DETRUSITOL SR CAPSULE 4 MG [SIN11857P]

Product Info

DETRUSITOL SR CAPSULE 4 MG

[SIN11857P]

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
The extended-release capsules can be taken with or without food and must be swallowed whole (see Section 5.2 – Pharmacokinetic Properties, Pharmacokinetic characteristics – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Adults (including the Elderly)
The recommended total daily dose is 4 mg. Dosage with tolterodine capsules is 4 mg once 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 capsules 2 mg once 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 capsules 2 mg once 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 capsules 2 mg once 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
Tolterodine is contraindicated in patients with:

• Known hypersensitivity to tolterodine or any other component of the product

• Urinary retention

• Uncontrolled narrow angle glaucoma