Source: European Medicines Agency (EU) Revision Year: 2021 Publisher: Novartis Europharm Limited, Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland
Zimbus Breezhaler is indicated as a maintenance treatment of asthma in adult patients not adequately controlled with a maintenance combination of a long-acting beta2-agonist and a high dose of an inhaled corticosteroid who experienced one or more asthma exacerbations in the previous year.
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.
No dose adjustment is required in elderly patients (65 years of age or older) (see section 5.2).
No dose adjustment is required in patients with mild to moderate renal impairment. Caution should be observed in patients with severe renal impairment or end-stage renal disease requiring dialysis (see sections 4.4 and 5.2).
No dose adjustment is required in patients with mild or moderate hepatic impairment. No data are available for the use of the medicinal product in patients with severe hepatic impairment, therefore it should be used in these patients only if the expected benefit outweighs the potential risk (see section 5.2).
The safety and efficacy of Zimbus Breezhaler in paediatric patients below 18 years of age have not been established. No data are available.
For inhalation use only. The capsules must not be swallowed.
The capsules must be administered only using the inhaler provided (see section 6.6) 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.
After inhalation, patients should rinse their mouth with water without swallowing (see sections 4.4 and 6.6).
For instructions on use of the medicinal product before administration, see section 6.6.
The pack may contain an electronic sensor to be attached to the base of the inhaler.
The sensor and App are not required for administration of the medicinal product to the patient. The sensor and App do not control or interfere with delivery of the medicinal product using the inhaler.
The prescribing physician may discuss with the patient whether the use of the sensor and App is appropriate.
For detailed instructions on how to use the sensor and the App, see the Instructions for Use provided in the sensor pack and the App.
General supportive measures and symptomatic treatment should be initiated in cases of suspected overdose.
An overdose will likely produce signs, symptoms or adverse effects associated with the pharmacological actions of the individual components (e.g. tachycardia, tremor, palpitations, headache, nausea, vomiting, drowsiness, ventricular arrhythmias, metabolic acidosis, hypokalaemia, hyperglycaemia, increased intraocular pressure [causing pain, vision disturbances or reddening of the eye], constipation or difficulties in voiding, suppression of hypothalamic pituitary adrenal axis function).
Use of cardioselective beta blockers may be considered for treating beta2-adrenergic effects, but only under the supervision of a physician and with extreme caution, since the use of beta2-adrenergic blockers may provoke bronchospasm. In serious cases, patients should be hospitalised.
30 months.
Do not store above 30°C.
Store in the original package in order to protect from light and moisture.
Inhaler body and cap are made from acrylonitrile butadiene styrene, push buttons are made from methyl metacrylate acrylonitrile butadiene styrene. Needles and springs are made from stainless steel.
PA/Alu/PVC – Alu perforated unit-dose blister. Each blister contains 10 hard capsules.
Single pack containing 10 × 1, 30 × 1 or 90 × 1 hard capsules, together with 1 inhaler.
Pack containing 30 × 1 hard capsules, together with 1 inhaler and 1 sensor.
Multipacks containing 150 (15 packs of 10 × 1) hard capsules and 15 inhalers.
Not all pack sizes may be marketed.
The inhaler provided with each new prescription should be used. The inhaler in each pack should be disposed of after all capsules in that pack have been used.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
Please read the full Instructions for Use before using the Zimbus Breezhaler.
For detailed instructions on use of the sensor and the App, see the Instructions for Use provided in the sensor pack and the App.
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