MELATONIN

Posology Adults with jet lag The standard dose is 3 ml (equivalent to 3 mg). The dose may be increased to 5 or 6 mg once daily if necessary or reduced to 1 or 2 mg once daily if sufficient. 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 oral solution should not be taken before 20:00 hr or after 04:00 hr at destination.

The maximum recommended daily dose is 5 to 6ml (equivalent to 5 to 6mg) for a maximum of 5 days. A maximum of 16 treatment cycles may occur per year. Paediatric population with ADHD The recommended starting dose is 1-2 ml (equivalent to 1-2 mg) 30 to 60 minutes before bedtime.

The dose should be adjusted individually to a maximum of 5 ml (equivalent to 5 mg) daily regardless of age. The lowest effective dose should be sought. The maximum recommended daily dose is 5 ml (equivalent to 5 mg). 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 melatonin 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 degree of renal impairment on the pharmacokinetics of melatonin has not been studied.

Published data show elevated endogenous melatonin levels in patients with chronic renal failure. 2). Hepatic impairment There are no known studies on the use of melatonin in patients with hepatic impairment. Published data show markedly elevated endogenous melatonin levels in patients with hepatic impairment.

2). Children below 6 years of age Melatonin oral solution is not recommended for children below 6 years with ADHD. 2). 4). It is recommended that food is not consumed 2 h before and 2 h after intake of Melatonin. g. headache, morning fatigue, concentration) it is recommended that alcohol is not consumed when taking Melatonin.

Method of administration Oral use. 5 mg of melatonin with an adaptor. Instruction for use 1. Open the bottle by removing the cap. 2. Push the adapter into the opening of the bottle. 3. Insert the syringe into the hole in the adapter and turn the bottle upside down.

Melatonin causes few and no serious adverse reactions in the short term, up to three months. There is limited documentation of long-term treatment with melatonin. Reported adverse reactions are mainly fatigue, dizziness and headache.

However, these side effects are also common for placebo-treated patients. Tabulated risks of adverse reactions In the table below all adverse reactions are listed according to organ class and frequency: Very common (≥1/10), Common (≥100, <1/10), Uncommon (≥1/1000, <1/100), Rare (≥1/10 000, <1/1000), Very rare (<1/10 000), Not known (cannot be estimated from the available data).

System Organ Class Frequency Adverse reaction Infections and infestations Rare Herpes Zoster Blood and lymphatic system disorders Rare Leukopenia, thrombocytopenia Immune system disorders Not known Hypersensitivity reaction Metabolism and nutrition disorders Rare Hypertriglyceridemia, hypocalcaemia, hyponatraemia Uncommon Irritability, nervousness, restlessness, insomnia, abnormal dreams, nightmares, anxiety Psychiatric disorders Rare Irritability, nervousness, restlessness, insomnia, abnormal dreams, nightmares, anxiety Common Headache, somnolence Uncommon Migraine, lethargy, psychomotor hyperactivity, dizziness Nervous system disorders Rare Syncope, memory impairment, disturbance in attention, dreamy state, restless legs syndrome, poor quality sleep, paraesthesia Eyes Rare Visual acuity reduced, vision blurred, lacrimation increased Ear and labyrinth disorders Rare Vertigo positional, vertigo Cardiac disorders Rare Angina pectoris, palpitations Uncommon HypertensionVascular disorders Rare Hot flush Uncommon Abdominal pain, abdominal pain upper, dyspepsia, mouth ulceration, dry mouth, nausea Gastrointestinal disorders Rare 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 Uncommon Hyperbilirubinemia Uncommon Dermatitis, night sweats, pruritus, rash, pruritus generalised, dry skin Rare Eczema, erythema, hand dermatitis, psoriasis, rash generalised, rash pruritic, nail disorder Skin and subcutaneous tissue disorders Not known Angioedema, oedema of mouth, tongue oedema Uncommon Pain in extremityMusculoskeletal and connective tissue disorders Rare Arthritis, muscle spasms, neck pain, night cramps Uncommon Glycosuria, proteinuriaRenal and urinary disorders Rare Polyuria, haematuria, nocturia Uncommon Menopausal symptoms Rare Priapism, prostatitis Reproductive system and breast disorders Not known Galactorrhoea Uncommon Asthenia, chest painGeneral disorders and administration site conditions Rare Fatigue, pain, thirst Uncommon Abnormal liver function test, increased weight Investigations Rare Hepatic enzyme increased, blood electrolytes abnormal, laboratory test abnormal Paediatric population In the paediatric population, a low frequency of generally mild adverse reactions has been reported.

The possible long-term effects of melatonin have been inadequately studied. g. immunological regulation, effects on the threshold for seizures and endocrinological effects, which could affect puberty development and fertility, respectively.

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 the treatment of this age group and individual dosage is recommended.

Epilepsy Caution when used in people with epilepsy, as melatonin has been reported to both increase and decrease the frequency of seizures. Immunological diseases Occasional case reports have described exacerbation of an autoimmune disease in patients taking melatonin.

There is no data regarding the use of melatonin in patients with autoimmune diseases. Melatonin oral solution is not recommended in patients with autoimmune diseases. Drowsiness Melatonin can cause drowsiness. Therefore, the drug should be used with caution if it is likely that the drowsiness may be associated with a safety risk.

Diabetes Limited data suggest that melatonin taken close to ingestion of carbohydrate-rich meals may impair blood glucose control for several hours. Melatonin 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.

Switching formulations Caution is advised when switching between immediate-release formulations as the peak plasma-melatonin concentration may be higher with the oral solution than with tablets. Excipients in this formulation Melatonin oral solution contains sodium benzoate ( E211).

625 mg sodium benzoate in each ml of oral solution. Melatonin oral solution contains sodium. This medicine contains less than 1 mmol sodium (23 mg) per ml, that is to say essentially ‘sodium-free’.

1.