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MELATONIN SERB is a brand name for Melatonin. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Melatonin is indicated for: - Short-term treatment of jet lag in adults. - Sleep onset insomnia in children and adolescents aged 6-17 years with attention- deficit hyperactivity disorder (ADHD) where sleep hygiene measures have been insufficient. - Delayed sleep wake phase disorder (DSWPD) in children and adolescents…
Verbatim from this product's MHRA label. Tap a section to expand.
Posology Short-term treatment of jet lag Adults The recommended dose is 1 to 5 mg (1 to 5 ml) daily for a maximum of 5 days. The recommended starting dose is 3 mg (3 ml). The dose may be increased to 6 mg (6 ml) if the standard dose does not adequately alleviate symptoms.
The dose that adequately alleviates symptoms should be taken for the shortest period. 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 should not be taken before 20:00 hr or after 04:00 hr at destination.
g. 5). Melatonin may be taken for a maximum of 16 treatment periods per year. Children and adolescents under 18 years of age The safety and efficacy of melatonin for use in jet lag has not been established in children and adolescent under 18 years.
Sleep onset insomnia in children and adolescents aged 6-17 years with ADHD Treatment should be initiated by physicians experienced in ADHD and/or paediatric sleep medicine. The recommended starting dose is 1 to 2 mg (1 to 2 ml) 30-60 minutes before bedtime.
The dose of Melatonin can be increased by 1 mg (1 ml) every week until effect up to a maximum 5 mg (5 ml) per day, independent of age. The lowest effective dose that controls symptoms should be given. There is insufficient safety data to support long term use of melatonin in children approaching puberty.
After at least 3 months of treatment, the physician should evaluate the treatment effect and consider discontinuing the 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.
During ongoing treatment, especially if the treatment effect is uncertain, discontinuation attempts should be done regularly at least once per year. If insomnia has occurred during treatment with ADHD medication, dose adjustment or change of treatment should be considered.
Adults In adolescents whose symptoms persist into adulthood and who have shown clear benefit from treatment, it may be appropriate to continue treatment into adulthood. However, initiation of treatment in adults is not appropriate. Children under 6 years of age with ADHD The safety and efficacy of Melatonin in children aged 0-6 years have not been established.
Summary of the safety profile After single doses of melatonin, nausea and vomiting were common adverse effects. Drowsiness/sleepiness, headache, and dizziness/disorientation are the most frequently reported adverse effects when melatonin is taken on a short-term basis to treat jet lag.
Gastrointestinal symptoms, 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.
In longer term treatment of up to several months no additional long term adverse effects were seen, except an uncommon effect of abnormal dreams. 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) Infections and infestations herpes zoster Blood and lymphatic system disorders leucopenia, thrombocytopenia Immune system disorders Hypersensitivity Metabolism and nutrition disorders Hypertriglyceridaemia, hypocalcemia, hyponatraemia hyperglycaemia Psychiatric disorders irritability, nervousness, restlessness, insomnia, abnormal dreams, nightmare, anxiety mood altered, aggressive behaviour, agitation, stress disorientation, terminal insomnia, poor quality sleep, libido increased, depressed mood, depression Nervous system disorders headache, somnolence migraine, lethargy, psychomotor hyperactivity, dizziness syncope (fainting), memory impairment, dreamy state, restless legs syndrome, disturbance in attention, paraesthesia drowsiness, sedation Eye disorders visual acuity reduced, vision blurred, lacrimation increased Ear and labyrinth disorders vertigo positional, vertigo Cardiac disorders angina pectoris, palpitations Vascular disorders Hypertension Hot flush Gastrointestin al disorders Abdominal pain, abdominal pain upper, dyspepsia, mouth ulceration, dry mouth, nausea Gastroesophageal reflux disease, gastrointestinal disorder, diarrhoea, oral mucosal blistering, tongue ulceration, abdominal discomfort, vomiting, gastrointestinal sounds abnormal, flatulence, salivary hypersecretion, breath odour, gastrointestinal disorder, gastritis Tongue oedema, mouth oedema Hepatobilary Hyperbilirubinae 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) disorders mia Skin and subcutaneous tissue disorders Dermatitis, night sweats, pruritus, rash, dry skin Eczema, erythema, hand dermatitis, psoriasis, rash pruritic, nail disorder Angioedema, Musculoskelet al 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, malaise Fatigue, pain, thirst, crying, Hypothermia Investigations Liver function test abnormal, weight increased Hepatic enzyme increased, blood electrolytes abnormal, laboratory test abnormal Paediatric population In the paediatric population, a low frequency of generally mild side effects have been reported.
