CLEMENOS XL

Posology The recommended dose is 2 mg once daily, 1-2 hours before bedtime and after food. This dosage may be continued for up to thirteen weeks. Paediatric population The safety and efficacy of Melatonin prolonged-release tablets in children aged 0 to 18 years has not yet been established.

Other pharmaceutical forms/strengths may be more appropriate for administration to this population. 1. 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 such patients.

Hepatic impairment There is no experience of the use of Melatonin prolonged-release tablets in patients with liver impairment. Published data demonstrates markedly elevated endogenous melatonin levels during daytime hours due to decreased clearance in patients with hepatic impairment.

Therefore, Melatonin prolonged-release tablets is not recommended for use in patients with hepatic impairment. Method of Administration Oral use. Tablets should be swallowed whole to maintain prolonged release properties. Crushing or chewing should not be used to facilitate swallowing.

8% taking placebo. 743-placebo vs. 013-melatonin). The most common adverse reactions were headache, nasopharyngitis, back pain, and arthralgia, which were common, by MedDRA definition, in both the melatonin and placebo treated groups.

Tabulated list of adverse reactions The following adverse reactions were reported in clinical trials and from post- marketing spontaneous reporting. 4% of patients taking placebo. Only those adverse reactions reported during clinical trials occurring in patients at an equivalent or greater rate than placebo have been included below.

Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness. 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 established from the available data).

System Organ Class Very common Commo n Uncommon Rare Not known Infections and infestations Herpes zoster Blood and lymphatic system disorders Leukopenia, thrombocytope nia Immune system disorders Hyper- sensitivity reaction Metabolism and nutrition disorders Hypertriglyceri daemia, hypocalcaemia, hyponatraemia 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 Migraine, headache, lethargy, psychomotor, hyperactivity , dizziness, somnolence 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 Commo n Uncommon Rare Not known Cardiac disorders Angina pectoris, palpitations Vascular disorders Hypertension Hot flush Gastrointesti nal 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 Hepatobiliar y disorders Hyperbilirubi naemia Skin and subcutaneou s 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 Musculoskel etal and connective tissue disorders Pain in extremity Arthritis, muscle spasms, neck pain, night cramps Renal and urinary disorders Glycosuria, proteinuria Polyuria, haematuria, nocturia Reproductiv e system and Menopausal symptoms Priapism, prostatitis Galactorrho ea System Organ Class Very common Commo n Uncommon Rare Not known breast disorders General disorders and administrati on site conditions Asthenia, chest pain Fatigue, pain, thrist Investigatio ns Liver function test abnormal, weight increased 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. Therefore Melatonin prolonged-release tablets should be used with caution if the effects of drowsiness are likely to be associated with a risk to safety. No clinical data exist concerning the use of melatonin in individuals with autoimmune diseases.

Therefore, Melatonin prolonged-release tablets is not recommended for use in patients with autoimmune diseases. Excipients This medicinal product contains lactose. Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicine.

This medicine contains less than 1 mmol sodium (23 mg) per dosage unit, that is to say essentially ‘sodium-free’”.

1.