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FINASTERIDE 1 MG FILM-COATED TABLETS

Active substance(s): FINASTERIDE

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S0051-28-RM-PIL-07.09.2015

PACKAGE LEAFLET: INFORMATION FOR THE USER
PROPECIA® 1 MG FILM-COATED TABLETS /
FINASTERIDE 1 MG FILM-COATED TABLETS
(finasteride)
This medicine is for use in men only
Your medicine is available using the above two names, but will be
referred to as Propecia throughout the remainder of this 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 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.

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
(prostate specific 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

1. What Propecia is and what it is used for

See section 4.

Propecia contains a medicine called finasteride. This belongs to a group
of medicines called Type II ‘5-alpha reductase inhibitors’.

Children and adolescents

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 Propecia.

Other medicines and Propecia

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

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 should not be used in children. There are no data
demonstrating efficacy or safety of finasteride in children under the
age of 18.

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
Healthy Hair
(Thick, actively
growing &
fully pigmented)

Progressive hair thinning
(Thicker, shorter & less pigmented)

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
Male pattern
hair loss

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.

No male
pattern hair
loss

If you stop taking Propecia

5. How to store 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.

KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.
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 25°C. Keep them in the original package.
Do not use Propecia 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.
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.
If the tablets become discoloured or show any signs of deterioration, you
should seek the advice of your pharmacist.

6. Contents of the pack and other information
What Propecia contains
 Each film-coated tablet contains 1 mg finasteride as the active

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.

ingredient.
 The other ingredients in Propecia are: lactose monohydrate,

microcrystalline cellulose, pregelatinised maize starch, sodium starch
glycollate, docusate sodium, magnesium stearate, hypromellose,
hydroxypropyl cellulose, titanium dioxide (E171), 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 is supplied in blister packs of 28 tablets.

These side effects above may disappear after a while if you continue
taking Propecia. If these symptoms persist, they usually resolve after
stopping Propecia.

Manufactured by:
Merck Sharp & Dohme Ltd., United Kingdom;
Merck Sharp & Dohme BV, The Netherlands.

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
 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.

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

Procured from within the EU and repackaged by: Amimed Direct Ltd,
Hendon, London, NW9 6AQ.
Product Licence Holder: Sam Pharma Ltd, Unit 20, Garrick Industrial
Estate, Irving Way, Hendon, London, NW9 6AQ.
POM

PL No: 33902/0051

This leaflet was last revised: 07/09/2015
Propecia® is a registered trademark of Merck & Co., Inc., USA

S0051-28-RM-PIL-07.09.2015

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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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