Contraindications
Concomitant use with fluvoxamine or alcohol.
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Special Precautions
Patient with autoimmune disease, epilepsy. Cigarette smokers. Not recommended in patients with hepatic impairment. Renal impairment. Elderly. Pregnancy and lactation. Patient Counselling This drug may cause CNS depression (e.g. drowsiness), if affected, do not drive or operate machinery.
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Adverse Reactions
Significant: CNS depression, exacerbation of autoimmune disease; may increase seizure frequency.
Gastrointestinal disorders: Abdominal pain, constipation, diarrhoea, nausea, vomiting.
General disorders and administration site conditions: Asthenia.
Infections and infestations: Influenza.
Musculoskeletal and connective tissue disorders: Arthralgia, back or neck pain, muscle cramp, pain in extremity.
Nervous system disorders: Headache, somnolence, dizziness, migraine.
Psychiatric disorders: Nervousness, anxiety, restlessness.
Respiratory, thoracic and mediastinal disorders: Respiratory tract infection, nasopharyngitis, pharyngitis, pharyngolaryngeal pain, cough, rhinitis.
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Drug Interactions
Increased plasma concentrations with CYP1A2 inhibitors (e.g. ciprofloxacin, norfloxacin, verapamil, contraceptives or hormone replacement therapy), 5- or 8-methoxypsoralen (5- or 8-MOP), cimetidine, and caffeine. Decreased plasma concentrations with CYP1A2 inducers (e.g. carbamazepine, phenytoin, rifampicin, omeprazole). May reduce the hypotensive effect of Ca channel antagonists (e.g. nifedipine). May enhance the sedative effects of benzodiazepines and non-benzodiazepine hypnotics (e.g. zolpidem, zopiclone, zaleplon). Concomitant use with vitamin K antagonists (e.g. warfarin) may lead to increased or decreased prothrombin levels.
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CIMS Class
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ATC Classification
N05CH01 - melatonin ; Belongs to the class of melatonin receptor agonists. Used as hypnotics and sedatives.
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