The listed adverse drug reactions are based on spontaneous reports, thus an organisation according to CIOMS III categories of frequency is not possible.
Immune System Disorders:
Hypersensitivity reactions have very rarely been reported. Clinical symptoms may include rash, urticaria, pruritus, angioedema, difficulty in breathing and anaphylaxis.
Metabolism and Nutrition Disorders:
Especially in patients with impaired renal function, prolonged use of high doses can result in hypermagnesaemia or hypercalcaemia and alkalosis which may give rise to gastric symptoms and muscular weakness (see below).
Gastrointestinal Disorders:
Nausea, vomiting, stomach discomfort, constipation and diarrhoea may occur.
Musculoskeletal and Connective Tissue
Disorders: Muscular weakness may occur.
Undesirable effects occurring in the context of milk-alkali syndrome (see section 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.