Proscar 5 mg film-coated tablets

البلد: أيرلندا

اللغة: الإنجليزية

المصدر: HPRA (Health Products Regulatory Authority)

العنصر النشط:

Finasteride

متاح من:

PCO Manufacturing Ltd.

ATC رمز:

G04CB; G04CB01

INN (الاسم الدولي):

Finasteride

جرعة:

5 milligram(s)

الشكل الصيدلاني:

Film-coated tablet

نوع الوصفة الطبية :

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

المجال العلاجي:

Testosterone-5-alpha reductase inhibitors; finasteride

الوضع إذن:

Authorised

تاريخ الترخيص:

2003-01-10

نشرة المعلومات

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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

خصائص المنتج

Health Products Regulatory Authority
09 September 2022
CRN00D55T
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 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 Greece, Spain and Poland;_
Blue, apple-shaped, 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
Microcrystalline cellulose (E460)
Docusate sodium
Lactose monohydrate
Magnesium stearate (E572)
Pregelatinised maize starch
Sodium starch glycolate (Type A)
Yellow iron oxide (E172)
Hydroxypropylcellulose (E463)
Indigo carmine aluminium lake (E132)
Hypromellose (E464)
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 container and outer package of the product on the
market in the country of origin.
Health Products Regulatory Authority
09 September 2022
CRN00D55T
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 and moisture.
6.5 NATURE AND CONTENTS OF CONTAINER
Blister pack containing 14 or 28 tablets contained in an outer
cardboard carton.
Not all pack sizes may be marketed.
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 section
4.3.'Contraindications', section 4.6.'Pregnancy and lactation', of
SmPC PA23198/007/001, _Exposure to finasteride -risk to male _
_foetus)._
7 PARALLEL PRODUCT AUTHORISATION HOLDER
PCO Manufacturin