CYSTITIS RELIEF TABLETS - summary of medicine characteristics

1 NAME OF THE MEDICINAL PRODUCT

Cystitis Relief Tablets

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

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.