XOTERNA BREEZHALER Inhalation powder, hard capsule Ref.[51241] Active ingredients: Glycopyrronium Indacaterol Indacaterol and Glycopyrronium bromide

Posology

The recommended dose is the inhalation of the content of one capsule once daily using the Xoterna Breezhaler inhaler.

Xoterna Breezhaler is recommended to be administered at the same time of the day each day. If a dose is missed, it should be taken as soon as possible on the same day. Patients should be instructed not to take more than one dose in a day.

Special populations

Elderly population

Xoterna Breezhaler can be used at the recommended dose in elderly patients (75 years of age and older).

Renal impairment

Xoterna Breezhaler 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 (see sections 4.4 and 5.2).

Hepatic impairment

Xoterna Breezhaler can be used at the recommended dose in patients with mild and moderate hepatic impairment. There are no data available for the use of Xoterna Breezhaler in patients with severe hepatic impairment, therefore caution should be observed in these patients (see section 5.2).

Paediatric population

There is no relevant use of Xoterna Breezhaler in the paediatric population (under 18 years) in the indication COPD. The safety and efficacy of Xoterna Breezhaler in children have not been established.

No data are available.

Method of administration

For inhalation use only. The capsules must not be swallowed.

The capsules must be administered only using the Xoterna Breezhaler inhaler (see section 6.6). The inhaler provided with each new prescription should be used.

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.

For instructions on use of the medicinal product before administration, see section 6.6.

There is no information on clinically relevant overdosing with Xoterna Breezhaler.

An overdose could lead to exaggerated effects typical of beta₂adrenergic stimulants, i.e. tachycardia, tremor, palpitations, headache, nausea, vomiting, drowsiness, ventricular arrhythmias, metabolic acidosis, hypokalaemia and hyperglycaemia or could induce anticholinergic effects such as increased intraocular pressure (causing pain, vision disturbances or reddening of the eye), obstipation or difficulties in voiding. Supportive and symptomatic treatment is indicated. In serious cases, patients should be hospitalised. 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 beta-adrenergic blockers may provoke bronchospasm.

2 years.

The inhaler in each pack should be disposed of after all capsules in that pack have been used.

Do not store above 25°C.

The capsules must always be stored in the original blister to protect from moisture and only removed immediately before use.

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 either 6 or 10 hard capsules.

Single pack containing 6x1, 10x1, 12x1, 30x1 or 90x1 hard capsules, together with 1 inhaler.

Multipacks containing 96 (4 packs of 24x1) hard capsules and 4 inhalers.
Multipacks containing 150 (15 packs of 10x1) hard capsules and 15 inhalers.
Multipacks containing 150 (25 packs of 6x1) hard capsules and 25 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.

Instructions for handling and use

Please read the full Instructions for Use before using the Xoterna Breezhaler.