DUORESP® SPIROMAX® DRY POWDER FOR INHALATION 320 MCG/9 MCG

POWDER, METERED

**4.2 Posology and method of administration** **Posology** _**Asthma**_ DuoResp Spiromax is not intended for the initial management of asthma. The dosage of the components of DuoResp Spiromax is individual and should be adjusted to the severity of the disease. This should be considered not only when treatment with combination 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-agonists and/or corticosteroids by individual inhalers should be prescribed. _**Recommended doses:**_ **Adults (18 years and older):** 1 inhalation twice daily. Some patients may require up to a maximum of 2 inhalations twice daily. **Adolescents (12–17 years):** 1 inhalation twice daily. Patients should be regularly reassessed by their prescriber/healthcare provider, so that the dosage of DuoResp Spiromax remains optimal. The dose should be titrated to the lowest dose at which effective control of symptoms is maintained. When control of symptoms is maintained with the lowest recommended dosage, then the next step could include a test of inhaled corticosteroid alone. In usual practice when control of symptoms is achieved with the twice-daily regimen, titration to the lowest effective dose could include DuoResp Spiromax given once daily, when in the opinion of the prescriber, a long-acting bronchodilator would be required to maintain control. DuoResp Spiromax 320 micrograms/9 micrograms should be used as maintenance therapy only. A lower strength of DuoResp Spiromax is available for the maintenance and reliever therapy regimen. _**COPD**_ _**Recommended doses:**_ **Adults**: 1 inhalation twice daily **General information** _**Special patient groups:**_ There are no special dosing requirements for elderly patients. There are no data available for use of DuoResp Spiromax 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. **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 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). 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 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_) The patient may notice a taste when using DuoResp Spiromax due to the lactose excipient.