Aclidinium Other names: Aclidinium bromide

Consistent with its anticholinergic activity, aclidinium bromide should be used with caution in patients with symptomatic prostatic hyperplasia or bladder-neck obstruction or with narrow-angle glaucoma (even though direct contact of the product with the eyes is very unlikely).

Aclidinium bromide should be used with caution in patients who had a myocardial infarction during the previous 6 months, unstable angina, newly diagnosed arrhythmia within the previous 3 months, or hospitalisation within the previous 12 months for heart failure functional classes III and IV as per the “New York Heart Association”. Experience in patients with cardiovascular comorbidities in clinical trials is limited. These conditions may be affected by the anticholinergic mechanism of action.

There are no data available on the use of aclidinium bromide in pregnant women.

Studies in animals have shown fetotoxicity only at dose levels much higher than the maximum human exposure to aclidinium bromide. Aclidinium bromide should only be used during pregnancy if the expected benefits outweigh the potential risks.

It is unknown whether aclidinium bromide/metabolites are excreted in human milk. Animal studies have shown excretion of small amounts of aclidinium bromide and/or metabolites into milk. A risk to newborns/infants cannot be excluded. A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from aclidinium bromide therapy taking into account the benefit of breastfeeding for the child and the benefit of therapy for the woman.

Fertility

Studies in rats have shown slight reductions in fertility only at dose levels much higher than the maximum human exposure to aclidinium bromide. It is considered unlikely that aclidinium bromide administered at the recommended dose will affect fertility in humans.

Aclidinium bromide may have minor influence on the ability to drive and use machines. The occurrence of headache, dizziness or blurred vision following administration of aclidinium bromide may influence the ability to drive or to use machinery.

Summary of the safety profile

The most frequently reported adverse reactions with aclidinium bromide were headache (6.6%) and nasopharyngitis (5.5%).

Tabulated summary of adverse reactions

The frequencies assigned to the undesirable effects listed below are based on crude incidence rates of adverse reactions (i.e. events attributed to aclidinium bromide) observed with aclidinium bromide 322 µg (636 patients) in the pooled analysis of one 6-month and two 3-month randomised, placebo-controlled clinical trials.

A placebo-controlled trial in 1791 patients with moderate to very severe COPD treated with aclidinium bromide up to 36 months did not identify other adverse reactions.

The frequency of adverse reactions is defined using the following convention: 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) and not known (cannot be estimated from the available data). System organ class Preferred term Frequency.