ALU-CAP Capsules Ref.[6151] Active ingredients: Aluminium hydroxide

Phosphate depletion

Aluminium salts may cause phosphate depletion, which is generally negligible. On prolonged treatment with large doses hypophosphataemia may occur, especially in patients with restricted phosphate intake. This syndrome is characterised by anorexia, malaise and muscle weakness. If left unchecked this condition may give rise to osteomalacia, osteoporosis and urinary calculi. Serum phosphate levels should be monitored regularly (bi-monthly) in patients on maintenance haemodialysis who are receiving chronic aluminium hydroxide therapy.

Renal failure

In patients with chronic renal failure, hyperaluminaemia may occur. Aluminium accumulates in the bone, lungs and nerve tissue. Aluminium accumulation in the CNS may be the cause of dialysis dementia which sometimes occurs in chronic renal failure patients receiving long term aluminium therapy for hyperphosphataemia.

Effect on drug absorption

Aluminium hydroxide reduces absorption of tetracyclines and vitamins and may delay the absorption of quinidine (see interactions). Aluminium hydroxide and such drugs should be administered 2 hours apart.

Reported to interfere with absorption of some drugs including tetracyclines. Penicillin, sulphonamides, iron, digoxin, indometacin, naproxen, phenylbutazone and vitamins, Aluminium hydroxide and such drugs should be administered 2 hours apart.

There are no adequate data from the use of Aluminium hydroxide in pregnant women. Animal studies are insufficient with respects to effects on pregnancy, embryonal and foetal development, parturition and postnatal development (see section 5.3). The potential risk for humans is unknown.

Alu-Cap capsules should not be used during pregnancy unless clearly necessary.

None.

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.

Aluminium hydroxide is astringent and may cause constipation.

None known.