Fesoterodine Aristo 8 mg prolonged-release tablets

Country: Ирска

Језик: Енглески

Извор: HPRA (Health Products Regulatory Authority)

Активни састојак:

Fesoterodine fumarate

Доступно од:

Aristo Pharma GmbH

АТЦ код:

G04BD11

INN (Међународно име):

Fesoterodine fumarate

Дозирање:

8 milligram(s)

Фармацеутски облик:

Prolonged-release tablet

Терапеутска област:

fesoterodine

Статус ауторизације:

Marketed

Датум одобрења:

2021-11-26

Информативни летак

PACKAGE LEAFLET: INFORMATION FOR THE USER
FESOTERODINE ARISTO 4 MG PROLONGED-RELEASE TABLETS
FESOTERODINE ARISTO 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 Aristo is and what it is used for
2. What you need to know before you take Fesoterodine Aristo
3. How to take Fesoterodine Aristo
4. Possible side effects
5. How to store Fesoterodine Aristo
6. Contents of the pack and other information
1. WHAT FESOTERODINE ARISTO IS AND WHAT IT IS USED FOR
Fesoterodine Aristo 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 Aristo 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 ARISTO
DO NOT TAKE FESOTERODINE ARISTO:

if you are allergic to fesoterodine or to any of the other ingredients
of Fesoterodine Aristo (listed
in section 6) (see section 2, “Fesoterodine Aristo contains lactose
and sodium”);

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 call

Карактеристике производа

Health Products Regulatory Authority
25 April 2023
CRN00DC79
Page 1 of 9
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Fesoterodine Aristo 8 mg prolonged-release tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each prolonged-release tablet contains 8 mg fesoterodine fumarate
corresponding to 6.2 mg of fesoterodine.
Excipients with known effect
Each 8 mg prolonged-release tablet contains 117.9 mg of lactose (as
lactose monohydrate).
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Prolonged-release tablet.
The 8 mg tablets are blue, oval, biconvex, 13.1 x 6.6mm film-coated
tablets and engraved on one side with the number '8'.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Fesoterodine Aristo 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 Aristo 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)
4 mg
Should be avoided
Moderate
4→8 mg
(2)
4 mg
Contraindicated
Severe
4 mg
Should be avoided
Contraindicate