Toviaz

Country: European Union

Language: English

Source: EMA (European Medicines Agency)

Active ingredient:

fesoterodine fumarate

Available from:

Pfizer Europe MA EEIG

ATC code:

G04BD11

INN (International Name):

fesoterodine

Therapeutic group:

Urologicals

Therapeutic area:

Urinary Bladder, Overactive

Therapeutic indications:

Treatment of the symptoms (increased urinary frequency and / or urgency and / or urgency incontinence) that may occur in patients with overactive-bladder syndrome.

Product summary:

Revision: 27

Authorization status:

Authorised

Authorization date:

2007-04-20

Patient Information leaflet

31
B. PACKAGE LEAFLET
32
PACKAGE LEAFLET: INFORMATION FOR THE USER
TOVIAZ 4 MG PROLONGED-RELEASE TABLETS
TOVIAZ 8 MG PROLONGED-RELEASE TABLETS
fesoterodine fumarate
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor or pharmacist.
-
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them,
even if their signs of illness are the same as yours.
-
If you get any side effects talk to your doctor or pharmacist. This
includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What TOVIAZ is and what it is used for
2.
What you need to know before you take TOVIAZ
3.
How to take TOVIAZ
4.
Possible side effects
5.
How to store TOVIAZ
6.
Contents of the pack and other information
1.
WHAT TOVIAZ IS AND WHAT IT IS USED FOR
TOVIAZ contains an active substance called fesoterodine fumarate, and
is a so called antimuscarinic
treatment which reduces the activity of an overactive bladder and it
is used in adults to treat the
symptoms.
TOVIAZ treats the symptoms of an overactive bladder such as

not being able to control when you empty your bladder (called urgency
incontinence)

suddenly needing to empty your bladder (called urgency)

having to empty your bladder more often than usual (called increased
urinary frequency)
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE TOVIAZ
DO NOT TAKE TOVIAZ:
-
if you are allergic to fesoterodine or to peanut or soya or to any of
the other ingredients of
TOVIAZ (listed in section 6) (see section 2, “TOVIAZ contains
lactose and soya oil”)
-
if you are not able to completely empty your bladder (urinary
retention)
-
if your stomach empties slowly (gastric retention)
-
if you have an eye disease called narrow angle glaucoma (high pressure
in the eye), which is not
under control
-
if you have excessive weakness of the muscles (myasthenia gra

Summary of Product characteristics

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
TOVIAZ 4 mg prolonged-release tablets
TOVIAZ 8 mg prolonged-release tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
TOVIAZ 4 mg tablets
Each prolonged-release tablet contains fesoterodine fumarate 4 mg
corresponding to 3.1 mg of
fesoterodine.
TOVIAZ 8 mg tablets
Each prolonged-release tablet contains fesoterodine fumarate 8 mg
corresponding to 6.2 mg of
fesoterodine.
Excipients with known effect
_TOVIAZ 4 mg tablets_
Each 4 mg prolonged-release tablet contains 0.525 mg of soya lecithin
and 91.125 mg of lactose.
_TOVIAZ 8 mg tablets_
Each 8 mg prolonged-release tablet contains 0.525 mg of soya lecithin
and 58.125 mg of lactose.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Prolonged-release tablet.
TOVIAZ 4 mg tablets
The 4 mg tablets are light blue, oval, biconvex, film-coated, and
engraved on one side with the letters
‘FS’.
TOVIAZ 8 mg tablets
The 8 mg tablets are blue, oval, biconvex, film-coated, and engraved
on one side with the letters ‘FT’.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
TOVIAZ is indicated in adults for treatment of the symptoms (increased
urinary frequency and/or
urgency and/or urgency incontinence) that may occur with overactive
bladder syndrome.
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.
3
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 4.5).
Special population
_Renal and hepatic impairment_
The following table provides the daily dosing recommendations for
subjects with r