Land: Irland
Sprache: Englisch
Quelle: HPRA (Health Products Regulatory Authority)
PHENYLPROPANOLAMINE HYDROCHLORIDE PARACETAMOL
Novartis Consumer Health UK Limited
PHENYLPROPANOLAMINE HYDROCHLORIDE PARACETAMOL
25/500 Milligram
Tablets
Withdrawn
2006-11-22
PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Mu-Cron Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION For excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film coated tablet White capsule-shaped tablet, imprinted ‘Mu-Cron’ on one side with a scoreline on the other side. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS As an analgesic/antipyretic agent where a decongestant effect is also required. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Adults: One tablet up to four times daily with a minimum interval of 4 hours between doses. The maximum daily dose of four tablets should not be exceeded. Children under 12 years: Not recommended. Route of administration: Oral. 4.3 CONTRAINDICATIONS Use in patients hypersensitive to the active ingredient. Use in patients with severe heart disease_, _including acute ischaemic heart disease, hypertension, hyperthyroidism, diabetes, glaucoma, urinary retention, high fever. Use in patients who are currently receiving, or have within two weeks received, monoamine oxidase inhibitors or tricyclic antidepressants. Use concurrently with other sympathomimetic agents. ACTIVE SUBSTANCE Paracetamol 500 mg Phenypropanolamine hydrochloride 25 mg IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 30/09/2006_ _CRN 2028449_ _page number: 1_ 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE Patients are advised to consult their doctor before taking Mu-Cron tablets if they are under the care of their doctor, receiving continual prescribed medication, pregnant or if their symptoms persist. This product should be used with great care in patients suffering from angina. Patients with prostatic hypertrophy may have increased difficulty with micturition. This product may ac Lesen Sie das vollständige Dokument