Not reported in available sources.

The clinical development programme in COPD (including ~4,000 patients, 1,222 on aclidinium bromide-formoterol 340/12 micrograms) demonstrated that the medication improved lung function, breathlessness, daily symptoms, health-related quality of life, reduced exacerbation rates and delayed time to first exacerbation, and improved lung volumes, exercise endurance and physical activity compared with placebo and monocomponents. No sex-specific differences in efficacy were reported.

The same recommended dose applies to women as to men: one inhalation of aclidinium bromide-formoterol twice daily, with no sex-specific dose adjustments. Dose adjustments are not required in elderly patients or in patients with renal or hepatic impairment.

No dose adjustments are recommended based on sex. Dose adjustments are not required for elderly patients or those with renal or hepatic impairment.

No sex-specific differences in adverse reactions were identified in the available sources.

In clinical trials and post‑marketing experience, adverse reactions with Duaklir Genuair were similar to those of its individual components. The most frequently reported adverse reactions were nasopharyngitis (7.9%) and headache (6.8%), both classified as common. Other common adverse reactions included urinary tract infection, sinusitis, tooth abscess, insomnia, anxiety, dizziness, tremor, cough, diarrhoea, nausea, dry mouth, stomatitis, muscle spasms, myalgia, increased blood creatine phosphokinase and increased blood pressure. Clinically important but less frequent reactions included hypokalaemia and hyperglycaemia (uncommon), cardiac arrhythmias including atrial fibrillation and paroxysmal tachycardia, tachycardia, QTc prolongation, palpitations and angina pectoris (uncommon), bronchospasm including paradoxical bronchospasm (rare), hypersensitivity reactions including angioedema and anaphylactic reaction (rare/not known), blurred vision, dysphonia, urinary retention, rash and pruritus. The document does not specify particular reasons for treatment discontinuation.

There are no data on use of aclidinium bromide-formoterol in pregnant women and it should only be used during pregnancy if the expected benefits outweigh the potential risks. It is unknown whether aclidinium or formoterol are excreted in human milk; animal studies showed small amounts in rat milk, so use in breast-feeding women should only be considered if the expected benefit to the woman outweighs any possible risk to the infant.

Nonclinical reproductive toxicity studies showed slight reductions in fertility and foetotoxic effects at exposures far above human levels for both aclidinium and formoterol. These included decreased conception rate, fewer corpora lutea and increased pre‑ and post‑implantation losses with aclidinium, and reduced fertility, decreased early postnatal survival and reduced birth weight with high systemic exposure to formoterol. These findings are considered of little relevance at therapeutic doses.