RENODYRA

Posology In patients with severe hypocitraturia (urinary citrate <150 mg/day), therapy should be initiated at a dosage of 6480 mg (60 mEq) per day (6 tablets) divided into 3 intakes per day. In patients with mild hypocitraturia (urinary citrate >150 mg/day), therapy should be initiated at a dosage of 3240 mg (30 mEq) per day (3 tablets) divided into 3 intakes per day.

If necessary, the dosage may be increased as long as the 10800 mg (100 mEq)/day limit is not exceeded. 3). 4). 3). 4). Paediatric population The safety and efficacy of Renodyra in children have not been established. No data are available.

Method of administration Renodyra is administered orally. The tablets should be taken with meals or within 30 minutes after meals to avoid gastrointestinal reactions. The tablets must be swallowed whole with enough liquid and should not be taken with alcohol, crushed, chewed or dissolved as this may result in the medicine being released too early.

The tablets should be taken in conjunction with a diet that avoids foods with high sodium content and avoids the use of table salts. Patients who take Renodyra modified-release tablets should increase their fluid intake. It is recommended that 24-hour urinary citrate and urinary pH measurement is used to determine the adequacy of the initial dosage and to evaluate the effectiveness of any dosage change.

0, the daily dose should be adjusted in accordance with the needs of the patient. This is preferably done with the evening dose.

The most common adverse reaction relates to the formulation and potassium products causing gastro-intestinal upset including nausea, vomiting, diarrhoea, abdominal pain and discomfort, and can potentially lead to gastro-intestinal ulceration, bleeding, perforation and/or obstruction.

Adverse reactions are listed according to MedDRA organ classes and frequency.

Frequencies are defined as:

Very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1 000 to <1/100), rare (≥1/10 000 to <1/1 000), very rare (<1/10 000), not known (cannot be estimated from the available data). System organ class/frequency MedDRA preferred term Gastrointestinal disorders Very common Abdominal pain, nausea Common Abdominal pain upper, diarrhoea, dyspepsia, dysphagia, oesophagitis, vomiting, gaseousness (bloating, belching, flatulence) Not known Gastrointestinal mucosal damage, gastrointestinal bleeding or obstruction Metabolism and nutrition disorders Not known Hyperkalaemia Skin Common Rash In patients with rapid gastrointestinal transit time, the tablet wax matrix may be present in their faeces.

Description of selected adverse reactions Ingestion of potassium citrate may induce hyperkalaemia. , heart block, ventricular arrhythmias, asystole). 4). 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 products. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

Hyperkalaemia and cardiotoxicity In patients with impaired mechanisms for excreting potassium, the administration of Renodyra may produce hyperkalaemia and cardiac arrest. Potentially fatal hyperkalaemia may develop rapidly and be asymptomatic.

5). Serum electrolytes (sodium, potassium, chloride and carbon dioxide), serum creatinine, and complete blood count should be monitored every four months. 2). 73m2 and plasma potassium levels in the normal ranges, regular monitoring of renal function parameters and blood potassium levels is recommended at starting dose, after new dose increase or in case of decreased GFR.

Then frequency should be according to the physician’s criteria, but at least twice a year. Excipients This medicinal product contains 390 mg potassium per tablet. To be taken into consideration by patients with reduced kidney function or patients on a controlled potassium diet.

73 m2) − Active or persistent urinary tract infections − Significant or complete obstruction of the urinary tract − Hyperkalaemia − Severe myocardial injury − Uncontrolled diabetes mellitus − Adrenal insufficiency − Metabolic or respiratory alkalosis − Active peptic ulcer − Delayed gastric emptying − Intestinal obstruction