Propecia 1mg film-coated Tablets

Land: Malta

Språk: engelska

Källa: Medicines Authority

Aktiva substanser:

FINASTERIDE

Tillgänglig från:

N.V. Organon Kloosterstraat 6, NL-5349 AB Oss, Netherlands

ATC-kod:

D11AX10

INN (International namn):

FINASTERIDE 1 mg

Läkemedelsform:

FILM-COATED TABLET

Sammansättning:

FINASTERIDE 1 mg

Receptbelagda typ:

POM

Terapiområde:

OTHER DERMATOLOGICAL PREPARATIONS

Bemyndigande status:

Authorised

Tillstånd datum:

2005-08-25

Bipacksedel

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).

Produktens egenskaper

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.
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
stabilises 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 stabilisation 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 section 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 _
No dosage adjustment is required in patients with renal insufficiency.
4.3
CONTRAINDICATIONS
Contraindicated in women: see section 4.6 Fertility, pregnancy and
lactation and section 5.1
Pharmacodynamic properties.
Hype