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Atectura Breezhaler is a brand name for Indacaterol. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Atectura Breezhaler is indicated as a maintenance treatment of asthma in adults and adolescents 12 years of age and older not adequately controlled with inhaled corticosteroids and inhaled short- acting beta2-agonists.
Verbatim from this product's EMA label. Tap a section to expand.
Posology Adults and adolescents aged 12 years and over The recommended dose is one capsule to be inhaled once daily. Patients should be given the strength containing the appropriate mometasone furoate dose for the severity of their disease and should be regularly reassessed by a healthcare professional.
The maximum recommended dose is 125 mcg/260 mcg once daily. Treatment should be administered at the same time of the day each day. It can be administered irrespective of the time of the day. If a dose is missed, it should be taken as soon as possible.
Patients should be instructed not to take more than one dose in a day. 2). 2). Hepatic impairment No dose adjustment is required in patients with mild or moderate hepatic impairment. 2). Paediatric population The posology in patients 12 years of age and older is the same posology as in adults.
The safety and efficacy in paediatric patients below 12 years of age have not been established. No data are available. Method of administration For inhalation use only. The capsules must not be swallowed. 6) with each new prescription.
Patients should be instructed on how to administer the medicinal product correctly. Patients who do not experience improvement in breathing should be asked if they are swallowing the medicinal product rather than inhaling it. The capsules must only be removed from the blister immediately before use.
6). 6.
8%). Tabulated list of adverse reactions Adverse reactions are listed by MedDRA system organ class (Table 1). The frequency of the adverse reactions is based on the PALLADIUM study. Within each system organ class, the adverse reactions are ranked by frequency, with the most frequent reactions first.
Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness. In addition, the corresponding frequency category for each adverse reaction is based on the following convention (CIOMS III): 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).
8 Table 1 Adverse reactions System organ class Adverse reactions Frequency category Infections and infestations Nasopharyngitis Very common Upper respiratory tract infection Common Candidiasis*1 Uncommon Immune system disorders Hypersensitivity*2 Common Angioedema*3 Uncommon Metabolism and nutrition disorders Hyperglycaemia*4 Uncommon Nervous system disorders Headache*5 Common Eye disorders Vision blurred Uncommon Cataract*6 Uncommon Cardiac disorders Tachycardia*7 Uncommon Respiratory, thoracic and mediastinal disorders Asthma (exacerbation) Very common Oropharyngeal pain*8 Common Dysphonia Common Skin and subcutaneous tissue disorders Rash*9 Uncommon Pruritus*10 Uncommon Musculoskeletal and connective tissue disorders Musculoskeletal pain*11 Common Muscle spasms Uncommon * Indicates grouping of preferred terms (PTs): 1 Oral candidiasis, oropharyngeal candidiasis.
2 Drug eruption, drug hypersensitivity, hypersensitivity, rash, rash erythematous, rash pruritic, urticaria. 3 Allergic oedema, angioedema, periorbital swelling, swelling of eyelid. 4 Blood glucose increased, hyperglycaemia. 5 Headache, tension headache.
6 Cataract, cataract cortical. 7 Heart rate increased, tachycardia, sinus tachycardia, supraventricular tachycardia. 8 Oral pain, oropharyngeal discomfort, oropharyngeal pain, throat irritation, odynophagia. 9 Drug eruption, rash, rash erythematous, rash pruritic.
Deterioration of disease This medicinal product should not be used to treat acute asthma symptoms, including acute episodes of bronchospasm, for which a short-acting bronchodilator is required. Increasing use of short-acting bronchodilators to relieve symptoms indicates deterioration of control and patients should be reviewed by a physician.
Patients should not stop treatment without physician supervision since symptoms may recur after discontinuation. It is recommended that treatment with this medicinal product should not be stopped abruptly. If patients find the treatment ineffective, they should continue treatment but must seek medical attention.
Increasing use of reliever bronchodilators indicates a worsening of the underlying condition and warrants a reassessment of the therapy. Sudden and progressive deterioration in the symptoms of asthma is potentially life-threatening and the patient should undergo urgent medical assessment.
Hypersensitivity Immediate hypersensitivity reactions have been observed after administration of this medicinal product. If signs suggesting allergic reactions occur, in particular angioedema (including difficulties in breathing or swallowing, swelling of the tongue, lips and face), urticaria or skin rash, treatment should be discontinued immediately and alternative therapy instituted.
