SPIRIVA® RESPIMAT® RE-USABLE SOLUTION FOR INHALATION 2.5 MICROGRAM
4.1 Therapeutic indications
COPD
SPIRIVA RESPIMAT re-usable is indicated as a maintenance bronchodilator treatment to relieve symptoms of patients with chronic obstructive pulmonary disease (COPD).
Asthma
SPIRIVA RESPIMAT re-usable is indicated as add-on maintenance bronchodilator treatment in patients aged 6 years and older with moderate to severe asthma.
4.3 Contraindications
SPIRIVA RESPIMAT re-usable is contraindicated in patients with hypersensitivity to tiotropium bromide, atropine or its derivatives, e.g. ipratropium or oxitropium or to any of the excipients (see 6.1 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).
4.2 Posology and method of administration
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 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).
Hepatically impaired patients can use tiotropium bromide at the recommended dose (see 5.2 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).
Paediatric population
COPD
SPIRIVA RESPIMAT re-usable is not recommended for use in children and adolescents below 18 years due to lack of data on safety and efficacy (see 5.1 and 5.2 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).
Asthma
In asthma, the recommended dosage of tiotropium using the SPIRIVA RESPIMAT re-usable in patients 6 to 17 years of age is 5 micrograms. This is administered as two puffs once daily from the RESPIMAT inhaler, at the same time each day (see RESPIMAT inhaler Instructions for Use – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).
SPIRIVA RESPIMAT re-usable has not been studied in children less than 1 year old.
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.
