Finasteride 5 mg film-coated tablets

Država: Malta

Jezik: engleski

Izvor: Medicines Authority

Aktivni sastojci:

FINASTERIDE

Dostupno od:

Cipla (EU) Limited Hillbrow House, Hillbrow Road, Esher, Surrey, KT10 9NW, United Kingdom

ATC koda:

G04CB01

INN (International ime):

FINASTERIDE 5 mg

Farmaceutski oblik:

FILM-COATED TABLET

Sastav:

FINASTERIDE 5 mg

Tip recepta:

POM

Područje terapije:

UROLOGICALS

Status autorizacije:

Withdrawn

Datum autorizacije:

2015-01-27

Uputa o lijeku

PACKAGE LEAFLET: INFORMATION FOR THE USER
FINASTERIDE 5MG FILM-COATED TABLETS
(FINASTERIDE)
This medicine is for use in men only
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 to 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 is and what it is used for
2. What you need to know before you take finasteride
3. How to take Finasteride
4. Possible side effects
5. How to store Finasteride
6. Contents of the pack and other information
1.
WHAT FINASTERIDE IS AND WHAT IT IS USED FOR
The name of your medicine is Finasteride 5 mg Film-coated Tablets.
Finasteride tablets are film-
coated tablets and contain the active ingredient finasteride. This
belongs to a group of medicines
called ‘testosterone-5-alpha reductase inhibitors’.
Finasteride shrinks the prostate gland in adult men when it is
swollen. 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 mo

Svojstava lijeka

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Finasteride 5 mg film-coated tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 5 mg of finasteride
Excipients include lactose monohydrate (see section
_4.3_
).
For a full list of excipients, see section
_6.1_
.
3
PHARMACEUTICAL FORM
Film-coated tablet
Finasteride tablets are light blue, circular, biconvex, film coated
tablets, debossed with FIN
on one side and plain on the other side.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Finasteride 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.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
The recommended adult dose is one 5 mg tablet daily, with or without
food.
'Finasteride' can be administered alone or in combination with the
alpha-blocker doxazosin
(see section 5.1).
Although early improvement in symptoms may be seen, treatment for at
least six months
may be necessary to assess whether a beneficial response has been
achieved. Thereafter,
treatment should be continued long term.
Page
1
of
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No dosage adjustment is required in the elderly or in patients with
varying degrees of renal
insufficiency (creatinine clearances as low as 9 ml/min).
There are no data available in patients with hepatic insufficiency.
'Finasteride' is contra-indicated in children.
4.3
CONTRAINDICATIONS
Finasteride is not indicated for use in women or children.
Finasteride is contraindicated in the following:
•
Hypersensitivity to the active substance or to any of the excipients
listed in section
6.1.
•
Pregnancy - Use in women when they are or may potentially be pregnant.
(see
section 4.6 Pregnancy and lactation, Exposure to finasteride - risk to
male fetus).
4.4
SPEC