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The following additions, all frequency not known, have been made to Section 4.8 Undesirable effects (highlighted in red) below:
Syncope; Torsade de pointes (potentially fatal); Hepatitis; Electrocardiogram QT prolonged; Elevated liver enzyme levels
The subsection previously entitled Laboratory Parameters has been reorganised into Investigations and Metabolism and Nutrition Disorders
4.8 Undesirable effects
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 (>1/10000, <1/1000), very rare (<1/10000), not known (cannot be estimated from the available data).
Blood and the 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: Torsade de pointes (potentially fatal) (see sections 4.4 and 4.5)
Gastrointestinal disorders:
Uncommon: vomiting
Rare: nausea, constipation, dry mouth
Very rare: pancreatitis
Renal and urinary disorders:
Very rare: renal failure
Hepato-biliary disorders:
Very rare: abnormal hepatic function
Not known:
- Possibility of onset of hepatic encephalopathy in case of hepatic insufficiency (see sections 4.3 and 4.4)
- 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, Steven Johnson syndrome
Not known: possible worsening of pre-existing acute disseminated lupus erythematosus.
Cases of photosensitivity reactions have been reported (see section 4.4).
Investigations
Not known:
- Electrocardiogram QT prolonged (see sections 4.4 and 4.5)
- 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 to 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 section 4.4).
- 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
10. Date of revision of the text
08/2011
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