SUMMARY OF PRODUCT CHARACTERISTICS

1    NAME OF THE MEDICINAL PRODUCT

Urogon Cystitis Relief 4g granules for oral solution

2    QUALITATIVE AND QUANTITATIVE COMPOSITION

Each sachet contains 4g sodium citrate Also contains sucrose as an excipient.

For full list of excipients, see section 6.1

3    PHARMACEUTICAL FORM

Granules for oral solution.

White granules

4    CLINICAL PARTICULARS

4.1    Therapeutic indications

For the relief of the symptoms of cystitis in women.

4.2    Posology and method of administration

For oral administration only.

Adult women: The contents of one sachet dissolved in a glass of water, to be taken three times a day for two days.

Men and children: Not recommended.

4.3    Contraindications

Patients with diabetes, heart disease, hypertension, history of renal disease or those on a low salt diet.

During pregnancy and lactation.

4.4    Special warnings and precautions    for use

If symptoms persist after the two day course of treatment is completed, medical attention should be sought.

Sodium content: 939mg per sachet. To be taken into consideration by patients on a controlled sodium diet.

Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.

4.5    Interaction with other medicinal products and other forms of interaction

None stated

4.6    Fertility, pregnancy and lactation

Contraindicated during pregnancy and lactation

4.7    Effects on ability to drive and use machines

None stated

4.8    Undesirable effects

None stated

4.9    Overdose

In the unlikely event of overdosage occurring with this product, treatment should be symptomatic.

5    PHARMACOLOGICAL PROPERTIES

5.1    Pharmacodynamic properties ATC Code: B05C B02

The effect of sodium citrate is to render the urine less acidic.

5.2    Pharmacokinetic properties

None relevant.

5.3    Preclinical safety data

None stated

6 PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Sucrose (1.5g) Colloidal Silica Saccharin Sodium Cranberry Flavouring

6.2 Incompatibilities

None stated

6.3 Shelf life

The granules have a two year shelf life.

The reconstituted solution should be used immediately.

6.4 Special precautions for storage

Do not store above 25°C. Store in the original package.

6.5 Nature and contents of container

Foil laminate sachets containing 5.575g of granule enclosed in a cardboard outer. The composition of the sachets is paper/PE/Aluminium foil/PE Each pack contains 6 sachets.

6.6 Special precautions for disposal

None stated.

7 MARKETING AUTHORISATION HOLDER

ASPAR PHARMACEUTICALS LIMITED

29-30 CAPITOL WAY

COLINDALE

LONDON

NW9 OEQ

UNITED KINGDOM

8    MARKETING AUTHORISATION NUMBER(S)

PL 08977/0020

9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

13/09/2011

10 DATE OF REVISION OF THE TEXT

13/09/2011