Finasteride 5mg Film-coated Tablets

Страна: Малта

Език: английски

Източник: Medicines Authority

Активна съставка:

FINASTERIDE

Предлага се от:

Accord Healthcare Ireland Ltd Euro House, Euro Business Park, Little Island Cork, T45 K857, Ireland

АТС код:

D11AX10

INN (Международно Name):

FINASTERIDE 5 mg

Лекарствена форма:

FILM-COATED TABLET

Композиция:

FINASTERIDE 5 mg

Вид предписание :

POM

Терапевтична област:

OTHER DERMATOLOGICAL PREPARATIONS

Статус Оторизация:

Withdrawn

Дата Оторизация:

2011-04-01

Листовка

Page
1
of
6
PACKAGE LEAFLET: INFORMATION FOR THE USER
FINASTERIDE 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, pharmacist or
nurse.
−
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 of the side effects, talk to your doctor, pharmacist or
nurse. This includes any
possible side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Finasteride 5 mg Tablets is and what it is used for
2.
What you need to know before you take Finasteride 5 mg Tablets
3.
How to take Finasteride 5 mg Tablets
4.
Possible side effects
5.
How to store Finasteride 5 mg Tablets
6.
Contents of the pack and other information
1.
WHAT FINASTERIDE 5 MG TABLETS IS AND WHAT IT IS USED FOR
Finasteride belongs to the group of medicines called 5-alpha reductase
inhibitors.
They act by reducing the size of the prostate gland in men.
Finasteride shrinks the prostate gland in men when it is swollen.
Finasteride is used in the treatment
and control of benign (i.e., non-cancerous) enlargement of the
prostate (benign prostatic hyperplasia
- BPH). The prostate gland is found underneath the bladder (but only
in man). It produces the fluid
found
in
semen.
A
swollen
prostate
gland
can
lead
to
a
condition
called
‘benign
prostatic
hyperplaia’ (BPH). Finasteride causes shrinkage of the enlarged
prostate, improves urinary flow and
symptoms caused by BPH, and reduces the risk of you developing a
sudden inability to pass urine
(known as acute urinary retention) and the need for surgery.
WHAT IS BPH?
If you have BPH it means that your prostate gland is swollen. It can
press on the tube that urine
passes through, on its way out of your body.
This can lead to problems such as
- Feeling like yo

Данни за продукта

Page 1 of 11
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Finasteride 5 mg Film-coated Tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
One film-coated tablet contains 5 mg finasteride
Excipient(s) with known effect: lactose monohydrate (90.95 mg)
For the full list of excipients, see section 6.1
3.
PHARMACEUTICAL FORM
Film-coated tablet.
Blue, round biconvex, film-coated tablet with "F5" marking on one side
and
plain on other side.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Finasteride 5 mg Tablets are 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.
Finasteride 5 mg tablets should 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 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 _
Page 2 of 11
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_
The effect of hepatic insufficiency on the pharmacokinetics of
finasteride has
not been studied. (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