PROPECIA 1MG TABLETS

Active substance: FINASTERIDE

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PACKAGE LEAFLET: INFORMATION FOR THE USER
PROPECIA® 1 MG FILM-COATED TABLETS
(finasteride)

2. Before you take Propecia

Do not take Propecia if:
you are a woman (because this medicine is for men). It has been
This product will be referred to as Propecia throughout this leaflet.
shown in clinical trials that Propecia does not work in women with hair
loss.
This medicine is for use in men only
you are allergic (hypersensitive) to finasteride or any of the other
ingredients (listed in Section 6)
Read all of this leaflet carefully before you start to take this
you are already taking finasteride or dutasteride used for a prostate
medicine.
problem called benign prostatic hyperplasia (BPH).
Keep this leaflet. You may want to read it again.
Do not take Propecia if any of the above applies to you. If you are not
If you have any further questions, ask your doctor or pharmacist.
sure, talk to your doctor or pharmacist.
This medicine has been prescribed for you. Do not pass it on to others. Propecia should not be used in children.
It may harm them, even if their symptoms are the same as yours.
Take special care with Propecia
If any of the side effects get serious, or if you notice any side effects
Check with your doctor or pharmacist before taking your medicine if you
not listed in this leaflet, please tell your doctor or pharmacist.
are going to have a blood test for prostate cancer called PSA
(prostate-specific antigen). This is because Propecia can affect the result
In this leaflet:
of this test.
1. What Propecia is and what it is used for
2. Before you take Propecia
Taking other medicines
3. How to take Propecia
Propecia does not usually affect other medicines. Always tell your doctor
4. Possible side effects
about all medicines you are taking or planning to take, including any
5. How to store Propecia
obtained without a prescription.
6. Further information.
Do not take Propecia if you are already taking finasteride or dustasteride,
used for a prostate problem called benign prostatic hyperplasia (BPH).
1. What Propecia is and what it is used for
Taking Propecia with food and drink
Propecia can be taken with or without food.
Propecia contains a medicine called finasteride. This belongs to a group
of medicines called Type II ‘5-alpha reductase inhibitors’.
Pregnancy and Breast feeding
Propecia should not be taken by women.
Your doctor has prescribed Propecia because you have male pattern hair
loss (also known as androgenetic alopecia). Propecia increases hair
Do not touch crushed or broken Propecia tablets if you are a woman
growth on the scalp and prevents further hair loss in men. Men with mild
who is pregnant or planning to become pregnant (whole tablets are
to moderate, but not complete hair loss, can benefit from using Propecia.
coated to stop contact with the medicine during normal use). This is
because this medicine may affect the baby’s sex organs.
How does the hair on your head grow?
If a woman who is pregnant comes into contact with crushed or
On average your hair grows about 1 centimetre (half an inch) each month.
broken Propecia tablets, speak to your doctor.
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
Driving and using machines
out. In its place a new healthy hair begins to grow, and the cycle is
Propecia is not likely to affect you being able to drive, use tools or
repeated. The hairs on your scalp are always in different stages of this
machines.
cycle so it is normal to lose scalp hair every day.
Important information about some of the ingredients of Propecia.
What is male pattern hair loss?
Propecia contains lactose, which is a type of sugar. If you have ever been
Male pattern hair loss is a common condition in which men experience
told by your doctor that you cannot tolerate or digest some sugars (have
thinning of the hair on the scalp, often resulting in a receding hairline and/ an intolerance to some sugars), talk to your doctor before taking this
or balding on the top of the head. This condition is thought to be caused
medicine.
by a combination of genetic factors and a particular hormone, DHT
(dihydrotestosterone).
Using other medicine for male pattern hair loss with Propecia
No information is available about the use of Propecia with minoxidil,
DHT causes a decrease in the growth phase and thinning of the hair (see another type of medicine for male pattern hair loss which is applied to the
picture). This leads to male pattern hair loss. These changes can start to
head.
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
3. How to take Propecia
permanently lost.
Always take Propecia exactly as your doctor has told you. Check with
your doctor or pharmacist if you are not sure.
Taking this medicine
The usual dose is one tablet each day.
Take this medicine by mouth.
Propecia will not work faster or better if you take it more than once a
day.
If you take more Propecia than you should
If you take too many tablets by mistake, contact your doctor immediately.
If you forget to take Propecia
If you forget to take a tablet, skip the missed dose.
Take the next one as usual.
Do not take a double dose to make up for a forgotten dose.

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.

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, Propecia can cause side effects, although not
everybody gets them. The following side effects may happen with this
medicine:
Allergic reactions
If you have an allergic reaction, stop taking it and see your doctor
straight away. The signs may include:
Skin rashes, itching, or lumps under your skin (hives)
Swelling of lips, face, tongue or throat
difficulty swallowing
breathing difficulties.
Other side effects may include:
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.
Other side effects reported in men are:
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
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
depressed mood.
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.
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
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
Do not store above 30°C. Store in the original package.
Do not use after the expiry date shown on the carton label or blister
strip.
KEEP OUT OF THE SIGHT AND REACH OF CHILDREN
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
pharmacist.
Important
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.
6. 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.

