Land: Storbritannia
Språk: engelsk
Kilde: MHRA (Medicines & Healthcare Products Regulatory Agency)
Potassium citrate; Citric acid monohydrate
Alliance Healthcare (Distribution) Ltd
A12BA02
Potassium citrate; Citric acid monohydrate
300mg/1ml ; 50mg/1ml
Oral solution
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 07040300
_Data Matrix:_ _ _ 21518812 VERIFIED PCP HEADER BOX APPROVED BY DATE OPERATOR ARTWORK NO CRN FIX REASON F SUF OR CHANGE ISSUED BY DATE MHRA/IMB SUBMISSION REQUIRED Yes A gill.kennedy 573079 12041 Replace "chloroform" with "sodium benzoate". MHRA HEADER BOX PRODUCT TITLE C FONTS USED OLOURS USED COMPONENT PACK SIZE IG CODE DIMENSIONS PROOF NO. DATE Landscape peelable label 200ml 21518812 65mm x 170mm 2 14.05.2015 Process Cyan Process Magenta Process Yellow Process Black Keyline (non-printing) Braille Text free area (non-printing) Potassium Citrate Mixture Braille BQ Helvetica Helvetica Neue LT Optima _POTASSIUM_ _CITRATE MIXTURE_ RELIEVES SYMPTOMS OF CYSTITIS & OTHER MINOR URINARY TRACT INFECTIONS P 200ML PEEL HERE IMPORTANT: PEEL THIS LABEL AT CORNER AND READ BEFORE USE. DO NOT TEAR OFF, RE-FIX FOR FUTURE USE. For symptomatic relief of cystitis and other mild urinary tract infections. Take the solution by mouth. SHAKE THE BOTTLE. ADULTS, THE ELDERLY AND CHILDREN OVER 6 YEARS: Take 2 x 5ml spoonfuls, well diluted with water, three times a day after meals. CHILDREN 1-6 YEARS: Take 1 x 5ml spoonful as above. DO NOT GIVE TO CHILDREN UNDER 1 YEAR OLD unless your doctor tells you to. If symptoms persist consult your doctor. PEEL WHERE SHOWN FOR FURTHER PRECAUTIONS. ACTIVE INGREDIENT PER 5ML: potassium citrate 1.5g. ALSO CONTAINS amongst other ingredients: ethanol and sucrose. Sucrose 1.1g per 5ml. PEEL WHERE SHOWN FOR FULL LIST OF INGREDIENTS. Do not store above 25°C. Once opened use within 2 months. KEEP OUT OF THE SIGHT AND REACH OF CHILDREN. Manufactured by the licence holder L.C.M. Ltd., Huddersfield, HD7 5QH, UK for Thornton and Ross Ltd., Huddersfield, HD7 5QH, UK. PL 12965/0031 PIP: 102-2029 21518812 This medicine contains potassium citrate which makes the urine less acidic, and so reduces irritation when urinating. 1. BEFORE YOU USE THIS MEDICINE DO NOT USE THE MEDICINE IF YOU OR YOUR CHILD HAVE…. • An ALLERGY to any of the ingredients listed in section 3. • KIDNEY PROBLEMS. • HEART PROBLEMS including Les hele dokumentet
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Potassium Citrate Mixture 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Potassium Citrate 1.5g/5ml. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Solution 4. CLINICAL PARTICULARS 4.1. THERAPEUTIC INDICATIONS For the symptomatic relief of dysuria associated with mild urinary tract infections, especially cystitis. Indications stated on label: For the relief of the symptoms of cystitis and other mild urinary tract infections. 4.2. POSOLOGY AND METHOD OF ADMINISTRATION Oral: Recommended Doses Unless directed otherwise by a doctor: Adults including the elderly, and children over 6 years: 10ml. Children 1 - 6 years: 5ml. It should be taken well diluted with water, after meals. Shake the bottle before use. Dosage Schedule The dose may be taken three times a day. 4.3. CONTRA-INDICATIONS Contraindicated in hyperkalaemia, renal dysfunction, ventricular arrhythmics and Addison’s Disease. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE Potassium Citrate Mixture provides symptomatic relief only and is not anti-bacterial. Effective anti-bacterial therapy should be co-prescribed. It should be used with caution when renal or cardiac dysfunction is present. Labels to state: if symptoms persist consult your doctor. Discard any unused mixture 2 months after opening. Use with caution in the elderly 4.5 INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF INTERACTION Concurrent administration of potassium-containing drugs, potassium sparing diuretics or other drugs that increase potassium levels (e.g. ACE inhibitors, ciclosporin,_ _aliskiren) may lead to hyperkalaemia. May interact with cardiac glycosides. Citrates alkalinise the urine and thus may alter the urinary excretion of a number of drugs. This may lead to increased renal clearance of acidic drugs, such as salicylates, tetracylines and barbiturates, and prolongation of the half-life of basic drugs, such as sympathomimetics and stimulants. Particularly noteworthy is the diminishe Les hele dokumentet