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

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


What it is and what it is used for
The active substance of 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 (travelling 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:
- renal impairment. If you suffer from severe renal 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 this case, 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. Melatonin Noxarem should be used according to the instructions.

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

Smoking may reduce the effectiveness of Melatonin Noxarem, as the components of tobacco smoke may 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 not known.


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 drowsiness, and disorientation.

Melatonin, when used for other disorders, 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 ulceration, dry mouth, nausea, changes in blood composition which may cause yellowing of the skin or eyes, inflammation of the skin, 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 increased body weight.

Rare (may affect up to 1 in 1,000 people):
Shingles, high 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, disturbances in attention, dreaminess, restless legs syndrome, poor quality sleep, tingling sensation, watery eyes, dizziness when standing or sitting, hot flushes, acid reflux, upset stomach, mouth sores, tongue ulceration, stomach pain, vomiting, abnormal stomach sounds, gas, excessive saliva production, bad breath, abdominal discomfort, stomach upset, inflammation of the stomach lining, eczema, skin rash, hand dermatitis, itchy rash, nail disorders, arthritis, muscle spasms, neck pain, night cramps, large volumes of urine, need 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 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 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.