Medicinal Products

DUORESP SPIROMAX 320 micrograms / 9 micrograms

Generic drug of the therapeutic class: Pneumology
active ingredients: Budesonide + Formoterol
laboratory: Teva Sante

Inhalation powder
box of 1 inhaler device of 60 doses
All forms

Indication

DuoResp Spiromax is indicated for use in adults 18 years and older only.

Asthma

DuoResp Spiromax is indicated for the continuous treatment of asthma, when the administration of a combination (inhaled corticosteroid and long-acting β 2 -adrenergic agonist) is justified:

- in patients inadequately controlled with inhaled corticosteroids and β 2 -adrenergic agonists with short-acting "on-demand" agonists.

or

- in patients who are already sufficiently controlled with inhaled corticosteroids and long-acting β 2 -adrenergic agonists.

COPD

Symptomatic treatment of severe COPD (FEV1 <50% of the theoretical value) in patients with a history of repeated exacerbations and significant symptoms despite continued long-acting bronchodilator therapy.

Dosage DUORESP SPIROMAX 320 micrograms / 9 micrograms inhalation powder box of 1 60-dose inhaler device

DuoResp Spiromax is indicated for use in adults 18 years and older only.

Asthma

DuoResp Spiromax is indicated for the continuous treatment of asthma, when the administration of a combination (inhaled corticosteroid and long-acting β 2 -adrenergic agonist) is justified:

- in patients inadequately controlled with inhaled corticosteroids and β 2 -adrenergic agonists with short-acting "on-demand" agonists.

or

- in patients who are already sufficiently controlled with inhaled corticosteroids and long-acting β 2 -adrenergic agonists.

COPD

Symptomatic treatment of severe COPD (FEV1 <50% of the theoretical value) in patients with a history of repeated exacerbations and significant symptoms despite continued long-acting bronchodilator therapy.

Against indications

Hypersensitivity to the active substances or to any of the excipients listed under Composition .

Side effects Duoresp Spiromax

Summary of the security profile

As DuoResp Spiromax contains both budesonide and formoterol, adverse effects of the same nature as those reported for each of these components may occur. No increase in these adverse effects has been reported following the simultaneous administration of these two components. The most common adverse drug reactions are the pharmacologically predictable adverse effects of a β 2 -adrenergic agonist, such as tremors and palpitations. They tend to be relatively mild and usually go away after a few days of treatment. In a clinical study of the use of budesonide in COPD for 3 years, bruising and pneumonia were observed at frequencies of 10% and 6% respectively, compared to 4% and 3% in the placebo group (p. <0.001 and p <0.01, respectively). DuoResp Spiromax is not indicated in children and adolescents under 18 years of age (see section Dosage and method of administration ).

Table listing adverse effects

The undesirable effects associated with budesonide or formoterol are listed below, classified by organ system class and frequency. Frequencies are defined as follows: very common (≥ 1/10), common (≥1 / 100, <1/10), uncommon (≥1 / 1000, <1/100), rare (≥1 / 10) 000

<1/1 000), very rare (<1 / 10, 000) and frequency not known (can not be estimated from the available data).

Class of organ systems

Frequency

Undesirable effect

Infections and infestations

Frequent

Oropharyngeal candidiasis

Immune system disorders

Rare

Immediate and delayed hypersensitivity reactions, eg, exanthem, urticaria, pruritus, dermatitis, angioedema and anaphylactic reaction

Endocrine disorders

Very rare

Cushing's syndrome, adrenal suppression, stunting, decreased bone mineral density

Metabolism and nutrition disorders

Rare

hypokalemia

Very rare

hyperglycemia

Psychiatric disorders

Rare

Aggressiveness, psychomotor hyperactivity, anxiety, sleep disorders

Very rare

Depression, behavioral changes (especially in children)

Nervous system disorders

Frequent

Headaches, tremors

Rare

dizziness

Very rare

dysgeusia

Eye disorders

Very rare

Cataracts and glaucoma

Heart conditions

Frequent

palpitations

Rare

tachycardia

Rare

Cardiac arrhythmias, eg, atrial fibrillation, supraventricular tachycardia, extrasystoles

Very rare

Angina pectoris, QTc interval prolongation

Vascular disorders

Very rare

Unstable blood pressure

Respiratory, thoracic and mediastinal disorders

Frequent

Slight throat irritation, cough, hoarseness

Rare

bronchospasm

Very rare

Paradoxical bronchospasm

Gastrointestinal disorders

Rare

nausea

Skin and subcutaneous tissue disorders

Rare

bruising

Musculoskeletal disorders

Rare

Muscle cramps

skeletal and systemic

Description of some adverse effects

Oropharyngeal candidiasis is due to the deposition of the active substance. The patient should be advised to rinse their mouth with water after each dose to minimize this risk. Oropharyngeal candidiasis generally responds to local antifungal therapy without interrupting inhaled corticosteroid therapy.

Paradoxical bronchospasm can occur very rarely, affecting less than 1 in 10, 000 people, with an immediate increase in wheezing and shortness of breath after inhalation. Paradoxical bronchospasm responds to a fast-acting inhaled bronchodilator and should be treated immediately. DuoResp Spiromax should be discontinued immediately, the patient reassessed, and if necessary, alternative therapy should be initiated (see Warnings and Precautions ).

Systemic effects may occur with inhaled corticosteroids, especially when high doses are administered for long periods. These effects probably occur less often than during oral corticosteroid therapy. Potential systemic effects are: Cushing's syndrome, adrenal suppression, growth retardation in children and adolescents, decreased bone mineral density, cataracts and glaucoma. An increase in susceptibility to infections and a stress adaptation disorder can also occur. The effects are probably dependent on dose, time of exposure, concomitant and prior exposure to corticosteroids and individual sensitivity.

Treatment with β 2 -adrenergic agonists may lead to increased blood levels of insulin, free fatty acids, glycerol and ketone bodies.

Reporting of suspected adverse reactions

The reporting of suspected adverse reactions after authorization of the drug is important. It allows continuous monitoring of the benefit / risk ratio of the drug. Health professionals report any suspected adverse reactions via the national reporting system - see Annex V.

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