Proscar 5 mg film-coated tablets

Land: Irland

Sprog: engelsk

Kilde: HPRA (Health Products Regulatory Authority)

Aktiv bestanddel:

Finasteride

Tilgængelig fra:

Imbat Limited

ATC-kode:

G04CB; G04CB01

INN (International Name):

Finasteride

Dosering:

5 milligram(s)

Lægemiddelform:

Film-coated tablet

Recept type:

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

Terapeutisk område:

Testosterone-5-alpha reductase inhibitors; finasteride

Autorisation status:

Authorised

Autorisation dato:

2007-12-19

Indlægsseddel

Page 1 of 2
PACKAGE LEAFLET: INFORMATION FOR THE USER
PROSCAR
® 5MG FILM-COATED TABLETS
(finasteride)
THIS MEDICINE IS FOR USE IN MEN ONLY
Your medicine is available using the above name but will be
referred to as Proscar throughout this leaflet.
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU
START TO TAKE THIS MEDICINE.

Keep this leaflet. You may want to read it again.

If you have any further questions, ask your doctor or
pharmacist.

This medicine has been prescribed for you. Do not pass
it on to others. It may harm them, even if their
symptoms are the same as yours.

If any of the side effects get serious, or if you notice any
side effects not listed in this leaflet, please tell your
doctor or pharmacist.
IN THIS LEAFLET:
1.
What Proscar is and what it is used for
2.
Before you take Proscar
3.
How to take Proscar
4.
Possible side effects
5.
How to store Proscar
6.
Contents of the pack and other information
1.
WHAT PROSCAR IS AND WHAT IT IS USED FOR
Proscar contains a medicine called finasteride. This belongs to
a group of medicines called ‘5-alpha reductase inhibitors’.
Proscar shrinks the prostate gland in 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 more serious problems, such
as:

urinary tract infections

a sudden inability to pass urine

the need for surgery.

Produktets egenskaber

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Proscar 5mg Film-Coated Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 5mg of the active ingredient finasteride.
Excipient: lactose
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet.
_Product imported from the UK and Spain:_
Blue, apple-shaped, tablets, marked ‘Proscar’ on one side and
‘MSD 72’ on the other.
4 CLINICAL PARTICULARS
As per PA1286/017/001
5 PHARMACOLOGICAL PROPERTIES
As per PA1286/017/001
6 PHARMACEUTICAL PARTICULARS
6.1 LIST OF EXCIPIENTS
Product Imported from the UK:
Tablet Core
Microcrystalline cellulose
Docusate sodium
Lactose
Magnesium stearate
Pregelatinised maize starch
Sodium starch glycolate type A
Yellow iron oxide (E172)
Film-Coating
Hyprolose
Indigo carmine aluminium lake (E132)
Hypromellose
Talc
Titanium dioxide (E171)
Product Imported from Spain:
Tablet Core
Microcrystalline cellulose
Docusate sodium
Lactose
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Magnesium stearate
Maize starch
Sodium glycolate
Iron oxide (E172)
Film-Coating
Hydroxypropyl cellulose
Indigo carmine aluminium lake (E132)
Methylhydroxypropyl cellulosee
Talc
Titanium dioxide (E171)
6.2 INCOMPATIBILITIES
Not applicable.
6.3 SHELF LIFE
The shelf life expiry date for this product shall be the date shown on
the co