EUSOM 2 mg Tabletki O Przedłużonym Uwalnianiu
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Treść ulotki
Eusom 2 mg prolonged-release tablets
Melatonin
Generic medicine
Read this leaflet carefully before taking this medicine as 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 pass it on to others, even if they have the same symptoms as you, as it could be harmful.
- If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.
Contents of this leaflet:
- 1. What Eusom is and what it is used for
- 2. What you need to know before you take Eusom
- 3. How to take Eusom
- 4. Possible side effects
- 5. How to store Eusom
- 6. Contents of the pack and other information
1. What is Eusom and what is it for
The active ingredient of Eusom, melatonin, belongs to a group of natural hormones produced
by the body.
This medicine is used alone for the short-term treatment of primary insomnia
(persistent difficulty falling asleep or staying asleep, or poor sleep quality), in patients aged 55 years or over. “Primary” means that no cause has been
identified for the insomnia, including a medical, mental or
environmental cause.
2. What you need to know before taking Eusom
Do not take Eusom
- if you are allergic to melatonin or any of the other ingredients of this medicine (listed in section 6).
Warnings and precautions
Talk to your doctor or pharmacist before taking Eusom:
- If you have liver or kidney problems. Studies have not been conducted on the use of this medicine in people with liver or kidney disease; talk to your doctor before taking this medicine, as its use is not recommended.
- If your doctor has told you that you have an intolerance to certain sugars.
- If you have been told that you suffer from an autoimmune disease (where the body is “attacked” by its own immune defenses). Studies have not been conducted on the use of this medicine in people with autoimmune diseases, therefore talk to your doctor before taking this medicine, as its use is not recommended.
- This medicine may cause drowsiness, be careful if you experience drowsiness, as this may impair your ability in activities such as driving.
- Smoking may reduce the effectiveness of this medicine, as the components of tobacco smoke are able to increase the transformation of melatonin by the liver.
tabacco.
Children and adolescents
Do not give this medicine to children between the ages of 0 and 18 years, as it has not been
tested and its effects are not known. In children between the ages of 2 and 18 years, it may be more
appropriate to administer another medicine containing melatonin; ask your doctor or
pharmacist for advice.
Other medicines and Eusom
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines.
These medicines include:
- Fluvoxamine (used to treat depression and obsessive-compulsive disorder), psoralens (used to treat skin diseases, e.g. psoriasis), cimetidine (used to treat stomach problems, such as ulcers), quinolones and rifampicin (used to treat bacterial infections), estrogens (used in contraceptives or hormone replacement therapy) and carbamazepine (used to treat epilepsy).
- Agonists/antagonists adrenergic (such as some types of medicines used to control blood pressure by narrowing blood vessels, nasal decongestants, medicines to lower blood pressure), agonists/antagonists opioids (such as medicines used to treat drug addiction), prostaglandin inhibitors (such as non-steroidal anti-inflammatory drugs), antidepressants, tryptophan and alcohol.
- Benzodiazepines and non-benzodiazepine hypnotics (medicines used to induce sleep, such as zaleplon, zolpidem and zopiclone).
- Thioridazine (for the treatment of schizophrenia) and imipramine (for the treatment of depression).
Eusom with food, drinks and alcohol
Take this medicine after eating. Do not consume alcohol before, during or after
taking this medicine, as it reduces the effectiveness of this medicine.
Pregnancy and breastfeeding
Do not take this medicine if you are pregnant, if you suspect or are planning a pregnancy or
if you are breastfeeding. Ask your doctor or pharmacist for advice before taking
this medicine.
Driving and using machines
This medicine may cause drowsiness. In such cases, you should not drive or operate
machinery. If you experience prolonged drowsiness, consult your doctor.
Eusom contains lactose monohydrate
If your doctor has diagnosed you with an intolerance to certain sugars, contact them before taking
this medicine.
3. How to take Eusom
Always take this medicine exactly as your doctor or pharmacist has told you. If you have any doubts, ask your doctor or pharmacist.
