MELATONIN

Posology The standard dose is 3 mg daily for a maximum of 5 days. The dose may be increased to 5 mg or 6 mg if the standard dose does not adequately alleviate symptoms. The dose that adequately alleviates symptoms should be taken for the shortest period.

A lower dose of 2mg may be sufficient for some individuals. The first dose should be taken on arrival at destination at the habitual bed-time. Due to the potential for incorrectly timed intake of melatonin to have no effect, or an adverse effect, on re-synchronisation following jet-lag, Melatonin Capsules should not be taken before 20:00 hr or after 04:00 hr at destination.

2). 4). It is recommended that food is not consumed 2 h before and 2 h after intake of Melatonin Capsules. g. headache, morning fatigue, concentration) it is recommended that alcohol is not consumed when taking Melatonin Capsules. Melatonin Capsules may be taken for a maximum of 16 treatment periods per year.

2). Renal impairment There is only limited experience regarding the use of Melatonin Capsules in patients with renal impairment. Caution should be exercised if melatonin is used by patients with renal impairment. 2). Hepatic impairment There is no experience regarding the use of Melatonin Capsules in patients with hepatic impairment.

Limited data indicate that plasma clearance of melatonin is significantly reduced in patients with liver cirrhosis. 2). Paediatric population The safety and efficacy of Melatonin Capsules in children and adolescents aged 0 – 18 years have not been established.

1). Method of administration For oral use. Capsules should be swallowed whole with fluid.

Summary of the safety profile Drowsiness / sleepiness, headache, and dizziness / disorientation are the most frequently report adverse effects when melatonin is taken on a short-term basis to treat jet-lag. Drowsiness, headache, dizziness, and nausea are also the adverse effects reported most frequently when typical clinical doses of melatonin have been taken for periods of several days to several weeks by healthy persons and patients.

Tabulated list adverse reactions The following adverse reactions to melatonin in general have been reported in clinical trials or spontaneous case reports. Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.

System Organ Class Very Common (≥ 1/10) Common (≥1/100 to <1/10) Uncommon (≥1/1,000 to <1/100) Rare (≥1/10,000 to <1/1,000) Not known: (cannot be established from the available data) Blood and lymphatic system disorders leucopenia, thrombocytopenia Immune system disorders hyper- sensitivity reaction Metabolism and nutrition disorders hypertriglyceridaemia hyperglycaemia Psychiatric disrs irritability, nervousness, restlessness, abnormal dreams, anxiety mood altered, aggressive behaviour, disorientation, libido increased Nervous system disorders headache, somnolence dizziness syncope (fainting), memory impairment, restless legs syndrome, paraesthesia Eye disorders visual acuity reduced, vision blurred, lacrimation increased Cardiac disorders palpitations Vascular disorders hypertension hot flushes Gastrointestinal disorders abdominal pain, upper abdominal pain, dyspepsia, oral ulcers, dry mouth, nausea vomiting, flatulence, salivary hypersecretion, halitosis, gastritis Skin and subcutaneous tissue disorders pruritus, rash, dry skin nail disorder tongue edema, edema of the oral mucosa Musculoskeletal and connective tissue disorders arthritis, muscle spasms Renal and urinary disorders glycosuria, proteinuria polyuria, haematuria Reproductive system and breast disorders priapism, prostatitis galactorrhoea General disorders and administration site conditions chest pain, malaise thirst Laboratory and other examinations weight increased blood electrolytes abnormal Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.

Melatonin may cause drowsiness. Therefore, the product should be used with caution, if the effects of drowsiness are likely to be associated with a risk to patient safety. g. epileptic patients). Patients suffering from seizures must be informed about this possibility before using Melatonin Capsules.

Melatonin may promote or increase the incidence of seizures in children and adolescents with multiple neurological defects. Occasional case reports have described exacerbation of an autoimmune disease in patients taking melatonin. There are no data regarding use of Melatonin Capsules in patients with autoimmune diseases.

Melatonin Capsules are not recommended in patients with autoimmune diseases. Limited data suggest that melatonin taken in close proximity to ingestion of carbohydrate-rich meals may impair blood glucose control for several hours. Melatonin Capsules should be taken at least 2 hours before and at least 2 hours after a meal; ideally at least 3 hours after meal by persons with significantly impaired glucose tolerance or diabetes.

Only limited data are available on the safety and efficiency of melatonin in patients with renal impairment or hepatic impairment. Melatonin Capsules are not recommended for use in patients suffering from severe renal impairment or moderate or severe hepatic impairment.

Paediatric population The safety and efficacy of Melatonin Capsules in children and adolescents aged 0 – 18 years have not been established. 1). Melatonin 2 mg Capsules contain sodium. These medicines contain less than 1 mmol sodium (23 mg) per capsule, that is to say essentially “sodium-free”.

1.