PROPECIA

البلد: إسرائيل

اللغة: الإنجليزية

المصدر: Ministry of Health

العنصر النشط:

FINASTERIDE

متاح من:

ORGANON PHARMA ISRAEL LTD., ISRAEL

ATC رمز:

G04CB01

الشكل الصيدلاني:

FILM COATED TABLETS

تركيب:

FINASTERIDE 1 MG

طريقة التعاطي:

PER OS

نوع الوصفة الطبية :

Required

المصنعة من قبل:

ORGANON LLC, USA

المجموعة العلاجية:

FINASTERIDE

المجال العلاجي:

FINASTERIDE

الخصائص العلاجية:

Propecia is indicated for the treatment of men with male pattern hair loss (androgenetic alopecia) to increase hair growth and prevent further hair loss

تاريخ الترخيص:

2014-04-30

نشرة المعلومات

PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE PHARMACISTS REGULATIONS
(PREPARATIONS) 1986
This medicine is marketed upon physician’s prescription only
PROPECIA
®
FILM COATED TABLETS
Each film coated tablet contains:
Finasteride 1 mg
For a list of inactive ingredients see section 6.1 "What PROPECIA
contains". See also section 2.6
“Important information about some of the ingredients of PROPECIA".
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE.
•
This leaflet contains concise information about PROPECIA. 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 medical condition seems similar to yours.
•
THIS MEDICINE IS INTENDED FOR USE IN MEN ONLY AND SHOULD NOT BE USED
BY WOMEN OR CHILDREN.
1. WHAT PROPECIA IS INTENDED FOR?
PROPECIA is indicated for the treatment of men with male pattern hair
loss (androgenetic alopecia)
to increase hair growth and prevent further hair loss
THERAPEUTIC GROUP: 5α-reductase inhibitor
2. BEFORE USING PROPECIA
2.1 DO NOT USE PROPECIA IF:
−
You are a woman (because this medicine is for men). It has been shown
in clinical trials that
PROPECIA does not work in women with hair loss.
−
You are hypersensitive (allergic) to finasteride or any of the other
ingredients of this medicine (for
a list of inactive ingredients, see section 6.1).
−
You are already taking finasteride or dutasteride used for a prostate
problem called benign prostatic
hyperplasia (BPH).
Do not take PROPECIA if any of the above applies to you. If you are
not sure, talk to your doctor or
pharmacist.
2.2 SPECIAL WARNINGS REGARDING USE OF PROPECIA
Talk to your doctor or pharmacist before taking PROPECIA if:
•
You are going to have a blood test for prostate cancer called PSA
(prostate-specific antigen). This is
because PROPECIA can affect the result of this test.
BREAST CANCER
See section 4 "Side effects".
MOOD ALTERATIONS AND DEPRESSION
Mood alterations such as depre

خصائص المنتج

1
PROPECIA
®
1.
NAME OF THE MEDICINAL PRODUCT
PROPECIA
®
Film-Coated Tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet of PROPECIA contains 1 mg of finasteride as
the active
ingredient.
Excipients with known effect:
Each tablet contains 110.4 mg of lactose monohydrate.
For a full of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablets. Tan, octagonal, film-coated tablets, marked with
a ‘P’ logo on one
side and ‘PROPECIA’ on the other.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
PROPECIA is indicated for the treatment of men with male pattern hair
loss
(androgenetic alopecia) to increase hair growth and prevent further
hair loss
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
PROPECIA may be administered with or without meals.
The recommended dose of PROPECIA is one tablet (1 mg) taken once
daily.
In general, daily use for three months or more is necessary before
benefit is observed.
Continued
use
is
recommended
to
sustain
benefit,
which
should
be
re-evaluated
periodically. Withdrawal of treatment leads to reversal of effect
within 12 months.
Method of administration
Crushed or broken tablets of ‘Propecia’ should not be handled by
women when they are
or may potentially be pregnant because of the possibility of
absorption of finasteride and
the subsequent potential risk to a male foetus (see section 4.6
Fertility, pregnancy and
lactation). ‘Propecia’ tablets are coated to prevent contact with
the active ingredient
during normal handling, provided that the tablets are not broken or
crushed.
PEDIATRIC USE
PROPECIA is not indicated for use in pediatric patients.
Safety and effectiveness in pediatric patients have not been
established.
GERIATRIC USE
2
Clinical efficacy studies with PROPECIA did not include subjects aged
65 and over.
Based on the pharmacokinetics of finasteride 5 mg, no dosage
adjustment is necessary in
the elderly for PROPECIA. However, the efficacy of PROPECIA in the
elderly has not
been established.
PATIENTS WITH HEPATIC IMPAIRMENT
Caut