Trokide Vertical-Haler^® Prescribing Information

Prescribing Information Trokide 18 micrograms, inhalation powder, hard capsules

Please refer to the Summary of Product Characteristics (SmPC) before prescribing Trokide.

Presentation:  Each capsule contains 22.5 micrograms tiotropium bromide monohydrate equivalent to 18 micrograms tiotropium. The delivered dose is 10 micrograms tiotropium.

Indication: For maintenance bronchodilator treatment to relieve symptoms of patients with chronic obstructive pulmonary disease (COPD).

Dosage and administration: One capsule once daily at the same time of day. The recommended dose should not be exceeded. Tiotropium should only be inhaled with the Vertical-Haler device.

Contraindications: Hypersensitivity to the active substance, milk proteins, the excipients, atropine or its derivatives.

Warnings and precautions: Tiotropium should not be used for the initial treatment of acute episodes of bronchospasm. Immediate hypersensitivity reactions may occur. Tiotropium should be used with caution in patients with narrow-angle glaucoma, prostatic hyperplasia or bladder-neck obstruction. Inhaled medicines may cause inhalation-induced bronchospasm. Tiotropium should be used with caution in patients with recent myocardial infarction < 6 months; any unstable or life-threatening cardiac arrhythmia or cardiac arrhythmia requiring intervention or a change in medicinal product therapy in the past year; hospitalisation of heart failure (NYHA Class III or IV) within the past year. In patients with moderate to severe renal impairment (creatinine clearance ≤ 50 ml/min), tiotropium should be used only if the expected benefit outweighs the potential risk.  Patients should be cautioned to avoid getting the inhalation powder into their eyes, this may result in precipitation or worsening of narrow-angle glaucoma, eye pain or discomfort, temporary blurring of vision, visual halos or coloured images in association with red eyes from conjunctival congestion and corneal oedema. Patients with rare hereditary problems of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicinal product. Co-administration of tiotropium with other anticholinergic-containing medicinal products is not recommended. The occurrence of dizziness, blurred vision, or headache may influence the ability to drive and use machinery.

Pregnancy and breast-feeding: Pregnancy – As a precautionary measure, it is preferable to avoid the use of Trokide during pregnancy. Breastfeeding – Use of tiotropium is not recommended.

Undesirable effects: Serious side effects: Glaucoma, atrial fibrillation, intestinal obstruction, ileus paralytic, hypersensitivity, angioedema, anaphylactic reaction, urinary retention. Common side effects: Dry mouth. For full list of side effects, consult SmPC.

Legal Category: POM

Pack size and price: Device and 30 capsules £12.50. 30 capsules £8.50.

MA number(s): PL 06831/0381

MA Holder: Genus Pharmaceuticals Ltd. t/a ‘STADA’ Linthwaite Huddersfield HD7 5QH, United Kingdom

Date of Preparation: July 2024

Unique ID number:  UK-TROK-2