Інструкція із застосування YAYOI
Зміст інструкції
YAYOI 2 mg prolonged-release tablets
melatonin
Generic medicine
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 pass it on to others, even if their symptoms are the same as yours, 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 YAYOI is and what it is used for
- 2. What you need to know before you take YAYOI
- 3. How to take YAYOI
- 4. Possible side effects
- 5. How to store YAYOI
- 6. Contents of the pack and other information
1. What is YAYOI and what is it for
The active substance of YAYOI, 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 older. “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 YAYOI
Do not take YAYOI
- 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 YAYOI
- If you suffer from liver or kidney problems. Studies have not been conducted on the use of this medicine in people with liver or kidney disease; consult 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 consult your doctor before taking this medicine as its use is not recommended.
- This medicine can cause drowsiness; be careful if you experience drowsiness, as this may impair your ability to perform 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.
Children and adolescents
Do not administer this medicine to children between 0 and 18 years of age, as it has not been
tested and its effects are not known. In children between 2 and 18 years of age, it may be more
appropriate to administer another medicine containing melatonin; ask your doctor or
pharmacist for advice.
Other medicines and YAYOI
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicine.
These medicines include:
- Fluvoxamine (used to treat depression and obsessive-compulsive disorder), psoralens (used in the treatment of 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 constricting blood vessels, nasal decongestants, medicines to lower blood pressure), agonists/antagonists of opioids (such as medicines used in the treatment of 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).
YAYOI with food, beverages and alcohol
Take this medicine after eating. Do not consume alcohol before, during or after
taking this medicine, as it reduces the effectiveness of the medicine.
Pregnancy and breastfeeding
Do not take this medicine if you are pregnant, suspect you may be pregnant or are
breastfeeding. Ask your doctor or pharmacist for advice before taking this
medicine.
Driving and operating machinery
This medicine can cause drowsiness. In this case, you should not drive or operate machinery.
If you experience prolonged drowsiness, consult your doctor.
YAYOI 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 YAYOI
Take this medicine following the instructions of your doctor or pharmacist exactly. If you
have any doubts, consult your doctor or pharmacist.
The recommended dose is one tablet (2 mg) to be taken daily by mouth, after a meal, 1-2
hours before bedtime. This dosage can be maintained for up to thirteen weeks.
The tablet must be swallowed whole. The tablets must not be crushed or divided in
half.
If you take more YAYOI 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 YAYOI
If you forget to take a tablet, take another one as soon as you remember, before going
to sleep, or wait until the time of your next dose, then continue as before.
Do not take a double dose to make up for a missed dose.
If you stop taking YAYOI
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 doubts about 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
- Noticeable heartbeats
- 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, which increases the risk of 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, hypertension, upper abdominal pain, indigestion, mouth ulceration,
dry mouth, nausea, alteration of blood composition that can cause
yellowing of the skin or eyes, skin inflammation, night sweats, itching,
skin rash, dry skin, pain in the limbs, menopause symptoms, feeling of weakness,
glucose excretion in the urine, excess protein in the urine, abnormal liver function and
weight gain.
Rare: (may affect up to 1 in 1,000 people)
Herpes zoster (shingles), 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 sleep quality, sensation of pins and needles (tingling), eye watering, dizziness
when assuming an upright or seated position, hot flashes, 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, skin rash, hand dermatitis,
pruritic rash, nail disorder, arthritis, muscle spasms, neck pain, nocturnal cramps, prolonged erection that may be painful, prostate inflammation, 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 available data)
Hypersensitivity reaction, swelling of the mouth or tongue, skin swelling and abnormal
milk secretion.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. 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 YAYOI
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.
Blisters:
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 YAYOI 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 “YAYOI contains lactose monohydrate”), silica (colloidal anhydrous), talc and magnesium stearate.
Description of the appearance of YAYOI and contents of the pack
YAYOI prolonged-release tablets are oval-shaped tablets, from white to off-white in colour, of
dimensions 5.2 mm x 10 mm, with “A6” imprinted on one side.
