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Safety

Incruse is generally well tolerated 1

The safety profile of Incruse was evaluated from 1,663 patients with COPD who received doses of 55 mcg or greater* for up to one year. This includes 576 patients who received the recommended dose of 55 mcg once daily. 1

Incruse Ellipta summary of common adverse reactions (≥1/100 to <1/10) 1

System organ class

Common adverse reactions

Infections and infestations

Nasopharyngitis
Sinusitis
Upper respiratory tract infection
Urinary tract infection

Nervous system disorders

Headache

Cardiac disorders

Tachycardia

Respiratory, thoracic and mediastinal disorders

Cough

*Umeclidinium 113 mcg was tested in clinical trials but is not licensed. It is included for provision of additional safety data only. 1

Safety information 1

Contraindications 1

Hypersensitivity to the active substance(s) or to any of the excipients.

Special warnings and precautions for use 1

Asthma
Incruse should not be used in patients with asthma since it has not been studied in this patient population.

Paradoxical bronchospasm
Administration of Incruse may produce paradoxical bronchospasm that may be life-threatening. Treatment should be discontinued immediately if paradoxical bronchospasm occurs and alternative therapy instituted if necessary.

Deterioration of disease
Incruse is intended for the maintenance treatment of COPD. It should not be used for the relief of acute symptoms, i.e. as rescue therapy for the treatment of acute episodes of bronchospasm. Acute symptoms should be treated with an inhaled short-acting bronchodilator. Increasing use of short-acting bronchodilators to relieve symptoms indicates deterioration of control. In the event of deterioration of COPD during treatment with Incruse, a re-evaluation of the patient and of the COPD treatment regimen should be undertaken.

Cardiovascular effects
Cardiovascular effects, such as cardiac arrhythmias e.g. atrial fibrillation and tachycardia, may be seen after the administration of muscarinic receptor antagonists including Incruse. In addition, patients with clinically significant uncontrolled cardiovascular disease were excluded from clinical studies. Therefore, Incruse should be used with caution in patients with severe cardiovascular disorders, particularly cardiac arrhythmias.

Antimuscarinic activity
Consistent with its antimuscarinic activity, Incruse should be used with caution in patients with urinary retention or with narrow-angle glaucoma.

Excipients
This medicinal product contains lactose. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicinal product.

Fertility, pregnancy and lactation 1

Pregnancy
There are no data from the use of Incruse in pregnant women. Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity. Incruse should be used during pregnancy only if the expected benefit to the mother justifies the potential risk to the fetus.

Breast feeding
It is unknown whether Incruse is excreted in human milk. A risk to breastfed newborns/infants cannot be excluded. A decision must be made whether to discontinue breast feeding or to discontinue Incruse therapy taking into account the benefit of breastfeeding for the child and the benefit of therapy for the woman.

Fertility
There are no data on the effects of Incruse on human fertility. Animal studies indicate no effects of Incruse on fertility.

This information does not contain all safety information. For a complete description of adverse events, special warnings and precautions, please consult the full SmPC before prescribing this medicine, which you can request from GSK or you can access from the Website of the Pharmaceutical Services of the Ministry of Health 

 

Reference:

  1. Incruse Ellipta SmPC.

Before prescribing please consult the full SPC which you can request from GSK or access on the website of the Pharmaceutical Services of the Ministry of Health
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