DuoResp Spiromax
Authorised
This medicine is authorised for use in the European Union
budesonide / formoterol
MedicineHumanAuthorised
Overview
DuoResp Spiromax is a medicine that contains the active substances budesonide and formoterol. It is used to treat asthma in adults and adolescents aged 12 years and above for whom a combination product is considered appropriate. It can be used in patients whose disease is not adequately controlled by treatment with other asthma medicines called corticosteroids and ‘short-acting beta-2 agonists’ taken by inhalation, or in patients whose disease is adequately controlled by treatment with corticosteroids and ‘long-acting beta-2 agonists’ (such as budesonide and formoterol) taken by inhalation.
DuoResp Spiromax is also used to relieve the symptoms of severe chronic obstructive pulmonary disease (COPD) in adults who have had exacerbations (flare–ups) of the disease in the past despite regular treatment. COPD is a long-term disease in which the airways and air sacs inside the lungs become damaged or blocked, leading to difficulty in breathing.
DuoResp Spiromax is a ‘hybrid medicine’. This means that it is similar to a ‘reference medicine’ containing the same active substances, but DuoResp Spiromax is given using a different inhaler. The reference medicine for DuoResp Spiromax is Symbicort Turbohaler.
The medicine can only be obtained with a prescription. It is available as an inhalation powder in a portable inhaler device, and each inhalation provides a fixed dose of the medicine. DuoResp Spiromax 160/4.5 microgram (160 micrograms of budesonide and 4.5 micrograms of formoterol) can be used for the regular treatment of asthma and when needed as a reliever. It can also be used for the treatment of COPD symptoms in adult patients. The higher strength, DuoResp Spiromax 320/9 micrograms (320 micrograms of budesonide and 9 micrograms of formoterol), can only be used for the regular treatment of asthma and for the treatment of COPD symptoms.
For the regular treatment of asthma, the recommended dose is 1 to 4 inhalations twice a day, depending on the strength being used, age, and the severity of the asthma. As asthma reliever therapy, patients can take 1 or 2 additional inhalations of DuoResp Spiromax 160/4.5 microgram only to relieve their symptoms. If patients need to take more than 8 inhalations per day, it is recommended they speak to their doctor to have their asthma therapy reconsidered.
For the treatment of COPD, the recommended dose is 1 or 2 inhalations twice a day, depending on the strength being used.
For further information, see the package leaflet or contact your doctor or pharmacist.
The two active substances in DuoResp Spiromax are well known and are present in several medicines used to treat asthma and COPD, either alone or in combination with other medicines.
Budesonide belongs to a group of anti-inflammatory medicines known as corticosteroids. It works in a similar way to naturally occurring corticosteroid hormones, reducing the activity of the immune system by attaching to receptors in various types of immune cell. This leads to a reduction in the release of substances that are involved in the inflammation process, such as histamine, thereby helping to keep the airways clear and allowing the patient to breathe more easily.
Formoterol is a long-acting beta-2 agonist. It works by attaching to receptors known as beta-2 receptors found in the muscles of the airways. When it attaches to these receptors, it causes the muscles to relax, which keeps the airways open and helps with the patient’s breathing.
Studies on the benefits and risks of the active substances in the authorised uses have already been carried out with the reference medicine, Symbicort Turbohaler, and do not need to be repeated for DuoResp Spiromax.
As for every medicine, the company provided studies on the quality of DuoResp Spiromax. The company also carried out studies that showed that it is ‘bioequivalent’ to the reference medicine. Two medicines are bioequivalent when they produce the same levels of the active substance in the body.
Because DuoResp Spiromax is a hybrid medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine’s.
The European Medicines Agency concluded that, in accordance with EU requirements, DuoResp Spiromax 160/4.5 microgram and 320/9 micrograms have been shown to have comparable quality and to be bioequivalent to the corresponding strengths of Symbicort Turbohaler. Therefore, the Agency’s view was that, as for Symbicort Turbohaler, the benefit outweighs the identified 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 DuoResp Spiromax have been included in the summary of product characteristics and the package leaflet.
As for all medicines, data on the use of DuoResp Spiromax are continuously monitored. Suspected side effects reported with the medicine are carefully evaluated and any necessary action taken to protect patients.
DuoResp Spiromax received a marketing authorisation valid throughout the EU on 28 April 2014.
Product information
Latest procedure affecting product information: IA/0041
04/05/2023
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
- DuoResp Spiromax
- Active substance
- Budesonide
- formoterol fumarate dihydrate
- International non-proprietary name (INN) or common name
- budesonide
- formoterol
- Therapeutic area (MeSH)
- Pulmonary Disease, Chronic Obstructive
- Asthma
- Anatomical therapeutic chemical (ATC) code
- R03AK07
Pharmacotherapeutic group
Drugs for obstructive airway diseasesTherapeutic indication
Asthma
DuoResp Spiromax is indicated in adults and adolescents (12 years and older) for the regular treatment of asthma, where use of a combination (inhaled corticosteroid and long-acting ?? adrenoceptor agonist) is appropriate:
- in patients not adequately controlled with inhaled corticosteroids and “as needed” inhaled short-acting ?? adrenoceptor agonists.
or
- in patients already adequately controlled on both inhaled corticosteroids and long-acting ?? adrenoceptor agonists.
COPD
DuoResp Spiromax is indicated in adults, aged 18 years and older for the symptomatic treatment of patients with COPD with forced expiratory volume in 1 second (FEV?) <70% predicted normal (post bronchodilator) and a history of repeated exacerbations, who have significant symptoms despite regular therapy with long-acting bronchodilators.
Assessment history
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