BEVESPI AEROSPHERE Pressurised inhalation, suspension Ref.[51295] Active ingredients: Eformoterol Formoterol and Glycopyrronium bromide Glycopyrronium

Posology

The recommended dose is two inhalations twice daily (two inhalations in the morning and two inhalations in the evening).

Patients should be advised not to take more than 2 inhalations twice daily.

If a dose is missed, it should be taken as soon as possible and the next dose should be taken at the usual time. A double dose should not be taken to make up for a forgotten dose.

Special populations

Elderly

No dose adjustments are required in elderly patients (see section 5.2).

Renal impairment

Bevespi Aerosphere 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

Bevespi Aerosphere can be used at the recommended dose in patients with mild to moderate hepatic impairment. There are no relevant data on the use of Bevespi Aerosphere in patients with severe hepatic impairment and the medicinal product should be used with caution in these patients (see sections 4.4 and 5.2).

Paediatric population

There is no relevant use of Bevespi Aerosphere in children and adolescents (under 18 years of age) for the indication of COPD.

Method of administration

For inhalation use.

Instructions for use

On actuation of Bevespi Aerosphere, a volume of the suspension is expelled from the pressurised container at high velocity. When the patient inhales through the mouthpiece at the same time as actuating the inhaler, the substance will follow the inspired air into the airways.

Note: Patients should be instructed on the correct inhalation technique. It is important to instruct the patient to:

• Carefully read the instructions for use in the package leaflet, which is packed together with each inhaler.
• Not use the inhaler if the drying agent, which is inside the foil pouch, has leaked out of its packet.
• Prime the inhaler by shaking it and actuating into the air four times before first use or two times when the inhaler has not been used for more than seven days, has been exposed to low temperatures, or has been dropped.

To get adequate lung deposition of the active substances, actuation must be co-ordinated with inhalation.

Patients who find it difficult to co-ordinate actuation with inspiration of breath may use Bevespi Aerosphere with a spacer to ensure proper administration of the product. Compatibility with the Aerochamber Plus Flow-Vu spacer device has been demonstrated (see section 5.2).

An overdose of Bevespi Aerosphere may lead to exaggerated anticholinergic and/or β2-adrenergic signs and symptoms, the most frequent of which include blurred vision, dry mouth, nausea, muscle spasm, tremor, headache, palpitations and systolic hypertension.

If overdose occurs, the patient should be treated supportively with appropriate monitoring as necessary.

30 months.

To be used within 3 months of opening the pouch.

Do not store above 30°C.

Do not expose to temperatures higher than 50°C.

Do not pierce the pressurised container.

The inhaler is a pressurised metered dose inhaler, comprising an aluminium pressurised container with an attached dose indicator, supplied with a white plastic actuator body and mouthpiece with an orange dust cap. Each inhaler is individually packaged in a foil laminate pouch containing a desiccant sachet and packed into a carton.

Pack sizes:

Pack of 1 inhaler with 120 actuations.

Multipack containing 360 (3 inhalers of 120) actuations.

Not all pack sizes may be marketed.

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.

The pressurised container should not be broken, punctured or burnt, even when apparently empty.