Seffalair Spiromax · 4.4 Special warnings and precautions for use · 1

HOS-098869 · has-adverse-reaction-information · PDF-Seite 8

Summary of the safety profile As this medicinal product contains salmeterol and fluticasone propionate, the type and severity of adverse reactions associated with each of the active substance may be expected. No increased incidence of adverse reactions has been seen following concurrent administration of the two compounds. The most frequently reported adverse reactions were nasopharyngitis (6.3%), headache (4.4%), cough (3.7%) and oral candidiasis (3.4%). 8 Tabulated list of adverse reactions Adverse reactions which have been associated with fluticasone propionate and salmeterol are presented below, listed by system organ class and frequency. Frequencies are defined as: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to < 1/100), rare (≥1/10,000 to < 1/1,000), very rare (<1/10,000) and not known (cannot be estimated from the available data). Frequencies were derived from clinical trial data. Table 1: Tabulated list of adverse reactions System Organ Class Adverse reaction Frequency Oral candidiasisa Common1 Influenza Common Nasopharyngitis Common Rhinitis Common Infections and infestations Sinusitis Common Pharyngitis Uncommon Respiratory tract infection Uncommon Oesophageal candidiasis Rare Cushing's syndrome, Cushingoid features, Endocrine disorders adrenal suppression and growth retardation Rare1 in children and adolescents Metabolism and nutrition Hypokalaemia Common2 disorders Hyperglycaemia Uncommon Anxiety Uncommon Insomnia Uncommon Psychiatric disorders Beh

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HOS-098865 · has-contraindication-information · PDF-Seite 4

Hypersensitivity to the active substances or to any of the excipients listed in section 6.1.

HOS-098864 · has-indication-information · PDF-Seite 2

Seffalair Spiromax is indicated in the regular treatment of asthma in adults and adolescents aged 12 years and older not adequately controlled with inhaled corticosteroids and ‘as needed’ inhaled short-acting β2 agonists.

HOS-098867 · has-interaction-information · PDF-Seite 6

6 Interactions with beta blockers Beta adrenergic blockers may weaken or antagonise the effect of salmeterol. Both non-selective and selective β blockers should be avoided unless there are compelling reasons for their use. Potentially serious hypokalaemia may result from β2 agonist therapy (see section 4.4). Particular caution is advised in acute severe asthma as this effect may be potentiated by concomitant treatment with xanthine derivatives, steroids, and diuretics. Salmeterol Potent CYP3A4 inhibitors Co-administration of ketoconazole (400 mg orally once daily) and salmeterol (50 micrograms inhaled twice daily) in 15 healthy subjects for 7 days resulted in a significant increase in plasma salmeterol exposure (1.4- fold Cmax and 15-fold AUC). This may lead to an increase in the incidence of other systemic effects of salmeterol treatment (e.g. prolongation of QTc interval and palpitations) compared with salmeterol or ketoconazole treatment alone (see section 4.4). Clinically significant effects were not seen on blood pressure, heart rate, blood glucose, and blood potassium levels. Co-administration with ketoconazole did not increase the elimination half-life of salmeterol or increase salmeterol accumulation with repeat dosing. The concomitant administration of ketoconazole should be avoided, unless the benefits outweigh the potentially increased risk of systemic effects of salmeterol treatment. There is likely to be a similar risk of interaction with other potent CYP3A4 inhibitors (e.g., itraconazole, telithromycin, ritonavir). Moderate CYP3A4 inhibitors Co-administration of erythromycin (500 mg orally 3 times a day) and salmeterol (50 micrograms inhaled twice daily) in 15 healthy subjects for 6 days resulted in a small but non-statistically significant increase in salmeterol exposure (1.4-fold Cmax and 1.2-fold AUC). Co-administration with erythromycin was not associated with any serious adverse effects. Fluticasone propionate Under normal circumstances, low plasma concentrations of fluticasone propionate are achieved after inhaled dosing, due to extensive first pass metabolism and high systemic clearance mediated by cytochrome P450 3A4 in the gut and liver. Hence, clinically significant drug interactions mediated by fluticasone propionate are unlikely. In an interaction study in healthy subjects with intranasal fluticasone propionate, ritonavir (a highly potent cytochrome P450 3A4 inhibitor) administered 100 mg twice daily increased the flutic

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HOS-098868 · has-pregnancy-information · PDF-Seite 8

Pregnancy A moderate amount of data on pregnant women (between 300 to 1000 pregnancy outcomes) indicates no malformative or foeto/neonatal toxicity of salmeterol and fluticasone propionate. Animal studies have shown reproductive toxicity after administration of β2 adrenoreceptor agonists and glucocorticosteroids (see section 5.3). This medicianl product should only be used during pregnancy if the expected benefit to the patient justifies the potential risk to the foetus. Breast-feeding It is unknown whether salmeterol and fluticasone propionate/metabolites are excreted in human milk. Studies have shown that salmeterol and fluticasone propionate and their metabolites, are excreted into the milk of lactating rats. A risk to breastfed newborns/infants cannot be excluded. A decision must be made whether to discontinue breast-feeding or to discontinue salmeterol/fluticasone propionate therapy taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman. Fertility There are no fertility data in humans. However, animal studies showed no effects of salmeterol or fluticasone propionate on fertility (see section 5.3).

HOS-098866 · has-warning-information · PDF-Seite 4

Deterioration of disease Salmeterol/fluticasone propionate should not be used to treat acute asthma symptoms for which a fast- and short-acting bronchodilator is required. Patients should be advised to have their rescue inhaler available to be used for relief in an acute asthma attack at all times. Patients should not be initiated on salmeterol/fluticasone propionate during an exacerbation, or if they have significantly worsening or acutely deteriorating asthma. Serious asthma-related adverse events and exacerbations may occur during treatment with salmeterol/fluticasone propionate. Patients should be asked to continue treatment but to seek medical advice if asthma symptoms remain uncontrolled or worsen after initiation on salmeterol/fluticasone propionate. Increased requirements for use of reliever medication (short-acting bronchodilators), or decreased response to reliever medication indicate deterioration of asthma control and patients should be reviewed by a physician. Sudden and progressive deterioration in control of asthma is potentially life-threatening and the patient should undergo urgent medical assessment. Consideration should be given to increasing inhaled corticosteroid therapy. Cessation of therapy Treatment with salmeterol/fluticasone propionate should not be stopped abruptly in patients with asthma due to risk of exacerbation. Therapy should be down-titrated under physician supervision. Coexisting conditions Salmeterol/fluticasone propionate should be administered with caution in patients with active or quiescent pulmonary tuberculosis and fungal, viral, or other infections of the airway. Appropriate treatment should be promptly instituted, if indicated. Cardiovascular effects 4 Rarely, salmeterol/fluticasone propionate may cause cardiac arrhythmias e.g., supraventricular tachycardia, extrasystoles and atrial fibrillation, and a mild transient reduction in serum potassium at high therapeutic doses. Salmeterol/fluticasone propionate should be used with caution in patients with severe cardiovascular disorders or heart rhythm abnormalities and in patients with thyrotoxicosis,. Hypokalaemia and hyperglycaemia Beta-adrenergic agonist medicines may produce significant hypokalaemia in some patients, possibly through intracellular shunting, which has the potential to product adverse cardiovascular effects. The decrease in serum potassium is usually transient, not requiring suppl

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