Summary of Product Characteristics (SmPC) - Cystitis Relief tablets
1 NAME OF THE MEDICINAL PRODUCT
Cystitis Relief Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Active ingredients mg/tablet
Citric acid 1470
Sodium bicarbonate 1735
Anhydrous sodium carbonate 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
Adult women: Two tablets to be taken dissolved in water three times a day for 2 days.
Adult men: Not recommended.
Children: Not recommended.
For oral administration.
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 Relief 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
There are no preclinical data of relevance to the prescriber which are additional to that already included.
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Saccharin Sodium Ph Eur
Sorbitol Ph Eur
Flay 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
Not applicable.
7 MARKETING AUTHORISATION HOLDER
Max Remedies Limited
Stoney Gate House
2 Greenfield Road
Holmfirth
West Yorkshire
HD9 2JT
8 MARKETING AUTHORISATION NUMBER(S)
PL 31308/0024
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
17 December 1996
10 DATE OF REVISION OF THE TEXT
11/10/2011