TOVIAZ 8 mg prolonged-release tablets

Krajina: Malajzia

Jazyk: angličtina

Zdroj: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Aktívna zložka:

FESOTERODINE FUMARATE

Dostupné z:

PFIZER (MALAYSIA) SDN. BHD.

INN (Medzinárodný Name):

FESOTERODINE FUMARATE

Počet v balení:

gmml14Tablet mL; gmml7Tablet mL; gmml56Tablet mL; gmml28Tablet mL; gmml98Tablet mL; gmml84Tablet mL; gmml30Tablet mL

Výrobca:

Aesica Pharmaceuticals GmbH

Príbalový leták

Not Applicable.

Súhrn charakteristických

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