When treating insomnia in children and adolescents, melatonin should only be administered after other treatable causes of insomnia have been ruled out by appropriate specialist investigation and nonpharmacological measures have been inadequate.
g. epileptic patients). Caution should be exercised when prescribing to patients with epilepsy and/or with multiple neurological defects and/or with concomitant medications that could increase seizure frequency. Drowsiness Melatonin may cause drowsiness.
Melatonin should be used with caution if the effects of drowsiness are likely to be associated with a risk to patient safety. 7. Impaired glucose tolerance and 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 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. Auto-immune diseases Occasional case reports have described exacerbation of an autoimmune disease in patients taking melatonin.
There are no data regarding use of melatonin in patients with autoimmune diseases. Melatonin is not recommended in patients with autoimmune diseases. Renal and hepatic impairment Only limited data are available on the safety and efficiency of melatonin in patients with renal impairment or hepatic impairment.
Melatonin is not recommended for use in patients suffering from severe renal impairment or moderate or severe hepatic impairment. Switching between formulations Caution may be taken when switching between melatonin products as the mean Cmax on single dose administration for the suspension may be higher than that observed with tablet formulations.
Children and Adolescents There is insufficient data to analyse the impact of long-term exposure to melatonin in children and adolescents on the sexual maturation of this population. g. immunological regulation, effects on the threshold for seizures and endocrinological effects, which could affect puberty development and fertility, respectively.
1.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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Delayed sleep wake phase disorder In children and adolescents (6-17 years) and adults up to 25 years of age Treatment should be initiated by physicians experienced in DSWPD and/or paediatric sleep medicine. The recommended starting dose is 1 to 2 mg once every day, 1 to 2 hours before the fixed desired bedtime, given as 1 to 2 ml of Melatonin.
The dose of Melatonin should be adjusted individually until effect up to a maximum of 5 mg per day, independent of age. The lowest effective dose that controls symptoms should be givenand taken for the shortest period. After 6 weeks of treatment, the physician should evaluate the treatment effect and consider discontinuing the treatment if no clinically relevant treatment effect is seen.
In patients with significant continuing daytime sleepiness or misaligned circadian rhythm the possibility of high residual melatonin in the morning should be considered. In these cases, melatonin can be stopped and restarted at a lower dose.
The dose that adequately alleviates symptoms should be taken for the shortest period. There is insufficient safety data to support long term use of melatonin in children approaching puberty. After the achievement of advanced sleep-wake phase for 6 weeks, treatment should be stopped to evaluate if the patient can independently maintain an advanced sleep-wake schedule.
If withdrawal of melatonin results in clinical relapse, melatonin can be resumed and continued. 4). Adults over 25 years of age In adults whose symptoms persist past the age of 25 and who have shown clear benefit from treatment, it may be appropriate to continue treatment.
However, initiation of treatment in adults over 25 years of age is not appropriate. Children under 6 years of age with DSWPD The safety and efficacy of Melatonin in children aged 0-6 years have not been established. Single use for short-term sedation under medical supervision to facilitate EEG in children and adolescents from 1 to 18 years Melatonin should be given 30 to 45 minutes before the anticipated start of the procedure as a single dose of 3 mg for children weighing less than 15 kg and 6 mg for those weighing more than 15 kg.
Where possible this dose should be administered after a period of sleep deprivation to maximise the sedative effects. 5 mg (<15 kg) or 3 mg (>15 kg) may be given if sleep is not achieved after 45 minutes. 5 mg in children weighing less than 15 kg and 9 mg for those weighing more than 15 kg.
Children under 1 year The safety and efficacy of Melatonin in children aged below 1 year have not been established. 2). However, individual elderly patients may be more likely to be slow metabolisers of melatonin with the potential for high residual morning levels of melatonin.
In cases where there is excessive morning sleepiness, a lack of effect on DLMO and / or advancing sleep phase the possibility of impaired […]
The number of side effects did not differ significantly between children who received placebo and children who received melatonin. The most common side effects were headache, hyperactivity, dizziness and abdominal pain. No serious side effects have been observed.
Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via Yellow Card Scheme.
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Therefore, treatment should be taken for the shortest period and evaluated on a regular basis (at least every 6 months) to check that melatonin is still the most appropriate treatment. Elderly (65 years old and over) Exposure levels to melatonin after oral administration in young and moderately older adults are comparable.
Although prolonged elevated levels of melatonin have been seen in some elderly patients it is unclear if all 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.
Excipients warnings This medicinal product contains propylene glycol (E1520), methylparaben (E218), propylparaben (E216) and sodium. This medicinal product contains 53 mg propylene glycol in each ml. Co- administration with any substrate for alcohol dehydrogenase such as ethanol may induce serious adverse effects in neonates.
This medicinal product contains methylparaben (E218) and propylparaben (E216) which may cause allergic reactions (possibly delayed). This medicinal product contains less than 1 mmol (23 mg) sodium per maximum 6 ml dose , that is to say essentially ‘sodium-free’.