Spiriva Handihaler/Spiriva Respimat Special Precautions

Spiriva Handihaler: SPIRIVA, as a once daily maintenance bronchodilator, should not be used for the initial treatment of acute episodes of bronchospasm, i.e. rescue therapy.
Spiriva Respimat: SPIRIVA RESPIMAT, as a once daily maintenance bronchodilator, should not be used for the initial treatment of acute episodes of bronchospasm or for the relief of acute symptoms. In the event of an acute attack, a rapid-acting beta-2-agonist should be used.
SPIRIVA RESPIMAT should not be used as a first-line treatment for asthma. Asthma patients must be advised to continue taking anti-inflammatory therapy, i.e. inhaled corticosteroids, unchanged after the introduction of SPIRIVA RESPIMAT, even when their symptoms improve.
Immediate hypersensitivity reactions may occur after administration of SPIRIVA inhalation powder/SPIRIVA RESPIMAT inhalation solution.
As with other anticholinergic drugs, SPIRIVA/SPIRIVA RESPIMAT should be used with caution in patients with narrow-angle glaucoma, prostatic hyperplasia or bladder-neck obstruction.
Inhaled medicines may cause inhalation-induced bronchospasm.
As with all predominantly renally excreted drugs, SPIRIVA/SPIRIVA RESPIMAT use should be monitored closely in patients with moderate to severe renal impairment (creatinine clearance of ≤ 50 ml/min).
Patients must be instructed in the correct administration of SPIRIVA capsules/SPIRIVA RESPIMAT. Care must be taken not to allow the powder to enter into the eyes. Eye pain or discomfort, blurred vision, visual halos or coloured images in association with red eyes from conjunctival congestion and corneal oedema may be signs of acute narrow-angle glaucoma. Should any combination of these symptoms develop specialist advice should be sought immediately.
Miotic eye drops are not considered to be effective treatment.
SPIRIVA/SPIRIVA RESPIMAT should not be used more frequently than once daily.
SPIRIVA capsules and SPIRIVA cartridges are to be used only with the HandiHaler device and RESPIMAT inhaler, respectively.
Excipients: Spiriva Respimat contains Benzalkonium chloride.
This medicine contains 0.0011 mg benzalkonium chloride in each actuation.
Benzalkonium chloride may cause wheezing and breathing difficulties. Patients with asthma are at an increased risk for these adverse events.
Effects on ability to drive and use machines: No studies on the effects on the ability to drive and use machines have been performed. The occurrence of dizziness or blurred vision may influence the ability to drive and use machinery.