NEOMEL

Posology The standard dose is 3 mg daily for a maximum of 5 days. The dose may be increased to 6 mg 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, Neomel 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 Neomel. g. headache, morning fatigue, concentration) it is recommended that alcohol is not consumed when taking Neomel. Neomel may be taken for a maximum of 16 treatment periods per year.

2). Renal impairment There is only limited experience regarding the use of Neomel 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 Neomel 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 Neomel in children and adolescents aged 0 – 18 years have not been established.

1). Method of administration Neomel is for oral use only. 5 ml and a “Press- In” Bottle Adapter (PIBA) is provided with the product. 1. Remove the child-resistant, tamper evident cap from the bottle by pushing it down and turning it anti-clockwise.

(Figure 1) 2. Push the PIBA into the neck of the product bottle (Figure 2) 3. With the plunger of the syringe pressed completely down, insert the syringe into the PIBA (Figure 3) and draw out the required volume from the inverted bottle (Figure 4) 4.

Remove the filled syringe from the bottle in the upright position (Figure 5) 5. Discharge the syringe contents into the mouth (Figure 6) 6. Wash the syringe inside and out by rinsing in water and replace the cap on the bottle (Figure 7) Figure 1 Figure 2 Figure 3 Figure 4 Figure 5 Figure 6 Figure 7

Summary of the safety profile 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. 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 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 zpster Blood and lymphatic systemdisorders Rare Leukopenia, thrombocytopenia Immune system disorders Not known Hypersensitivity reaction Metabolism and nutrition disorders Rare Hypertriglyceridaemia, hypocalcaemia, hyponatraemia Psychiatric disorders Uncommon Irritability, nervousness, restlessness, insomnia, abnormal dreams, nightmares, anxiety Rare Mood altered, aggression, agitation, crying, stress symptoms, disorientation, early morning awakening, libido increased, depressed mood, depression 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 activity reduces, vision blurred, lacrimation increased Ear and labyrinth disorders Rare Vertigo positional, vertigo Cardiac disorders Rare Angina pectoris, palpitations Uncommon Hypertension Vascular disorders Rare Hot flush Uncommon Abdominal pain, abdominal pain upper, dyspepsia, mouth ulceration, dry mouth, nausea Gastrointestinal disorders Rare Gastro-esophageal 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 Hyperbilirubinaemia 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, proteinuria Renal and urinary disorders Rare Polyuria, haematuria, nocturia Uncommon Meopausal symptoms Rare Priapism, prostatitis Reproductive system and breast disorders Not known Galactorrhea Uncommon Astenia, chest painGeneral disorders and administration site conditions Rare Fatigue, pain, thirst Uncommon Liver function test abnormal, weight increased Investigations Rare Hepatic enzyme increased, blood electrolytes abnormal, laboratory test abnormal Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.

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

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 Neomel in patients with autoimmune diseases.

Neomel is 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. Neomel 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. Neomel is not recommended for use in patients suffering from severe renal impairment or moderate or severe hepatic impairment.

Dose equivalence and conversion for melatonin 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. Paediatric population The safety and efficacy of Neomel in children and adolescents aged 0 – 18 years have not been established.

1). This medicine contains methyl parahydroxybenzoate and propyl parahydroxybenzoate which may cause allergic reactions (possibly delayed). This medicine contains less than 1 mmol sodium (23 mg) per ml, that is to say essentially ‘sodium-free’.

This medicine contains sorbitol and propylene glycol in each ml. This medicinal product contains sorbitol. Patients with hereditary fructose intolerance (HFI) should not take/be given this medicinal product. The additive effect of concomitantly administered products containing sorbitol (or fructose) and dietary intake of sorbitol (or fructose) should be taken into account.

1.