DUORESP® SPIROMAX® DRY POWDER FOR INHALATION 160 MCG/4.5 MCG [SIN16056P]

Product Info

DUORESP® SPIROMAX® DRY POWDER FOR INHALATION 160 MCG/4.5 MCG

[SIN16056P]

4.1 Therapeutic indications

Asthma
DuoResp Spiromax is indicated in the treatment of asthma to achieve overall asthma control, including the prevention and relief of symptoms as well as the reduction of the risk of exacerbations.

DuoResp Spiromax is indicated for treatment of asthma, where the use of inhaled corticosteroids is appropriate.

Chronic Obstructive Pulmonary Disease (COPD)
Symptomatic treatment of patients with COPD with FEV1 <70% predicted normal (post-bronchodilator) and a history of repeated exacerbations, despite regular long-acting bronchodilator therapy (see section Special warnings and precautions for use – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

4.2 Posology and method of administration
The dosage of DUORESP SPIROMAX should be individualised according to disease severity.

Asthma
DuoResp Siromax can be used according to different treatment approaches:

1. DuoResp anti-inflammatory reliever therapy.

2. DuoResp anti-inflammatory reliever plus maintenance therapy.

As an alternative, DuoResp can be used in a fixed-dose therapy:

1. DuoResp maintenance therapy.

DuoResp anti-inflammatory reliever therapy (patients with mild disease):
DuoResp is taken as needed for the relief of asthma symptoms when they occur, and to prevent allergen- or exercise-induced bronchoconstriction (or to prevent symptoms in those circumstances recognised by the patient to precipitate an asthma attack). The formoterol component in DuoResp Spiromax provides fast onset of effect (within 1–3 minutes) with long-acting (at least 12 hours after a single dose) bronchodilation in reversible airways obstruction. Patients should be advised to always have DuoResp available for relief of symptoms.

Clinical studies have demonstrated that DuoResp anti-inflammatory reliever therapy provides significant reductions in severe exacerbations and was statistically superior on daily asthma symptom control compared to a short-acting β₂ agonist therapy alone (see section Pharmacodynamic properties – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). Asthma symptom control was inferior for DuoResp as needed compared to a maintenance dose of corticosteroid given with as needed short-acting β₂ agonist.

Recommended doses:
Physicians should discuss allergen exposure and exercise patterns with the patients and take these into consideration when recommending the dose frequency.

Adults and adolescents (12 years and older): Patients should take 1 inhalation as needed in response to symptoms and for the prevention of allergen- or exercise-induced bronchoconstriction to control asthma. 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 normally not needed, however a total daily dose of up to 12 inhalations can be used temporarily. Patients using more than 8 inhalations daily should be reassessed for alternative explanations of persisting symptoms.

Children under 12 years: Efficacy and safety of DuoResp anti-inflammatory reliever therapy in children under 12 years have not been studied.

DuoResp anti-inflammatory reliever plus maintenance therapy:
When maintenance treatment with a combination of inhaled corticosteroid and long-acting β₂ agonist is required, DuoResp is taken as anti-inflammatory reliever therapy and in addition, patients take a daily maintenance dose of DuoResp. The as needed inhalations provide both rapid relief of symptoms and improved overall asthma control. Patients should be advised to have DuoResp available for relief of symptoms at all times. A separate inhaler for relief of symptoms is not necessary.

Clinical studies have demonstrated that DuoResp anti-inflammatory reliever plus maintenance therapy provides clinically meaningful reductions in severe exacerbations while maintaining symptom control, compared to DuoResp maintenance therapy with a separate short-acting bronchodilator (see section Pharmacodynamic properties – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Recommended doses:
Physicians should discuss allergen exposure and exercise patterns with the patients and take these into consideration when recommending the dose frequency.

Adults and adolescents (12 years and older): Patients should take 1 inhalation as needed in response to symptoms and for the prevention of allergen- or exercise-induced bronchoconstriction to control asthma. 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. Patients also take the recommended maintenance dose, which is 2 inhalations per day, given either as one inhalation in the morning and evening or as 2 inhalations in either the morning or the evening. For some patients, a maintenance dose of 2 inhalations twice daily may be appropriate.

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.

Children under 12 years: DuoResp anti-inflammatory reliever plus maintenance therapy is not recommended for children under 12 years.

DuoResp maintenance therapy (fixed dose):
When maintenance treatment with a combination of inhaled corticosteroid and long-acting β₂ agonist is required, DuoResp is taken as a fixed daily dose treatment, with a separate short-acting bronchodilator for relief of symptoms. Patients should be advised to have their separate short-acting bronchodilator available for relief of symptoms 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.

Adolescents (12–17 years): 1–2 inhalations twice daily. During worsening of asthma, the dose may temporarily be increased to a maximum of 4 inhalations twice daily.

COPD
Adults: 2 inhalations twice daily.

General information
If patients take DuoResp as a maintenance therapy, they should be instructed to take the maintenance dose of DuoResp Spiromax even when asymptomatic for optimal benefit.

Special patient groups: There is no need to adjust the dose in 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.

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.

4.3 Contraindications

Hypersensitivity to the active substances or the excipient listed in section 6.1 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information.