Antihistamines (anti-emetics).

Cyclizine

Cyclizine hydrochloride BP 50.0 mg per tablet.

Tablet

Valoid is indicated for the prevention and treatment of nausea and vomiting including motion sickness, nausea and vomiting caused by narcotic analgesics and by general anaesthetics in the post-operative period and radiotherapy, especially for breast cancer since cyclizine does not elevate prolactin levels. Valoid may be of value in relieving vomiting and attacks of vertigo associated with Meniere's disease and other forms of vestibular disturbance.

One tablet up to three times daily.

Children 6 – 12 Years:

Half a tablet up to three times daily.

Under 6 Years:

Formulation not applicable.

There have been no specific studies of Valoid in the elderly. Experience has indicated that normal adult dosage is appropriate.

Valoid should not be given to individuals with known hypersensitivity to cyclizine.

As with other anticholinergic agents, Valoid should be used with caution and appropriate monitoring in patients with glaucoma, obstructive disease of the gastrointestinal tract, hepatic disease, epilepsy and in males with possible prostatic hypertrophy.

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

There have been reports of abuse of cyclizine, either oral or intravenous, for its euphoric or hallucinatory effects. The concomitant misuse of cyclizine with large amounts of alcohol is particularly dangerous, since the antiemetic effect of cyclizine may increase the toxicity of alcohol.

A dose reduction may be necessary in patients with renal impairment.

Cyclizine should be avoided in porphyria.

Cyclizine was not mutagenic in a full Ames test, including use of S9-microsomes.

No long-term studies have been conducted in animals to determine whether cyclizine has a potential for carcinogenesis.

Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.

Valoid may have additive effects with alcohol and other central nervous system depressants e.g. hypnotics, tranquillisers. Valoid enhances the soporific effect of pethidine. Because of its anticholinergic activity cyclizine may enhance the side-effects of other anticholinergic drugs.

Urticaria, drug rash, drowsiness, headache, dryness of the mouth, nose and throat, blurred vision, tachycardia, urinary retention, constipation, restlessness, nervousness, insomnia and auditory and visual hallucinations have been reported, particularly when dosage recommendations have been exceeded.

Other Central Nervous System effects which have been recorded rarely include dystonia, dyskinesia, extrapyramidal motor disturbances, tremor, twitching, muscle spasms, convulsions, disorientation, dizziness, decreased consciousness, transient speech disorders, hypertension and paraesthesia. Cholestatic jaundice has occurred in association with cyclizine. Rare reports of Cholestatic hepatitis and hypersensitivity reactions, including anaphylaxis, angioedema, allergic skin reactions and bronchospasm, have been reported in association with cyclizine. There have also been a few reports of fixed drug eruption, apnoea, generalised chorea, hypersensitivity hepatitis, hepatic dysfunction and agranulocytosis.

Amdipharm

(POM)

27 March 2009