ADAFLEX

Posology Adults with jet lag The recommended dose is 1-5 mg for a maximum of 5 days. The dose should be taken at the time of destination bedtime for journeys of 5 time zones or longer, especially when traveling in an easterly direction.

Due to the potential for incorrectly timed intake of melatonin to have no effect, or an adverse effect, on re-synchronisation following jet lag, Adaflex tablets should not be taken before 20:00 hr or after 04:00 hr at destination. g.

headache, morning fatigue, concentration) it is recommended that alcohol is not consumed when taking Adaflex tablets. A maximum of 16 treatment cycles may occur per year. Insomnia in children and adolescents with ADHD Treatment should be initiated by physicians experienced in ADHD and/or paediatric sleep medicine.

Recommended starting dose of Adaflex tablet: 1-2 mg 30-60 minutes before bedtime. The dose of melatonin can be increased by 1 mg every week until effect up to a maximum 5 mg per day, independent of age. The lowest effective dose should be sought.

Limited data are available for up to 3 years of treatment. After at least 3 months of treatment, the physician should evaluate the treatment effect and consider stopping treatment if no clinically relevant treatment effect is seen. The patient should be monitored at regular intervals (at least every 6 months) to check that Adaflex is still the most appropriate treatment.

g. once per year. If the sleep disorder has started during treatment with medicinal products for ADHD, dose adjustment or switching to another product should be considered. 2). Renal impairment The effect of any stage of renal impairment on melatonin pharmacokinetics has not been studied.

Caution should be used when melatonin is administered to patients with renal impairment. Hepatic impairment Limited data indicate that plasma clearance of melatonin is significantly reduced in patients with liver cirrhosis. 2). Children below 6 years of age Adaflex tablets are not recommended for children below 6 years with ADHD.

Method of administration Oral use. The tablet can be crushed and mixed with water directly before the administration. 2). 4). It is recommended that food is not consumed 2 h before and 2 h after intake of Adaflex tablets.

Summary of the safety profile Melatonin causes few, and no serious, adverse reactions in the short term, up to three months. Long-term effects are poorly studied. Reported adverse reactions to melatonin are mainly headache, nausea and fatigue in both adults and children.

These adverse reactions are however also common for placebo-treated patients in presented clinical studies and there is no significant difference between patients who received active treatments and placebo in these studies. No common or very common adverse reactions have been reported.

Adverse reactions in adults are listed according to MedDRA system organ class and presented within each frequency category according to the following: 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); Very rare (<1/10,000); Not known (cannot be estimated from the available data).

System organ class Very common Common Uncommon Rare Not known (cannot be estimated from the available data) Infections and infestations Herpes zoster Blood and lymphatic system disorders Leukopenia, thrombocytopenia Immune system disorders Hypersensitivity reaction Metabolism and nutrition disorders Hypertriglyceridemia, hypocalcaemia, hyponatraemia Hyperglycaemia Psychiatric disorders Irritability, nervousness, restlessness, insomnia, abnormal dreams, nightmares, anxiety Mood altered, aggression, agitation, crying, stress symptoms, disorientation, early morning awakening, libido increased, depressed mood, depression Nervous system disorders Headache, somnolence Migraine, lethargy, psychomotor hyperactivity, dizziness Syncope, memory impairment, disturbance in attention, dreamy state, restless legs syndrome, poor quality sleep, paraesthesia Eye disorders Visual acuity reduced, vision blurred, lacrimation increased Ear and labyrinth disorders Vertigo positional, vertigo System organ class Very common Common Uncommon Rare Not known (cannot be estimated from the available data) Cardiac disorders Angina pectoris, palpitations Vascular disorders Hypertension Hot flush Gastrointestinal disorders Abdominal pain, abdominal pain upper, dyspepsia, mouth ulceration, dry mouth, nausea Gastro-oesophageal reflux disease, gastrointestinal disorder, oral mucosal blistering, tongue ulceration, gastrointestinal upset, vomiting, bowel sounds abnormal, flatulence, salivary hypersecretion, halitosis, abdominal discomfort, gastric disorder, gastritis Hepatobiliary disorders Hyperbilirubinemia Skin and subcutaneous tissue disorders Dermatitis, night sweats, pruritus, rash, pruritus generalised, dry skin Eczema, erythema, hand dermatitis, psoriasis, rash generalised, rash pruritic, nail disorder Angioedema, oedema of mouth, tongue oedema Musculoskeletal and connective tissue disorders Pain in extremity Arthritis, muscle spasms, neck pain, night cramps Renal and urinary disorders Glycosuria, proteinuria Polyuria, haematuria, nocturia Reproductive system and breast disorders Menopausal symptoms Priapism, prostatitis Galactorrhoea General disorders and administration site conditions Asthenia, chest pain Fatigue, pain, thirst Investigations Liver function test abnormal, weight increased Hepatic enzyme increased, blood electrolytes abnormal, laboratory test abnormal Paediatric population A low frequency of in general mild adverse reactions have been reported in the paediatric population.

Melatonin may cause drowsiness. Melatonin tablets should be used with caution if the effects of drowsiness are likely to be associated with a risk to patient safety. Elderly Exposure levels to melatonin after oral administration in young and moderately older adults are comparable.

It is unclear if significantly older persons are especially sensitive to exogenous melatonin. Caution should therefore be exercised in treatment of this age group and individual dosage is recommended. Immunological diseases Occasional case reports have described exacerbation of an autoimmune disease in patients taking melatonin.

There are no data regarding use of melatonin tablets in patients with autoimmune diseases. Melatonin tablets are not recommended in patients with autoimmune diseases. Epilepsy Melatonin has been reported to increase, decrease and have no effect on seizure frequency.

Because of the uncertainty of the effect of melatonin on epileptic seizures, some caution should be exercised for use in people with epilepsy. Diabetes Limited data suggest that melatonin taken in close proximity to ingestion of carbohydrate-rich meals may impair blood glucose control for several hours.

Melatonin tablets 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.

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