Land: Irland
Sprog: engelsk
Kilde: HPRA (Health Products Regulatory Authority)
DIHYDROCODEINE BITARTRATE
Napp Pharmaceuticals Limited
90 Milligram
Tablets
1995-04-19
PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT DHC Continus Prolonged-release Tablets 90 mg 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Dihydrocodeine Tartrate 90 mg For excipients, see 6.1 3 PHARMACEUTICAL FORM Prolonged release tablets. White to off-white, capsule-shaped, biconvex tablet with ‘DHC 90’ 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. 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. 4.4 SPECIAL WARNINGS AND SPECIAL PRECAUTIONS FOR USE Prolonged use of high dosage may induce dependence with a withdrawal syndrome on discontinuation. Repeated use may result in the development of tolerance. DHC CONTINUS tablets should be used with great caution in patients with a history of asthma. Opioid analgesics should be avoided in patients with raised intracranial pressure or head IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Issued 01/09/2005_ _CRN 2014432_ _page number: 1_ injury. Reduced dosage or increased intervals between doses may be required in patients with hypothyroidism and in those with renal or hepatic dysfun Læs hele dokumentet