Selective a1 -blockers (alpha- blockers / alpha-adrenoceptor blocking drugs).

Thymoxamine [moxisylyte]

Each tablet contains moxisylyte hydrochloride 45.22mg (equivalent to moxisylyte base 40mg).

A pale yellow film-coated tablet

Moxisylyte is an alpha-adrenergic blocking agent. Opilon tablets are indicated in the short term control of the symptoms of primary Raynaud's phenomenon.

Oral administration.

Adults:

Initially one tablet to be taken four times a day. This may be increased to two tablets four times a day if initial response is poor. For patients exposed to the cold during the daytime, one tablet should be administered every three hours during the period when symptoms are most likely to occur. In the

Not recommended.

As for adults.

No clinical or pharmacokinetic data specific to this age group are available. Whilst at normal dosage no problems have been reported, caution nevertheless is advised when Opilon tablets are prescribed in the elderly.

Opilon tablets are contraindicated in those with a hypersensitivity to any of the ingredients or who have active liver disease.

The alpha-adrenergic blocking action of Opilon tablets will produce a vasodilating effect which may theoretically potentiate the effect of a number of drugs used in the management of hypertension. In practice, with the recommended dosage of Opilon tablets, this has not been reported.

Opilon tablets should be used with caution in diabetes as, theoretically, insulin requirements may be reduced. Tricyclic antidepressants may increase any hypotensive effect produced by alpha blockade.

TCADs, antihypertensives

Occasionally, mild nausea, diarrhoea, vertigo, headache, facial flushing and rash may be encountered. These are, however, rare and transient.

There have also been rare reports of hepatotoxicity, including cases of hepatitis and cholestatic jaundice, which are reversible on stopping treatment. Opilon tablets should be withdrawn promptly if hepatic dysfunction develops.

Concord Pharmaceuticals Ltd

(POM)

18 May 2009