Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
POTASSIUM CITRATE
G & A Licensing Limited
3 Grams
Granules for oral solution
2010-04-16
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Cystopurin 3g Granules for Oral Solution 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Contains Potassium Citrate 3g/sachet Excipients-Contains Aspartame (E951), sucrose and ethanol For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Granules for oral solution _Product imported from the UK:_ Pink-brown granules for dissolution in water. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS For the symptomatic relief of mild urinary tract infections (cystitis). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION For oral administration. _Adults (including the elderly and children over 6 years):_ One 3 g sachet, dissolved in 200 ml of cold water, three times daily for two days. All six sachets must be taken to complete the treatment. Not recommended for children under six years of age. 4.3 CONTRAINDICATIONS Use in patients with renal insufficiency. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE This product is intended for short term treatment. Patients should seek doctor's advice if symptoms persist after 48 hours treatment. This product should only be used with caution in patients with cardiac disease. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 26/10/2011_ _CRN 2107054_ _page number: 1_ 4.5 INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF INTERACTION Concurrent administration of potassium sparing diuretics or ACE inhibitors may lead to hyperkalaemia. The activity of cardiac glycosides is to some extent dependant upon serum potassium levels. Therefore, there is a possible interaction and caution is advised. 4.6 FERTILITY, PREGNANCY AND LACTATION There is no information available from animal studies and there is no epid Read the complete document