Country: Irlanda
Lingwa: Ingliż
Sors: HPRA (Health Products Regulatory Authority)
DIHYDROCODEINE BITARTRATE
Napp Pharmaceuticals Limited
60 Milligram
Tablets
1997-03-06
PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT DHC Continus Prolonged-release Tablets 60 mg 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Dihydrocodeine Tartrate 60mg For excipients, see 6.1. 3 PHARMACEUTICAL FORM Prolonged-release tablets. White capsule-shaped tablets with 'DHC 60' on one side. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS As an analgesic in the relief of moderate to severe pain. 4.2 POSOLOGY AND METHOD OF ADMINSTRATION _Adults only_ One tablet 12 hourly. _Elderly_ Reduced dosage or increased intervals between doses may be required. _Route of Administration_ Oral. 4.3 CONTRAINDICATIONS DHC CONTINUS tablets should not be used in patients hypersensitive to the active ingredient or any of the other constituents of the product or in patients with respiratory depression or obstructive airways disease, paralytic ileus, head injury, raised intracranial pressure or acute alcoholism. As dihydrocodeine may cause the release of histamine it should not be given during an attack of asthma. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine. DHC CONTINUS tablets should not be used in children under 12 years of age. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE DHC CONTINUS tablets should be used with great caution in patients with a history of asthma. Reduced dosage or increased intervals between doses may be required in patients with hypothyroidism and in those with renal or hepatic dysfunction. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 21/04/2006_ _CRN 2022387_ _page number: 1_ Dihydrocodeine should be administered with caution to patients with a history Aqra d-dokument sħiħ