Fesoterodine Liconsa 4 mg prolonged-release tablets

Negara: Irlandia

Bahasa: Inggris

Sumber: HPRA (Health Products Regulatory Authority)

Bahan aktif:

Fesoterodine fumarate

Tersedia dari:

Laboratorios LICONSA, S.A.

Kode ATC:

G04BD11

INN (Nama Internasional):

Fesoterodine fumarate

Bentuk farmasi:

Prolonged-release tablet

Area terapi:

fesoterodine

Status otorisasi:

Not marketed

Tanggal Otorisasi:

2022-08-12

Selebaran informasi

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PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
FESOTERODINE LICONSA 4 MG PROLONGED-RELEASE TABLETS
FESOTERODINE LICONSA 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 Fesoterodine Liconsa is and what it is used for
2.
What you need to know before you take Fesoterodine Liconsa
3.
How to take Fesoterodine Liconsa
4.
Possible side effects
5.
How to store Fesoterodine Liconsa
6.
Contents of the pack and other information
1.
WHAT FESOTERODINE LICONSA IS AND WHAT IT IS USED FOR
Fesoterodine
Liconsa
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.
Fesoterodine Liconsa 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 FESOTERODINE LICONSA DO NOT TAKE
FESOTERODINE LICONSA
:
-
if you are allergic to fesoterodine or fructose or to any of the other
ingredients of Fesoterodine
Liconsa (listed in section 6) (see section 2, “Fesoterodine Liconsa
contains lactose and fructose”)
-
if you are not able to completely empty your bladder (urinary
retention)
-
if your stomach empties slowly (gastric retention)
-
if you have an

Karakteristik produk

Health Products Regulatory Authority
12 August 2022
CRN00CJ0H
Page 1 of 10
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Fesoterodine Liconsa 4 mg prolonged-release tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Fesoterodine Liconsa 4 mg prolonged-release tablets
Each prolonged-release tablet contains 4 mg fesoterodine fumarate
corresponding to 3.1 mg of fesoterodine.
Excipients with known effect
Fesoterodine Liconsa 4 mg prolonged-release tablets
Each tablet contains 72 mg of fructose and 58 mg of lactose.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Prolonged-release tablet.
Fesoterodine Liconsa 4 mg prolonged-release tablets: Blue elliptical,
biconvex film-coated tablets approximately 6 mm
diameter and debossed with "F4" on one side.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Fesoterodine Liconsa 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.
In subjects with normal renal and hepatic function receiving
concomitant administration of potent CYP3A4 inhibitors, the
maximum daily dose of Fesoterodine Liconsa 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 moderate and potent CYP3A4 inhibitors (see sections
4.3, 4.4, 4.5 and 5.2).
​
Moderate(3) or potent(4) CYP3A4 inhibitors ​
​
​
​
None
Moderate
Potent
Renal impairment(1)
Mild
4→8 mg(2)