Products Ninotalem' - High quality melatonin tablets Melatonin is a natural hormone that is produced by the pineal gland, located in the human brain. It plays a vital role in the regulation of the body' circadian rhythm, also known as the 'biological clock'. Ninotalem' tablets contain a chemically synthesized melatonin that meets all regulatory quality requirements for the use in human medicinal products. Melatonin is used worldwide for disorders related to disturbances in the circadian rhythm, such as jet-lag and sleep disorders. What makes Ninotalem' stand out from other brands of melatonin products is its high quality and consistency. Furthermore, in contrast to the majority of existing brands, Ninotalem' can boast a proven track record in a range of clinical trials. In 2006, Circa Dia obtained a product license for Ninotalem' from Health Canada. The quality dossier meets all requirements for a melatonin-containing product to be commercialized in Canada. Ninotalem' is indicated for sleep disorders and jet-lag and will become available without prescription. Health Canada considers melatonin to be a natural health product that requires a product license. Ninotalem' 5 mg tablets - Product Information Ninotalem' is available as white to off-white circular tablets (diameter: 5 mm, average weight: 75 mg). Each tablet contains 5 mg synthetic melatonin. Ninotalem' contains the following non-medicinal ingredients: calcium hydrogen phosphate, dihydrate, mannitol, sodium starch glycolate, talc and magnesium stearate. Packaging: Ninotalem' tablets are packed in aluminum/pentalayer blisters with 10 tablets per blister. The blisters are packed, together with an information leaflet on the product and its usage, in a carton box. Stability and storage: Ninotalem' tablets packed in aluminum/pentalayer blisters are stable for at least five years. Storage at room temperature in a dry, dark environment is advised. Ninotalem' - Quality Ninotalem' tablets contain a chemically synthesized melatonin that meets all regulatory requirements. Active Pharmaceutical Ingredient (API): Melatonin Manufacturing, packaging, quality control and quality assurance release of API melatonin are performed in full compliance with current Good Manufacturing Practices (GMP). The stability testing program (long term and accelerated stability) is performed in compliance with ICH guidelines. Stability data of 60 months are currently available. Ninotalem' tablets Production, packaging, quality control and quality assurance release of Ninotalem' tablets are performed in full compliance with current GMP and PIC-regulations as recommended by the World Health Organization (WHO). The excipients are commonly used for direct compression tablets and are manufactured according to EP/USP quality standards. The release specifications (test parameters, test methods and acceptance limits) of Ninotalem' tablets are in line with the European Pharmacopoeia. The stability testing program (long term and accelerated stability) is performed in compliance with ICH guidelines. Stability data of 60 months are available. Ninotalem' tablets are stable for at least five years.