Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2017 Publisher: Kyowa Kirin Limited, Galabank Business Park, Galashiels, TD1 1QH, United Kingdom
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.
None known.
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 Opilon tablets should be withdrawn promptly if hepatic dysfunction develops.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 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.
None known.
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