Proscar 5mg Film-coated tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Finasteride

Available from:

LTT Pharma Limited

ATC code:

G04CB; G04CB01

INN (International Name):

Finasteride

Dosage:

5 milligram(s)

Pharmaceutical form:

Film-coated tablet

Prescription type:

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

Therapeutic area:

Testosterone-5-alpha reductase inhibitors; finasteride

Authorization status:

Authorised

Authorization date:

2012-01-06

Patient Information leaflet

PROSCAR 5MG FILM-COATED TABLETS
(finasteride)
THIS MEDICINE IS FOR USE IN MEN ONLY
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:
What Proscar is and what it is used for
Before you take Proscar
How to take Proscar
Possible side effects
How to store Proscar
Further information
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.
WHAT ELSE SHOULD YOU KNOW ABOUT BPH?
*
BPH is NOT cancer and does not lead to cancer, but the two conditions
can
be present at the same time.
*
Before you start Proscar, your doctor will do some simple tests to
check
whether you have p

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Proscar 5mg Film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 5 mg of the active ingredient finasteride
Excipient: Each tablet contains lactose monohydrate
For a full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Film-coated tablet (tablet).
_Product imported from Austria:_
Blue, apple-shaped, film-coated 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
Lactose monohydrate
Microcrystalline cellulose
Pregelatinised maize starch
Poly (o-carboxymethyl)-starch sodium
Docusate sodium
Magnesium stearate
Hypromellose
Hydroxypropyl cellulose
Talc
Iron oxide (E172)
Titanium dioxide (E171)
Indigo carmine aluminum lake (E132)
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
Do not store above 30°C. Store in original package in order to
protect from light.
6.5 NATURE AND CONTENTS OF CONTAINER
Opaque blisters lidded with aluminium foil i