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PROPECIA 1 MG FILM-COATED TABLETS

Active substance(s): FINASTERIDE

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• the number of men who had a high score
in a tumour grading system was higher
in some of those taking finasteride
compared to those taking nothing
• the effect of long-term use of finasteride
on tumours of this kind is unknown.
If you would like further information about
the tumour grading system or this trial,
please talk to your doctor.

5. How to store Propecia
Keep this medicine out of the sight and
reach of children.
Do not use this medicine after the expiry
date which is stated on the carton after the
letters EXP. The expiry date refers to the
last day of that month.
Do not put the tablets into another container,
they might get mixed up. Do not remove the
tablet from the pack until you are ready to
take it.
Do not store above 30°C. Keep them in the
original package.
Do not throw away any medicines via
wastewater or household waste. Ask your
pharmacist how to throw away medicines
you no longer use. These measures will help
to protect the environment.
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What Propecia contains
• The active substance is finasteride.
Each tablet contains 1 mg finasteride.
• The other ingredients are: lactose,
microcrystalline
cellulose
E460,
pregelatinised maize starch, sodium
starch glycollate, docusate sodium,
magnesium stearate E572, hypromellose
E464, hydroxypropyl cellulose E463,
titanium dioxide, talc, yellow iron oxide
E172, red iron oxide E172.
What Propecia looks like and the content
of the pack.
• Propecia is available as tan, eight-sided,
film-coated tablets, marked with a ‘P’ logo
on one side and Propecia on the other.
• Propecia Tablets are supplied in blister
packs of 28 tablets or 84 tablets.
Marketing Authorisation Holder and
Manufacturer
The Marketing Authorisation Holder is Merck
Sharp & Dohme Limited, Hertford Road,
Hoddesdon, Hertfordshire EN11 9BU, UK.
The Manufacturer of the tablets is Merck
Sharp & Dohme Limited, Shotton Lane,
Cramlington, Northumberland NE23 3JU, UK.
This leaflet was last revised in July 2015.
© Merck Sharp & Dohme Limited 2015. All
rights reserved.
PIL.PPC.15.UK.4587

1 mg
film-coated Tablets
Finasteride

This medicine is for use in men only

For Position Only

Reporting of side effects
If you get any side effects, talk to your doctor
or pharmacist. This includes any possible
side effects not listed in this leaflet. You can
also report side effects directly (see details
below). By reporting side effects you can
help provide more information on the safety
of this medicine.
United Kingdom: Yellow Card Scheme at
www.mhra.gov.uk/yellowcard
Malta: ADR Reporting at
www.medicinesauthority.gov.mt/adrportal

Package Leaflet: Information for the user

6. Contents of the pack and other
information

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. 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 other
information

1. What Propecia is and what it is
used for

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  months (rest phase). After
this the hair falls out. In its place a new
healthy hair begins to grow, and the cycle
is repeated. The hairs on your scalp are
always in different stages of this cycle so it
is normal to lose scalp hair every day.
What is male pattern hair loss?
Male pattern hair loss is a common
condition in which men experience thinning
of the hair on the scalp, often resulting in
a receding hairline and/or balding on the
top of the head. This condition is thought
to be caused by a combination of genetic
factors and a particular hormone, DHT
(dihydrotestosterone).
DHT causes a decrease in the growth phase
and thinning of the hair (see picture). This leads
to male pattern hair loss. These changes can
start to occur in some men in their 20s and
become more common with age. Once hair
loss has occurred over a long period of time,
the hair may be permanently lost.
MALE PATTERN HAIR LOSS

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). Propecia increases hair growth
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How does Propecia work?
Propecia lowers the levels of DHT in the
scalp. This helps to reverse the balding
process, leading to an increased hair
growth and prevention of further hair loss.

2. What you need to know before
you take Propecia
Do not take Propecia:
• if you are a woman (because this
medicine is for men). It has been shown
in clinical trials that Propecia does not
work in women with hair loss.
• if you are allergic (hypersensitive) to
finasteride or any of the other ingredients
of this medicine (listed in Section 6).
• If you are already taking finasteride or
dutasteride used for a prostate problem
called benign prostatic hyperplasia (BPH).
Do not take Propecia if any of the above
apply to you. If you are not sure, talk to your
doctor or pharmacist.
Warnings and Precautions
Talk to your doctor or pharmacist before
taking Propecia if:
• you are going to have a blood test for
prostate cancer called PSA (prostatespecific antigen). This is because
Propecia can affect the result of this test.
Effects on fertility
Infertility has been reported in men who took
finasteride for long time and had other risk
factors that may affect fertility. Normalisation
or improvement of seminal quality has been
reported after discontinuation of finasteride.
Long-term clinical studies about the effects
of finasteride on fertility in men have not
been conducted.
Breast Cancer
See section 4.
Children and adolescents
Propecia should not be used in children.
There are no data demonstrating efficacy
or safety of finasteride in children under the
age of 18.

