PRO-CURE 5 MG

Nazione: Israele

Lingua: inglese

Fonte: Ministry of Health

Principio attivo:

FINASTERIDE

Commercializzato da:

MERCK SHARP & DOHME ISRAEL LTD

Codice ATC:

G04CB01

Forma farmaceutica:

TABLETS

Composizione:

FINASTERIDE 5 MG

Via di somministrazione:

PER OS

Tipo di ricetta:

Required

Prodotto da:

MERCK SHARP & DOHME UK LTD

Gruppo terapeutico:

FINASTERIDE

Area terapeutica:

FINASTERIDE

Indicazioni terapeutiche:

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. Pro-cure causes regression of the enlarged prostate, improves urinary flow and improves the symptoms assocciated with BPH. Patients with an enlarged prostate are the appropriate candidates for therapy with Pro-cure.

Data dell'autorizzazione:

2015-02-28

Foglio illustrativo

PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE PHARMACISTS REGULATIONS
(PREPARATIONS) 1986
This medicine can be sold under doctor's prescription only
PRO-CURE
® 5 MG
TABLETS
Each tablet contains:
Finasteride 5 mg
For a list of inactive ingredients see section 6.1 "What PRO-CURE 5 MG
contains". See also section 2.6
“IMPORTANT INFORMATION ABOUT SOME OF THE INGREDIENTS OF PRO-CURE 5
MG.
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE.

This leaflet contains concise information about PRO-CURE 5 MG. 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 ailment seems similar to yours.

The condition which PRO-CURE 5 MG is prescribed occurs only in men.
This medicine is not
intended for women or children.
1. WHAT PRO-CURE 5 MG IS AND WHAT IT IS USED FOR?
THERAPEUTIC GROUP: 5α-reductase inhibitor
For the treatment and control of benign prostatic hyperplasia (BPH) to
cause regression of the enlarged
prostate, and by this improve urinary flow and improve symptoms
associated with BPH. PRO-CURE 5 MG
reduces the risk of acute urinary retention and the need for prostate
surgery.
2. BEFORE YOU TAKE PRO-CURE 5 MG
2.1 DO NOT TAKE PRO-CURE 5 MG IF YOU:

are a woman and you are or may potentially be pregnant. Women should
also not handle crushed
or broken tablets of PRO- CURE 5 MG (see also section 2.5
"pregnancy").

This medicine is not intended for women or children.

are hypersensitive (allergic) to finasteride or any of the other
ingredients of PRO-CURE 5 MG
(for a list of inactive ingredients, see section 6.1).
2.2 SPECIAL WARNINGS CONCERNING USE OF PRO-CURE 5 MG
BEFORE STARTING TREATMENT WITH PRO-CURE 5 MG, TELL YOUR DOCTOR IF:

you are suffering, or have suffered in the past, from impaired
function of the liver.

PRO-CURE 5 MG can affect a blood test called PSA. If you have a PSA
test done, tell your doctor
that you are taking PRO-CURE 5 MG.

you are sensi

Scheda tecnica

1
HIGHLIGHTS OF PRESCRIBING INFORMATIONTHESE HIGHLIGHTS
DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE PRO- CURE
SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR PRO-
CURE.
PRO-CURE (FINASTERIDE) TABLETS --------------------------- RECENT MAJOR CHANGES
--------------------------- ----------------------------INDICATIONS AND USAGE
----------------------------
PRO-CURE, is a
5α-reductase inhibitor, indicated for the treatment
and control
of symptomatic benign prostatic hyperplasia (BPH) in men
with an enlarged prostate to (1.1):

Reduce the risk of acute urinary retention

Reduce the risk of the need for surgery including transurethral
resection of the prostate (TURP) and prostatectomy.
LIMITATIONS OF USE: PRO-CURE is not approved for the prevention of
prostate cancer (1.3). ----------------------- DOSAGE AND ADMINISTRATION
-----------------------
PRO-CURE may be administered with or without meals (2).
Monotherapy: One tablet (5 mg) taken once a day (2.1).
Combination with Doxazosin: One tablet (5 mg) taken once a day in
combination with the alpha-blocker doxazosin_ _(2.2). --------------------- DOSAGE FORMS AND STRENGTHS
---------------------
5-mg film-coated tablets (3). ------------------------------ CONTRAINDICATIONS
-------------------------------
Hypersensitivity to any components of this product (4).
Women who are or may potentially be pregnant (4, 5.4, 8.1, 16). ----------------------- WARNINGS AND PRECAUTIONS
-----------------------

PRO-CURE
reduces
serum
prostate
specific
antigen
(PSA)
levels by approximately 50%. However, any confirmed increase
in PSA while on PRO-CURE may signal the presence of prostate
cancer and should be evaluated, even if those values are still
within
the
normal
range
for
men
not
taking
a
5α-reductase
inhibitor (5.1).

PRO-CURE may increase the risk of high-grade prostate cancer
(5.2, 6.1).

Women should not handle crushed or broken PRO-CURE tablets
when they are pregnant or may potentially be pregnant due to
potential risk to a male fetus
(5.3, 8.1, 1