The recommended dose is one tablet (2 mg) to be taken by mouth every day after a meal, 1-2 hours before bedtime.
This dosage may be maintained for a period of up to thirteen weeks.
The tablet must be swallowed whole. The tablets must not be crushed or divided in half.
If you take more Eusom than you should
If you have accidentally taken an excessive dose of the medicine, contact your doctor or pharmacist as soon as possible.
Taking more than the recommended daily dose may cause you to feel drowsy.
If you forget to take Eusom
If you forget to take a tablet, take it as soon as you remember, before bedtime, or wait until the time to take the next dose, then continue as usual.
Do not take a double dose to make up for a missed dose.
If you stop taking Eusom
No adverse effects are known in case of interruption or premature discontinuation of treatment.
No withdrawal symptoms are known for this medicine after completion of therapy.
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.
If you experience any of the following serious side effects, stop taking this medicine and
immediatelycontact your doctor:
Uncommon: (may affect up to 1 in 100 people)
- Chest pain
Rare: (may affect up to 1 in 1,000 people)
- Loss of consciousness or fainting
- Severe chest pain caused by angina
- Awareness of your heartbeat
- Depression
- Impaired vision
- Blurred vision
- Disorientation
- Dizziness (a sensation of spinning or “lightheadedness”)
- Presence of red blood cells in the urine
- Reduced number of white blood cells in the blood
- Reduced platelets, resulting in increased bleeding or bruising
- Psoriasis
If any of the following non-serious side effects occur, contact your doctor and/or seek medical advice:
Uncommon: (may affect up to 1 in 100 people)
Irritability, nervousness, restlessness, insomnia, abnormal dreams, nightmares, anxiety, migraine, headache, lethargy (tiredness, lack of energy), restlessness associated with increased activity,
dizziness, fatigue, high blood pressure, upper abdominal pain, indigestion,
mouth ulceration, dry mouth, nausea, alteration of blood composition
which can cause a yellowing of the skin or eyes, skin inflammation,
night sweats, itching, rash, dry skin, pain in the limbs, menopause symptoms, feeling of weakness, presence of glucose in the urine, excess protein in the
urine, abnormalities in liver function tests and weight gain.
Rare: (may affect up to 1 in 1,000 people)
Herpes zoster, high levels of fats in the blood, low levels of calcium in the serum, low levels of
sodium in the blood, mood alteration, aggressiveness, agitation, crying, stress symptoms,
early morning awakening, increased sexual desire, depressed mood, memory deficit, attention impairment, dreamy state, restless legs syndrome, poor quality sleep, sensation of pins and needles (tingling), watering eyes, dizziness
when assuming an upright or seated position, hot flushes, acid reflux, stomach discomfort, ulcers in the mouth, ulcers on the tongue, stomach pain, vomiting, abnormal intestinal noises, intestinal gas, excessive saliva production, bad breath, abdominal discomfort, gastric disorder, inflammation of the gastric mucosa, eczema, rash,
hand dermatitis, itchy rash, nail disorder, arthritis, muscle spasms,
neck pain, nocturnal cramps, prolonged erection which may be painful, inflammation of the
prostate, fatigue, pain, thirst, increased urine production, nocturnal urination, increased liver enzymes, abnormalities in blood electrolyte tests and abnormalities in laboratory test results.
Frequency not known: (cannot be estimated from the available data)
Hypersensitivity reaction, swelling of the mouth or tongue, skin swelling and abnormal secretion of milk.
Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. You can also report side effects directly through
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 Eusom
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the pack after Exp. The expiry
date refers to the last day of that month.
Do not store at a temperature above 25°C. Store in the original packaging to
protect the medicine from light.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.
6. Contents of the pack and other information
What Eusom contains
- The active ingredient is melatonin. Each prolonged-release tablet contains 2 mg of melatonin.
- The other ingredients are: type B methacrylic acid copolymer, dibasic calcium phosphate dihydrate, lactose monohydrate (see section 2 “Eusom contains lactose monohydrate”), silica (colloidal anhydrous), talc and magnesium stearate.
