Opilon 40 Mg Tablets
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Opilon 40mg Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains Moxisylyte hydrochloride BP 45.22mg (equivalent to moxisylyte base 40 mg).
3 PHARMACEUTICAL FORM
A pale yellow film-coated tablet
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
Moxisylyte is an alpha-adrenergic blocking agent. Opilon is indicated in the short term control of the symptoms of primary Raynaud's phenomenon.
4.2 Posology and method of administration
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 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 is available. Whilst at normal dosage no problems have been reported, caution nevertheless is advised when Opilon is prescribed in the elderly.
Children
Opilon tablets are not indicated for use in children.
4.3 Contraindications
Opilon Tablets are contraindicated in those with a hypersensitivity to any of the ingredients, or who have active liver disease.
4.4 Special warnings and precautions for use
The alpha-adrenergic blocking action of Opilon 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, this has not been reported.
Opilon 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.
4.5 Interaction with other medicinal products and other forms of interaction
See section 4.4 (Special warnings and special precautions for use)
4.6 Pregnancy and lactation
The safety of Opilon for use during pregnancy and lactation has not been established. It should not, therefore, be used by women who are pregnant or breast feeding.
4.7 Effects on ability to drive and use machines
None known.
4.8 Undesirable Effects
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 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. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.
4.9 Overdose
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.
5 PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
Moxisylyte is an alpha-adrenergic blocking agent which is used for the treatment of the symptoms of Raynaud's phenomenon.
5.2 Pharmacokinetic properties
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 1-2 hours.
5.3 Preclinical safety data
Preclinical safety data does not add anything of further significance to the prescriber.
6.1 List of excipients
Lactose
Colloidal silicon dioxide Microcrystalline cellulose Magnesium stearate Maize starch
The film coating contains:
Methylhydroxypropylcellulose Propylene glycol
Opaspray M-1-22900 Yellow (E464, E171, E104, E124 and E132) Water
6.2 Incompatibilities
None known.
6.3 Shelf life
36 months
6.4 Special precautions for storage
Store at a temperature not exceeding 30°C.
6.5 Nature and contents of container
Blister pack comprising white PVC and aluminium foil backing containing 112 or 120 tablets.
White, high density, polyethylene bottle with low density polyethylene tamper evident wadless ‘J' cap containing 50, 250 or 500 tablets.
6.6 Special precautions for disposal
Not applicable
7 MARKETING AUTHORISATION HOLDER
Archimedes Pharma UK Limited
Galabank Business Park
Galashiels
TD11QH
United Kingdom
8 MARKETING AUTHORISATION NUMBER(S)
PL 12406/0017
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
22/01/1990 / 27/08/2003
10 DATE OF REVISION OF THE TEXT
18/05/2015