Country: Malaysia
Bahasa: Inggeris
Sumber: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
FESOTERODINE FUMARATE
PFIZER (MALAYSIA) SDN. BHD.
FESOTERODINE FUMARATE
gmml7Tablet mL; gmml28Tablet mL; gmml84Tablet mL; gmml56Tablet mL; gmml98Tablet mL; gmml14Tablet mL; gmml30Tablet mL
Aesica Pharmaceuticals GmBH (i)
Not Applicable. Baca dokumen lengkap
Pfizer Confidential CLD Title : TOVIAZ (Fesoterodine fumarate) CLD Date : 06 July 2021 Country : Malaysia Reference Documents : USPI dated 9 July 2021, EU SmPC dated 27 November, 2020, CDS v12.0 dated 5 Feb 2021 Reason for change : PfLEET 2021-0070962 (M): To align information under section 4.4, 4.5 and 4.8 with the respective reference labels. : PfLEET 2021-0068326 (S2): To update Post marketing experience in section 4.8. Pfizer Confidential 1 1. NAME OF THE MEDICINAL PRODUCT Toviaz ® 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Toviaz ® (Fesoterodine fumarate) prolonged-release tablets 4 mg are light blue, oval, biconvex, film-coated and engraved with “FS” on one side. Each tablet contains fesoterodine fumarate equivalent to 3.1 mg fesoterodine. Toviaz ® (Fesoterodine fumarate) prolonged-release tablets 8 mg are blue, oval, biconvex, film-coated and engraved with “FT” on one side. Each tablet contains fesoterodine fumarate equivalent to 6.2 mg fesoterodine. 3. PHARMACEUTICAL FORM Prolonged-release tablets 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATION Toviaz ® is indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and frequency. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION POSOLOGY _Adults (including elderly)_ The recommended starting dose is 4 mg once daily. Based upon individual response, the dose may be increased to 8 mg once daily. The maximum daily dose is 8 mg. Full treatment effect was observed between 2 and 8 weeks. Hence, it is recommended to re-evaluate the efficacy for the individual patient after 8 weeks of treatment. Tablets are to be taken once daily with liquid and swallowed whole. Toviaz ® can be administered with or without food and should not be chewed, divided, or crushed. In subjects with normal renal and hepatic function receiving concomitant administration of potent CYP3A4 inhibitors, the maximum daily dose of Toviaz ® should be 4 mg once daily [see section INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF INTERACT Baca dokumen lengkap