What is Oslif Breezhaler?
Oslif Breezhaler is a medicine that contains the active substance indacaterol. It is available as capsules containing a powder for inhalation (150 and 300 micrograms).
What is Oslif Breezhaler used for?
Oslif Breezhaler is used to keep the airways open in adults with chronic obstructive pulmonary disease (COPD). COPD is a long-term disease in which the airways and alveoli inside the lungs are damaged or blocked, resulting in breathing difficulties.
The medicine can only be obtained with a prescription.
How is Oslif Breezhaler used?
Oslif Breezhaler capsules should only be used with the Oslif Breezhaler inhaler and should not be swallowed. To take a dose, the patient must insert a capsule into the inhaler by inhaling the powder through the mouth.
The recommended dose is one 150 microgram capsule once a day, at the same time each day. In the case of severe COPD the 300 micrograms dose can be used, but only on instruction of the doctor.
How does Oslif Breezhaler work?
The active substance in Oslif Breezhaler, indacaterol, is an beta-2 adrenergic receptor agonist.
It works by adhering to beta-2 receptors located in the muscle cells of numerous organs and causing muscle relaxation. When Oslif Breezhaler is inhaled, indacaterol reaches the receptors in the airways by activating them. This causes the muscles of the airways to relax, helping to keep the airway open and allowing the patient to breathe more easily.
What studies have been carried out on Oslif Breezhaler?
The effects of Oslif Breezhaler were tested in experimental models before being studied in
human beings.
In three main studies involving over 4, 000 patients with COPD, Oslif Breezhaler, in different doses, was compared with placebo (a dummy treatment), tiotropium or formoterol (other inhaled medicines used for the treatment of COPD). The main measure of effectiveness was how Oslif Breezhaler improved, compared to placebo, the forced expiratory volumes of patients (FEV1) after 12 weeks.
FEV1 is the maximum amount of air a person can breathe out in a second.
What benefit has Oslif Breezhaler shown during the studies?
Oslif Breezhaler was more effective than placebo in improving lung activity in COPD patients. On average, the improvement in FEV1 in patients who received Oslif Breezhaler was 150-190 ml, while in patients who took placebo, FEV1 changed between - 10 ml and + 20 ml. In general, the effects of the 150 and 300 microgram doses of Oslif Breezhaler were similar, although the results showed that the 300 microgram dose can bring greater relief to patients whose disease is more severe.
What are the risks associated with Oslif Breezhaler?
In most cases the side effects associated with Oslif Breezhaler (seen in 1-10 patients in 100) are nasopharyngitis (inflammation of the nose and throat), upper respiratory tract infections (colds), sinusitis (inflammation of the paranasal sinuses), diabetes mellitus and hyperglycemia (high blood sugar levels), headache, ischemic heart disease (heart disease caused by insufficient blood supply), cough, laryngopharyngeal pain (throat), rhinorrhea (runny nose), respiratory tract congestion (obstruction of the tract aerial), muscle spasm (cramps) and peripheral edema (swelling, especially of the ankles and feet). For the full list of all side effects reported with Oslif Breezhaler, see the Package Leaflet. Oslif Breezhaler should not be used in people who may be hypersensitive (allergic) to indacaterol, lactose or any of the other ingredients.
Why has Oslif Breezhaler been approved?
The Committee for Medicinal Products for Human Use (CHMP) decided that Oslif Breezhaler's benefits are greater than its risks and recommended that Oslif Breezhaler be given marketing authorization.
More information on Oslif Breezhaler
On November 30, 2009, the European Commission granted a marketing authorization valid for the entire EU to Oslif Breezhaler to Novartis Europharm Limited.
The marketing authorization is valid for five years, after which it can be renewed.
The full EPAR for Oslif Breezhaler can be found here.
Last update of this summary: 10-2009.
