NEPHROTRANS Gastro-resistant capsule Ref.[27924] Active ingredients: Sodium bicarbonate

The effect of Nephrotrans 500 mg should initially be monitored at intervals of at least one to two weeks (e.g. by pH measurement, standard bicarbonate, alkali reserve), especially at higher doses. Plasma electrolytes, especially sodium, potassium and calcium, should likewise be regularly monitored. These checks should also be performed regularly during long-term medication. Further dosing should be determined based on the outcome of these checks. Any possible hyperalkalinity can be corrected by a dose reduction.

Particular caution is required in the presence of hypoventilation, hypocalcaemia and hyperosmolar conditions.

This medicinal product contains 137 mg sodium per capsule, equivalent to approximately 7% of the WHO recommended maximum daily intake of 2 g sodium for an adult. The maximum daily dose of this product (10 capsules) is equivalent to 68% of the WHO recommended maximum daily intake for sodium. This should be particularly taken into account for those on a low salt diet.

Nephrotrans 500 mg contains 50 mg sorbitol in each capsule. Patients with rare hereditary problems of fructose intolerance (HFI) should not take this medicinal product.

Due to the increase in pH levels in the stomach and intestines, absorption and excretion of weak acids and bases may be affected. This applies, for example, to sympathomimetics, anticholinergics, tricyclic antidepressants, barbiturates, H2 antagonists, captopril and quinidine.

Functional interactions are possible with glucocorticoids and mineralocorticoids, androgens and potassium-depleting diuretics.

Vigilance is required for a possible effect on the solubility of medicines eliminated with the urine (e.g. ciprofloxacin).

Pregnancy and breast-feeding

There is no experience with the use of Nephrotrans 500 mg in pregnancy and breast-feeding. In principle, there are no objections to the use of sodium hydrogen carbonate in the appropriate indication. However, it should be borne in mind that orally administered sodium hydrogen carbonate is well absorbed and readily crosses the placental barrier. Existing blood pressure dysregulation, such as the physiological respiratory alkalosis associated with pregnancy, may also be increased due to the sodium load.

Fertility

No data are available on the effect of Nephrotrans 500 mg on fertility.

Nephrotrans 500 mg has no influence on the ability to drive and use machines.

The following frequencies are used for the evaluation of adverse reactions: 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).

Gastrointestinal disorders

Not known: flatulence and abdominal pain.

Renal and urinary disorders

Not known: promotion of calcium or magnesium phosphate nephrolithiasis in chronic use.

Musculoskeletal and connective tissue disorders

Not known: hypocalcaemic tetany (muscle hyperexcitability due to decreased calcium) if the dose is exceeded. In patients with pre-existing disorders of the gastrointestinal tract, e.g. diarrhoea, exacerbation of such disorders is possible.

Skin and subcutaneous tissue disorders

Very rare: allergic reactions due to soya oil.

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: United Kingdom, Yellow Card Scheme, Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

Not applicable.