Hyplafin 5mg Film-Coated Tablets

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

FINASTERIDE

Available from:

Actavis Group PTC ehf Revkjavikurvegi 76-78, 220 Hafnarfjordur, Iceland

ATC code:

G04CB01

INN (International Name):

FINASTERIDE 5 mg

Pharmaceutical form:

FILM-COATED TABLET

Composition:

FINASTERIDE 5 mg

Prescription type:

POM

Therapeutic area:

UROLOGICALS

Authorization status:

Withdrawn

Authorization date:

2010-02-25

Patient Information leaflet

Page 1 of 5
PACKAGE LEAFLET: INFORMATION FOR THE USER
HYPLAFIN 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 Hyplafin is and what it is used for
2.
What you need to know before you take Hyplafin
3.
How to take Hyplafin
4.
Possible side effects
5.
How to store Hyplafin
6.
Contents of the pack and other information 1.
WHAT HYPLAFIN IS AND WHAT IT IS USED FOR
Hyplafin 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.
Hyplafin is used in the treatment and control of benign (not
cancerous)_ _enlargement of the prostate.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE HYPLAFIN
DO NOT TAKE HYPLAFIN:
-
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 Hyplafin
-
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
Hyplafin 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 pro

Summary of Product characteristics

Page 1 of 9
SUMMARY OF THE PRODUCT CHARACTERISTICS
1
N
AME OF THE
M
EDICINAL
P
RODUCT
Hyplafin 5 mg film-coated tablets
2
Q
UALITATIVE AND
Q
UANTITATIVE
C
OMPOSITION
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
P
HARMACEUTICAL
F
ORM
Film-coated tablet
Blue, round biconvex tablet marked “F5”. The diameter is 7 mm.
4
C
LINICAL
P
ARTICULARS
4.1
THERAPEUTIC INDICATIONS
Hyplafin 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.
Hyplafin 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.
Page 2 of 9
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