MELATONIN NOXAREM*10TABS 5MG

Melatonin Noxarem 3 mg tablets
Melatonin Noxarem 5 mg tablets
Melatonin

What it is and what it is used 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 the symptoms caused by the time difference when crossing several time zones (travelling east or west).

Consult 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 (where the body is "attacked" by its own immune system). In this case, the use of melatonin is not recommended.
- cardiovascular condition for which you are taking an antihypertensive medicine. In this case, the use of melatonin is not recommended.

The timing of melatonin administration is important. Melatonin Noxarem should be used as instructed.

Melatonin Noxarem may cause drowsiness. Therefore, caution should be exercised if you feel drowsy, as this could impair your ability to perform activities such as driving.

Smoking may reduce the effectiveness of Melatonin Noxarem, as components of tobacco smoke can promote the breakdown 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 of short-term use of melatonin for jet lag are 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
• Impaired vision
• Disorientation
• Vertigo (dizziness or "spinning sensation")
• Blood in the urine
• Decrease in the number of white blood cells
• Decrease in the number of platelets in the blood, which increases the risk of bleeding or bruising
• Psoriasis

Frequency unknown (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 assistance:

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, fatigue, high blood pressure, abdominal pain, indigestion, mouth ulceration, 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, glucose excretion in urine, excess protein in urine, menopausal symptoms, weakness, abnormal liver function, and weight gain.

Rare (may affect up to 1 in 1,000 people):
Herpes zoster, high levels of fat molecules in the blood, mood changes, aggression, agitation, crying spells, stress symptoms, early morning awakening, increased sex drive, depressed mood, memory deficit, attention disorders, dreamlike state, restless legs syndrome, poor quality sleep, tingling sensation, watery eyes, dizziness when standing or sitting, hot flashes, acid reflux, stomach upset, blistering in the mouth, tongue ulceration, stomach ache, vomiting, abnormal abdominal sounds, intestinal gas, excessive saliva production, bad breath, abdominal discomfort, gastric disturbances, inflammation of the stomach lining, eczema, skin rash, dermatitis of the hands, itchy skin rash, nail disorders, arthritis, muscle spasms, neck pain, nocturnal cramps, large volumes of urine, need to urinate during the night, prolonged and potentially painful erection, prostate inflammation, fatigue, pain, thirst, increased liver enzymes, electrolyte abnormalities in the blood, and abnormal laboratory tests.

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

Reporting of side effects
If you get 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.