Proscar 5 mg Film-coated tablets

Nazione: Irlanda

Lingua: inglese

Fonte: HPRA (Health Products Regulatory Authority)

Principio attivo:

Finasteride

Commercializzato da:

IMED Healthcare Ltd.

Codice ATC:

G04CB; G04CB01

INN (Nome Internazionale):

Finasteride

Dosaggio:

5 milligram(s)

Forma farmaceutica:

Film-coated tablet

Area terapeutica:

Testosterone-5-alpha reductase inhibitors; finasteride

Data dell'autorizzazione:

2019-11-08

Foglio illustrativo

PACKAGE LEAFLET: INFORMATION FOR THE USER
PROSCAR® 5 MG FILM-COATED TABLETS
finasteride
THIS MEDICINE IS FOR USE BY MEN ONLY
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TO TAKE 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 Proscar is and what it is used for
2. What you need to know 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
WHAT PROSCAR IS
Proscar contains the active substance finasteride. This belongs to a
group of medicines called ‘5-alpha reductase inhibitors’.
HOW PROSCAR WORKS
Proscar shrinks the prostate gland in men when it is swollen. The
prostate gland is found underneath the bladder (in men only). 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

Scheda tecnica

Health Products Regulatory Authority
29 November 2021
CRN00CNWF
Page 1 of 2
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Proscar 5 mg film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 5 mg of the active ingredient finasteride.
Excipient with known effect: Each tablet contains lactose monohydrate
For the full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Film-coated tablet (tablet).
_Product imported from Poland_
Blue, film-coated tablets, marked 'PROSCAR' on one side and 'MSD 72'
on the other.
4 CLINICAL PARTICULARS
As per PA23198/007/001
5 PHARMACOLOGICAL PROPERTIES
As per PA23198/007/001
6 PHARMACEUTICAL PARTICULARS
6.1 LIST OF EXCIPIENTS
Tablet core:
Microcrystalline cellulose
Sodium docusate
Lactose monohydrate
Magnesium stearate
Pregelatinised starch
Sodium starch glycolate type A
Yellow iron oxide (E172)
Film-Coating
Hypromellose
Indigo carmine (E132)
Hydroxypropyl cellulose
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 blister and outer package of the product on the
market in the country of origin.
Health Products Regulatory Authority
29 November 2021
CRN00CNWF
Page 2 of 2
6.4 SPECIAL PRECAUTIONS FOR STORAGE
Do not store above 30°C. Store in the original package in order to
protect from light.
6.5 NATURE AND CONTENTS OF CONTAINER
Opaque blisters lidded with foil in an outer carton; packs of 28
tablets.
6.6 SPECIAL PRECAUTIONS FOR DISPOSAL OF A USED MEDICINAL PRODUCT OR
WASTE MATERIALS DERIVED FROM SUCH MEDICINAL
PRODUCT AND OTHER HANDLING OF THE PRODUCT
Women should not handle crushed or broken 'Proscar' Tablets when they
are or may potentially be pregnant (see 4.3
'Contra-indications', 4.6 'Pregnancy and lactation', _Exposureto
finasteride-riskto malefoetus_).
7 PARALLEL PRODUCT AUTHORISATION HOLDER
IMED Healthcare Ltd.
Unit 625 Kilshane Avenue
Northwest Business Park
Ballycoolin
Dublin 15
Ireland
8 PARALLEL PRODUCT AUTHORISATIO