ACTION AND DESCRIPTION

Dietary supplement. Melatonin helps reduce the time it takes to fall asleep.

STORAGE AND EXPIRATION

Store in a cool, dry place. Do not freeze. Keep away from direct light and heat.

INGREDIENTS

Fructose, purified water, melatonin, preservatives: potassium sorbate, sodium benzoate; flavorings; thickener: xanthan gum.

Per dose: melatonin 1 mg.

INSTRUCTIONS FOR USE

4 drops a day.

Take the recommended dose directly into the mouth or dilute it in non-alcoholic beverages. Take 30 minutes before bedtime.

Shake before use.

OTHERS

According to the Report of the Scientific Committee of the Spanish Agency for Consumer Affairs, Food Safety and Nutrition (AECOSAN) on the conditions of use of certain substances to be used in food supplements: Melatonin

AECOSAN has proposed a maximum daily intake of melatonin of 1 mg. This proposal is based on the authorization of two health claims, in relation to the fact that melatonin contributes to

• relieve the subjective feeling of jet lag:

It can only be used with foods containing a minimum of 0.5 mg of melatonin per quantified portion. For a product to bear this claim, the consumer must be informed that the beneficial effect is obtained with a minimum intake of 0.5 mg, to be taken shortly before bedtime on the first day of travel and a few days after arrival at the destination (EU, 2012).

• Melatonin helps reduce the time needed to fall asleep

It can only be used with foods containing 1 mg of melatonin per quantified portion. For a product to bear this claim, the consumer must be informed that the beneficial effect is obtained with an intake of 1 mg of melatonin shortly before going to sleep (EU, 2012).

Melatonin (N-acetyl-5-methoxytryptamine) is a neurohormone produced by the pineal gland of mammals and other organs, especially the enterochromaffin cells of the gastrointestinal tract and the retina (Hardeland et al., 1993) (Huether, 1993), whose main physiological function is the regulation or control of circadian and seasonal rhythms (Armstrong et al., 1986). It was discovered in the 1950s (Lerner et al., 1958, 1959).

In recent years, it has been shown that melatonin also has numerous additional functions. It is produced and acts on numerous tissues or cells that express melatonin receptors, at much lower levels (Hardeland, 2009). Melatonin receptors MT1 and MT2 (membrane receptors) have been detected in numerous tissues of the CNS (Central Nervous System), in peripheral organs such as the gastrointestinal tract, liver, lung, skin, adrenal gland, gonads, male organs, breast tissue, kidney, heart, blood vessels, adipose tissue, neutrophils, lymphocytes and lymphoid tissue (Ishii et al., 2009). Both receptors involve signaling through cAMP inhibition, protein kinase A activity, effects on phospholipase A2 and C, and effects on potassium and calcium channels (Mathes, 2010). A third receptor, MT3, has also been described, which is an enzyme identified as quinone reductase 2.

Deficiencies in melatonin production or receptor expression, or decreases in melatonin levels (such as those that occur with age) cause numerous dysfunctions. In these cases, with insufficient melatonin levels or poor melatoninergic signaling, numerous pathophysiological alterations can occur, reflecting the molecule's pleiotropy. For example, decreased nocturnal melatonin levels have been repeatedly observed in patients with neurodegenerative disorders and sleep disturbances (Uchida et al., 1996).

PRECAUTIONS AND WARNINGS

Do not exceed the recommended daily dose.

Keep out of reach of children under 3 years of age.

It should not be used as a substitute for a balanced diet.

USE IN PATIENTS WITH FOOD INTOLERANCE

This product can be taken by people with celiac disease, egg allergy/intolerance, or milk intolerance.