Mingocare 4 mg prolonged-release tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Fesoterodine fumarate

Available from:

Ceres Pharma

ATC code:

G04BD11

INN (International Name):

Fesoterodine fumarate

Pharmaceutical form:

Prolonged-release tablet

Therapeutic area:

fesoterodine

Authorization status:

Not marketed

Authorization date:

2023-01-06

Patient Information leaflet

Package leaflet
Mingocare
1 / 2
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
MINGOCARE 4 MG PROLONGED-RELEASE TABLETS
MINGOCARE 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 Mingocare is and what it is used for
2.
What you need to know before you take Mingocare
3.
How to take Mingocare
4.
Possible side effects
5.
How to store Mingocare
6.
Contents of the pack and other information
1.
WHAT MINGOCARE IS AND WHAT IT IS USED FOR
Mingocare 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.
Mingocare 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 MINGOCARE
DO NOT TAKE MINGOCARE

If you are allergic to fesoterodine or fructose or to any of the other
ingredients of Mingocare (listed in section
6) (see section 2, “Mingocare 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 eye disease called narrow angle glaucoma (high pressure
in the eye), which is not under
control.
�

Summary of Product characteristics

Health Products Regulatory Authority
06 January 2023
CRN00CG82
Page 1 of 8
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Mingocare 4 mg prolonged-release tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
_Mingocare 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
_Mingocare 4 mg prolonged-release tablets_
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.
Mingocare 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
Mingocare 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 Mingocare 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
​
Moderat