Finil 16 Adverse Reactions

Treatment of Hypertension: The overall incidence of adverse events showed no association with dose or age. The most commonly reported adverse reactions were dizziness/vertigo, headache and respiratory infection. (See Table 1.)

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Laboratory findings: In general, there were no clinically important influences of Finil 16 on routine laboratory variables. As for other inhibitors of the renin-angiotensin-aldosterone system, small decreases in hemoglobin have been seen. No routine monitoring of laboratory variables is usually necessary for patients receiving Finil 16. However, in patients with renal impairment, periodic monitoring of serum potassium and creatinine levels is recommended.
Pediatric population: Whilst the nature and severity of the adverse events are similar to those in adults (see the Table 1 previously), the frequency of all adverse events are higher in children and adolescent, particularly in: Headache, dizziness and upper respiratory tract infection; Cough; Rash; Hyperkalemia, hyponatremia and abnormal liver function; Sinus arrhythmia, nasopharyngitis, pyrexia and oropharyngeal pain. However these are temporary and widespread childhood illnesses.
The overall safety profile of Candesartan cilexetil in pediatric patients does not differ significantly from the safety profile in adults.
Treatment of Heart Failure: The adverse experience profile of Finil 16 in adult heart failure patients was consistent with the pharmacology of the drug and the health status of the patients. The most commonly reported adverse reactions were hyperkalemia, hypotension and renal impairment. These events were more common in patients over 70 years of age, diabetics, or subjects who received other medicinal products which affect the renin-angiotensin-aldosterone system, in particular an ACE inhibitor and/or Spironolactone. (See Table 2.)

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Laboratory findings: Hyperkalemia and renal impairment are common in patients treated with Finil 16 for the indication of heart failure. Periodic monitoring of serum creatinine and potassium is recommended.