Immune System Disorders:
Hypersensitivity reactions have very rarely been reported. Clinical symptoms may include rash, pruritus, urticaria, angioedema dyspnea and anaphylaxis.
Metabolism and nutrition disorders:
Prolonged use of high doses may possibly result in hypermagnesaemia or hypercalcaemia and alkalosis (GI symptoms such as nausea and vomiting, fatigue, confusion, polyuria, polydypsia, dehydration), particularly in patients with impaired renal function. Prolonged use of high doses of calcium carbonate with milk may lead to Burnett syndrome (milkalkali syndrome).
Gastrointestinal disorders:
Nausea, vomiting, stomach discomfort, constipation and diarrhoea may occur.
Musculoskeletal and Connective Tissue Disorders:
Muscular weakness may occur.
Undesirable effects only occurring in the context of milk-alkali syndrome (see 4.9):
Gastrointestinal Disorders:
Ageusia may occur in the context of milk-alkali syndrome.
General Disorders and Administration Site Conditions:
Calcinosis and asthenia may occur in the context of milk-alkali syndrome.
Nervous System Disorders:
Headache may occur in the context of milk-alkali syndrome.
Renal and Urinary Disorders:
Azotemia may occur in the context of milk-alkali syndrome.
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 or search for MHRA Yellow Card in the Google Play or Apple App Store.