CYCLIZINE HYDROCHLORIDE

Posology To prevent motion sickness cyclizine hydrochloride should be taken about one to two hours before departure. Elderly • There have been no specific studies of cyclizine hydrochloride in the elderly. • Experience has indicated that normal adult dosage is appropriate.

Paediatric population Children less than 6 years of age:

Cyclizine hydrochloride tablets are not recommended for children less than 6 years of age. Children 6 to 12 years of age: 25 mg orally, which may be repeated up to three times a day. Children over 12 years of age: 50 mg orally, which may be repeated up to three times a day.

Adults 50 mg orally, which may be repeated up to three times a day. Method of administration For oral administration

Adverse reactions are ranked under heading of frequency, the most frequent first, using the following convention: 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 estimated from the available data.

The following undesirable effects have been reported with a frequency of Not known. System Organ Class Frequency Adverse reactions Blood and lymphatic system disorders Not known Agranulocytosis, leucopenia, haemolytic anaemia, thrombocytopenia.

Cardiac disorders Not known Tachycardia palpitations, arrhythmias Ear and labyrinth disorders Not known Tinnitus. Eye disorders Not known Blurred vision, oculogyric crisis Gastrointestinal system disorders Not known Dryness of the mouth, nose and throat, constipation, increased gastric reflux, nausea, vomiting, diarrhoea, stomach pain, loss of appetite.

General disorders and administration site conditions Not known Asthenia Hepatobiliary disorders Not known Hepatic dysfunction, hypersensitivity hepatitis, cholestatic jaundice and cholestatic hepatitis have occurred in association with cyclizine.

Immune system disorders Not known Hypersensitivity reactions, including anaphylaxis have occurred. Musculoskeletal and connective tissue disorders Not known Twitching, muscle spasms Nervous system disorders Not known Effects on the central nervous system have been reported with cyclizine.

These include somnolence, drowsiness, incoordination, headache, dystonia, dyskinesia, extrapyramidal motor disturbances, restless leg syndrome, tremor, convulsions, dizziness, decreased consciousness, transient speech disorders, paraesthesia, and generalised chorea.

Psychiatric disorders Not known Disorientation, restlessness, nervousness, euphoria, insomnia and auditory and visual hallucinations have been reported, particularly when dosage recommendations have been exceeded. Renal and urinary disorders Not known Urinary retention Respiratory, thoracic and mediastinal disorders Not known Bronchospasm, apnoea Skin and subcutaneous tissue disorders Not known Urticaria, drug rash, angioedema, allergic skin reactions, fixed drug eruption, photosensitivity Vascular disorders Not known Hypertension, hypotension Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.

As with other anticholinergic agents, cyclizine 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 tablet contains lactose monohydrate. 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.