Active Substance: aclidinium bromide, micronised
Common Name: aclidinium bromide
ATC Code: R03BB
Marketing Authorisation Holder: AstraZeneca AB
Active Substance: aclidinium bromide, micronised
Authorisation Date: 2012-07-20
Therapeutic Area: Pulmonary Disease, Chronic Obstructive
Pharmacotherapeutic Group: Drugs for obstructive airway diseases
Bretaris Genuair is indicated as a maintenance bronchodilator treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease (COPD).
What is Bretaris Genuair and what is it used for?
Bretaris Genuair is a medicine that is used to relieve the symptoms of chronic obstructive pulmonary disease (COPD) in adults. COPD is a long-term disease in which the airways and air sacs inside the lungs become damaged or blocked, leading to difficulty breathing. Bretaris Genuair is used for maintenance (regular) treatment.
Bretaris Genuair contains the active substance aclidinium bromide.
How is Bretaris Genuair used?
Bretaris Genuair is available as an inhalation powder in a portable inhaler device. Each inhalation provides 375 micrograms of aclidinium bromide equivalent to 322 micrograms of aclidinium.
The recommended dose of Bretaris Genuair is one inhalation twice a day. For detailed information on using the inhaler correctly, see the instructions in the package leaflet.
Bretaris Genuair can only be obtained with a prescription.
How does Bretaris Genuair work?
The active substance in Bretaris Genuair, aclidinium bromide, is an antimuscarinic bronchodilator. This means that it widens the airways by blocking muscarinic receptors. Muscarinic receptors control the contraction of muscles and when aclidinium bromide is inhaled, it relaxes the muscles of the airways. This helps to keep the airways open and allows the patient to breathe more easily.
What benefits of Bretaris Genuair have been shown in studies?
A main study involving 828 patients with COPD found that Bretaris Genuair was more effective than placebo (a dummy treatment) at improving how well the lungs work. The study compared two doses of Bretaris Genuair (200 and 400 micrograms) inhaled twice a day with placebo. The main measure of effectiveness was how Bretaris Genuair improved patients’ forced expiratory volumes (FEV1, the maximum volume of air a person can breathe out in one second). On average, after six months of treatment, the FEV1 in patients who used 200 and 400 micrograms Bretaris Genuair increased compared with placebo by 99 ml and 128 ml respectively. The dose of 400 micrograms Bretaris Genuair corresponds to an inhalation providing 322 micrograms of aclidinium.
What are the risks associated with Bretaris Genuair?
The most common side effects with Bretaris Genuair (which may affect more than 5 patients in 100) are headache and nasopharyngitis (inflammation of the nose and throat). Other common side effects (which may affect more than 1 patient in 100) are sinusitis (inflammation of the sinuses), cough, nausea (feeling sick) and diarrhoea. For the full list of all side effects and restrictions with Bretaris Genuair, see the package leaflet.
Why is Bretaris Genuair approved?
The CHMP noted that Bretaris Genuair was shown to be effective at improving the symptoms of COPD, and its beneficial effects are maintained for up to a year. The CHMP also noted that there were no major safety concerns with Bretaris Genuair, with side effects being reversible and similar to other antimuscarinic bronchodilator medicines. Therefore, the CHMP decided that Bretaris Genuair’s benefits are greater than its risks and recommended that it be given marketing authorisation.
What measures are being taken to ensure the safe use of Bretaris Genuair?
As antimuscarinic bronchodilator medicines may have an effect on the heart and blood vessels, the company will closely monitor the medicine’s cardiovascular effects and will carry out a further study in patients to identify any potential risks.
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Bretaris Genuair have also been included in the summary of product characteristics and the package leaflet.
Other information about Bretaris Genuair
The European Commission granted a marketing authorisation valid throughout the European Union for Bretaris Genuair on 20 July 2012.
For more information about treatment with Bretaris Genuair, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Source: European Medicines Agency
Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.