Finasteride 1mg film-coated Tablets

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

FINASTERIDE

Available from:

Aurobindo Pharma (Malta) Limited Vault 14, Level 2, Valletta Waterfront, Floriana FRN 1913, Malta

ATC code:

D11AX10

INN (International Name):

FINASTERIDE 1 mg

Pharmaceutical form:

FILM-COATED TABLET

Composition:

FINASTERIDE 1 mg

Prescription type:

POM

Therapeutic area:

OTHER DERMATOLOGICAL PREPARATIONS

Authorization status:

Authorised

Authorization date:

2013-09-12

Patient Information leaflet

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PACKAGE LEAFLET: INFORMATION FOR THE USER
FINASTERIDE 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 not listed in this leaflet.
See section 4.
WHAT IS IN THIS LEAFLET
1.
What Finasteride is and what it is used for
2.
What you need to know before you take Finasteride
3.
How to take Finasteride
4.
Possible side effects
5.
How to store Finasteride
6.
Contents of the pack and other information
1.
WHAT FINASTERIDE IS AND WHAT IT IS USED FOR
-
Finasteride 1 mg film-coated tablets contains the active substance
finasteride.
Finasteride is for use in men only.
-
Finasteride 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, Finasteride 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 Finasteride.
In most of the men treated
with Finasteride 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 FINASTERIDE
DO NOT TAKE FINASTER

Summary of Product characteristics

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SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Finasteride 1 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 1 mg finasteride.
Excipient with known effect:
Each film-coated tablet contains 101.50 mg lactose monohydrate.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
Brown coloured, octagonal, biconvex, film-coated tablets debossed with
‘J’ on one side and ‘81’ on
the other side.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Finasteride is indicated in men 18-41 years of age for the early
stages of androgenetic alopecia.
Finasteride 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 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.
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Method of administration
Crushed or broken tablets of Finasteride 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). Finasteride 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 4.6 Fertility, pregnancy and lactation
and