What is the problem?
Las melatonin capsules Melatonin 7 They have the category of food supplement, they are not a medicine. However, the amount of active ingredient, melatonin in this case, exceeds that authorized for this type of supplements: it has 5 mg per capsule, which makes it a medicine, but It has not passed the controls of the Medicines Agency and therefore has not been authorized: It is an illegal product. In view of this, since AEMPS The precautionary measure has been taken to prohibit its marketing and request the withdrawal of all batches of Melatonin 7 from the market.
What is the affected product?
The alert refers to Melatonin 7a capsule supplement sold by Polish company 7 Nutrition.
What should you do?
Marketing has ceased and has been withdrawn from sale: If you have it at home, do not consume this illegal product.
Melatonin, effective, but not harmless
Melatonin is a hormone produced naturally in the body. Melatonin (or N-acetyl-5-methoxytryptamine) is closely related to serotonin and participates in a wide variety of physiological processes. In particular It is involved in the control of circadian rhythms, adaptation to the light-dark cycle. In addition, its effect as a sleep stimulant is recognized..
In Spain, melatonin doses equal to or greater than 2 mg must be marketed as a medicine and go through all the regulatory channels that correspond to medicines. The Melatonin food supplements should contain doses less than 2 mg.
The EFSA, European Food Safety Agency recognizes two “healthy” claims to melatonin in its form as a food supplement: improves the subjective effects of jet lag and reduces the time needed to fall asleep.
The consumption of melatonin is not free of adverse effects: in doses of medication it should not be taken without control, as it can cause nervousness, irritability, restlessness, drowsiness, lethargy, hypertension or dizziness, among others.
More information about this alert in AEMPS
