Flomyst F

This Fluticasone Propionate + Formoterol Fumarate inhaler (a pressurised inhalation suspension) contains two active ingredients. Fluticasone propionate belongs to a group of medicines called steroids, and steroids help to reduce swelling and inflammation in the lungs. Formoterol fumarate dihydrate belongs to a group called long-acting beta 2 agonists. These are long-acting bronchodilators, so they help the airways in your lungs stay open and make it easier for you to breathe. Used together, the two ingredients help to improve your breathing. You should use this medicine every day, as directed by your doctor or asthma nurse. It helps to prevent breathing problems such as asthma, and it helps to stop you becoming breathless and wheezy. It does not work, however, if you are already having an asthma attack, that is, if you are already breathless and wheezing. In that case you will need a fast acting "reliever" medicine such as salbutamol.

Pregnancy: There are limited data on the use of Fluticasone Propionate and Formoterol Fumarate in pregnant women. This is true whether the two medicines are used alone, used together from separate inhalers, or used as this fixed-dose combination in a single inhaler. Studies in animals have shown reproductive toxicity. The inhaler is not recommended during pregnancy. It should only be considered if the expected benefit to the mother is greater than any possible risk to the fetus. If it is used, the lowest effective dose needed to maintain adequate asthma control should be given.

Breastfeeding: It is not known whether Fluticasone Propionate or Formoterol Fumarate passes into human breast milk. So a decision has to be made, either to stop breastfeeding or to stop or avoid the inhaler therapy. This should take into account the benefit of breastfeeding for the child and the benefit of therapy for the woman.

Fertility: There are no data on the effects of this inhaler on fertility. In animal studies, the individual active substances did not affect fertility at clinically relevant doses.

Special patient groups

Elderly patients don't need a change in dose.

Hepatic or renal impairment

There are no data on the use of this inhaler in patients with hepatic or renal impairment.

Paediatric population

Children who are on prolonged treatment with inhaled corticosteroids should have their height checked regularly. If growth slows, the treatment should be reviewed, and the aim is to bring the inhaled corticosteroid down to the lowest dose that still keeps asthma under effective control, if that is possible. The doctor should also consider referring the child to a paediatric respiratory specialist.

Only limited data are available on the use of this inhaler in children under 12 years of age. Until more data become available, it is not recommended for children under 12 years of age.

There are no clinical trial data on overdose with this Fluticasone Propionate + Formoterol Fumarate inhaler. Data on overdose with each of the two medicines on its own are given below.

Formoterol Fumarate: An overdose of Formoterol would likely exaggerate the effects that are typical of ß2 agonists. If that happens, the following adverse experiences may occur: angina, hypertension or hypotension, palpitations, tachycardia, arrhythmia, prolonged QTc interval, headache, tremor, nervousness, muscle cramps, dry mouth, insomnia, fatigue, malaise, seizures, metabolic acidosis, hypokalaemia, hyperglycaemia, nausea and vomiting.

Fluticasone Propionate: Acute overdose with Fluticasone Propionate usually doesn't cause a clinical problem. The only harmful effect after inhaling a large amount over a short period is suppression of hypothalamic pituitary adrenocortical (HPA) axis function. HPA axis function usually recovers in a few days, as verified by plasma cortisol measurements. The inhaled corticosteroid should be continued at the recommended dose to control asthma.

Keep this medicine in a cool, dry place and away from light.