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Active substance: FINASTERIDE

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This product will be referred to as Propecia throughout this leaflet.
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. See
section 4.


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.

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

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.

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). 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
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
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.
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.

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
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

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.
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.

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
Malta: ADR Reporting at

If you have any further questions on the use of this medicine, ask
your doctor or pharmacist.



 Do not store above 30°C. Store in the original package.
 Do not use after the expiry date shown on the carton label or

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
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
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
 persistent decrease in sex drive after discontinuation of
 persistent problems with ejaculation after discontinuation of
 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
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
 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.

How to store Propecia

blister strip.

 If your doctor tells you to stop using this medicine, take any
unused medicine to your pharmacist for safe disposal. Only
keep it if told to do so by your doctor.
 If you notice signs of your medicine deteriorating, consult your
This medicine has been prescribed for you. Never give it to anyone
else because it may harm them even though they may seem to
have the same symptoms as you.
Medicines should not be disposed of via wastewater or household
waste. Ask your pharmacist how to dispose of medicines no longer
required. These measures will help to protect the environment.

Further Information

What Propecia contains
 Each tablet contains 1mg of the active ingredient finasteride.
 Each tablet also contains the following ingredients: lactose
monohydrate, microcrystalline cellulose, pregelatinised maize
starch, sodium starch glycollate, docusate sodium, magnesium
stearate, talc, hypromellose, hydroxypropylcellulose (E463),
titanium dioxide (E171), yellow iron oxide (E172) and red iron
oxide (E172).
What Propecia looks like and the content of the pack.
Your tablets are pink, eight sided film coated tablets, imprinted with
‘P’ logo on one side and ‘PROPECIA’ on the other. They are
available in calendar blister packs of 28 tablets.
This product is manufactured by:
Merck Sharp & Dohme Ltd,
Cramlington, Northumberland, UK
Procured from within the EU. Parallel Import Product Licence
holder: G Pharma Ltd, Salford M50 2PU.

PL NO: 16369/1056
PROPECIA 1 mg film-coated Tablets


7th September 2015

‘Propecia’ is a registered trademark belonging to Merck Sharp &

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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.