- moxisylyte hydrochloride
POM: Prescription only medicine
This information is intended for use by health professionals
Opilon 40mg tablets
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.
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 event that a response is not evident within 2 weeks, the drug should be discontinued.
Elderly (over 65 years):
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 not indicated for use in children.
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.
See section 4.4 (Special Warnings and Precautions for Use).
The safety of Opilon tablets for use during pregnancy and lactation has not been established. Opilon tablets should not, therefore, be used by women who are pregnant or breast-feeding.
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 Opilon tablets should be withdrawn promptly if hepatic dysfunction develops.
Reporting of suspected adverse reactionsReporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.
In excessive overdosage a fall in blood pressure is the main symptom. The patient should be nursed in the supine position until the blood pressure has been restored to normal.
Moxisylyte is an alpha-adrenergic blocking agent which is used for the treatment of the symptoms of Raynaud's phenomenon.
Moxisylyte is rapidly absorbed after oral administration. In plasma, the drug is rapidly converted to desacetylmoxisylyte (metabolite I) and desmethyldesacetylmoxisylyte (metabolite II) which are pharmacologically active. Other circulatory species are the sulphate and glucuronide conjugates of metabolites I and II. Excretion is almost exclusively via the kidneys. The half life of total radioactivity, after radiolabelled moxisylyte was administered to man, was 1 to 2 hours.
There are no pre-clinical safety data of relevance to the prescriber which are additional to those already included in other sections of the Summary of Product Characteristics.
Colloidal silicon dioxide
The film coating contains:
Opaspray M-1-22900 (E464, E171, E104, E124 and E132)
Store at a temperature not exceeding 30°C.
Blister pack comprising white PVC and aluminium foil backing containing 112 tablets.
Kyowa Kirin Limited
Galabank Business Park
1 May 1999
® Opilon is a registered trade mark
Galabank Business Park, Galashiels, TD1 1QH
+ 44 (0)1896 664 000