PROSCAR TABLETS

Active substance: FINASTERIDE

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Proscar Tablets/
Finasteride 5mg tablets
(finasteride)

Patient Information Leaflet
Your medicine is known by either of the above names but will be referred to
as Proscar throughout this leaflet.

This medicine is for use in men only
Read all of this leaflet carefully before you start to take this medicine.
 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. Do not pass it on to others. It
may harm them, even if their symptoms are the same as yours.
 If any of the side effects gets serious, or if you notice any side effects not
listed in this leaflet, please tell your doctor or pharmacist
In this leaflet:
1) What Proscar is and what it is used for
2) Before you take Proscar
3) How to take Proscar
4) Possible side effects
5) How to store Proscar
6) Further 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.

2) Before you take Proscar
Do not take Proscar if:
 you are a woman (because this medicine is for men)
 you are allergic (hypersensitive) to finasteride or any of the other
ingredients (listed in Section 6).
Do not take Proscar if any of the above apply to you. If you are not sure,
talk to your doctor or pharmacist.
Proscar should not be used in children.
Take special care with Proscar
Check with your doctor or pharmacist before taking your medicine 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.
Taking other medicines
Proscar does not usually affect other medicines. Always tell your doctor
about all medicines you are taking or planning to take, including any
obtained without a prescription.
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.
Important information about some of the ingredients of Proscar
Proscar contains lactose, which 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 before taking this medicine.

3) How to take Proscar
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.

You should take your tablets 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.
 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.
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.

4) Possible side effects
Like all medicines, Proscar 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 your lips and face.
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.
 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.

5) How to store Proscar
 Keep all medicines out of the sight and reach of children.
 Proscar Tablets/Finasteride 5mg Tablets should not be stored above
30°C. Store in the original package.
 Do not use after the expiry date printed on the carton.
 If the tablets become discoloured or show any other signs of deterioration,
you should seek the advice of your pharmacist who will tell you what to
do.
 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 Proscar contains:
The active ingredient in Proscar Tablets is finasteride.
Each tablet contains 5mg of the active ingredient, Finasteride.
Proscar also contain the following:
docusate sodium, hydroxypropyl cellulose, hypromellose, indigo carmine,
aluminium lake (E172), lactose, magnesium stearate, microcrystalline
cellulose, pregelatinised maize starch, sodium starch glycollate, talc,
titanium dioxide (E171) and yellow iron oxide.
What Proscar looks like and content of the pack
A blue shield-shaped tablet, coded ‘PROSCAR’ on one side and MSD 72
on the reverse.
Proscar Tablets/Finasteride 5mg Tablets are available as calendar blister
packs of 28 tablets.
PL 10383/0264

Proscar tablets /Finasteride 5mg tablets POM

Who makes and repackages your medicine?
Your medicine is manufactured by Merck Sharp and Dohme Ltd, Shotton
Lane, Cramlington, Northumberland, NE32 9JU, England, UK. Procured
from within the EU and repackaged by Product Licence Holder: Primecrown
Ltd, 4/5 Northolt Trading Estate, Belvue Road, Northolt, Middlesex, UB5
5QS.
Leaflet date: 06.06.2013

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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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