PROPECIA 1mg Film-Coated Tablets

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

FINASTERIDE

Available from:

Merck Sharp & Dohme Limited

ATC code:

D11AX10

INN (International Name):

FINASTERIDE

Pharmaceutical form:

FILM-COATED TABLET

Composition:

FINASTERIDE 1 mg

Prescription type:

POM

Therapeutic area:

OTHER DERMATOLOGICAL PREPARATIONS

Authorization status:

Authorised

Authorization date:

2005-08-25

Patient Information leaflet

1 
PACKAGE LEAFLET: INFORMATION FOR THE USER 
PROPECIA 1 MG FILM-COATED TABLETS 
FINASTERIDE 

This medicine is for use in men only 

READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINS 
IMPORTANT INFORMATION FOR YOU. 


Keep this leaflet. You may want 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, please tell your doctor or pharmacist. 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 information. 

1. 
WHAT PROPECIA IS AND WHAT IT IS USED FOR 

Propecia contains a medicine called finasteride. This belongs to a group of medicines called Type II ‘5-
alpha reductase inhibitors’. 

Propecia is used for the treatment of male pattern hair loss (also known as androgenetic alopecia) in men 
18-41. Propecia increases hair growth on the scalp and prevents further hair loss in men. Men with mild 
to moderate, but not complete hair loss, can benefit from using Propecia. 

HOW DOES THE HAIR ON YOUR HEAD GROW? 
On average your hair grows about 1 centimetre (half an inch) each month. Hair grows from hair follicles, 
which are located under your skin. 

A single scalp hair grows continuously for 2-4 years (growth
phase) and then stops growing for 
2-4 mon

Summary of Product characteristics

Page 1 of 9
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Propecia 1 mg Film-Coated Tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 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.
This medicinal product contain 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 tablets,
marked with a ‘P’ logo on
one side and ‘PROPECIA’ on the other.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
‘Propecia’ is indicated in men 18-41 years of age for the
treatment of male pattern hair loss
(androgenetic alopecia) to increase hair growth and prevent further
hair loss.
‘Propecia’ is NOT indicated for use in women or children and
adolescents.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The recommended dosage is one 1 mg tablet daily. ‘Propecia’ may be
taken 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. Continuous use is
recommended to sustain benefit.
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 ‘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).
Page 2 of 9
‘Propecia’ tablets are coated to prevent contact with the active
ingredient during normal
handling, provided that the tablets are not broken or crushed.
Patients with renal impairment
N