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Cyclizine Tablets Leaflet.Pdf Cyclizine 50 mg tablets This information is a summary only. It does not contain all information about this medicine. If you would like more information about the medicine you are taking, check with your doctor or other health care provider. No rights can be derived from the information provided in this medicine leaflet. Therapeutic indications Effects on ability to drive and use machines Cyclizine tablets is indicated for the prevention and treatment of nausea and Studies designed to detect drowsiness did not reveal sedation in healthy adults vomiting including: who took a single oral therapeutic dose (50 mg) of cyclizine. Motion sickness. Patients should not drive or operate machinery until they have determined their Nausea and vomiting caused by narcotic analgesics and by general anaesthetics in the post own response. operative period. Although there are no data available, patients should be cautioned that Cyclizine Vomiting associated with radiotherapy, especially for breast cancer since tablets may have additive effects with alcohol and other central nervous system cyclizine does not elevate prolactin levels. depressants, e.g. hypnotics and tranquillisers. Cyclizine tablets may be of value in relieving vomiting and attacks of vertigo associated with Meniere's disease and other forms of vestibular Undesirable effects disturbance. Blood and lymphatic system disorders Agranulocytosis Posology and method of administration Cardiac disorders Adults and Children over 12 Years: Tachycardia 50 mg orally, which may be repeated up to three times a day. Eye disorders Children 6 – 12 Years: Blurred vision, oculogyric crisis 25 mg orally, which may be repeated up to three times a day. Gastrointestinal system disorders Dryness of the mouth, nose and throat, constipation Children less than 6 years of age: General disorders and administration site conditions Cyclizine tablets tablets are not recommended for children less than 6 years of Asthenia age. Hepatobiliary disorders Use in the Elderly: Hepatic dysfunction, hypersensitivity hepatitis, cholestatic jaundice and There have been no specific studies of Cyclizine tablets in the elderly. Experience cholestatic hepatitis have occurred in association with cyclizine. has indicated that normal adult dosage is appropriate. Immune system disorders Hypersensitivity reactions, including anaphylaxis have occurred To prevent motion sickness Cyclizine tablets should be taken about one to two Musculoskeletal and connective tissue disorders hours before departure. Twitching, muscle spasms Nervous system disorders Effects on the central nervous system have been reported with cyclizine Contraindications these include somnolence, headache, dystonia, dyskinesia, extrapyramidal Cyclizine tablets should not be given to individuals with known hypersensitivity to motor disturbances, tremor, convulsions, dizziness, decreased cyclizine. consciousness, transient speech disorders, paraesthesia and generalised chorea. Special warnings and precautions for use Psychiatric disorders As with other anticholinergic agents, Cyclizine tablets may precipitate incipient Disorientation, restlessness, nervousness, insomnia and auditory and visual glaucoma and it should be used with caution and appropriate monitoring in hallucinations have been reported, particularly when dosage patients with glaucoma, obstructive disease of the gastrointestinal tract, hepatic recommendations have been exceeded. Renal and urinary disorders disease, epilepsy and in males with possible prostatic hypertrophy. Urinary retention Respiratory, thoracic and mediastinal disorders Cyclizine should be used with caution in patients with severe heart failure. In such Bronchospasm, apnoea patients, cyclizine may cause a fall in cardiac output associated with increases in Skin and subcutaneous tissue disorders heart rate, mean arterial pressure and pulmonary wedge pressure. Urticaria, drug rash, angioedema, allergic skin reactions, fixed drug eruption Vascular disorders Cyclizine should be avoided in porphyria. Hypertension There have been reports of abuse of cyclizine, either oral or intravenous, for its Overdose euphoric or hallucinatory effects. The concomitant misuse of Cyclizine tablets Symptoms of acute toxicity from cyclizine arise from peripheral anticholinergic with large amounts of alcohol is particularly dangerous, since the antiemetic effects and effects on the central nervous system. Peripheral anticholinergic symptoms include dry mouth, nose and throat, blurred effect of cyclizine may increase the toxicity of alcohol. vision, tachycardia and urinary retention. Central nervous system effects include drowsiness, dizziness, incoordination, ataxia, weakness, hyperexcitability, Patients with rare hereditary problems of galactose intolerance, the Lapp lactase disorientation, impaired judgement, hallucinations, hyperkinesia, extrapyramidal deficiency or glucose-galactose malabsorption should not take this medicine. motor disturbances, convulsions, hyperpyrexia and respiratory depression.An oral Interaction with other medicinal products and other forms of interaction dose of 5 mg/kg is likely to be associated with at least one of the clinical Cyclizine tablets may have additive effects with alcohol and other central nervous symptoms stated above. Younger children are more susceptible to convulsions. system depressants e.g. hypnotics, tranquillisers, anaesthetics. The incidence of convulsions, in children less than 5 years, is about 60% when the Cyclizine tablets enhances the soporific effect of pethidine. oral dose ingested exceeds 40 mg/kg. Because of its anticholinergic activity cyclizine may enhance the side-effects of Treatment: other anticholinergic drugs. In the management of acute overdosage with Cyclizine tablets, gastric lavage and Pregnancy and lactation supportive measures for respiration and circulation should be performed if In the absence of any definitive human data, the use of Cyclizine tablets in necessary. Convulsions should be controlled in the usual way with parenteral pregnancy is not advised. anticonvulsant therapy. It is not known whether cyclizine or its metabolite are excreted in human milk. Special precautions for storage Store below 25°C. Lagaay International BV Van Helmontstraat 99 3029 AA Rotterdam, The Netherlands Tel: +31 - 10 4123871 .
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