CYCLIZINE HYDROCHLORIDE

Method of administration:

Oral Adults and children over 12 years of age: 50mg orally, which may be repeated up to three times a day Children 6- 12 years of age: 25mg orally, which may be repeated up to three times a day Children less than 6 years of age: Cyclizine Hydrochloride are not recommended for use in children under 6 years of age.

Elderly There have been no specific studies with Cyclizine Hydrochloride in the elderly. Experience has indicated that the normal adult dose is appropriate. For the prevention of motion sickness, Cyclizine Hydrochloride should be taken one to two hours before departure.

The following side effects have been reported with cyclizine hydrochloride:

Blood and lymphatic system disorders Agranulocytosis, leucopenia, haemolytic anaemia, thrombocytopenia. Immune system disorders Hypersensitivity reactions, including anaphylaxis have occurred Psychiatric disorders Disorientation, restlessness, nervousness, euphoria, insomnia and auditory and visual hallucinations have been reported, particularly when dosage recommendations have been exceeded.

Nervous system disorders Effects on the central nervous system have been reported with cyclizine these include somnolence, drowsiness, incoordination, headache, dystonia, dyskinesia, extrapyramidal motor disturbances, tremor, convulsions, dizziness, decreased consciousness, transient speech disorders, paraesthesia, generalised chorea and Restless leg syndrome.

Ear and labyrinth disorders tinnitus Eye disorders Blurred vision, oculogyric crisis Cardiac disorders Tachycardia, palpitations, arrhythmias Vascular disorders Hypertension, hypotension Respiratory, thoracic and mediastinal disorders Bronchospasm, apnoea Gastrointestinal system disorders Dryness of the mouth, nose and throat, constipation increased gastric reflux Nausea, vomiting, diarrhea, stomach pain Loss of appetite Hepatobiliary disorders Hepatic dysfunction, hypersensitivity hepatitis, cholestatic jaundice and cholestatic hepatitis have occurred in association with cyclizine.

Skin and subcutaneous tissue disorders Urticaria, drug rash, angioedema, allergic skin reactions, fixed drug eruption, photosensitivity Musculoskeletal and connective tissue disorders Twitching, muscle spasms Renal and urinary disorders Urinary retention General disorders and administration site conditions Asthenia 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.

As with other anticholinergic agents, Cyclizine Hydrochloride may precipitate incipient glaucoma and it should be used with caution and appropriate monitoring in patients with glaucoma, urinary retention, obstructive disease of the gastrointestinal tract, hepatic disease, phaeochromocytoma, hypertension, epilepsy and in males with possible prostatic hypertrophy.

Cyclizine should be used with caution in patients with severe heart failure or acute myocardial infarction. In such patients, cyclizine may cause a fall in cardiac output associated with increases in heart rate, mean arterial pressure and pulmonary wedge pressure.

Cyclizine should be avoided in porphyria. There have been reports of abuse of cyclizine, either oral or intravenous, for its euphoric or hallucinatory effects. 5 ). Cyclizine Hydrochloride contains lactose Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.

1 Cyclizine is contraindicated in the presence of acute alcohol intoxication. The anti- emetic properties of cyclizine may increase the toxicity of alcohol.