Finasteride Rowex 5 mg film-coated tablets

Država: Irska

Jezik: angleščina

Source: HPRA (Health Products Regulatory Authority)

Aktivna sestavina:

Finasteride

Dostopno od:

Rowex Ltd

Koda artikla:

G04CB; G04CB01

INN (mednarodno ime):

Finasteride

Odmerek:

5 milligram(s)

Farmacevtska oblika:

Film-coated tablet

Tip zastaranja:

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

Terapevtsko območje:

Testosterone-5-alpha reductase inhibitors; finasteride

Status dovoljenje:

Not marketed

Datum dovoljenje:

2005-06-07

Navodilo za uporabo

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
FINASTERIDE ROWEX 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 Finasteride Rowex is and what it is used for
2.
What you need to know before you take Finasteride Rowex
3.
How to take Finasteride Rowex
4.
Possible side effects
5.
How to store Finasteride Rowex
6.
Contents of the pack and other information
1
WHAT FINASTERIDE ROWEX IS AND WHAT IT IS USED FOR
Finasteride Rowex is used for men to treat and control:

BENIGN PROSTATE ENLARGEMENT,
which is a nonaggressive prostate growth.
Finasteride Rowex belongs to a group of medicines called 5-alpha
reductase inhibitors. It reduces the
size of the prostate gland, improving urinary flow and other symptoms
of prostate enlargement.
Finasteride Rowex decreases the risk of suddenly being unable to pass
urine and needing surgery.
2
WHAT YOU NEED TO KNOW BEFORE YOU TAKE FINASTERIDE ROWEX
DO NOT TAKE FINASTERIDE ROWEX

if you are
ALLERGIC TO FINASTERIDE
or any of the other ingredients of this medicine (listed in section
6)

FEMALE
(see also under "Pregnancy and breast-feeding")

a
CHILD
under 18 years.
WARNINGS AND PRECAUTIONS
Talk to your doctor before taking Finasteride Rowex.
Inform your doctor if any of the following apply to you:

DIFFICULTY EMPTYING
your BLADDER
completely or a greatly REDUCED FLOW OF URINE
Your doctor will examine you before beginning Finasteride Rowex
treatment to eliminate the
possibility of other urinary tract obstructions.
�

Lastnosti izdelka

Health Products Regulatory Authority
07 May 2020
CRN009P1Q
Page 1 of 8
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Finasteride Rowex 5 mg film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 5 mg of finasteride.
Excipient with known effect
Each film-coated tablet contains 85.5 mg of lactose (as monohydrate).
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet
Blue, round, biconvex, film-coated tablet, plain on both sides.
Diameter approx. 8 mm.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Treatment and control of benign prostatic hyperplasia (BPH) tocause
regression of the enlarged prostate, improve urinary flow
and symptoms associated with BPH, reduce the incidence of acute
urinary retention and reduce need for surgery.
Finasteride Rowex 5 mg film-coated tablets should be administered in
patients with an enlarged prostate (prostate volume
above ca. 40 ml).
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
_Posology_
The recommended dosage is one 5 mg tablet daily with or without food.
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 hepatic insufficiency
There are 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 of finasteride.
Finasteride has not been studied in patients on hemodialysis.
Dosage in older people
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.
_Method of administration_
Oral use
The tablet should be swallowed whole and