Not reported in available sources.

Efficacy outcomes were not reported separately by sex in the available information; no sex-specific differences in efficacy were described.

Recommended dose is one inhalation of aclidinium-formoterol fumarate dihydrate 340/12 micrograms twice daily via an inhalation device (morning and evening); no sex-based differences in dosing are specified.

No sex-specific dose adjustments are recommended; the same dose is used regardless of sex, and no adjustments are required for elderly patients or for renal or hepatic impairment.

Adverse reactions include mainly nasopharyngitis, headache and other respiratory, gastrointestinal, musculoskeletal, cardiac and hypersensitivity events, with no sex-specific differences in adverse reaction profile described.

In clinical trials and post‑marketing experience, 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, myalgia, muscle spasms, increased blood creatine phosphokinase and combination of sore throat and runny nose (nasopharyngitis). Uncommon reactions included hypokalaemia, hyperglycaemia, agitation, dysgeusia, blurred vision, dysphonia, throat irritation, stomatitis, rash, pruritus, urinary retention and increased blood pressure. Cardiac events such as cardiac arrhythmias (including atrial fibrillation and paroxysmal tachycardia), tachycardia, QTc prolongation, palpitations and angina pectoris were reported as uncommon. Rare and more serious reactions included bronchospasm (including paradoxical bronchospasm) and hypersensitivity reactions, with angioedema and anaphylactic reaction reported with frequency not known. These serious hypersensitivity and bronchospasm events could necessitate discontinuation and urgent medical management.

There are no data in pregnant women; animal data for the components showed reproductive toxicity only at exposures much higher than human, so use in pregnancy or breastfeeding should be limited to situations where expected benefit outweighs potential risk, and an effect on human fertility at therapeutic doses is considered unlikely.

Non-clinical reproductive toxicity studies for the components showed foetotoxicity and slight reductions in fertility parameters, as well as reduced fertility, decreased early postnatal survival, lower birth weight and a small increase in uterine leiomyomas in rodents at exposures far above human therapeutic levels; these findings are considered of limited relevance to clinical use.