Source: European Medicines Agency (EU) Revision Year: 2021 Publisher: Novartis Europharm Limited, Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland
Onbrez Breezhaler is indicated for maintenance bronchodilator treatment of airflow obstruction in adult patients with chronic obstructive pulmonary disease (COPD).
The recommended dose is the inhalation of the content of one 150 microgram capsule once a day, using the Onbrez Breezhaler inhaler. The dose should only be increased on medical advice.
The inhalation of the content of one 300 microgram capsule once a day, using the Onbrez Breezhaler inhaler has been shown to provide additional clinical benefit with regard to breathlessness, particularly for patients with severe COPD. The maximum dose is 300 microgram once daily.
Onbrez Breezhaler should be administered at the same time of the day each day.
If a dose is missed the next dose should be taken at the usual time the next day.
Maximum plasma concentration and overall systemic exposure increase with age but no dose adjustment is required in elderly patients.
No dose adjustment is required for patients with mild and moderate hepatic impairment. There are no data available for use of Onbrez Breezhaler in patients with severe hepatic impairment.
No dose adjustment is required for patients with renal impairment.
There is no relevant use of Onbrez Breezhaler in the paediatric population (under 18 years).
For inhalation use only. Onbrez Breezhaler capsules must not be swallowed.
The capsules must only be removed from the blister immediately before use.
The capsules must be administered only using the Onbrez Breezhaler inhaler (see section 6.6). The Onbrez Breezhaler inhaler provided with each new prescription should be used.
Patients should be instructed on how to administer the product correctly. Patients who do not experience improvement in breathing should be asked if they are swallowing the medicine rather than inhaling it.
For instructions on use of the medicinal product before administration, see section 6.6.
In COPD patients, single doses of 10 times the maximum recommended therapeutic dose were associated with a moderate increase in pulse rate, systolic blood pressure and QTc interval.
An overdose of indacaterol is likely to lead to exaggerated effects typical of beta2-adrenergic stimulants, i.e. tachycardia, tremor, palpitations, headache, nausea, vomiting, drowsiness, ventricular arrhythmias, metabolic acidosis, hypokalaemia and hyperglycaemia.
Supportive and symptomatic treatment is indicated. In serious cases, patients should be hospitalised. Use of cardioselective beta blockers may be considered, but only under the supervision of a physician and with extreme caution since the use of beta-adrenergic blockers may provoke bronchospasm.
30 months.
Do not store above 30°C.
Store in the blister in order to protect from moisture and only remove immediately before use.
Onbrez Breezhaler is a single-dose inhalation device. Inhaler body and cap are made from acrylonitrile butadiene styrene, push buttons are made from methyl methacrylate acrylonitrile butadiene styrene. Needles and springs are made from stainless steel.
PA/Alu/PVC – Alu blister containing 10 hard capsules.
Carton containing 10 capsules and one Onbrez Breezhaler inhaler. Carton containing 30 capsules and one Onbrez Breezhaler inhaler.
Multipack comprising 2 packs (each containing 30 capsules and 1 inhaler). Multipack comprising 3 packs (each containing 30 capsules and 1 inhaler). Multipack comprising 30 packs (each containing 10 capsules and 1 inhaler).
Not all pack sizes may be marketed.
Each inhaler should be disposed of after all capsules have been used.
Please read the full Instructions for Use before using the Onbrez Breezhaler.
Pull off the cap.
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