Treatment of Hypertension: In controlled clinical studies adverse reactions were mild and transient. The overall incidence of adverse events showed no association with dose or age. Withdrawals from treatment due to adverse events were similar with candesartan cilexetil (3.1%) and placebo (3.2%).
In a pooled analysis of clinical trial data of hypertensive patients, adverse reactions with candesartan cilexetil were defined based on an incidence of adverse events with candesartan cilexetil at least 1% higher than the incidence seen with placebo. By this definition, the most commonly reported adverse reactions were dizziness/vertigo, headache and respiratory infection.
The table as follows presents adverse reactions from clinical trials and post-marketing experience.
The frequencies used in the tables throughout this section are: 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). (See Table 1.)
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Laboratory findings: In general, there were no clinically important influences of candesartan cilexetil on routine laboratory variables. As for other inhibitors of the renin-angiotensin-aldosterone system, small decreases in haemoglobin have been seen. No routine monitoring of laboratory variables is usually necessary for patients receiving Candesartan Cilexetil. However, in patients with renal impairment, periodic monitoring of serum potassium and creatinine levels is recommended.
Paediatric population: The safety of candesartan cilexetil was monitored in 255 hypertensive children and adolescents, aged 6 to <18 years old, during a 4 week clinical efficacy study and a 1 year open label study. In nearly all different system organ classes, the frequency of adverse events in children are within common/uncommon range. Whilst the nature and severity of the adverse events are similar to those in adults (see Table 1), the frequency of all adverse events are higher in children and adolescents, particularly in: Headache, dizziness and upper respiratory tract infection, are "very common" (ie, ≥1/10) in children and common (≥1/100 to <1/10) in adults.
Cough is "very common" (ie, >1/10) in children and very rare ( <1/10,000) in adults.
Rash is "common" (ie, ≥1/100 to <1/10) in children and "very rare" (<1/10,000) in adults.
Hyperkalaemia, hyponatraemia and abnormal liver function are uncommon (≥1/1,000 to < 1/100) in children and very rare (< 1/10,000) in adults.
Sinus arrhythmia, nasopharyngitis, pyrexia are "common" (ie, ≥1/100 to <1/10) and oropharyngeal pain is "very common" (ie, ≥1/10) in children; but none are reported in adults. However these are temporary and widespread childhood illnesses.
The overall safety profile for candesartan cilexetil in paediatric patients does not differ significantly from the safety profile in adults.
Treatment of Heart Failure: The adverse experience profile of candesartan cilexetil in heart failure patients was consistent with the pharmacology of the medicinal product and the health status of the patients. In the CHARM clinical programme, comparing candesartan cilexetil in doses up to 32 mg (n=3,803) to placebo (n=3,796), 21.0% of the candesartan cilexetil group and 16.1 % of the placebo group discontinued treatment because of adverse events. The most commonly reported adverse reactions were hyperkalaemia, 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.
The table as follows presents adverse reactions from clinical trials and post-marketing experience. (See Table 2.)
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Laboratory findings: Hyperkalaemia and renal impairment are common in patients treated with Candesartan Cilexetil for the indication of heart failure. Periodic monitoring of serum creatinine and potassium is recommended (see Precautions).