What is Budesonide / Formoterol Teva used for and what is it used for?
Budesonide / Formoterol Teva is a medicine containing the active substances budesonide and formoterol . It is used for the treatment of asthma in adults when the use of an association is appropriate. It can be used in patients whose disease is not adequately controlled by treatment with other anti-asthmatic medicines, called corticosteroids and "short-acting beta2 agonists" taken by inhalation, or in patients whose disease is adequately controlled by therapy with corticosteroids and "long-acting beta2 agonists" taken by inhalation. Budesonide / Formoterol Teva is also indicated to relieve the symptoms of chronic obstructive pulmonary disease (COPD) in adults with a history of exacerbations of the disease, despite having been subjected to regular therapy in the past. COPD is a chronic disease in which the airways and pulmonary alveoli are damaged or blocked, resulting in difficulty breathing. Budesonide / Formoterol Teva is a "hybrid" medicine. This means that Budesonide / Formoterol Teva is similar to a "reference medicine" that contains the same active ingredients, but is administered with a different inhaler. The reference medicine for Budesonide / Formoterol Teva is Symbicort Turbohaler.
How is Budesonide / Formoterol Teva used?
The medicine can only be obtained with a prescription. It is available as an inhalation powder contained in a portable inhaler; each inhalation provides a fixed dose of medicine. Budesonide / Formoterol Teva can be used for the regular treatment of asthma. It can also be used for the treatment of COPD. As for the regular treatment of asthma, the recommended dose is one to four inhalations twice a day, depending on the dose used and the severity of the asthma. As an asthma relief therapy, patients should use a distinct "relief inhaler" to relieve symptoms. Patients who need to take more than eight inhalations a day should seek medical attention, which will evaluate the need to change therapy. Regarding the treatment of COPD, the recommended dose is one or two inhalations twice a day, depending on the dosage used. For more information, see the package leaflet.
How does Budesonide / Formoterol Teva work?
The two active ingredients of Budesonide / Formoterol Teva are known and are present in a variety of medicines used to treat asthma and COPD, either alone or in combination with other medicines. Budesonide belongs to a group of anti-inflammatory medicines called corticosteroids. It acts in a manner similar to natural corticosteroid hormones: by binding to receptors on different types of immune cells, it reduces the activity of the immune system. This in turn leads to a decrease in the release of substances involved in the inflammatory process (including histamine), thus helping to keep the airways free and allowing the patient to breathe more easily. Formoterol is a long-acting beta2 agonist. It works by binding to beta2 receptors in the musculature. Once inhaled, it binds mostly to these receptors in the airways, inducing muscle relaxation, which in turn helps keep the airways wide and promotes patient breathing.
What are the benefits and risks of Budesonide / Formoterol Teva?
Studies have been conducted to show that Budesonide / Formoterol Teva is bioequivalent to the reference medicine (ie it produces the same level of active substance in the body) and that the two medicines have the same mechanism of action. It is therefore considered that the benefits and risks of Budesonide / Formoterol Teva are the same as those of the reference medicine.
Why has Budesonide / Formoterol Teva been approved?
The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Budesonide / Formoterol Teva 160 / 4.5 micrograms and 320/9 micrograms has been shown to have a comparable quality profile and to be bioequivalent to the corresponding dosages of Symbicort Turbohaler. Therefore, the CHMP considered that, as in the case of Symbicort Turbohaler, the benefits outweigh the identified risks and recommended the granting of the marketing authorization for Budesonide / Formoterol Teva.
What measures are being taken to ensure the safe and effective use of Budesonide / Formoterol Teva?
A risk management plan has been developed to ensure that Budesonide / Formoterol Teva is used as safely as possible. Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Budesonide / Formoterol Teva, including the appropriate precautions to be followed by healthcare professionals and patients. Further information is available in the summary of the risk management plan.
More information on Budesonide / Formoterol Teva
On 19 November 2014, the European Commission issued a marketing authorization for Budesonide / Formoterol Teva, valid throughout the European Union. For the full EPAR and the summary of the Budesonide / Formoterol Teva risk management plan, consult the Agency's website: ema.Europa.eu/Find medicine / Human medicines / European public assessment reports. For more information about treatment with Budesonide / Formoterol Teva, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist. Last update of this summary: 11-2014.
