Summary of the safety profile: The most commonly reported adverse reactions during treatment are gastrointestinal disturbances and injection site reactions. Other important adverse reactions include hypokalaemia and/or hypernatraemia.
Tabulated list of adverse reactions: Undesirable effects are listed by body system and frequency in accordance with the following classification: 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. (See Table 6.)
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Description of selected adverse reactions: Hypokalaemia may result in diffuse symptoms such as weakness, tiredness or oedema and/or muscle twitching. Severe forms may cause hyporeflexia and cardiac arrhythmia. Hypernatraemia may be associated with hypertension and signs of fluid overload such as oedema (see Precautions).
Paediatric population: Limited safety information is available from the paediatric population. Frequency, type and severity of adverse reactions may be expected to be similar to the adult population.