URALYT-U Granules Ref.[115338] Active ingredients: Citric acid Potassium citrate Sodium citrate

• Simultaneous administration of citrate and aluminium containing antacids in patients with compromised renal function can result in absorption of dangerously high amounts of aluminium.
• Before taking the first dose the serum electrolytes should be determined and renal function should be monitored.
• Furthermore, the acid base status should be checked when renal tubular acidosis (RTA) is suspected.
• Patients with congestive cardiac failure should not use this product.
• Administer with care in cases of adrenal insufficiency.
• The average daily dose of Uralyt-U (10 g granules) contains approximately 1,7 g of potassium.
• Before starting therapy all circumstances/malconditions that may be in favour of urinary stones should be excluded. The same is true if there exists a specific therapy (adenoma of parathyroid glands, malignoma with generation of uric acid stones etc.).
• When dissolving uric acid stones, urine pH values of 7,0 and over must be avoided to prevent the formation of a phosphate layer over the existing stone.
• Patients with urinary tract infections should continue antibacterial therapy during treatment with Uralyt-U (also see section 4.5).
• This medicine contains the colouring agent yellow orange S (E110) which may induce allergic reactions including asthma in a sensitive person. Allergy is more often seen in people reacting to 2-acetoxybenzoic acid (acetylsalicylic acid).

• Quinolones: Uralyt-U may reduce the solubility of ciprofloxacin, norfloxacin and ofloxacin in the urine. Patients should be monitored for signs of crystalluria and nephrotoxicity.
• Salicylates: The efficacy of salicylates, when given concurrently with Uralyt-U, may be decreased due to the alkalisation of the urine and increased urinary excretion.
• Urinary antiseptics: The efficacy of urinary antiseptics which require an acid urine, such as methenamine mandelate and methenamine Hippurate, may be lowered when used concurrently with Uralyt-U.
• Antacids: Systemic alkalosis may occur when antacids are used concurrently with Uralyt-U (see section 4.4).
• Any increase in extracellular potassium concentration will weaken the effect of cardiac glycosides, while any decrease will potentiate the arrhythmogenic effect of cardiac glycosides.
• Aldosterone antagonists, potassium-saving diuretics, ACE inhibitors, angiotensin receptor antagonists, nonsteroidal anti-inflammatory medicines and peripheral analgesics diminish renal potassium excretion.
• Medicines containing citrate given at the same time as medicines containing aluminium can cause an increase in aluminium absorption. If such medicines must be taken, an interval of at least 2 hours must be allowed between taking each kind of medicine.

To be used with caution.

Uralyt-U has no or negligible influence on the ability to drive and use machines.

a. Summary of the safety profile

• Gastro-intestinal complaints may occur.
• Yellow orange S (E110) which may cause allergic reactions.

b. Tabulated list of adverse reactions

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicine is important. It allows continued monitoring of the benefit/risk balance of the medicine. Healthcare providers are asked to report any suspected adverse reactions to SAHPRA via the “6.04 Adverse Drug Reactions Reporting Form”, found online under SAHPRA’s publications: https://www.sahpra.org.za/Publications/Index/8

Not applicable.