PROFAL 5 Milligram Film Coated Tablet

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

FINASTERIDE

Available from:

Actavis Group PTC ehf

ATC code:

G04CB01

INN (International Name):

FINASTERIDE

Dosage:

5 Milligram

Pharmaceutical form:

Film Coated Tablet

Prescription type:

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

Therapeutic area:

Testosterone-5-alpha reductase inhibitors

Authorization status:

Authorised

Authorization date:

2009-01-09

Patient Information leaflet

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
PROFAL 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 Profal is and what it is used for
2.
What you need to know before you take Profal
3.
How to take Profal
4.
Possible side effects
5.
How to store Profal
6.
Contents of the pack and other information 1.
WHAT PROFAL IS AND WHAT IT IS USED FOR
Profal contains the active substance finasteride which belongs to a
group of medicines called ‘5-alpha
reductase inhibitors’. They act by reducing the size of the prostate
gland in men.
Profal is used in the treatment and control of benign (not cancerous)_
_enlargement of the prostate.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE PROFAL
DO NOT TAKE PROFAL:
-
if you are allergic to finasteride or any of the other ingredients of
this medicine (listed in section
6).
-
if you are a woman or a child (see also ‘Pregnancy and
breast-feeding’ in this section).
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before taking Profal
-
if you have reduced liver function.
-
if you have difficulty emptying your bladder completely or a greatly
reduced flow of urine, your
doctor should examine you thoroughly_ _before you start taking Profal
to exclude other
obstructions in the urinary tract.
-
if you notice any changes in your breast tissue such as lumps, pain,
enlargement of the breast
tissue or nipple discharge as these may be signs of a serious
condition, such as breast cancer.
You should promptly report to your doctor if you

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Profal 5 mg film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 5 mg finasteride.
Excipient with known effect: Each film-coated tablet contains 90.96 mg
lactose monohydrate.
For the full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Film-coated tablet
Blue, round biconvex tablet marked “F5”. The diameter is 7 mm.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Profal is indicated for the treatment and control of benign prostatic
hyperplasia (BPH) in patients with an enlarged
prostate 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 the need for
surgery including transurethral resection of the
prostate (TURP) and prostatectomy.
Profal 5 mg tablets should only be administered in patients with an
enlarged prostate (prostate volume above ca. 40
ml).
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
For oral use only.
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 if 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 (with creatinine clearance
down to 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
haemodialysis.
Dosage in the elderly
Dosage adjustments are not
necessary although pharmacokinetic studies have shown that
the elimination rate of
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