TOLTERODINE MEVON IR FILM-COATED TABLET 1 MG [SIN16314P]

Product Info

TOLTERODINE MEVON IR FILM-COATED TABLET 1 MG

[SIN16314P]

4.1 Therapeutic indications
Tolterodine is indicated for the treatment of overactive bladder with symptoms of urinary urgency, frequency, and/or urge incontinence.

4.2 Posology and method of administration

Adults (including the Elderly)
The recommended total daily dose is 4 mg. Dosage with tolterodine tablets is 2 mg twice daily. The total daily dose may be reduced to 2 mg, based on individual tolerability.

Use in Children
Safety and effectiveness in children have not yet been established.

Use in Impaired Renal Function
The recommended total daily dose is 2 mg (i.e., tolterodine tablets 1 mg twice daily) for patients with impaired renal function (see Section 4.4 – Special Warnings and Precautions for Use – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Use in Impaired Hepatic Function
The recommended total daily dose is 2 mg (i.e., tolterodine tablets 1 mg twice daily) for patients with impaired hepatic function (see Section 4.4 – Special Warnings and Precautions for Use – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Use with Potent CYP3A4 Inhibitors
The recommended total daily dose is 2 mg (i.e., tolterodine tablets 1 mg twice daily) for patients receiving concomitant ketoconazole or other potent CYP3A4 inhibitors (see Section 4.4 – Special Warnings and Precautions for Use, CYP3A4 inhibitors, and Section 4.5 – Interactions with Other Medicinal Products and Other Forms of Interaction – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

4.3 Contraindications

• Hypersensitivity to the active substance or to any of the excipients

• Urinary retention

• Uncontrolled narrow angle glaucoma

• Myasthenia gravis

• Severe ulcerative colitis

• Toxic megacolon