Sunday, 3 June 2012

Cystitis Relief Tablets





1. Name Of The Medicinal Product



Cystitis Relief Tablets


2. Qualitative And Quantitative Composition












Active ingredient




mg/tablet




Citric Acid Ph Eur




1470.0




Sodium Bicarbonate Ph Eur




1735.0




Anhydrous Sodium Carbonate Ph Eur




137.5



3. Pharmaceutical Form



Effervescent tablet



4. Clinical Particulars



4.1 Therapeutic Indications



For the relief of the symptoms of cystitis in women only.



4.2 Posology And Method Of Administration



For oral administration.



Adult Women: Two tablets to be taken dissolved in water three times a day for 2 days.



Adult Men: Not recommended.



Children: Not recommended.



4.3 Contraindications



Hypertension, cardiovascular disease, renal disease, pregnancy, diabetes and patients on a low sodium diet.



4.4 Special Warnings And Precautions For Use



Medical advice should be sought if symptoms persist after the 2 day course of treatment.



4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction



No clinically significant interactions known.



4.6 Pregnancy And Lactation



Cystitis tablets should not be taken during pregnancy.



4.7 Effects On Ability To Drive And Use Machines



No adverse effects known.



4.8 Undesirable Effects



In view of the short duration of treatment, side effects are unlikely.



4.9 Overdose



In the event of overdosage, symptoms of fluid and electrolyte disturbance may occur. Treatment need only be symptomatic.



5. Pharmacological Properties



5.1 Pharmacodynamic Properties



Sodium citrate, produced from the reaction between citric acid and sodium bicarbonate, is an alkalinising agent which consequently renders the urine less acidic.



5.2 Pharmacokinetic Properties



Sodium citrate is readily absorbed from the gastrointestinal tract and metabolised in the liver to sodium bicarbonate. Less than 5% of the drug is excreted in the urine unchanged.



5.3 Preclinical Safety Data



Not applicable



6. Pharmaceutical Particulars



6.1 List Of Excipients



Saccharin Sodium Ph Eur



Sorbitol Ph Eur



Flav F Pineapple 501085 Firme HSE



Purified Water Ph Eur



Total sodium per tablet is 535mg



6.2 Incompatibilities



None known



6.3 Shelf Life



24 months



6.4 Special Precautions For Storage



Not applicable



6.5 Nature And Contents Of Container



Cold form strip pack containing a nylon/aluminium/polythene laminate and aluminium/polythene laminate.



Pack size: 12



6.6 Special Precautions For Disposal And Other Handling



Not applicable.



7. Marketing Authorisation Holder



The Boots Company PLC



1 Thane Road West



Nottingham NG2 3AA



8. Marketing Authorisation Number(S)



PL 0014/0559



9. Date Of First Authorisation/Renewal Of The Authorisation



17 December 1996



10. Date Of Revision Of The Text



November 1996




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