Finasteride 1mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Finasteride

Available from:

Milpharm Ltd

ATC code:

D11AX10

INN (International Name):

Finasteride

Dosage:

1mg

Pharmaceutical form:

Oral tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Invalid to prescribe in NHS primary care

Product summary:

BNF: 13090000; GTIN: 08901175030798

Patient Information leaflet

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
-
Finasteride 1 mg film-coated tablets
contains the active substance called
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.
DO NOT TAKE FINASTERIDE
-
if you are allergic to finasteride or any of
the other ingredients of this medicine
(listed in section 6).
-
you are a woman (because this
medicine is for men, see Pregnancy). It
has been s

Summary of Product characteristics

OBJECT 1
Finasteride 1mg tablets
Summary of Product Characteristics Updated 14-Jul-2021 | Aurobindo
Pharma - Milpharm Ltd.
•
1. Name of the medicinal product
•
2. Qualitative and quantitative composition
•
3. Pharmaceutical form
•
4. Clinical particulars
•
4.1 Therapeutic indications
•
4.2 Posology and method of administration
•
4.3 Contraindications
•
4.4 Special warnings and precautions for use
•
4.5 Interaction with other medicinal products and other forms of
interaction
•
4.6 Fertility, pregnancy and lactation
•
4.7 Effects on ability to drive and use machines
•
4.8 Undesirable effects
•
4.9 Overdose
•
5. Pharmacological properties
•
5.1 Pharmacodynamic properties
•
5.2 Pharmacokinetic properties
•
5.3 Preclinical safety data
•
6. Pharmaceutical particulars
•
6.1 List of excipients
•
6.2 Incompatibilities
•
6.3 Shelf life
•
6.4 Special precautions for storage
•
6.5 Nature and contents of container
•
6.6 Special precautions for disposal and other handling
•
7. Marketing authorisation holder
•
8. Marketing authorisation number(s)
•
9. Date of first authorisation/renewal of the authorisation
•
10. Date of revision of the text
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