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

29th July 2013

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

PACKAGE LEAFLET: INFORMATION FOR THE USER
PROPECIA® 1 MG FILM-COATED TABLETS
(finasteride)

2. Before you take Propecia

Do not take Propecia if:
you are a woman (because this medicine is for men). It has been
This product will be referred to as Propecia throughout this leaflet.
shown in clinical trials that Propecia does not work in women with hair
loss.
This medicine is for use in men only
you are allergic (hypersensitive) to finasteride or any of the other
ingredients (listed in Section 6)
Read all of this leaflet carefully before you start to take this
you are already taking finasteride or dutasteride used for a prostate
medicine.
problem called benign prostatic hyperplasia (BPH).
Keep this leaflet. You may want to read it again.
Do not take Propecia if any of the above applies to you. If you are not
If you have any further questions, ask your doctor or pharmacist.
sure, talk to your doctor or pharmacist.
This medicine has been prescribed for you. Do not pass it on to others. Propecia should not be used in children.
It may harm them, even if their symptoms are the same as yours.
Take special care with Propecia
If any of the side effects get serious, or if you notice any side effects
Check with your doctor or pharmacist before taking your medicine if you
not listed in this leaflet, please tell your doctor or pharmacist.
are going to have a blood test for prostate cancer called PSA
(prostate-specific antigen). This is because Propecia can affect the result
In this leaflet:
of this test.
1. What Propecia is and what it is used for
2. Before you take Propecia
Taking other medicines
3. How to take Propecia
Propecia does not usually affect other medicines. Always tell your doctor
4. Possible side effects
about all medicines you are taking or planning to take, including any
5. How to store Propecia
obtained without a prescription.
6. Further information.
Do not take Propecia if you are already taking finasteride or dustasteride,
used for a prostate problem called benign prostatic hyperplasia (BPH).
1. What Propecia is and what it is used for
Taking Propecia with food and drink
Propecia can be taken with or without food.
Propecia contains a medicine called finasteride. This belongs to a group
of medicines called Type II ‘5-alpha reductase inhibitors’.
Pregnancy and Breast feeding
Propecia should not be taken by women.
Your doctor has prescribed Propecia because you have male pattern hair
loss (also known as androgenetic alopecia). Propecia increases hair
Do not touch crushed or broken Propecia tablets if you are a woman
growth on the scalp and prevents further hair loss in men. Men with mild
who is pregnant or planning to become pregnant (whole tablets are
to moderate, but not complete hair loss, can benefit from using Propecia.
coated to stop contact with the medicine during normal use). This is
because this medicine may affect the baby’s sex organs.
How does the hair on your head grow?
If a woman who is pregnant comes into contact with crushed or
On average your hair grows about 1 centimetre (half an inch) each month.
broken Propecia tablets, speak to your doctor.
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
Driving and using machines
out. In its place a new healthy hair begins to grow, and the cycle is
Propecia is not likely to affect you being able to drive, use tools or
repeated. The hairs on your scalp are always in different stages of this
machines.
cycle so it is normal to lose scalp hair every day.
Important information about some of the ingredients of Propecia.
What is male pattern hair loss?
Propecia contains lactose, which is a type of sugar. If you have ever been
Male pattern hair loss is a common condition in which men experience
told by your doctor that you cannot tolerate or digest some sugars (have
thinning of the hair on the scalp, often resulting in a receding hairline and/ an intolerance to some sugars), talk to your doctor before taking this
or balding on the top of the head. This condition is thought to be caused
medicine.
by a combination of genetic factors and a particular hormone, DHT
(dihydrotestosterone).
Using other medicine for male pattern hair loss with Propecia
No information is available about the use of Propecia with minoxidil,
DHT causes a decrease in the growth phase and thinning of the hair (see another type of medicine for male pattern hair loss which is applied to the
picture). This leads to male pattern hair loss. These changes can start to
head.
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
3. How to take Propecia
permanently lost.
Always take Propecia exactly as your doctor has told you. Check with
your doctor or pharmacist if you are not sure.
Taking this medicine
The usual dose is one tablet each day.
Take this medicine by mouth.
Propecia will not work faster or better if you take it more than once a
day.
If you take more Propecia than you should
If you take too many tablets by mistake, contact your doctor immediately.
If you forget to take Propecia
If you forget to take a tablet, skip the missed dose.
Take the next one as usual.
Do not take a double dose to make up for a forgotten dose.

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.

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, Propecia can cause side effects, although not
everybody gets them. The following side effects may happen with this
medicine:
Allergic reactions
If you have an allergic reaction, stop taking it and see your doctor
straight away. The signs may include:
Skin rashes, itching, or lumps under your skin (hives)
Swelling of lips, face, tongue or throat
difficulty swallowing
breathing difficulties.
Other side effects may include:
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.
Other side effects reported in men are:
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
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
depressed mood.
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.
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
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
Do not store above 30°C. Store in the original package.
Do not use after the expiry date shown on the carton label or blister
strip.
KEEP OUT OF THE SIGHT AND REACH OF CHILDREN
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
pharmacist.
Important
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.
6. 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.

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

29th July 2013

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

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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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