Proscar 5mg Film-coated tablets

Страна: Ирландия

Език: английски

Източник: HPRA (Health Products Regulatory Authority)

Активна съставка:

Finasteride

Предлага се от:

Merck Sharp & Dohme Ireland (Human Health) Limited

АТС код:

G04CB; G04CB01

INN (Международно Name):

Finasteride

дозиране:

5 milligram(s)

Лекарствена форма:

Film-coated tablet

Вид предписание :

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

Терапевтична област:

Testosterone-5-alpha reductase inhibitors; finasteride

Статус Оторизация:

Marketed

Дата Оторизация:

1992-08-10

Листовка

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

Данни за продукта

Health Products Regulatory Authority
26 April 2021
CRN009Y0G
Page 1 of 7
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.
Excipients with known effect: Each tablet contains 102mg lactose (as
monohydrate).
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet (tablet).
Blue, apple‑shaped, film-coated tablets, marked 'PROSCAR' on one
side and 'MSD 72' on the other.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
‘Proscar’ is indicated for the treatment and control of benign
prostatic hyperplasia (BPH) and for the prevention of urologic
events to:
- reduce the risk of acute urinary retention
- reduce the risk of surgery including transurethral resection of the
prostate (TURP) and prostatectomy.
‘Proscar’ causes regression of the enlarged prostate, improves
urinary flow and improves the symptoms associated with BPH.
Patients with an enlarged prostate are the appropriate candidates for
therapy with ‘Proscar’.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The recommended dosage is one 5 mg tablet daily, with or without food.
Method of administration
'Proscar' can be administered alone or in combination with the
alpha-blocker doxazosin (see section 5.1 'Pharmacodynamic
properties').
Although early improvement in symptoms may be seen, treatment for at
least six months may be necessary to assess whether
a beneficial response has been achieved. The risk of acute urinary
retention is reduced within four months of treatment.
_Use in renal insufficiency_
No adjustment in dosage is required in patients with varying degrees
of renal insufficiency (creatinine clearances as low as 9
ml/min), as pharmacokinetic studies did not indicate any change in the
disposition of finasteride.
_Use in the elderly_
No dosage adjustment is required in elderly patients.
4.3 CONTRAINDICATIONS
'Proscar' is not indicated for use in wome