Description of the appearance of Eusom and contents of the pack
Eusom prolonged-release tablets are white to off-white, oval-shaped tablets, of
dimensions 5.2 mm x 10 mm, with “A6” imprinted on one side.
Eusom is available in blisters of 30 prolonged-release tablets.
Not all pack sizes may be marketed.
Marketing authorisation holder and manufacturer
Marketing authorisation holder:
Ecupharma S.r.l.
Via Mazzini 20
20123 Milano - Italy
Manufacturer:
Balkanpharma-Dupnitsa AD
3 Samokovsko Shosse Str.
2600 Dupnitsa
Bulgaria
This medicinal product is authorised in the Member States of the European Economic Area under the
following denominations:
IS: Eusom
IT: Eusom
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- Kraj rejestracji
- Postać farmaceutycznaExtended-release tablet, 2 MG
- Kod ATCN05CH01
- Substancja czynna
- Wymaga receptyTak
- Producent
- Te treści mają charakter wyłącznie informacyjny i nie zastępują konsultacji lekarskiej.
- Zamienniki EUSOMPostać farmaceutyczna: Oral solution, 1 MG/MLSubstancja czynna: melatoninProducent: FARMA GROUP S.R.L.Wymaga receptyPostać farmaceutyczna: Extended-release tablet, 2 MGSubstancja czynna: melatoninProducent: RAD NEURIM PHARMACEUTICALS EEC SARLWymaga receptyPostać farmaceutyczna: Extended-release tablet, 2 mgSubstancja czynna: melatoninProducent: RAD NEURIM PHARMACEUTICALS EEC SARLWymaga recepty
Odpowiedniki EUSOM w innych krajach
Leki z tą samą substancją czynną dostępne w innych krajach.
Odpowiednik EUSOM w Hiszpania
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Odpowiednik EUSOM w Ukraina
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Często zadawane pytania
EUSOM wymaga recepty w Włochy. Możesz skonsultować się z lekarzem online, aby sprawdzić, czy ten lek może być odpowiedni w Twojej sytuacji.
Substancją czynną w EUSOM jest melatonin. Informacja ta pomaga rozpoznać leki o tym samym składzie, ale pod różnymi nazwami handlowymi.
EUSOM jest produkowany przez ECUPHARMA S.R.L.. Nazwy handlowe i opakowania mogą się różnić w zależności od dystrybutora.
Lekarze, tacy jak Lekarze rodzinni, Psychiatrzy, Dermatolodzy, Kardiolodzy, Endokrynolodzy, Gastroenterolodzy, Pulmonolodzy, Nefrolodzy, Reumatolodzy, Hematolodzy, Zakaźnicy, Alergolodzy, Geriatrzy, Pediatrzy, Onkolodzy, mogą ocenić, czy stosowanie EUSOM jest odpowiednie w Twoim przypadku, w zależności od sytuacji klinicznej i lokalnych przepisów. Możesz umówić konsultację online, aby omówić objawy i możliwe dalsze kroki.
Polska posiada dobrze rozwiniętą infrastrukturę ochrony zdrowia w dużych miastach, takich jak Warszawa, Kraków, Wrocław i Gdańsk. Apteki są łatwo dostępne i działają zgodnie z obowiązującymi przepisami, zapewniając dostęp do leków na receptę.
Możesz kupić EUSOM w Warszawie, Krakowie, Wrocławiu lub Gdańsku w każdej aptece, posiadając ważną receptę.
Aby uzyskać receptę, możesz skorzystać z Oladoctor:
Inne leki zawierające tę samą substancję czynną (melatonin) to m.in. BALDINAS, KIRKADIN, MELATONIN NEURIM. Mogą one różnić się nazwą handlową lub postacią, ale zawierają ten sam składnik terapeutyczny. Przed zmianą lub rozpoczęciem nowego leku skonsultuj się z lekarzem.
