Natrixam

Natrixam Adverse Reactions

Manufacturer:

Servier

Distributor:

Zuellig Pharma
The information highlighted (if any) are the most recent updates for this brand.
Full Prescribing Info
Adverse Reactions
Summary of the safety profile: The most commonly reported adverse reactions with indapamide and amlodipine given separately are hypokalaemia, somnolence, dizziness, headache, visual impairment, diplopia, palpitations, flushing, dyspnoea, abdominal pain, nausea, dyspepsia, change of bowel habit, diarrhoea, constipation, rash maculo-papular, ankle swelling, muscle spasms, oedema, fatigue and asthenia.
Tabulated list of adverse reactions: The following adverse reactions have been observed and reported during treatment with indapamide and amlodipine with the following frequencies: 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.)

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Description of selected adverse reactions: During phase II and III studies comparing indapamide 1.5mg and 2.5mg, plasma potassium analysis showed a dose-dependent effect of indapamide: Indapamide 1.5mg: 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.
Indapamide 2.5 mg: Plasma potassium <3.4 mmol/l was seen in 25 % of patients and < 3.2 mmol/l in 10 % of patients after 4 to 6 weeks treatment. After 12 weeks treatment, the mean fall in plasma potassium was 0.41 mmol/l.
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