re 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.
COPD
Recommended doses:
Adults (18 years and older): 2 inhalations twice daily
Special populations:
Elderly patients (≥65 years old)
There are no special dosing requirements for elderly patients.
Patients with renal or hepatic impairment
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.
Paediatric population
The safety and efficacy of DuoResp Spiromax in children, 12 years and younger and adolescents, 13 to 17 years of age has not yet been established. No data are available.
This medicinal product is not recommended for use in children and adolescents under the age of 18 years.
Method of administration
Inhalation use.
Spiromax is a breath actuated, inspiratory flow-driven inhaler, which means that the active substances are delivered into the airways when the patient inhales through the mouthpiece. Moderate and severe asthmatic patients were shown to be able to generate sufficient inspiratory flow rate for Spiromax to deliver the therapeutic dose (see section 5.1).
DuoResp Spiromax should be used correctly in order to achieve effective treatment. As such, the patients should be advised to read the patient information leaflet carefully and follow the instructions for use as detailed in the leaflet.
The use of DuoResp Spiromax follows three simple steps: open, breathe and close which are outlined below.
Open: Hold the Spiromax 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 Spiromax 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 also important to advise patients not to shake the inhaler before use and not to breathe out through the Spiromax 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 DuoResp Spiromax due to the lactose excipient.
4.3 Contraindications
Hypersensitivity to the active substances or the excipient listed in section 6.1.
4.4 Special warnings and precautions for use
General
It is recommended that the dose is tapered when the treatment is discontinued and should not be stopped abruptly.
If patients find the treatment ineffective, or exceed the highest recommended dose of DuoResp Spiromax, medical attention must be sought (see section 4.2). Sudden and progressive deterioration
in control of asthma or COPD is potentially life-threatening and the patient should undergo urgent medical assessment. In this situation, consideration should be given t |
