Pregnancy: There are limited data on the use of fluticasone propionate and formoterol fumarate, either administered alone or together but administered from separate inhalers, or on the use of this fixed-dose combination, Flutiform inhaler in pregnant women. Studies in animals have shown reproductive toxicity (see Pharmacology: Toxicology: Preclinical safety data under Actions).
Administration of Flutiform inhaler is not recommended during pregnancy, and should only be considered if expected benefit to the mother is greater than any possible risk to the fetus. If this is the case, then the lowest effective dose needed to maintain adequate asthma control should be used.
Because of the potential for β agonist interference with uterine contractility, use of Flutiform inhaler for management of asthma during labour should be restricted to those patients in whom the benefit outweighs the risks.
Lactation: It is not known whether fluticasone propionate or formoterol fumarate is excreted in human breast milk. A risk to the suckling child cannot be excluded. Therefore, a decision must be made whether to discontinue breastfeeding or to discontinue/abstain from Flutiform inhaler therapy taking into account the benefit of breastfeeding for the child and the benefit of therapy for the woman.
Fertility: There are no data available on effects on fertility following administration of Flutiform inhaler. In animal studies, no effects on fertility have been seen following administration of the individual active substances at clinically relevant doses (see Pharmacology: Toxicology: Preclinical safety data under Actions).