Spiriva Respimat 2.5 microgram, inhalation solution
The delivered dose is 2.5 microgram tiotropium per puff (2 puffs comprise one medicinal dose) and is equivalent to 3.124 microgram tiotropium bromide monohydrate.
The delivered dose is the dose which is available for the patient after passing the mouthpiece.
For the full list of excipients, see section 6.1.
Inhalation solution
Clear, colourless, inhalation solution
COPD
Tiotropium is indicated as a maintenance bronchodilator treatment to relieve symptoms of patients with chronic obstructive pulmonary disease (COPD).
Asthma
Spiriva Respimat is indicated as an add-on maintenance bronchodilator treatment in adult patients with asthma who are currently treated with the maintenance combination of inhaled corticosteroids (≥800 µg budesonide/day or equivalent) and long-acting β2 agonists and who experienced one or more severe exacerbations in the previous year.
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.
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
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).
Asthma
The efficacy and safety of Spiriva Respimat in children and adolescents has not yet been established.
Method of administration
To ensure proper administration of the medicinal product, the patient should be shown how to use the inhaler by a physician or other health professionals.
Patient's instructions for use and handling
Spiriva Respimat inhaler and Spiriva Respimat cartridge
1) Inserting the cartridge
The following steps 1-6 are necessary before first use:
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1 With the green cap (A) closed, press the safety catch (E) while pulling off the clear base (G).
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2 Take the cartridge (H) out of the box. Push the narrow end of the cartridge into the inhaler until it clicks into place. The cartridge should be pushed firmly against a firm surface to ensure that it has gone all the way in (2b).
The cartridge will not be flush with the inhaler, you will still see the silver ring of the lower end of the cartridge.
Do not remove the cartridge once it has been inserted into the inhaler.
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3 Replace the clear base (G).
Do not remove the clear base again.
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2) To prepare the Spiriva Respimat inhaler for first-time use
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4 Hold the Spiriva Respimat inhaler upright, with the green cap (A) closed. Turn the base (G) in the direction of the black arrows on the label until it clicks (half a turn).
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5 Open the green cap (A) until it snaps fully open.
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6 Point the Spiriva Respimat inhaler towards the ground.
Press the dose release button (D). Close the green cap (A).
Repeat steps 4, 5 and 6 until a cloud is visible.
Then repeat steps 4, 5 and 6 three more times to ensure the inhaler is prepared for use.
Your Spiriva Respimat inhaler is now ready to use.
These steps will not affect the number of doses available. After preparation your Spiriva Respimat inhaler will be able to deliver your 60 puffs (30 medicinal doses).
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Daily use of your Spiriva Respimat inhaler
You will need to use this inhaler ONLY ONCE A DAY.
Each time you use it take TWO PUFFS.
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I Hold the Spiriva Respimat inhaler upright, with the green cap (A) closed, to avoid accidental release of dose. Turn the base (G) in the direction of the black arrows on the label until it clicks (half a turn).
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