MELATONINA 2 mg Tabletki O Przedłużonym Uwalnianiu
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Treść ulotki
Melatonina Viatris 2 mg prolonged-release tablets
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 may 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 Melatonina Viatris is and what it is used for
- 2. What you need to know before you take Melatonina Viatris
- 3. How to take Melatonina Viatris
- 4. Possible side effects
- 5. How to store Melatonina Viatris
- 6. Contents of the pack and other information
1. What is Melatonina Viatris and what is it used for
The active ingredient of Melatonina Viatris, melatonin, belongs to a group of natural hormones
produced by the body.
Melatonina Viatris 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 Melatonina Viatris
Do not take Melatonina Viatris
- if you are allergic to melatonin or to any of the other ingredients of this medicine (listed in section 6).
Warnings and precautions
Talk to your doctor or pharmacist before taking Melatonina Viatris:
- if you have liver or kidney problems. Studies have not been conducted on the use of melatonin in people with liver or kidney diseases; talk to your doctor before taking Melatonina Viatris, 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 on melatonin in people with autoimmune diseases have not been conducted, therefore, talk to your doctor before taking Melatonina Viatris, as its use is not recommended.
- Melatonina Viatris may 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 Melatonina Viatris, as 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 unknown. 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 Melatonina Viatris
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 constricting 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).
Melatonina Viatris with food, beverages and alcohol
Take Melatonina Viatris after eating. Do not consume alcohol before, during or after
taking Melatonina Viatris, as it reduces the effectiveness of Melatonina Viatris.
Pregnancy and breastfeeding
Do not take Melatonina Viatris 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
Melatonina Viatris may cause drowsiness. In this case, do not drive or use machines. If
you experience prolonged drowsiness, see your doctor.
Melatonina Viatris contains lactose monohydrate
Melatonina Viatris contains lactose monohydrate. If your doctor has diagnosed you with an intolerance to
certain sugars, contact him before taking this medicine.
3. How to take Melatonina Viatris
Always take this medicine exactly as your doctor or pharmacist has instructed. If you have any doubts, consult your doctor or pharmacist.
The recommended dose is one Melatonina Viatris (2 mg) tablet to be taken orally each 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. Melatonina Viatris tablets must not be crushed or divided.
If you take more Melatonina Viatris than you should
If you have accidentally taken an excessive dose of the medicine, seek medical advice or contact your pharmacist as soon as possible.
If you have taken a dose of medicine higher than the maximum recommended dose, you may experience drowsiness.
If you forget to take Melatonina Viatris
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 Melatonina Viatris
No adverse effects are known in case of discontinuation or premature suspension of treatment. No withdrawal symptoms of Melatonina Viatris are known 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
- Noticeable heartbeats
- Depression
- Impairment of 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 (fatigue, lack of energy), restlessness associated with increased activity, dizziness,
fatigue, hypertension, 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 increased body weight.
Rare: (may affect up to 1 in 1,000 people)
Herpes zoster (shingles), increased levels of fats in the blood, low levels of calcium
serum in the blood, low levels of sodium in the blood, mood alterations, aggressiveness, agitation,
crying, stress symptoms, early morning awakening, increased libido (increased sexual desire), depressed mood, impaired memory, attention disorders, dreamy state,
restless legs syndrome, poor sleep quality, sensation of “pins and needles”, watery eyes, postural dizziness (dizziness when assuming an upright or seated position), hot flashes,
acid reflux, stomach disorders, blisters in the mouth, ulcers on the tongue, discomfort in the
stomach, vomiting, abnormal intestinal noises, intestinal gas, excessive saliva production, bad breath,
abdominal pain, stomach disorders, inflammation of the gastric mucosa, eczema,
skin rash, hand dermatitis, itchy rash, nail disorders, arthritis, muscle spasms, neck pain, nocturnal cramps, prolonged erection that 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 Melatonina Viatris
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 box and blister after
EXP. The expiry date refers to the last day of that month.
Do not store at a temperature above 25ºC. 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. Package contents and other information What Melatonina Viatris 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 (E341 (ii)), lactose monohydrate, silica (colloidal anhydrous) (E551), talc (E533b) and magnesium stearate (E 470b).
Description of the appearance of Melatonina Viatris and contents of the pack
Melatonina Viatris 2 mg prolonged-release tablets are available as round,
biconvex tablets, from white to off-white in colour. Each tablet pack contains a blister strip with
21 tablets each (pack of 21 tablets) or two blister strips of 15 tablets each
(pack of 30 tablets).
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Mylan SpA
Via Vittor Pisani 20
20124 Milano
Italy
Manufacturer
Laboratorios Rubio S.A.
Calle Indústria 29
Polígono Industrial Comte De Sert
Castellbisbal
Barcelona
08755
Spain
This medicinal product is authorised in the Member States of the European Economic Area under the
following denominations:
Iceland: Melatonin Viatris
Denmark: Melatonin Viatris
France: MELATONINE VIATRIS LP 2 mg, prolonged-release tablet
Italy: Melatonina Viatris
Norway: Melatonin Viatris
Portugal: Melatonina Viatris 2 mg Prolonged-release tablet
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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 MELATONINA VIATRISPostać 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: ECUPHARMA S.R.L.Wymaga recepty
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Często zadawane pytania
MELATONINA VIATRIS wymaga recepty w Włochy. Możesz skonsultować się z lekarzem online, aby sprawdzić, czy ten lek może być odpowiedni w Twojej sytuacji.
Substancją czynną w MELATONINA VIATRIS jest melatonin. Informacja ta pomaga rozpoznać leki o tym samym składzie, ale pod różnymi nazwami handlowymi.
MELATONINA VIATRIS jest produkowany przez MYLAN S.P.A.. 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 MELATONINA VIATRIS 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 MELATONINA VIATRIS 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, EUSOM. Mogą one różnić się nazwą handlową lub postacią, ale zawierają ten sam składnik terapeutyczny. Przed zmianą lub rozpoczęciem nowego leku skonsultuj się z lekarzem.
