Страна: Ирландия
Язык: английский
Источник: HPRA (Health Products Regulatory Authority)
MOXISYLYTE HYDROCHLORIDE
Archimedes Pharma UK Limited
MOXISYLYTE HYDROCHLORIDE
40 Milligram
Tablets
Withdrawn
2007-06-21
PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Opilon 40mg Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains moxisylyte hydrochloride 45.22 mg (equivalent to moxisylyte base 40 mg). For excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablet. A round pale yellow film-coated tablet. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Moxisylyte is an alpha-adrenergic blocking agent indicated for use in the treatment of peripheral vascular disorders and in the vasospastic conditions such as Raynaud’s Phenomenon, and other such conditions where a peripheral vasodilator is required. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Oral administration. Adults: One tablet to be swallowed four times a day. For those conditions affected by climatic environment, one tablet should be administered every three hours during the 12-hour 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. However, at normal dosage no problems have been reported. Children: Opilon tablets are not indicated for use in children. 4.3 CONTRAINDICATIONS Opilon should not be given to patients who have suffered a recent cardiac infarction or are in the acute phase of a cerebrovascular accident or who have active liver disease. Hypersensitivity to any of the ingredients. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE The alpha-adrenergic blocking action of Opilon may potentiate the effect of a number of drugs used in the management IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Pr Прочитать полный документ