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PROSCAR 5MG TABLETS

Active substance(s): FINASTERIDE

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Assessed against UK PIL dated July 2017
PACKAGE LEAFLET: INFORMATION FOR THE USER

Proscar® 5 mg Tablets
MOCK-UP

(finasteride)
By rajeevkumarj at

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.
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).
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.
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
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.

Manufactured by Merck Sharp & Dohme Ltd. Shotton Lane,
Cramlington, Northumberland NE23 3JU. Procured from within
the EU. Product Licence holder: Quadrant Pharmaceuticals Ltd.
Lynstock House, Lynstock Way, Lostock, Bolton BL6 4SA.
Repackaged by Maxearn Ltd. Bolton BL6 4SA.
PL 20774/1253 Proscar 5mg Tablets

POM

th

Date of preparation 16 January 2018
Proscar is registered trademark of Merck Sharp & Dohme Corp.

Blind or partially sighted? Is this
leaflet hard to see or read? Contact
Quadrant Pharmaceuticals Ltd –
01204 473081

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.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side effects not listed on this leaflet. You
can also report side effects directly via the Yellow Card Scheme
at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow
Card in the Google Play or Apple App Store. By reporting side
effects, you can help provide more information on the safety of
this medicine.
5. How to store Proscar
Keep your tablets 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.
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. Contents of the pack and other information
What Proscar contains

The active ingredient in Proscar Tablets is finasteride. Each
tablet contains 5 mg finasteride.

The other ingredients in Proscar tablets are: docusate
sodium, hydroxypropyl cellulose, hypromellose, indigo
carmine aluminium lake, lactose, magnesium stearate,
microcrystalline cellulose, pregelatinised maize starch, talc,
titanium dioxide E171, yellow iron oxide E172 and sodium
starch glycollate.
What Proscar looks like and the content of the pack
Proscar is available as blue, apple-shaped tablets one side
marked with ‘MSD 72’and the reverse marked with ‘PROSCAR’.
Proscar Tablets are supplied in calendar blister packs of 28
tablets.

PP4/1253/V2

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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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