Paradoxical bronchospasm As with other inhalation therapy, administration of this medicinal product may result in paradoxical bronchospasm, which can be life-threatening. If this occurs, treatment should be discontinued immediately and alternative therapy instituted.
Cardiovascular effects of beta agonists Like other medicinal products containing beta2-adrenergic agonists, this medicinal product may produce a clinically significant cardiovascular effect in some patients, as measured by increases in pulse rate, blood pressure and/or symptoms.
1.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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10 Anal pruritus, eye pruritus, nasal pruritus, pruritus, pruritus genital. 11 Back pain, musculoskeletal pain, myalgia, neck pain, musculoskeletal chest pain. Paediatric population The safety profile of the medicinal product was assessed in the phase III study in adolescents (12 years and older) and adults.
Frequency, type and severity of adverse reactions in adolescents are similar to adults. Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product.
Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V.
If such effects occur, treatment may need to be discontinued. This medicinal product should be used with caution in patients with cardiovascular disorders (coronary artery disease, acute myocardial infarction, cardiac arrhythmias, hypertension), convulsive disorders or thyrotoxicosis, and in patients who are unusually responsive to beta2-adrenergic agonists.
Patients with unstable ischaemic heart disease, a history of myocardial infarction in last 12 months, New York Heart Association (NYHA) class III/IV left ventricular failure, arrhythmia, uncontrolled hypertension, cerebrovascular disease or history of long QT syndrome and patients being treated with medicinal products known to prolong QTc were excluded from studies in the indacaterol/mometasone furoate clinical development programme.
Thus safety outcomes in these populations are considered unknown. 5 While beta2-adrenergic agonists have been reported to produce electrocardiographic (ECG) changes, such as flattening of the T wave, prolongation of QT interval and ST segment depression, the clinical significance of these observations is unknown.
Long-acting beta2-adrenergic agonists (LABA) or LABA-containing combination products such as Atectura Breezhaler should therefore be used with caution in patients with known or suspected prolongation of the QT interval or who are being treated with medicinal products affecting the QT interval.
Hypokalaemia with beta agonists Beta2-adrenergic agonists may produce significant hypokalaemia in some patients, which has the potential to produce adverse cardiovascular effects. The decrease in serum potassium is usually transient, not requiring supplementation.
5). Clinically relevant hypokalaemia has not been observed in clinical studies of indacaterol/mometasone furoate at the recommended therapeutic dose. Hyperglycaemia Inhalation of high doses of beta2-adrenergic agonists and corticosteroids may produce increases in plasma glucose.
Upon initiation of treatment, plasma glucose should be monitored more closely in diabetic patients. This medicinal product has not been investigated in patients with Type I diabetes mellitus or uncontrolled Type II diabetes mellitus.
Prevention of oropharyngeal infections In order to reduce the risk of oropharyngeal candida infection, patients should be advised to rinse their mouth or gargle with water without swallowing it or brush their teeth after inhaling the prescribed dose.
Systemic effects of corticosteroids Systemic effects of inhaled corticosteroids may occur, particularly at high doses prescribed for prolonged periods. These effects are much less likely to occur than with oral corticosteroids and may vary in individual patients and between different corticosteroid preparations.
Possible systemic effects may include Cushing’s syndrome, Cushingoid features, adrenal suppression, growth retardation in children and adolescents, decrease in bone mineral density, cataracts, glaucoma, and, more rarely, a range of psychological or behavioural effects including psychomotor hyperactivity, sleep disorders, anxiety, depression or aggression (particularly in children).
It is therefore important that the dose of inhaled corticosteroid is titrated to the lowest dose at which effective control of asthma is maintained. Visual disturbance may be reported with systemic and topical (including intranasal, inhaled and intraocular) corticosteroid use.
Patients presenting with symptoms such as blurred vision or other visual disturbances should be considered for referral to an ophthalmologist for evaluation of possible causes of visual disturbances, which may include cataract, glaucoma or rare diseases such as central serous chorioretinopathy (CSCR) which have been reported after use of systemic and topical corticosteroids.
This medicinal product should be administered with caution in patients with pulmonary tuberculosis or in patients with chronic or untreated […]