Propecia 1mg film-coated Tablets

国: マルタ

言語: 英語

ソース: Medicines Authority

有効成分:

FINASTERIDE

から入手可能:

Merck Sharp & Dohme B.V. Waarderweg 39, Haarlem Noord-Holland, 2031 BN, Netherlands

ATCコード:

D11AX10

INN（国際名）:

FINASTERIDE

医薬品形態:

FILM-COATED TABLET

構図:

FINASTERIDE 1 milligram(s)

処方タイプ:

POM

治療領域:

OTHER DERMATOLOGICAL PREPARATIONS

認証ステータス:

Authorised

承認日:

2005-08-25

情報リーフレット

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
PROPECIA 1 MG FILM-COATED TABLETS
Finasteride
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING 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 no
listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1. What Propecia is and what it is used for
2. What you need to know before you take Propecia
3. How to take Propecia
4. Possible side effects
5. How to store Propecia
6. Contents of the pack and other information
1.
WHAT PROPECIA
IS AND WHAT IT IS USED FOR
Propecia contains the active substance finasteride.
PROPECIA IS FOR USE IN MEN ONLY.
Propecia is used for the treatment of male pattern hair loss (also
known as androgenetic alopecia) in men
aged 18-41. If after reading this leaflet, you have any questions
about male pattern hair loss, ask your
doctor.
Male pattern hair loss is a common condition thought to be caused by a
combination of genetic factors and
a particular hormone, called dihydrotestosterone (DHT). DHT
contributes to shortening of the growth
phase of the hair and to thinning of the hair.
In the scalp, Propecia specifically lowers the levels of DHT by
blocking an enzyme (Type II 5-alpha
reductase) that converts testosterone to DHT. Only men with mild to
moderate, but not complete hair loss
can expect to benefit from the use of Propecia. In most of the men
treated with Propecia for 5 years, the
progression of hair loss was slowed, and at least half of these men
also had some kind of improved hair
growth.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE PROPECIA
DO NOT TAKE PROPECIA:
•
if you are a woman (because this medicine is for men, see Pregnancy).

製品の特徴

1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Propecia
1 mg, film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 1 mg of finasteride.
Excipients with known effect
Each tablet contains 110.4 mg of lactose monohydrate. This medicinal
product contains less than 1 mmol
of sodium per tablet.
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablets.
Tan, octagonal, film-coated convex tablet embossed with ‘P’ logo
on one side and ‘ Propecia’ on the other
side.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Propecia is indicated in men 18-41 years of age for the early stages
of androgenetic alopecia. Propecia
stabilizes the process of androgenetic alopecia. Efficacy in
bitemporal recession and end-stage hair loss
has not been established.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
1 tablet (1 mg) daily with or without food.
There is no evidence that an increase in dosage will result in
increased efficacy.
Efficacy and duration of treatment should continuously be assessed by
the treating physician. Generally,
three to six months of once daily treatment are required before
evidence of stabilization of hair loss can be
expected. Continued use is recommended to sustain benefit. If
treatment is stopped, the beneficial effects
begin to reverse by 6 months and return to baseline by 9 to 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 subsequent potential risk to a male
foetus (see 4.6 Fertility, pregnancy and lactation). Propecia tablets
are coated and will prevent contact
with the active ingredient during normal handling, provided that the
tablets are not broken or crushed.
_Patients with renal impairment _
2
No dosage adjustment is required in patients with renal insufficiency.
4.3
CONTRAINDICATIONS
Contraindicated in women: see 4.6 Fertility, pregnancy and