Spiriva Respimat 2.5 microgram, inhalation solution

COPD

Spiriva Respimat is indicated as a maintenance bronchodilator treatment to relieve symptoms of patients with chronic obstructive pulmonary disease (COPD).

Asthma

Spiriva Respimat is indicated as add-on maintenance bronchodilator treatment in patients aged 6 years and older with severe asthma who experienced one or more severe asthma exacerbations in the preceding year (see sections 4.2 and 5.1).

Posology

The medicinal product is intended for inhalation use only. The cartridge can only be inserted and used in the Respimat inhaler (see 4.2).

Two puffs from the Respimat inhaler comprise one medicinal dose.

The recommended dose for adults is 5 microgram tiotropium given as two puffs from the Respimat inhaler once daily, at the same time of the day.

The recommended dose should not be exceeded.

In the treatment of asthma the full benefit will be apparent after several doses of the medicinal product. In adult patients with severe asthma, tiotropium should be used in addition to inhaled corticosteroids (≥ 800 μ g budesonide/day or equivalent) and at least one controller.

Special populations

Geriatric patients can use tiotropium bromide at the recommended dose.

Renally impaired patients can use tiotropium bromide at the recommended dose. For patients with moderate to severe impairment (creatinine clearance ≤ 50 ml/min, see 4.4 and 5.2).

Hepatically impaired patients can use tiotropium bromide at the recommended dose (see 5.2).

Paediatric population

Asthma

The recommended dose for patients 6 to 17 years of age is 5 microgram tiotropium given as two puffs from the Respimat inhaler once daily, at the same time of the day.

In adolescents (12 - 17 years) with severe asthma, tiotropium should be used in addition to inhaled corticosteroids (> 800 - 1600 µ g budesonide/day or equivalent) and one controller or in addition to inhaled corticosteroids (400 - 800 µ g budesonide/day or equivalent) with two controllers.

For children (6 - 11 years) with severe asthma, tiotropium should be used in addition to inhaled corticosteroids (> 400 µ g budesonide/day or equivalent) and one controller or in addition to inhaled corticosteroids (200 - 400 µ g budesonide/day or equivalent) with two controllers.

The safety and efficacy of Spiriva Respimat in children aged 6 - 17 years with moderate asthma has not been established. The safety and efficacy of Spiriva Respimat in children below 6 years of age has not been established. Currently available data are described in sections 5.1 and 5.2 but no recommendation on a posology can be made.

COPD

There is no relevant use of Spiriva Respimat in children and adolescents below 18 years.

Cystic fibrosis

The efficacy and safety of Spiriva Respimat has not been established (see sections 4.4 and 5.1).

Method of administration

This medicinal product is intended for inhalation use only. The cartridge can only be inserted and used in the Respimat re-usable inhaler. Respimat is an inhaler device that generates a spray for inhalation. It is meant for use by a single patient and intended for multiple doses delivered by one cartridge.

The Respimat re-usable inhaler allows for replacement of the cartridge, and can be used with up to 6 cartridges.

Patients should read the instructions on how to use the Respimat re-usable inhaler before they start using Spiriva Respimat.

To ensure proper administration of the medicinal product, the patient should be shown how to use the inhaler by a physician or other healthcare professional.

Instructions for handling and use of the Respimat re-usable inhaler

Children should use Spiriva Respimat with an adult's assistance.

The patient will need to use this inhaler only ONCE A DAY. Each time used take TWO PUFFS.

• If Spiriva Respimat has not been used for more than 7 days release one puff towards the ground.

• If Spiriva Respimat has not been used for more than 21 days repeat steps 4 to 6 under 'Prepare for use' until a cloud is visible. Then repeat steps 4 to 6 three more times.

How to care for the Respimat re-usable inhaler

Clean the mouthpiece including the metal part inside the mouthpiece with a damp cloth or tissue only, at least once a week.

Any minor discoloration in the mouthpiece does not affect the Respimat re-usable inhaler performance.

If necessary, wipe the outside of the Respimat re-usable inhaler with a damp cloth.

When to replace the inhaler

When the patient has used an inhaler with 6 cartridges, get a new Spiriva Respimat pack containing an inhaler. Do not use the Respimat re-usable inhaler for more than one year, after having inserted the first cartridge.

Prepare for use