Finasteride 1mg film-coated tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Finasteride

Available from:

Careforsons Ireland Limited

ATC code:

D11AX10

INN (International Name):

Finasteride

Dosage:

1 milligram(s)

Pharmaceutical form:

Film-coated tablet

Therapeutic area:

finasteride

Authorization status:

Marketed

Authorization date:

2020-10-16

Patient Information leaflet

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
FINASTERIDE CAREFORSONS 1MG FILM-COATED TABLETS
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING 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, pharmacist or nurse.
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 1mg film-coated tablets contain the active substance
finasteride.
Finasteride 1mg film-coated tablets are 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 cause 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 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 has some kind of improved hair
growth.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE FINASTERIDE
DO NOT USE FINAST

Summary of Product characteristics

Health Products Regulatory Authority
19 December 2022
CRN00D8DV
Page 1 of 7
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Finasteride 1mg film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 1 mg of finasteride.
Excipients with known effect
Each tablet contains 87.49 mg of lactose monohydrate.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet (tablet).
Round biconvex red film-coated tablets with a 6.5 mm nominal diameter.
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 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
One 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.
_Patients with renal impairment_
No dosage adjustment is required in patients with renal insufficiency.
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 section 4.6).
Finasteride tablets are coated and will prevent contact with the
active substance during normal handling, provided that the
tablets are not broken or crushed.
4.3 CONTRAINDICATIONS
-Contraindicated in women (see section 4.6 and 5.1).
-Hypersensitivity to the active substance or to any of th