Cystocalm 4g Granules For Oral Solution
1.
NAME OF THE MEDICINAL PRODUCT
Cystitis Relief
Care Cystitis Relief 4g granules for oral solution
Cystocalm 4g granules for oral solution
Cymalon 4g Granules for Oral Solution
CanesOasis Cystitis Relief 4g granules for oral solution
Sainsbury’s Healthcare Cystitis Relief 4g Granules for Oral Solution
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Sodium Citrate Dihydrate BP 4.0g
3 PHARMACEUTICAL FORM
Granules to be reconstituted for oral administration.
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
For the relief of the symptoms of cystitis in women.
4.2 Posology and method of administration
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 Special Precautions for Use
If symptoms persist after the two day course of treatment is completed, medical attention should be sought. Do not exceed the stated dose. Keep out of the sight and reach of children.
4.5. Interactions with other Medicinal Products and other forms of Interaction
Sodium containing preparations should be avoided by patients on lithium because sodium is preferentially absorbed by the kidney resulting in increased lithium excretion and reduced plasma levels.
Urinary alkalinisers should not be used with hexamine because it is only effective in acid urine.
The effects of a number of drugs may be reduced or increased by the alkalinisination of the urine and reduction in gastric pH brought about by the active ingredients in the product.
4.6 Pregnancy and lactation
Contraindicated during pregnancy and lactation.
4.7 Effects on ability to drive and use machines
None stated.
4.8. Undesirable Effects
Mild diuresis.
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.
4.9. Overdose Symptoms, Emergency Procedures, Antidotes
In the unlikely event of overdosage occurring with this product, treatment should be symptomatic.
Excessive administration of sodium citrate may cause gastrointestinal discomfort and diarrhoea. Excessive doses of sodium salts may lead to sodium overloading and hyperosmolality. Excessive administration of bicarbonate may lead to hypokalaemia and metabolic alkalosis, especially in patients with impaired renal function. Treatment is symptomatic and consists of appropriate correction of fluid and electrolyte balance.
5 PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
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 BP (1.5g)
Colloidal Silicon Dioxide BP Saccharin Sodium BP Cranberry Flavouring
6.2 Incompatibilities
None stated.
6.3 Shelf life
The granules have a three year shelf life.
The reconstituted solution should be used immediately.
6.4 Special precautions for storage
Store below 25°C, in dry place.
6.5 Nature and contents of container
Foil laminate sachets
or
paper (outer surface layer) /polyethylene (outer layer) /aluminium foil (outer layer) /ionomer resin (inner layer) sachets
Each sachet contains 5.575 g of granule enclosed in a cardboard outer.
6.6 Special precautions for disposal
None stated.
7 MARKETING AUTHORISATION HOLDER
Wrafton Laboratories Ltd
Wrafton
Braunton
North Devon
EX33 2DL
United Kingdom
8 MARKETING AUTHORISATION NUMBER(S)
PL 12063/0045
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
29/11/1996 / 04/12/2003
10
DATE OF REVISION OF THE TEXT
16/11/2015