Fesoterodine Pinewood 4 mg prolonged-release tablets

Country: Ireland

Bahasa: Inggeris

Sumber: HPRA (Health Products Regulatory Authority)

Beli sekarang

Download Risalah maklumat (PIL)
20-02-2024
Download Ciri produk (SPC)
29-01-2024

Bahan aktif:

Fesoterodine fumarate

Boleh didapati daripada:

Pinewood Laboratories Ltd

Kod ATC:

G04BD11

INN (Nama Antarabangsa):

Fesoterodine fumarate

Borang farmaseutikal:

Prolonged-release tablet

Kawasan terapeutik:

fesoterodine

Status kebenaran:

Marketed

Tarikh kebenaran:

2022-07-15

Risalah maklumat

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

                                Health Products Regulatory Authority
29 January 2024
CRN00DVT7
Page 1 of 9
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Fesoterodine Pinewood 4 mg prolonged-release tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each prolonged-release tablet contains 4 mg fesoterodine fumarate
corresponding to 3.1 mg of fesoterodine.
Excipients with known effect
Each prolonged-release tablet contains 72.0 mg of fructose and 58.07
mg of lactose.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Prolonged-release tablet
Blue elliptical, biconvex and debossed with "F4" on one side.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Fesoterodine 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 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
Contraindicated
Hepatic impairment ​
Mild
4→8 mg
(2)
4 mg
Should be avoided
Moderate
4
                                
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