Reasons for adding or updating:

• Change to section 4.4 - Special warnings and precautions for use
• Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
• Change to section 4.8 - Undesirable effects
• Change to section 4.9 - Overdose

Date of revision of text on the SPC: 16-Nov-2015

Legal Category:GSL

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



      Section 4.4 (warnings and precautions for use) -  addition of the following warning: “Do not exceed the state dose. Keep out of the sight and reach of children”.

Section 4.5 (interactions) – addition of the following 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.

Section 4.8 (undesirable effects) – inclusion of “mild diuresis” as an undesirable effect and addition of the mandatory MHRA adverse event reporting statement (yellow card scheme).

Section 4.9 (Overdose) – addition of the following information: “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.”

Reasons for adding or updating:

• Change to section 1 - Name of the medicinal product
• Change to section 4.8 - Undesirable effects - how to report a side effect

Date of revision of text on the SPC: 02-Feb-2015

Legal Category:GSL

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



-       Section 1  - removal of Canesten Oasis brand name (+change to Sainsbury’s brand name)

-       Section 4.8  - addition of ‘Yellow card reporting’ wording

Reasons for adding or updating:

• Change to section 1 - Name of the medicinal product

Date of revision of text on the SPC: 17-Apr-2014

Legal Category:GSL

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

Section 1: Addition of 'CanesOasis Cystitis Relief 4g granules for oral solution' as a name.

Reasons for adding or updating:

• Change to section 6. 3 - Shelf Life

Date of revision of text on the SPC: 26-Oct-2009

Legal Category:GSL

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

Shelf Life; extended from 3 to 3 years

Reasons for adding or updating:

• Transferred from eMC version 1

Reasons for adding or updating:

• No reasons supplied