MELATONIN 2 mg Tabletki O Przedłużonym Uwalnianiu
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Treść ulotki
Melatonin Neurim 2 mg prolonged-release tablets
melatonin
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 Melatonin Neurim is and what it is used for
- 2. What you need to know before you take Melatonin Neurim
- 3. How to take Melatonin Neurim
- 4. Possible side effects
- 5. How to store Melatonin Neurim
- 6. Contents of the pack and other information
1. What is Melatonin Neurim and what is it used for
The active substance of Melatonin Neurim, melatonin, belongs to a group of natural hormones
produced by the body.
Melatonin Neurim 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 and 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 Melatonin Neurim
Do not take Melatonin Neurim
- 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 Melatonin Neurim.
- if you have liver or kidney problems. Studies have not been conducted on the use of Melatonin Neurim in people with liver or kidney diseases; talk to your doctor before taking Melatonin Neurim, 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 (in which the body is “attacked” by its own immune defenses). Studies have not been conducted on Melatonin Neurim in people with autoimmune diseases, therefore talk to your doctor before taking Melatonin Neurim, as its use is not recommended.
- Melatonin Neurim 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 Melatonin Neurim, 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 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 Melatonin Neurim
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 (red and scaly patches of skin), 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).
Melatonin Neurim with food, beverages and alcohol
Take Melatonin Neurim after eating. Do not consume alcohol before, during or after
taking Melatonin Neurim, as it reduces the effectiveness of Melatonin Neurim.
Pregnancy and breastfeeding
Do not take Melatonin Neurim if you are pregnant, suspect you may be pregnant 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
Melatonin Neurim may cause drowsiness. In this case, do not drive or use machines.
If you experience prolonged drowsiness, see your doctor.
Melatonin Neurim contains lactose monohydrate
Melatonin Neurim 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 Melatonin Neurim
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 Melatonin Neurim tablet (2 mg) to be taken orally 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. Melatonin Neurim tablets must not be crushed or divided.
If you take more Melatonin Neurim than you should
If you have accidentally taken an excessive dose of the medicine, contact your doctor or 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 Melatonin Neurim
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 Melatonin Neurim
No harmful effects are known in case of interruption or premature discontinuation of treatment. No withdrawal symptoms of Melatonin Neurim 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
- Vision impairment (including reduced vision)
- Blurred vision
- Disorientation
- Dizziness (feeling of spinning)
- 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 (red, scaly patches of skin)
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, changes in blood composition that can cause yellowing of the skin or eyes, skin inflammation, night sweats, itching,
rash, dry skin, pain in the extremities, 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 (shingles), increased levels of fats in the blood, low levels of calcium
in the serum, low levels of sodium in the blood, mood alterations, aggressiveness, agitation, crying,
stress symptoms, early morning awakening, increased libido (increased sexual desire),
lowered mood, memory impairment, attention disorders, dreamy state, restless legs syndrome, poor sleep quality, tingling sensation, increased tearing,
postural dizziness (dizziness when assuming an upright or seated position), hot flushes,
acid reflux, stomach disorders, mouth ulcers, tongue ulcers, stomach discomfort, vomiting, intestinal noises, flatulence, excessive saliva production, bad breath,
abdominal pain, stomach upset, inflammation of the gastric mucosa, eczema, rash,
hand dermatitis, itchy rash, nail disease, 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, electrolyte abnormalities in the blood 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
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 listed in Annex V. By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store Melatonin Neurim
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 waste water 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 Melatonin Neurim contains
- The active ingredient is melatonin. Each prolonged-release tablet contains 2 mg of melatonin.
- The other ingredients are: ammonium methacrylate copolymer type B, dibasic calcium phosphate hydrate, lactose monohydrate, silica (colloidal anhydrous), talc and magnesium stearate.
Description of the appearance of Melatonin Neurim and contents of the pack
Melatonin Neurim 2 mg prolonged-release tablets are round, biconvex tablets, of
colour from white to off-white. Each tablet pack contains a blister strip with 7, 20 or
21 tablets or alternatively two blister strips of 15 tablets each (pack of
30 tablets). Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
RAD Neurim Pharmaceuticals EEC SARL
4 rue de Marivaux
75002 Paris
France
e-mail: [email protected]
Manufacturer:
Responsible sites for Batch Release within the European Economic Area (EEA):-
Iberfar Indústria Farmacêutica S.A.
Estrada Consiglieri Pedroso 123
Queluz De Baixo
Barcarena
2734-501
Portugal
Rovi Pharma Industrial Services, S.A.
Vía Complutense, 140
Alcalá de Henares
Madrid, 28805
Spain
Other sources of information
More detailed information on this medicine is available on the website of the European
Medicines Agency, http://www.ema.europa.eu.
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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 MELATONIN NEURIMPostać 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
MELATONIN NEURIM wymaga recepty w Włochy. Możesz skonsultować się z lekarzem online, aby sprawdzić, czy ten lek może być odpowiedni w Twojej sytuacji.
Substancją czynną w MELATONIN NEURIM jest melatonin. Informacja ta pomaga rozpoznać leki o tym samym składzie, ale pod różnymi nazwami handlowymi.
MELATONIN NEURIM jest produkowany przez RAD NEURIM PHARMACEUTICALS EEC SARL. 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 MELATONIN NEURIM 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 MELATONIN NEURIM 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.
