Summary of Product Characteristics (SmPC) - Urogon Cystitis Relief 4 g granules for oral solution
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