IFU — Tiotropex
IFU labeling artefact for Tiotropizone in Spain. Version 15.3. Language: en.
Artifact ID
LBL-013
Type
IFU
Product
Market
Spain
Version
15.3
Language
en
Status
Approved
Last Reviewed
2023-05-29
Included Statements (9)
| ID | Type | Source | Text | Approved |
|---|---|---|---|---|
| STMT-037 | PK | SmPC Section 4.1 | The mean terminal half-life is approximately 18 hours following oral administrat… | 2024-01-12 |
| STMT-038 | Contraindication | SmPC Section 4.2 | Renal impairment does not significantly alter the pharmacokinetics of this compo… | 2023-12-30 |
| STMT-039 | Dosing | SmPC Section 4.4 | Patients should be advised not to drive or operate machinery if they experience … | 2024-05-18 |
| STMT-040 | Special Population | SmPC Section 4.2 | Treatment should be initiated under the supervision of a physician experienced i… | 2022-11-09 |
| STMT-041 | Efficacy | SmPC Section 5.1 | Serious hypersensitivity reactions, including anaphylaxis, have been reported.… | 2022-12-07 |
| STMT-042 | Efficacy | SmPC Section 4.8 | This medicinal product is contraindicated in patients with known hypersensitivit… | 2023-09-28 |
| STMT-043 | Interaction | SmPC Section 5.2 | Drug interactions with strong CYP3A4 inhibitors may increase exposure by up to 3… | 2024-04-23 |
| STMT-044 | Contraindication | SmPC Section 5.1 | Long-term studies in animals have shown no evidence of carcinogenic potential.… | 2023-01-20 |
| STMT-045 | Interaction | SmPC Section 4.3 | The recommended dose is 10 mg once daily administered orally.… | 2024-06-16 |
Change History
Posology revision
Updated section 4.4 — special warnings