YAYOI is available in blisters containing 30 prolonged-release tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
I.B.N. Savio Srl
Via del Mare n. 36
00071 Pomezia (RM)
Manufacturer
Balkanpharma-Dupnitsa AD
3 Samokovsko Shosse Str.
2600 Dupnitsa
Bulgaria
- Країна реєстрації
- Лікарська формаExtended-release tablet, 2 MG
- Код АТХN05CH01
- Діюча речовина
- Потрібен рецептТак
- Виробник
- Ця інформація надана лише для ознайомлення і не є медичною порадою. Рішення щодо лікування завжди приймає лікар.
- Альтернативи до YAYOIЛікарська форма: Oral solution, 1 MG/MLДіюча речовина: МелатонинВиробник: FARMA GROUP S.R.L.Потрібен рецептЛікарська форма: Extended-release tablet, 2 MGДіюча речовина: МелатонинВиробник: RAD NEURIM PHARMACEUTICALS EEC SARLПотрібен рецептЛікарська форма: Extended-release tablet, 2 MGДіюча речовина: МелатонинВиробник: ECUPHARMA S.R.L.Потрібен рецепт
Аналоги YAYOI в інших країнах
Препарати з тією самою діючою речовиною, доступні в інших країнах.
Аналог YAYOI у Іспанія
Аналог YAYOI у Польща
Аналог YAYOI у Україна
Лікарі онлайн щодо YAYOI
Застосування, безпека та можливість призначення рецепта — за результатами медичної оцінки.
Отримайте рецепт на YAYOI онлайн
Заповніть форму за 2 хвилини
Розкажіть про симптоми, історію хвороби та потрібний препарат.
Оберіть лікаря або ми призначимо
Оберіть спеціаліста або ми підберемо найближчого доступного лікаря.
Лікар розглядає ваш випадок
Зазвичай протягом 30 хвилин. Може ставити уточнювальні запитання в чаті.
Отримайте в будь-якій аптеці
Електронний рецепт надсилається на вашу пошту — дійсний по всій Польщі.
Часті запитання
YAYOI потребує рецепта в Італія. Ви можете обговорити з лікарем онлайн, чи підходить цей лікарський засіб для вашої ситуації.
Діюча речовина у YAYOI — Мелатонин. Це допомагає визначити препарати з тим самим складом, але під іншими торговими назвами.
YAYOI виробляється компанією I.B.N. SAVIO S.R.L. Назва бренду та упаковка можуть відрізнятися залежно від дистрибʼютора.
Лікарі, зокрема Сімейні лікарі, Психіатри, Дерматологи, Кардіологи, Ендокринологи, Гастроентерологи, Пульмонологи, Нефрологи, Ревматологи, Гематологи, Інфекціоністи, Алергологи, Геріатри, Педіатри, Онкологи, можуть оцінити доцільність застосування YAYOI з урахуванням вашого стану та місцевих правил. Ви можете записатися на онлайн-консультацію, щоб обговорити симптоми та можливі подальші кроки.
Польща має добре розвинену систему охорони здоров'я у великих містах, таких як Варшава, Краків, Вроцлав і Гданськ. Аптеки широко доступні та працюють відповідно до чинного законодавства, забезпечуючи доступ до рецептурних препаратів.
Ви можете придбати YAYOI у Варшаві, Кракові, Вроцлаві або Гданську в будь-якій аптеці за наявності дійсного рецепта.
Щоб отримати рецепт, ви можете скористатися Oladoctor:
Інші препарати з тією самою діючою речовиною (Мелатонин) включають BALDINAS, KIRKADIN, EUSOM. Вони можуть відрізнятися торговою назвою або формою випуску, але містять той самий терапевтичний компонент. Перед зміною або початком прийому нового препарату варто проконсультуватися з лікарем.
















