FINTRID 5 Milligram Film Coated Tablet

Land: Irland

Sprache: Englisch

Quelle: HPRA (Health Products Regulatory Authority)

Wirkstoff:

FINASTERIDE

Verfügbar ab:

Aurobindo Pharma Limited

ATC-Code:

G04CB01

INN (Internationale Bezeichnung):

FINASTERIDE

Dosierung:

5 Milligram

Darreichungsform:

Film Coated Tablet

Verschreibungstyp:

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

Therapiebereich:

Testosterone-5-alpha reductase inhibitors

Berechtigungsstatus:

Transfer Pending

Berechtigungsdatum:

2008-06-20

Gebrauchsinformation

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. They act by reducing the
size of the prostate gland in men.
Fintrid is used in the treatment and control of benign enlargement of
the prostate (benign prostatic
hyperplasia - BPH). It causes regression of the enlarged prostate,
improves urinary flow and symptoms
caused by BPH, and reduces the risk of acute urinary retention and the
need for 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.
_ _
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before taking Fintrid.
−
if you have a large amount of residual urine and/or severely reduced
urinary flow. If this is the
case, you should be closely monitored for narrowing of the urinary
tract.
−
if you have a PSA test (test used to detect prostate cancer). Tell
your doctor that you are taking
finasteride. Finasteride can affect the blood levels of the substance
being tested, PSA.

Fachinformation

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
Fintrid is for oral use only.
Posology
DOSAGE IN ADULTS
The recommended dosage is one 5 mg tablet daily with or without food.
The tablet should be swallowed whole and
must not be divided or crushed (see section 6.6).
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 as 9 ml/min) as in pharmacokinetic studies renal
insufficiency was not found to affect the elimination
H
E
A