Finasteride Aurobindo 5 mg film-coated tablets

Država: Malta

Jezik: angleščina

Source: Medicines Authority

Aktivna sestavina:

FINASTERIDE

Dostopno od:

Aurobindo Pharma (Malta) Limited Vault 14, Level 2, Valletta Waterfront, Floriana FRN 1913, Malta

Koda artikla:

G04CB01

INN (mednarodno ime):

FINASTERIDE 5 mg

Farmacevtska oblika:

FILM-COATED TABLET

Sestava:

FINASTERIDE 5 mg

Tip zastaranja:

POM

Terapevtsko območje:

UROLOGICALS

Status dovoljenje:

Authorised

Datum dovoljenje:

2016-09-14

Navodilo za uporabo

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PACKAGE LEAFLET: INFORMATION FOR THE USER
FINASTERIDE AUROBINDO 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 Aurobindo is and what it is used for
2.
What you need to know before you take Finasteride Aurobindo
3.
How to take Finasteride Aurobindo
4.
Possible side effects
5.
How to store Finasteride Aurobindo
6.
Contents of the pack and other information
1.
WHAT FINASTERIDE AUROBINDO
IS AND WHAT IT IS USED FOR
Finasteride Aurobindo belongs to the group of medicines, called
5-alpha reductase inhibitors. They
act by reducing the size of the prostate gland in men.
The prostate gland is found underneath the bladder (but only in men).
It produces the fluid found in
semen. A swollen prostate gland can lead to a condition called
‘benign prostatic hyperplasia’ or BPH.
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 you need to pass urine more often, especially at night,
•
feeling that you must pass urine right away,
•
finding it difficult to start passing urine,
•
when you pass urine the flow of urine is weak,
•
when you pass urine the flow stops and starts,
•
feeling that you cannot empty your bladder completely.
In some men, BPH can lead to more serious problems, such as:
•
urinary tract infections,
•
a sudden inability to pass urine (acute urinary retention),
•
t

Lastnosti izdelka

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SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Finasteride Aurobindo 5 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 5 mg finasteride.
Excipient with known effect: contains 97.5 mg lactose monohydrate.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
Blue coloured, circular (diameter is 7.6 mm), 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
Finasteride Aurobindo 5 mg is indicated for the treatment and control
of benign prostatic hyperplasia
(BPH) in adult patients with 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 reduce need for
surgery including transurethral
resection of the prostate (TURP) and prostatectomy.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
DOSAGE IN ADULTS
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.
Special population:
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.
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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 of finasteride. Finasteride has
not been studied in patients on
haemodialysis.