Other medicines and Propecia
Tell your doctor or pharmacist if you are
taking, have recently taken or might take
any  other medicines. Propecia does not
usually affect other medicines.
• Do not take Propecia if you are already
taking finasteride or dustasteride, used
for a prostate problem called benign
prostatic hyperplasia (BPH).
• No information is available about the use
of Propecia with minoxidil, another type
of medicine for male pattern hair loss
which is applied to the head.
Pregnancy, breast feeding and fertility
Propecia is for the treatment of male
pattern hair loss in men only. For effects
on fertility see section 2.
• Propecia should not be taken by women.
• Do not touch crushed or broken Propecia
tablets if you are a woman who is pregnant
or planning to become pregnant (whole
tablets are coated to stop contact with
the medicine during normal use). This
is because this medicine may affect the
baby’s sex organs.
• If a woman who is pregnant comes into
contact with crushed or broken Propecia
tablets, speak to your doctor.
Driving and using machines
Propecia is not likely to affect you being
able to drive, use tools or machines.
Propecia contains Lactose
If you have been told by your doctor that you
have an intolerance to some sugars, contact
your doctor before taking this medicinal
product.

3. How to take Propecia
Always take this medicine exactly as your
doctor or pharmacist has told you. Check with
your doctor or pharmacist if you are not sure.
• The recommended dose is one tablet
each day. The tablet can be taken with or
without food.

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If you take more Propecia than you should
If you take too many tablets by mistake,
contact your doctor immediately. Propecia
will not work faster or better if you take it
more than once a day.
If you forget to take Propecia
• Do not take a double dose to make up
for a forgotten dose.
If you stop taking Propecia
It may take 3 to 6 months for the full effect
to develop. It is important to keep taking
Propecia for as long as your doctor tells
you. If you stop taking Propecia, you are
likely to lose the hair you have gained within
9 to 12 months.
If you have any further questions on the use of
this medicine, ask your doctor or pharmacist.

4. Possible side effects
Like all medicines, this medicine can cause
side effects, although not everybody gets
them.
Stop taking Propecia and talk to your doctor
immediately if you have any of the following
symptoms of an allergic reaction: swelling of
your lips, face, tongue and throat; difficulty
swallowing; lumps under your skin (hives)
and breathing difficulties.
You should promptly report to your doctor
any changes in your breast tissue such as
lumps, pain, enlargement or nipple discharge
as these may be signs of a serious condition,
such as breast cancer.
Uncommon: may affect up to 1  in 100
people
• you may be unable to have an erection
(impotence)
• you may have less desire to have sex
• you may have problems with ejaculation,
for example a decrease in the amount of
semen released during sex. This decrease
in the amount of semen does not appear
to affect normal sexual function.

These side effects above may disappear
after a while if you continue taking Propecia.
If these symptoms persist, they usually
resolve after stopping Propecia.
Frequency unknown:
• breast swelling or tenderness
• palpitations (feeling your heartbeat)
• changes in the way your liver is working,
which can be shown by a blood test
• pain in the testicles
• persistent difficulty having an erection
after discontinuation of treatment
• persistent decrease in sex drive after
discontinuation of treatment
• persistent problems with ejaculation
after discontinuation of treatment
• male infertility and/or poor quality of semen
• depressed mood
If any of these side effects gets serious,
or if you notice any side effects not listed
on this leaflet please tell your doctor or
pharmacist. It will help if you make a note
of what happened, when it started and how
long it lasted.
Will the use of Propecia affect the hair on
other parts of your body?
Propecia does not affect hair on other parts
of the body.
What else should you know about
Propecia?
Finasteride can also be used for a type of
prostate problem called ‘benign prostatic
hyperplasia’ or BPH. Information collected
from a clinical trial in men taking finasteride
5 mg (a dose 5 times higher than Propecia)
for 7 years showed:
• the number of men who developed
prostate cancer was lower in men taking
finasteride compared with those taking
nothing
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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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