Fintrid 5 mg film-coated tablets

Land: Ierland

Taal: Engels

Bron: HPRA (Health Products Regulatory Authority)

Werkstoffen:

Finasteride

Beschikbaar vanaf:

Aurobindo Pharma (Malta) Limited

ATC-code:

G04CB; G04CB01

INN (Algemene Internationale Benaming):

Finasteride

Dosering:

5 milligram(s)

farmaceutische vorm:

Film-coated tablet

Prescription-type:

Product subject to prescription which may not be renewed (A)

Therapeutisch gebied:

Testosterone-5-alpha reductase inhibitors; finasteride

Autorisatie-status:

Not marketed

Autorisatie datum:

2008-06-20

Bijsluiter

PACKAGE LEAFLET: INFORMATIONFOR THE USER
FINTRID 5 MG FILM-COATED TABLETS
Finasteride
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 Fintrid is and what it is used for
2.
What you need to know before
you take Fintrid
3.
How to take Fintrid
4.
Possible side effects
5.
How to store Fintrid
6.
Contents of the pack and other
information
1.
WHAT FINTRID
IS AND WHAT IT IS USED FOR
Fintrid belongs to the group of medicines, called 5-alpha reductase
inhibitors. It binds to the enzyme
5-alpha reductase, thereby inhibiting the formation of the substance
that plays a role in the
enlargement of the prostate. As a result of this inhibition, further
enlargement of the prostate is
prevented. With longer term use, the enlarged prostate becomes smaller
in most cases.
This medicine is intended for use with men only.
WHY HAS YOUR DOCTOR PRESCRIBED
FINTRID?
Finasteride is a specific enzyme inhibitor that is used to treat men
with benign prostatic enlargement
(benign prostatic hyperplasia, BPH). Fintrid reduces the enlarged
prostate and relieves urinary tract
symptoms. This medicine reduces the risk of suddenly being unable to
urinate (acute urinary retention)
and having to undergo surgery.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE FINTRID
DO NOT TAKE FINTRID
- if you are allergic to finasteride or any of the other ingredients
of this medicine (listed in section 6)
- if you are a woman (because this medicine is for men)
- if you are a child.
The condition for which Fintrid is prescribed only affects men. Women
who a

Productkenmerken

Health Products Regulatory Authority
12 October 2020
CRN009K13
Page 1 of 8
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Fintrid 5 mg film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 5 mg finasteride.
Excipient with known effect: lactose monohydrate (97.5 mg).
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet.
Blue coloured, circular, biconvex, beveled edged film-coated tablets
debossed with ‘E’ on one side and ‘61’ on the other side.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Fintrid 5 mg is indicated for the treatment and control of benign
prostatic hyperplasia (BPH) to:

cause regression of the enlarged prostate, improve urinary flow and
improve the symptoms associated with BPH,

reduce the incidence of acute urinary retention and reduce need for
surgery including transurethral resection of
the prostate (TURP) and prostatectomy.
Fintrid should be administered in patients with an enlarged prostate
(prostate volume above ca. 40ml).
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Dosage
The recommended dose is one Fintrid5 mg tablet daily (equivalent to 5
mg finasteride).
Fintrid can be given alone or in combination with the alpha-blocker
doxazosin (see section 5.1Pharmacodynamic properties).
Posology
Dosage in adults
Even though improvement can be seen within a short time, treatment for
at least 6 months may be necessary in order to
determine objectively whether a satisfactory response to treatment has
been achieved.
Dosage in the elderly
Dosage adjustments are not necessary although pharmacokinetic studies
have shown that the elimination rate of finasteride is
slightly decreased in patients over the age of 70.
DOSAGE IN HEPATIC INSUFFICIENCY
There is no data available in patients with hepatic insufficiency (see
section 4.4).
DOSAGE IN RENAL INSUFFICIENCY
Dosage adjustments are not necessary in patients with varying degrees
of renal insufficiency (starting from creatinine clearance
as low