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PROSCAR 5MG FILM-COATED TABLETS

Active substance(s): FINASTERIDE

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PACKAGE LEAFLET: INFORMATION FOR THE USER
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PROSCAR® 5 mg film-coated
tablets

Technical Info

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AMS Blue Braille Grid Version: 31.0 - 20-04-17

(finasteride)
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 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.
In this leaflet:
1. What Proscar is and what it is used for
2. What you need to know before you take Proscar
3. How to take Proscar
4. Possible side effects
5. How to store Proscar
6. Contents of the pack and other information

1. What Proscar is and what it is used for

Proscar contains a medicine called finasteride. This belongs
to a group of medicines called ‘5-alpha reductase inhibitors’.
Proscar shrinks the prostate gland in men when it is swollen.
The prostate gland is found underneath the bladder (but only
in men). It produces the fluid found in semen. A swollen
prostate gland can lead to a condition called ‘benign
prostatic hyperplasia’ or BPH.
What is BPH?
If you have BPH it means that your prostate gland is swollen.
It can press on the tube that urine passes through, on its way
out of your body.
This can lead to problems such as:
• feeling like you need to pass urine more often, especially
at night
• feeling that you must pass urine right away
• finding it difficult to start passing urine
• when you pass urine the flow of urine is weak
• when you pass urine the flow stops and starts
• feeling that you cannot empty your bladder completely
In some men, BPH can lead to more serious problems, such as:
• urinary tract infections
• a sudden inability to pass urine
• the need for surgery

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What else should you know about BPH?
• BPH is not cancer and does not lead to cancer, but the
two conditions can be present at the same time.
• Before you start Proscar, your doctor will do some simple
tests to check whether you have prostate cancer.
Talk to your doctor if you have any questions about this.

2. What you need to know before you take Proscar

Do not take Proscar:
• if you are a woman (because this medicine is for men)
• if you are allergic (hypersensitive) to finasteride or any of
the other ingredients of this medicine (listed in Section 6).
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Do not take Proscar 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 Proscar if:
• your partner is pregnant or planning to become pregnant.
You should use a condom or other barrier method of
contraception when taking Proscar. This is because your
semen could contain a tiny amount of the drug and may
affect the normal development of the baby’s sex organs.
• you are going to have a blood test called PSA. This is
because Proscar can affect the results of this test.
If you are not sure, talk to your doctor or pharmacist before
taking Proscar.
Mood alterations and depression
Mood alterations such as depressed mood, depression and, less
frequently, suicidal thoughts have been reported in patients
treated with Proscar. If you experience any of these symptoms
contact your doctor for further medical advice as soon as possible.
Children
Proscar should not be used in children.
Taking other medicines
Tell your doctor or pharmacist if you are taking, have recently
taken or might take any other medicines. Proscar does not
usually affect other medicines.
Taking Proscar with food and drink
Proscar can be taken with or without food.
Pregnancy and breast feeding
• Proscar should not be taken by women.
• Do not touch crushed or broken Proscar 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 normal development of the baby’s sex organs.
• If a woman who is pregnant comes into contact with
crushed or broken Proscar tablets, speak to your doctor.
Driving and using machines
Proscar is not likely to affect you being able to drive, use
tools or machines.
Proscar contains
• Lactose. This is a type of sugar. If you have ever been
told by your doctor that you cannot tolerate or digest
some sugars (have an intolerance to some sugars), talk to
your doctor or pharmacist before taking this medicine.

3. How to take Proscar

Always take this medicine exactly as your doctor or pharmacist
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.
• Your doctor may prescribe Proscar along with another
medicine (called doxazosin) to help control your BPH.
If you take more Proscar than you should
If you take too many tablets by mistake, contact your doctor
immediately.
If you forget to take Proscar
• If you forget to take a tablet, skip the missed dose.
• Take the next dose as usual.
• Do not take a double dose to make up for a forgotten dose.
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If you stop taking Proscar
Your condition may show an early improvement after taking
Proscar. However, it may take at least six months for the full
effect to develop. It is important to keep taking Proscar for
as long as your doctor tells you, even if you do not feel any
benefit straight away.
If you have any further questions on the use of this medicine,
ask your doctor or pharmacist.

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4. Possible side effects

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The effect of long-term use of finasteride on tumours of
this kind is not known.
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, pharmacist
or nurse. 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

5. How to store Proscar

Keep this medicine out of the sight and reach of children.
Do not store your tablets above 30°C. Keep them in the
original package.
If you have been given a calendar pack, do not remove the
tablets from the blister until you are ready to take the medicine.
Do not use Proscar 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 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.

6. Contents of the pack and other information

What Proscar contains
• The active substance is finasteride. Each tablet contains
5 mg finasteride.
• The other ingredients are: Docusate sodium,
Hydroxypropyl cellulose E463, Hypromellose E464, Indigo
carmine aluminium lake E132, Lactose monohydrate,
Magnesium stearate E572, Microcrystalline cellulose E460,
Pregelatinised maize starch, Sodium starch glycollate
Type A, Talc, Titanium dioxide E171, Yellow iron oxide E172.
What Proscar looks like and the content of the pack
Proscar is available as blue, apple-shaped tablets. Proscar
Tablets are supplied in blister packs of 28 tablets.
Marketing Authorisation Holder and Manufacturer
The Marketing Authorisation Holder Manufacturer
Merck Sharp & Dohme Limited
Merck Sharp & Dohme Limited
Hertford Road
Shotton Lane
Hoddesdon
Cramlington
Hertfordshire EN11 9BU
Northumberland NE23 3JU
United Kingdom
United Kingdom
This leaflet was last revised in July 2017
This leaflet gives you some important patient information
about Proscar. If you have questions after you read it ask your
doctor or pharmacist, who will give you further information.
© Merck Sharp & Dohme Limited 2017. All rights reserved.
PIL.PSC.17.UK.6019

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For Position Only

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Like all medicines, this medicine can cause side effects,
although not everybody gets them. The following side effects
may happen with this medicine:
Allergic reactions
Stop using Proscar and immediately contact a doctor if you
experience any of the following symptoms:
• Swelling of face, lips, tongue or throat, difficulty
swallowing and breathing difficulties (angioedema)
• Skin rashes, itching, or lumps under your skin (hives).
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 Proscar. If not, they usually resolve after
stopping Proscar. Other side effects reported in some 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 your testicles
• An inability to have an erection which may continue after
stopping the medication
• Male infertility and/or poor quality of semen. Improvement
in the quality of the semen has been reported after stopping
medication
• Depression
• Decrease in sex drive that may continue after stopping
the medication
• Problems with ejaculation that may continue after stopping
the medication
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 the side effects get serious, or if you notice any
side effects not listed in 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.
What else should you know about Proscar?
Proscar (finasteride) is not licensed to treat prostate cancer.
Information collected for a clinical trial in men taking
finasteride 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.

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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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