MELATONIN NOXAREM 5 MG TABLETS 10 TABLETS IN PVC/AL BLISTER

Name
Melatonin Noxarem 3 mg tablets
Melatonin Noxarem 5 mg tablets
Melatonin


What is it and what is it for?
The active ingredient in Melatonin Noxarem, melatonin, belongs to a group of natural hormones produced by the body.

Melatonin Noxarem is used for the short-term treatment of jet lag in adults. Jet lag refers to symptoms caused by time differences when crossing time zones (traveling east or west).

Talk to your doctor if you do not feel better or if you feel worse.


What you need to know before taking the medicine
Do not take Melatonin Noxarem:
- 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 Noxarem if you suffer from:
- kidney impairment. If you suffer from severe kidney disease, the use of Melatonin Noxarem is not recommended.
- liver impairment. If you suffer from liver disease, the use of Melatonin Noxarem is not recommended.
- autoimmune diseases (in which the body is "attacked" by its own immune system). In these cases, the use of melatonin is not recommended.
- cardiovascular condition for which you are taking an antihypertensive medication. In this case, the use of melatonin is not recommended.

The timing of melatonin administration is important. Noxarem melatonin should be used according to the instructions.

Melatonin Noxarem can cause drowsiness. Therefore, you should be careful if you experience any drowsiness, as it may impair your ability to perform activities such as driving.

Smoking may reduce the effectiveness of Melatonin Noxarem, as the components of tobacco smoke can promote the degradation of melatonin by the liver.

Children and adolescents
This medicine should not be given to children under 18 years of age as it has not been tested in these patients and its effects are unknown.


Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.

Possible adverse reactions from short-term use of melatonin for jet lag include headache, nausea, loss of appetite, dizziness, daytime sleepiness, and disorientation.

Melatonin, when used for other conditions, has been observed to cause a wide variety of adverse effects.

If you experience any of the following serious side effects, stop taking the medicine and contact your doctor immediately.

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 own heartbeat
• Depression
• Vision impairment
• Disorientation
• Vertigo (dizziness or “spinning”)
• Presence of blood in the urine
• Reduction in the number of white blood cells in the blood
• Reduction in the number of platelets in the blood, which increases the risk of bleeding or bruising
• Psoriasis

Frequency not known (frequency cannot be estimated from the available data):
• Hypersensitivity reaction
• Swelling of the skin

If you experience any of the following non-serious side effects, contact your doctor and/or seek medical attention:

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 hyperactivity, dizziness, tiredness, high blood pressure, abdominal pain, indigestion, mouth ulcers, dry mouth, nausea, changes in blood composition that may cause yellowing of the skin or eyes, skin inflammation, night sweats, itching, rash, dry skin, pain in the extremities, excretion of glucose in the urine, excess protein in the urine, symptoms of menopause, weakness, abnormal liver function, and weight gain.

Rare (may affect up to 1 in 1,000 people):
Shingles, elevated levels of fat molecules in the blood, mood changes, aggression, agitation, crying spells, symptoms of stress, waking up early in the morning, increased sex drive, depressed mood, memory impairment, attention deficit, dreaminess, restless leg syndrome, poor sleep, tingling sensation, watery eyes, dizziness when standing or sitting, hot flashes, acid reflux, stomach upset, mouth sores, tongue ulceration, stomach pain, vomiting, abnormal abdominal sounds, gas, excessive saliva production, bad breath, abdominal discomfort, stomach upset, inflammation of the stomach lining, eczema, rash, hand dermatitis, itchy rash, nail disorders, arthritis, muscle spasms, neck pain, night cramps, large volumes of urine, urge to urinate during the night, prolonged and potentially painful rash, inflammation of the prostate, tiredness, pain, thirst, increased liver enzymes, blood electrolyte abnormalities, and laboratory test abnormalities.

Frequency not known (frequency cannot be estimated from the available data):
Swelling of the mouth or tongue and abnormal milk secretion.

Reporting of side effects
If you experience any side effects, including any not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at: https://www.aifa.gov.it/content/segnalazionireazioni-avverse .
By reporting side effects you can help provide more information on the safety of this medicine.