TOVIAZ 8 MG

Țară: Israel

Limbă: engleză

Sursă: Ministry of Health

Ingredient activ:

FESOTERODINE FUMARATE

Disponibil de la:

PFIZER PHARMACEUTICALS ISRAEL LTD

Codul ATC:

G04BD11

Forma farmaceutică:

TABLETS SUSTAINED RELEASE

Compoziție:

FESOTERODINE FUMARATE 8 MG

Calea de administrare:

PER OS

Tip de prescriptie medicala:

Required

Produs de:

PFIZER INC, USA

Grupul Terapeutică:

FESOTERODINE

Zonă Terapeutică:

FESOTERODINE

Indicații terapeutice:

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

Data de autorizare:

2023-09-30

Prospect

Toviaz PIL WC 111223
2022-0082192, 2023-0088299
PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS' REGULATIONS
(PREPARATIONS) - 1986
This medicine is dispensed with a doctor's prescription only
TOVIAZ
® 4 MG
TOVIAZ
® 8 MG
SUSTAINED-RELEASE TABLETS
EACH TABLET CONTAINS:
FESOTERODINE FUMARATE 4 MG, 8 MG
Inactive ingredients and allergens: See section 2 under ‘Important
information about some of this medicine’s
ingredients’ and section 6 ‘Further information'.
READ THE ENTIRE LEAFLET CAREFULLY BEFORE USING THIS MEDICINE. This
leaflet contains concise information
about this medicine. If you have any further questions, consult your
doctor or pharmacist.
This medicine has been prescribed for you. Do not pass it on to
others. It may harm them, even if it seems to
you that their medical condition is similar to yours. This medicine is
generally not indicated in children under
the age of 18.
1.
WHAT IS THIS MEDICINE INTENDED FOR?
For the treatment of symptoms that may occur in patients with
overactive bladder syndrome such as
increased urinary frequency and/or urgency and/or urgency
incontinence.
THERAPEUTIC GROUP:
Muscarinic receptor antagonist.
2.
BEFORE USING THIS MEDICINE
DO NOT USE THIS MEDICINE IF:
•
You are sensitive (allergic) to the active ingredient, soya, peanuts
or to any of the other ingredients in this
medicine (listed in section 6) (see also section 2,’Important
information about some of this medicine’s
ingredients’).
•
You are unable to completely empty your bladder (urinary retention).
•
Your stomach empties slowly (gastric retention).
•
You have an eye disease called narrow angle glaucoma (high pressure in
the eye), which is not under control.
•
You have excessive weakness of the muscles (myasthenia gravis).
•
You have severe ulcerative colitis.
•
You have an abnormally large or distended colon (toxic megacolon).
•
You have severe liver problems.
•
You have kidney problems or moderate to severe liver problems and are
taking medicines containing any of
the following activ

Caracteristicilor produsului

Toviaz LPD CC 040124
2022-0082192, 2023-0088299, 2022-0083135
1
4 MG
®
TOVIAZ
8 MG
®
TOVIAZ
1.
NAME OF THE MEDICINAL PRODUCT
TOVIAZ 4 mg
TOVIAZ 8 mg
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
TOVIAZ 4 mg
Each sustained release tablet contains fesoterodine fumarate 4 mg.
TOVIAZ 8 mg
Each sustained release tablet contains fesoterodine fumarate 8 mg.
Excipients with known effect
_TOVIAZ 4 mg _
Each 4 mg sustained release tablet contains 0.525 mg of soya lecithin
and 91.125 mg of lactosemonohydrate.
_TOVIAZ 8 mg _
Each 8 mg sustained release tablet contains 0.525 mg of soya lecithin
and 58.125 mg of lactosemonohydrate.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Sustained release tablet.
TOVIAZ 4 mg
The 4 mg tablets are light blue, oval, biconvex, film-coated, and
engraved on one side with the letters ‘FS’.
TOVIAZ 8 mg
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
Treatment of the symptoms (increased urinary frequency and/or urgency
and/or urgency incontinence) that
may occur in patients 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.
Toviaz LPD CC 040124
2022-0082192, 2023-0088299, 2022-0083135
2
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 renal or hepatic
impairment in the absence and presence of moder