SYNCRODIN

Posology - Adults with jet-lag The standard dose is 3 mg (1 tablet) daily for a maximum of 5 days. The dose may be increased to 6 mg (2 tablets taken together) 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 to cause an adverse effect, on re-synchronisation following jet-lag, Syncrodin® tablets 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 Syncrodin®. As alcohol can impair sleep and potentially worsen certain symptoms of jet-lag (e. , headache, morning fatigue, concentration) it is recommended that alcohol is not consumed when taking Syncrodin®.

Syncrodin® may be taken for a maximum of 16 treatment periods per year. Paediatric population The safety and efficacy of melatonin in children and adolescents less than 18 years in jet-lag has not been established. - Delayed sleep wake phase disorder (DSWPD) in children and adolescents aged 6 to 17 years and adults up to 25 years of age, where sleep hygiene measures have been insufficient.

Diagnosis and treatment of DSWPD should be made and initiated by physicians experienced in DSWPD and/or paediatric sleep medicine. The recommended starting dose is 1 to 2 mg per day given 1 to 2 hours before the fixed desired bedtime or at the time advised by the treating physician.

The dose of melatonin should be adjusted individually until effective up to a maximum of 5 mg per day, independent of age. The lowest effective dose should be sought and taken for the shortest period. Syncrodin® is suitable only when the lowest effective dose has been established to be 3 mg.

Other formulations and strengths suitable for paediatric patients may also be available on the market. After 6 weeks of treatment, the physician should evaluate the effect of treatment and consider stopping 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, Syncrodin® 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 discontinuation of melatonin leads to clinical relapse, melatonin can be reinstated and continued. The patient should be monitored at regular intervals to check that Syncrodin® is still the most appropriate treatment. During ongoing treatment, especially if the treatment effect is uncertain, discontinuation attempts should take place regularly at the discretion of the treating physician.

Limited data are available for up to 3 years of treatment. Children under 6 years of age Syncrodin® is not recommended for children under 6 years of age. 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. - Insomnia in children and adolescents aged 6 to 17 years with attention deficit hyperactivity disorder (ADHD), where sleep hygiene measures have been insufficient.

Diagnosis and treatment of insomnia associated with ADHD should be made and initiated by physicians experienced in ADHD and/or paediatric sleep medicine. Syncrodin® is taken 30 to 60 minutes before bedtime. Syncrodin® is suitable only when the lowest effective dose has been established to be 3 mg.

If a patient requires other doses, then alternate formulations should be used. Maximum dose: 5 mg. The dose of melatonin should be adjusted individually until effective up to a maximum of 5 mg per day, independent of age. The lowest effective dose should be sought.

Other formulations and strengths suitable for paediatric patients may also be available on the market. Within the first 3 months of treatment, the physician should evaluate the effect of treatment and consider stopping treatment if no clinically relevant treatment effect is seen.

The patient should be monitored at regular intervals as determined by an appropriate prescriber to check that Syncrodin® is still the most appropriate treatment. Limited data are available for up to 3 years of treatment. During ongoing treatment discontinuation attempts should be attempted regularly, e.

g. once per year and treatment discontinued if it is not effective. If the sleep disorder has started during treatment with medicinal products for ADHD, dose adjustment or switching to another product should be considered. If significant problems are seen in sleep maintenance or early morning waking, an alternative formulation of melatonin should be considered.

Children under 6 years of age Syncrodin® is not recommended for children under 6 years of age. - Insomnia (prolonged sleep onset) in children and adolescents aged 6 to 17 years with autism spectrum disorder (ASD), where sleep hygiene measures have been insufficient.

Diagnosis and treatment of insomnia (prolonged sleep onset) associated with ASD should be made and initiated by physicians experienced in ASD and/or paediatric sleep medicine. The recommended starting dose is 1 to 2 mg. Syncrodin® is suitable when the effective dose […]

Summary of the safety profile Drowsiness / sleepiness, headache, and dizziness / disorientation are the most frequently reported adverse reactions when Syncrodin® is taken on a short-term basis to treat jet-lag. Drowsiness, headache, dizziness, and nausea are also the adverse reactions 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 summary of 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 estimated from the available data) 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 estimated from the available data) Blood and lymphatic system disorders leucopenia, thrombocytopenia Immune system disorders hypersensitivity reaction Metabolism and nutrition disorders hypertriglyceridaemia hyperglycaemia Psychiatric disorders irritability, nervousness, restlessness, abnormal dreams, anxiety mood altered, aggressive behaviour, disorientation, libido increased Nervous system disorders headache, somnolence dizziness syncope, 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 ulceration, dry mouth, nausea vomiting, flatulence, salivary hypersecretion, halitosis, gastritis Skin and subcutaneous tissue disorders pruritus, rash, dry skin nail disorder tongue oedema, oral mucosa swollen Musculoskeletal and connective tissue disorders arthritis, muscle spasms 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 estimated from the available data) 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 Investigations weight increased blood electrolytes abnormal Paediatric population A low frequency of mild adverse reactions has been reported in the paediatric population.

The number of adverse reactions in patients given melatonin or placebo is not significantly different. The most common adverse reactions include headache, hyperactivity, dizziness and abdominal pain. No serious adverse reactions have been reported.

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. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

Melatonin may cause drowsiness. Syncrodin® should be used with caution if the effects of drowsiness are likely to be associated with a risk to patient safety. Epilepsy Melatonin may increase seizure frequency in patients experiencing seizures (e.

, epileptic patients). Patients suffering from seizures must be informed about this possibility before using Syncrodin®. Syncrodin® may promote or increase the incidence of seizures in children and adolescents with multiple neurological defects.

Immunological diseases Occasional case reports have described exacerbation of an autoimmune disease in patients taking melatonin. Syncrodin® is not recommended in patients with autoimmune diseases. Diabetes/Impaired glucose tolerance Limited data suggest that melatonin taken in close proximity to ingestion of carbohydrate-rich meals may impair blood glucose control for several hours.

Syncrodin® should be taken at least 2 hours before and at least 2 hours after a meal; ideally at least 3 hours after a meal by people with significantly impaired glucose tolerance or diabetes. Renal and hepatic impairment Only limited data are available on the safety and efficacy of melatonin in patients with renal impairment or hepatic impairment.

2). Paediatric population 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. There are theoretical risks based on biological effects of melatonin, e.

g. immunological regulation, effects on the threshold for seizures and endocrinological effects, which could affect puberty development and fertility, respectively. Therefore, treatment should be taken for the shortest period and evaluated on a regular basis as determined by the treating physician to check that Syncrodin® is still the most appropriate treatment.

Sodium This medicinal product contains less than 1 mmol sodium (23 mg) per film-coated tablet, that is to say essentially ‘sodium-free’.

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