Presentation and Status in Health Basket
30 X 50 mcg
The recommended dose is the inhalation of the content of one capsule once daily using the inhaler. It is recommended to be administered, at the same time of the day each day. If a dose is missed, the next dose should be taken as soon as possible. Patients should be instructed not to take more than one dose in a day.
Elderly patients: can be used at the recommended dose in elderly patients 75 years of age and older.
Renal impairment: can be used at the recommended dose in patients with mild to moderate renal impairment. In patients with severe renal impairment or end-stage renal disease requiring dialysis it should be used only if the expected benefit outweighs the potential risk since the systemic exposure to glycopyrronium may be increased in this population.
Hepatic impairment: No specific studies have been conducted in patients with hepatic impairment. Glycopyrronium is predominantly cleared by renal excretion and therefore no major increase in exposure is expected in patients with hepatic impairment. No dose adjustment is required in patients with hepatic impairment.
Paediatrics: There is no relevant use of this product in the paediatric population (under 18 years) in the indication COPD.
Method of administration: For inhalation use only. The capsules must be administered only using the Seebri Breezhaler inhaler. The capsules must only be removed from the blister immediately before use. The capsules must not be swallowed. 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.
Maintenance bronchodilator treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease (COPD).
Hypersensitivity to the active substance or to any of the excipients.
Not indicated for acute episodes of bronchospasm, i.e. as a rescue therapy.
Hypersensitivity: Immediate hypersensitivity reactions have been reported after administration of Seebri Breezhaler. 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: In clinical studies with Seebri Breezhaler, paradoxical bronchospasm was not observed. However, paradoxical bronchospasm has been observed with other inhalation therapy and can be life-threatening. If this occurs, treatment should be discontinued immediately and alternative therapy instituted.
Anticholinergic effect: Seebri Breezhaler should be used with caution in patients with narrow-angle glaucoma or urinary retention. Patients should be informed about the signs and symptoms of acute narrow-angle glaucoma and should be informed to stop using this product and to contact their doctor immediately should any of these signs or symptoms develop.
Severe renal impairment: A moderate mean increase in total systemic exposure (AUClast) of up to 1.4-fold was seen in subjects with mild and moderate renal impairment and up to 2.2-fold in subjects with severe renal impairment and end-stage renal disease. In patients with severe renal impairment (estimated glomerular filtration rate below 30 ml/min/1.73 m2), including those with end-stage renal disease requiring dialysis, Seebri
Breezhaler should be used only if the expected benefit outweighs the potential risk. These patients should be monitored closely for potential adverse reactions.
Patients with a history of cardiovascular disease: Patients with unstable ischaemic heart disease, left ventricular failure, history of myocardial infarction, arrhythmia (excluding chronic stable atrial fibrillation), a history of long QT syndrome or whose QTc (Fridericia method) was prolonged (>450 ms for males or >470 ms for females) were excluded from the clinical trials, and therefore the experience in these patient groups is limited. Seebri Breezhaler should be used with caution in these patient groups.
Excipients: Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucosegalactose malabsorption should not take this medicinal product.
The most common anticholinergic adverse reaction was dry mouth (2.4%). The majority of the reports of dry mouth were suspected to be related to the medicinal product and were mild, with none being severe. The safety profile is further characterised by other symptoms related to the anticholinergic effects, including signs of urinary retention, which were uncommon. Gastrointestinal effects including gastroenteritis and dyspepsia were also observed. Adverse reactions related to local tolerability included throat irritation, nasopharyngitis, rhinitis and sinusitis.
Infections and infestations: Common: Nasopharyngitis
Psychiatric disorders: Common: Insomnia
Nervous system disorders: Common: Headache
Gastrointestinal disorders: Common: Dry mouth, Gastroenteritis.
Musculoskeletal and connective tissue disorders: Common: Musculoskeletal pain
Renal and urinary disorders: Common: Urinary tract infection
For full details see prescribing information.
The co-administration of this product with other anticholinergic-containing medicinal products has not been studied and is therefore not recommended. Although no formal drug interaction studies have been performed, Seebri Breezhaler has been used concomitantly with other drugs commonly used in the treatment of COPD without clinical evidence of drug interactions. These include sympathomimetic bronchodilators, ethylxanthines, oral and inhaled steroids. In a clinical study in healthy volunteers, cimetidine, an inhibitor of organic cation transport which is thought to contribute to the renal excretion of glycopyrronium, increased total exposure (AUC) to glycopyrronium by 22% and decreased renal clearance by 23%. Based on the magnitude of these changes, no clinically relevant drug interaction is expected when glycopyrronium is co-administered with cimetidine or other inhibitors of organic cation transport. Concomitant administration of glycopyrronium and orally inhaled indacaterol, a beta2-adrenergic agonist, under steady-state conditions of both active substances did not affect the pharmacokinetics of either medicinal product.
Pregnancy and Lactation
Pregnancy: There are no data from the use of Seebri Breezhaler in pregnant women. Glycopyrronium 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 glycopyrronium bromide is excreted in human milk. The use of glycopyrronium by breast-feeding women should only be considered if the expected benefit to the woman is greater than any possible risk to the infant.
For full details see prescribing information.
High doses of glycopyrronium may lead to anticholinergic signs and symptoms for which symptomatic treatment may be indicated. Acute intoxication by inadvertent oral ingestion of Seebri Breezhaler capsules is unlikely due to the low oral bioavailability (about 5%). Peak plasma levels and total systemic exposure following intravenous administration of 150 micrograms glycopyrronium bromide (equivalent to 120 micrograms glycopyrronium) in healthy volunteers were respectively about 50-fold and 6-fold higher than the peak and total exposure at steady-state achieved with the recommended dose (50 micrograms once daily) of Seebri Breezhaler and were well tolerated.
Storage: Do not store above 25°C.