Zimbus Breezhaler

Posology The recommended dose is one capsule to be inhaled once daily. The maximum recommended dose is 114 mcg/46 mcg/136 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). 3 Renal impairment No dose adjustment is required in patients with mild to moderate renal impairment.

2). Hepatic impairment No dose adjustment is required in patients with mild or moderate hepatic impairment. 2). Paediatric population The safety and efficacy of Zimbus Breezhaler in paediatric patients below 18 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.

2%). 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 IRIDIUM 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 Common Urinary tract infection*2 Common Immune system disorders Hypersensitivity*3 Common Metabolism and nutrition disorders Hyperglycaemia*4 Uncommon Nervous system disorders Headache*5 Common Eye disorders Cataract Uncommon Cardiac disorders Tachycardia*6 Common Respiratory, thoracic and mediastinal disorders Asthma (exacerbation) Very common Oropharyngeal pain*7 Common Cough Common Dysphonia Common Gastrointestinal disorders Gastroenteritis*8 Common Dry mouth*9 Uncommon Skin and subcutaneous tissue disorders Rash*10 Uncommon Pruritus*11 Uncommon Musculoskeletal and connective tissue disorders Musculoskeletal pain*12 Common Muscle spasms Common Renal and urinary disorders Dysuria Uncommon General disorders and administration site conditions Pyrexia Common * Indicates grouping of preferred terms (PTs): 1 Oral candidiasis, oropharyngeal candidiasis.

2 Asymptomatic bacteriuria, bacteriuria, cystitis, urethritis, urinary tract infection, urinary tract infection viral. 3 Drug eruption, drug hypersensitivity, hypersensitivity, rash, rash pruritic, urticaria. 4 Blood glucose increased, hyperglycaemia.

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.

4 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 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.