Finasteride Biorga 1 mg film-coated tablets

Land: Malta

Språk: engelska

Källa: Medicines Authority

Aktiva substanser:

FINASTERIDE

Tillgänglig från:

Laboratoires Bailleul S.A. 10-12 Avenue Pasteur L-2310 Luxembourg, Luxembourg

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:

2017-04-05

Bipacksedel

Page 1 of 5
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
FINASTERIDE BIORGA 1 MG FILM-COATED TABLET
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 not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Finasteride Biorga is and what it is used for
2.
What you need to know before you take Finasteride Biorga
3.
How to take Finasteride Biorga
4.
Possible side effects
5.
How to store Finasteride Biorga
6.
Contents of the pack and other information
1.
WHAT FINASTERIDE BIORGA IS AND WHAT IT IS USED FOR
Finasteride Biorga contains an active substance called finasteride.
FINASTERIDE BIORGA IS FOR THE EXCLUSIVE USE IN MALES.
Finasteride Biorga is used for the treatment at early stages of male
pattern hair loss (also known as
androgenetic alopecia) in men 18-41 years of age. If you have any
questions about male hair loss
after reading this package leaflet, ask your doctor.
Male hair loss is a common disorder believed to be caused by a
combination of genetic factors and
one specific hormone called dihydrotestosterone (DHT). DHT helps to
reduce the hair growth phase
and makes hair finer.
Finasteride specifically reduces DHT levels on the scalp, blocking an
enzyme (II 5-alpha-reductase)
that converts testosterone into DHT. Only males with mild to moderate,
but not complete, hair loss
can expect to benefit from the use of Finasteride Biorga. In many of
the males treated with
finasteride for 5 years, hair loss progression was slower and hair
growth also improved in some way
in at least half of those males.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE FINA

Produktens egenskaper

1
1.
NAME OF THE MEDICINAL PRODUCT
Finasteride Biorga 1 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 1 mg de finasteride.
Excipient(s) with known effect:
Each tablet contains 75.00 mg of lactose monohydrate.
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablets.
Round pink-orange film-coated tablet, with an “F1” on one side.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Finasteride Biorga is indicated in males between 18 and 41 years old
for the treatment of the early
phases of androgenetic alopecia. Finasteride Biorga stabilizes the
process of androgenic alopecia. Its
efficacy on bitemporal recession and loss of hair in the last stage
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 increased dose results in increased
effects.
Efficacy and duration of the treatment should be frequently evaluated
by the doctor responsible for
treatment. Three or six month’s daily treatment is usually necessary
before any evidence of
stabilisation of hair loss can be expected. Continued treatment is
recommended to maintain the
effect. If treatment is stopped, the beneficial effects begin to
reverse by six months and return to
baseline by 9 to 12 months.
Method of administration
Crushed or broken tablets of Finasteride Biorga 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).
Finasteride Biorga tablets are coated to prevent contact with the
active ingredient during normal
handling, provided that the tablets are not broken or crushed.
Page 2 of 9
Patients with renal impairment
No dosage adjustment is required in patients with renal insufficiency.
4.3
CONTRAINDICATIONS
Contraindicated in women: see 4.6 ‘Fertility, pregnancy and
lactation’ an