Source: European Medicines Agency (EU) Revision Year: 2024 Publisher: Teva Pharma B.V., Swensweg 5, 2031 GA Haarlem, The Netherlands
GoResp Digihaler is indicated in adults 18 years of age and older only.
GoResp Digihaler is indicated in the regular treatment of asthma, where use of a combination (inhaled corticosteroid and long-acting β2 adrenoceptor agonist) is appropriate:
or
Symptomatic treatment of patients with COPD with forced expiratory volume in 1 second (FEV1) <70% predicted normal (post bronchodilator) and a history of repeated exacerbations, who have significant symptoms despite regular therapy with long-acting bronchodilators.
This medicinal product is not intended for the initial management of asthma.
Budesonide/Formoterol fumarate dihydrate is not an appropriate treatment for adult patients with only mild asthma.
GoResp Digihaler should not be interchanged with other inhalation products containing the combination of the same strength of budesonide and formoterol (see also section 4.4).
The dose of this medicinal product is individual and should be adjusted to the severity of the disease. This should be considered not only when treatment with combination medicinal products is initiated but also when the maintenance dose is adjusted. If an individual patient should require a combination of doses other than those available in the combination inhaler, appropriate doses of β2 adrenoceptor agonists and/or corticosteroids by individual inhalers should be prescribed.
Once asthma symptoms are controlled, consideration may be given to gradually reducing the dose of Budesonide/Formoterol fumarate dihydrate. Patients should be reassessed regularly by their physician/healthcare provider so that the dose of this medicinal product remains optimal. The dose should be titrated to the lowest dose at which effective control of symptoms is maintained.
When it is appropriate to titrate down to a lower strength than is available for GoResp Digihaler, a change to an alternative fixed-dose combination of budesonide and formoterol fumarate containing a lower dose of the inhaled corticosteroid is required. When long-term control of symptoms is maintained with the lowest recommended dose, then the next step could include a test of inhaled corticosteroid alone.
For GoResp Digihaler there are two treatment approaches:
Maintenance therapy:
GoResp Digihaler is taken as regular maintenance treatment with a separate rapid-acting bronchodilator as rescue.
Maintenance and reliever therapy:
GoResp Digihaler is taken as regular maintenance treatment and as needed in response to symptoms.
Patients should be advised to have their separate rapid-acting bronchodilator available for rescue use at all times.
Recommended doses:
Adults (18 years and older): 1-2 inhalations twice daily. Some patients may require up to a maximum of 4 inhalations twice daily.
In usual practice when control of symptoms is achieved with the twice daily dose regimen with a lower strength product, titration to a lower effective dose could include once daily dosing when, in the opinion of the physician, a long-acting bronchodilator is required to maintain control rather than treatment with an inhaled corticosteroid alone.
Increasing use of a separate rapid-acting bronchodilator indicates a worsening of the underlying condition and warrants a reassessment of the asthma therapy.
Patients take a daily maintenance dose of GoResp Digihaler and in addition take this medicinal product as needed in response to symptoms. Patients should be advised to always have GoResp Digihaler available for rescue use.
For patients taking GoResp Digihaler as reliever, preventative use of this medicinal product for allergen- or exercise-induced bronchoconstriction should be discussed between physician and patient; the recommended use should take into consideration the frequency of need. In case of frequent need of bronchodilation without corresponding need for an increased dose of inhaled corticosteroids, an alternative reliever should be used.
Budesonide/Formoterol fumarate dihydrate maintenance and reliever therapy should especially be considered for patients with:
Close monitoring for dose-related adverse reactions is needed in patients who frequently take high numbers of this medicinal product as-needed inhalations.
Recommended doses:
Adults (18 years and older): The recommended maintenance dose is 2 inhalations per day, given either as one inhalation in the morning and evening or as 2 inhalations in either the morning or evening. For some patients a maintenance dose of 2 inhalations twice daily may be appropriate. Patients should take 1 additional inhalation as needed in response to symptoms. If symptoms persist after a few minutes, an additional inhalation should be taken. Not more than 6 inhalations should be taken on any single occasion.
A total daily dose of more than 8 inhalations is not normally needed; however, a total daily dose of up to 12 inhalations could be used for a limited period. Patients using more than 8 inhalations daily should be strongly recommended to seek medical advice. They should be reassessed and their maintenance therapy should be reconsidered.
The recommended dose for adults (18 years and older) is 2 inhalations twice daily.
There are no special dosing requirements for elderly patients.
