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Enurev Breezhaler (glycopyrronium bromide) - R03BB06

Updated on site: 06-Oct-2017

Medication nameEnurev Breezhaler
ATC CodeR03BB06
Substanceglycopyrronium bromide
ManufacturerNovartis Europharm Ltd

Enurev Breezhaler

glycopyrronium bromide

This is a summary of the European public assessment report (EPAR) for Enurev Breezhaler. It explains how the Agency assessed the medicine to recommend its authorisation in the EU and its conditions of use. It is not intended to provide practical advice on how to use Enurev Breezhaler.

For practical information about using Enurev Breezhaler, patients should read the package leaflet or contact their doctor or pharmacist.

What is Enurev Breezhaler and what is it used for?

Enurev Breezhaler 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. Enurev Breezhaler is used for maintenance (regular) treatment.

Enurev Breezhaler contains the active substance glycopyrronium bromide.

How is Enurev Breezhaler used?

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. For detailed information on how to use the inhaler correctly, see the instructions in the package leaflet.

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.

How does Enurev Breezhaler work?

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.

What benefits of Enurev Breezhaler have been shown in studies?

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.

What are the risks associated with Enurev Breezhaler?

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 all side effects and restrictions with Enurev Breezhaler, see the package leaflet.

Why is Enurev Breezhaler approved?

The 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 recommended that it be given marketing authorisation.

What measures are being taken to ensure the safe and effective use of Enurev Breezhaler?

As muscarinic receptor antagonist medicines may have an effect on the heart and blood vessels, the company that markets Enurev Breezhaler will continue to 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 Enurev Breezhaler have also been included in the summary of product characteristics and the package leaflet.

Other information about Enurev Breezhaler

The European Commission granted a marketing authorisation valid throughout the European Union for Enurev Breezhaler on 28 September 2012.

The full EPAR for Enurev Breezhaler can be found on the Agency’s website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports. For more information about treatment with Enurev Breezhaler, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.

This summary was last updated in 06-2017.

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