Finasteride 5 mg Film-coated Tablets

Nazione: Irlanda

Lingua: inglese

Fonte: HPRA (Health Products Regulatory Authority)

Principio attivo:

Finasteride

Commercializzato da:

LTT Pharma Limited

Codice ATC:

G04CB; G04CB01

INN (Nome Internazionale):

Finasteride

Dosaggio:

5 milligram(s)

Forma farmaceutica:

Film-coated tablet

Tipo di ricetta:

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

Area terapeutica:

Testosterone-5-alpha reductase inhibitors; finasteride

Stato dell'autorizzazione:

Authorised

Data dell'autorizzazione:

2016-09-16

Foglio illustrativo

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
What Finasteride 5 mg Tablets is and what it is used for
What you need to know before you take Finasteride 5 mg Tablets
How to take Finasteride 5 mg Tablets
Possible side effects
How to store Finasteride 5 mg Tablets
Contents of the pack and other information
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 hyperplasia’ (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 you need to pass urine more often, especially at night
*
Feeling that you must pass u

Scheda tecnica

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
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet.
_Product imported from the UK_
Blue, round biconvex, film-coated tablet with "F5" marking on one side
and plain on other side.
4 CLINICAL PARTICULARS
As per PA1390/013/002
5 PHARMACOLOGICAL PROPERTIES
As per PA1390/013/002
6 PHARMACEUTICAL PARTICULARS
6.1 LIST OF EXCIPIENTS
_TABLET CORE:_
Lactose monohydrate,
Cellulose microcrystalline (E460),
Starch pregelatinised (maize)
Lauroyl macrogolglycerides,
Sodium starch glycolate (type-A),
Magnesium stearate (E572)
_FILM COATING:_
Hypromellose (E464)
Titanium dioxide (E171)
Indigo carmine (E132)
Macrogol 6000
6.2 INCOMPATIBILITIES
Not applicable.
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6.3 SHELF LIFE
The shelf life expiry date for this product shall be the date shown on
the blister and outer package of the product on the
market in the country of origin.
6.4 SPECIAL PRECAUTIONS FOR STORAGE
This medicinal product does not require any special storage
conditions.
6.5 NATURE AND CONTENTS OF CONTAINER
An opaque white (PVC-PVdC /Aluminium) Blister
The finasteride 5mg