Adverse reactions : תופעות לוואי

4.8 Undesirable effects
Immune system disorders:
Very rarely, hypersensitivity reactions have been reported. The clinical symptoms were rash, urticaria, pruritus, angioedema, dyspnoea and anaphylaxis.

Metabolism and nutrition disorders:
Prolonged use of high doses may possibly lead to hypermagnesaemia or hypercalcaemia (may be accompanied by gastrointestinal symptoms and muscle weakness (see below), fatigue, confusion, polyuria, polydipsia and dehydration) and alkalosis, particularly in patients with renal dysfunction.

Gastrointestinal disorders:
Nausea, vomiting, stomach problems, constipation, and diarrhoea can occur.

Musculoskeletal and connective tissue disorders:
Muscle weakness can occur.
4.8.1 Undesirable effects only occurring with milk-alkali syndrome (see 4.9):

Gastrointestinal disorders:
Ageusia can occur with milk-alkali syndrome.

General disorders and administration site conditions:
Calcinosis and asthenia can occur with milk-alkali syndrome.
Nervous system disorders:
Headache can occur with milk-alkali syndrome.

Renal and urinary disorders:
Azotaemia can occur with milk-alkali syndrome.

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. Any suspected adverse events should be reported to the Ministry of Health according to the National Regulation by using an online form https://sideeffects.health.gov.il