There are no data available for use of a fixed-dose combination of budesonide and formoterol fumarate dihydrate in patients with hepatic or renal impairment. As budesonide and formoterol are primarily eliminated via hepatic metabolism, an increased exposure can be expected in patients with severe liver cirrhosis.
The safety and efficacy of this medicinal product in children, 12 years and younger and adolescents, 13 to 17 years of age has not yet been established. Currently available data are described in sections 4.8, 5.1 and 5.2 but no recommendation on a posology can be made.
This medicinal product is not recommended for use in children and adolescents under the age of 18 years.
For inhalation use only.
Digihaler is a breath actuated, inspiratory flow-driven inhaler, with integrated electronics. The active substances are delivered into the airways when the patient inhales through the mouthpiece. The integrated electronics do not impact the metering or dosing functionality of the inhaler. Moderate and severe asthmatic patients were shown to be able to generate sufficient inspiratory flow rate to deliver the therapeutic dose (see section 5.1).
This medicinal product should be used correctly in order to achieve effective treatment. As such, the patients should be advised to read the package leaflet carefully and follow the instructions for use as detailed in the leaflet. The use of GoResp Digihaler follows three steps: open, breathe and close which are outlined below.
Open: Hold the Digihaler with the mouthpiece cover at the bottom and open the mouthpiece cover by folding it down until it is fully opened when one click is heard.
Breathe: Place the mouthpiece between the teeth with the lips closed around the mouthpiece, do not bite the mouthpiece of the inhaler. Breathe in forcefully and deeply through the mouthpiece. Remove the Digihaler from mouth and hold the breath for 10 seconds or as long as comfortable for the patients.
Close: Breathe out gently and close the mouthpiece cover.
It is important to advise patients to close the mouthpiece cover after taking an inhalation.
It is also important to advise patients not to shake the inhaler before use and not to breathe out through the Digihaler and not to block the air vents when they are preparing the “Breathe” step.
Patients should also be advised to rinse their mouth with water after inhaling (see section 4.4).
The patient may notice a taste when using this medicinal product due to the lactose excipient.
Patients should be advised to not place the inhaler in water.
The Digihaler can be paired with the Digihaler App by scanning the Quick Response code (QR code), located on the top of the inhaler, from the Digihaler App. The Digihaler App allows patients to review and monitor inhaler usage data and set up medication reminders.
The inhaler does not need to be connected to the Digihaler App for administration of the medicinal product to the patient.
The integrated electronics on the inhaler and the App do not control or interfere with the delivery of the medicinal product.
The App is not intended to serve as a substitute for the advice of a physician or healthcare professional. Patients should be informed to not modify their prescribed treatment based on information from the App but to always consult with their physician or healthcare professional.
For detailed instructions on how to use the digital inhaler with the App, see the Instructions For Use (IFU) provided in the App.
An overdose of formoterol would likely lead to effects that are typical for β2 adrenoceptor agonists: tremor, headache, palpitations. Symptoms reported from isolated cases are tachycardia, hyperglycaemia, hypokalaemia, prolonged QTc-interval, arrhythmia, nausea and vomiting. Supportive and symptomatic treatment may be indicated. A dose of 90 micrograms administered during three hours in patients with acute bronchial obstruction raised no safety concerns.
Acute overdose with budesonide, even in excessive doses, is not expected to be a clinical problem. When used chronically in excessive doses, systemic glucocorticosteroid effects, such as hypercorticism and adrenal suppression, may appear.
If treatment has to be withdrawn due to overdose of the formoterol component of the medicinal product, provision of appropriate inhaled corticosteroid therapy must be considered.
3 years.
After opening the foil wrap: 6 months.
Do not store above 25°C.
Keep the mouthpiece cover closed after removal of the foil wrap.
The inhaler is white with integrated electronics at the top and a semi-transparent wine red mouthpiece cover. The drug/mucosal contact parts of the inhaler are made of acrylonitrile butadiene styrene (ABS), polyethylene (PE), and polypropylene (PP). Each inhaler contains 180 doses and is foilwrapped.
Pack sizes of 1, 2 or 3 inhalers.
Not all pack-sizes may be marketed.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
© All content on this website, including data entry, data processing, decision support tools, "RxReasoner" logo and graphics, is the intellectual property of RxReasoner and is protected by copyright laws. Unauthorized reproduction or distribution of any part of this content without explicit written permission from RxReasoner is strictly prohibited. Any third-party content used on this site is acknowledged and utilized under fair use principles.
