Enurev Breezhaler
Authorised
This medicine is authorised for use in the European Union
glycopyrronium bromide
MedicineHumanAuthorised
Overview
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.
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.
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 received a marketing authorisation valid throughout the EU on 28 September 2012.
Product information
Latest procedure affecting product information: WS2176
28/10/2021
This medicine’s product information is available in all official EU languages.
Select 'available languages' to access the language you need.
Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
Product details
- Name of medicine
- Enurev Breezhaler
- Active substance
- Glycopyrronium bromide
- International non-proprietary name (INN) or common name
- glycopyrronium bromide
- Therapeutic area (MeSH)
- Pulmonary Disease, Chronic Obstructive
- Anatomical therapeutic chemical (ATC) code
- R03BB06
Pharmacotherapeutic group
Drugs for obstructive airway diseasesTherapeutic indication
Enurev Breezhaler is indicated as a maintenance bronchodilator treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease (COPD).
Topics
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