Enurev Breezhaler

Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Enurev Breezhaler have been included in the summary of product characteristics and the package leaflet.

As for all medicines, data on the use of Enurev Breezhaler are continuously monitored. Side effects reported with Enurev Breezhaler are carefully evaluated and any necessary action taken to protect patients.

A Enurev Breezhaler : EPAR - Risk-management-plan summary is available.

Enurev Breezhaler capsules, which contain a powder for inhalation, are only used with the Enurev Breezhaler inhaler and must not be swallowed. To take a dose, the patient places a capsule into the inhaler and breathes in through the mouth the powder from the capsule.

The recommended dose is one capsule once a day at the same time each day. Patients should not use more than one capsule in a day.

Enurev Breezhaler can only be obtained with a prescription.

For more information about using Enurev Breezhaler, see the package leaflet or contact your doctor or pharmacist.

The active substance in Enurev Breezhaler, glycopyrronium bromide, is a muscarinic receptor antagonist. This means that it widens the airways by blocking muscarinic receptors (targets) in muscle cells in the lungs. Muscarinic receptors control the contraction of muscles and when glycopyrronium 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.

Enurev Breezhaler was found to be more effective than placebo (a dummy treatment) at relieving symptoms of COPD in two main studies involving a total of 1,888 patients with COPD. In both studies, the main measure of effectiveness was improvement in patients’ forced expiratory volumes (FEV1, the maximum volume of air a person can breathe out in one second).

After 12 weeks of treatment, Enurev Breezhaler increased FEV1 by 97 ml more than with placebo in the first study, and by 108 ml more in the second study.

The most common side effects with Enurev Breezhaler (seen in more than 1 patient in 100) are dry mouth, nasopharyngitis (inflammation of the nose and throat), insomnia (difficulty sleeping), muscle and bone pain and gastroenteritis (diarrhoea and vomiting). For the full list of side effects and restrictions with Enurev Breezhaler, see the package leaflet.

The European Medicines Agency noted that Enurev Breezhaler had a modest but relevant benefit for patients in terms of improving lung function, and also improved the symptoms of COPD. The Agency also noted that the fact that the medicine is used once a day may help patients to adhere to their treatment. In addition, there were no major safety concerns with Enurev Breezhaler, with side effects similar to other muscarinic receptor antagonist medicines. Therefore, the Agency decided that Enurev Breezhaler’s benefits are greater than its risks and it can be authorised for use in the EU.

Enurev Breezhaler received a marketing authorisation valid throughout the EU on 28 September 2012.