Natrilix SR Adverse Reactions

The majority of adverse reactions concerning clinical or laboratory parameters are dose-dependent. Thiazide-related diuretics, including indapamide, may cause the following undesirable effects ranked under the following frequency: Very common (≥1/10); common (≥1/100, <1/10); uncommon (≥1/1000, <1/100); rare (≥1/10,000); very rare (<1/10,000), not known (cannot be estimated from the available data).
Blood and Lymphatic System Disorders: Very rare: Thrombocytopenia, leucopenia, agranulocytosis, aplastic anaemia, haemolytic anaemia.
Nervous System Disorders: Rare: Vertigo, fatigue, headache, paresthesia. Not known: Syncope.
Cardiac Disorders: Very rare: Arrhythmia, hypotension. Not known: Torsades de pointes (potentially fatal) (see Precautions and Interactions).
Gastrointestinal Disorders: Uncommon: Vomiting. Rare: Nausea, constipation, dry mouth. Very rare: Pancreatitis.
Renal and Urinary Disorders: Very rare: Renal failure.
Hepatobiliary Disorders: Very rare: Abnormal hepatic function. Not known: Possibility of onset of hepatic encephalopathy in case of hepatic insufficiency (see Contraindications and Precautions), hepatitis.
Skin and Subcutaneous Tissue Disorders: Hypersensitivity reactions, mainly dermatological, in subjects with a predisposition to allergic and asthmatic reactions: Common: Maculopapular rashes. Uncommon: Purpura. Very rare: Angioneurotic oedema and/or urticaria, toxic epidermic necrolysis, Stevens-Johnson syndrome. Not known: Possible worsening of pre-existing acute disseminated lupus erythematosus. Cases of photosensitivity reactions have been reported (see Precautions).
Investigations: Not known: Electrocardiogram QT prolonged (see Precautions and Interactions); blood glucose increased and blood uric acid increased during treatment: Appropriateness of these diuretics must be very carefully weighed in patients with gout or diabetes; elevated liver enzyme levels.
Metabolism and Nutrition Disorder: During clinical trials, hypokalaemia (plasma potassium <3.4 mmol/L) was seen in 10% of patients and <3.2 mmol/L in 4% of patients after 4-6 weeks treatment. After 12 weeks treatment, the mean fall in plasma potassium was 0.23 mmol/L. Very rare : Hypercalcaemia. Not known: Potassium depletion with hypokalaemia, particularly serious in certain high risk populations (see Precautions). Hyponatraemia with hypovolaemia responsible for dehydration and orthostatic hypotension. Concomitant loss of chloride ions may lead to secondary compensatory metabolic alkalosis: The incidence and degree of this effect are slight.