasant effects such as stomach pain, headache and increased appetite may occur after stopping Esogno. In rare cases, seizures may occur after you stop taking medicines such as Esogno. Tell your doctor if you get any of these effects.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Very common side effects (may affect more than 1 in 10 people):
Common side effects (may affect 1 to 10 people in 100):
nervousness, depression, anxiety
headache, migraine, drowsiness, dizziness, nightmares, memory loss or difficulty, psychosis
blurred vision (mainly in patients over 65 years)
dry mouth, diarrhea, nausea, vomiting, indigestion, stomach pain
back pain, muscle pain
Uncommon side effects (may affect 1 to 10 people in 1,000):
infection, viral infection
discoloration of red blood cells, anemia, decrease in white blood cells, increase in white blood cells
overactive thyroid gland
swelling of the ankles, feet or toes, anorexia, thirst, increased appetite, low blood potassium
emotional lability, changes in sexual desire, confusion, arousal, hallucinations - when you see, hear or feel unreal things, especially around the time of sleep, insomnia, apathy, euphoria
dizziness, unusual gait, incoordination, tingling or numbness, trembling, tingling, stupor, tremor
ringing in the ears, pain in the ears
high blood pressure, seizures
difficulty breathing, runny nose, hiccups
bad breath, mouth ulcers, inflammation of the colon, upset stomach, swelling of the tongue
skin sensitivity to light, sweating, acne, dry skin, eczema
leg cramps, muscle spasms, muscle weakness, joint problems
frequent need to urinate, urinary tract infection, uncontrolled, involuntary urination, kidney pain, kidney stones, presence of protein albumin in the urine
painful, irregular or light menstrual cycles, chest pain, impotence
weight gain, weight loss
Rare side effects (may affect 1 to 10 people in 10,000):
angioedema (swelling of the face, lips, tongue or throat), anaphylactic reaction (a rapid allergic reaction with a rash, difficulty swallowing or breathing)
emotional disorder, aggression, anger, anxiety, thinking things that are not true (delusions), inappropriate behavior,
5. How to store Esogno
Keep out of reach of children.
Do not use this medicine after the expiry date which is stated on the carton or blister after EXP. The expiry date refers to the last day of that month.
[For 1 mg packed in PVC / PCTFE-Al and OPA / Alu / PVC-Al blisters; and for 2 mg and 3 mg packed in
CVC / PCTFE-AI, OPA / Alu / PVC-Al and PVC / PvdC / PVC-Al blisters]
This medicinal product does not require any special storage conditions.
[For 1 mg packed in PVC / PVdC / PVC-Al blisters]
Do not store above 30 0 C
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
6. Contents of the package and additional information
What Esogno contains
The active substance is esopiclone.
Esogno 1 mg film-coated tablets
Each film-coated tablet contains 1 mg eszopiclone
Esogno 2 mg film-coated tablets
Each film-coated tablet contains 2 mg eszopiclone
Esogno 3 mg film-coated tablets
Each film-coated tablet contains 3 mg eszopiclone
Tablet core: microcrystalline cellulose, calcium hydrogen phosphate, croscarmellose sodium, silicon dioxide, colloidal anhydrous, magnesium stearate.
Film coating: hypromellose, talc, titanium dioxide (E171), macrogol 3350.
The 1 mg and 3 mg tablets also contain aluminum varnish indigo carmine (E 132)
What Esogno looks like and contents of the pack
Esogno 1 mg film-coated tablets
Light blue, round, biconvex film-coated tablets, debossed with "1" on one side and a diameter of approximately 6,5 mm.
Esogno 2 mg film-coated tablets
White, round, biconvex film-coated tablets, debossed with "2" on one side and a diameter of approximately 6,5 mm.
Esogno 3 mg film-coated tablets
Blue, round, biconvex film-coated tablets, debossed with "3" on one side and a diameter of approximately 6,5 mm.
Esogno is packed in blisters. Pack sizes: 7, 10, 14, 20, 28, 30, 50, 56, 98 or 100 film-coated tablets.
Not all pack sizes may be marketed.
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