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FINASTERIDE 5MG TABLETS

Active substance(s): FINASTERIDE

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121 LEAFLET Proscar 20171202

PACKAGE LEAFLET: INFORMATION FOR THE USER

2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE

PROSCAR
PROSCAR® 5mg TABLETS
(finasteride)
Your medicine is known as PROSCAR® 5mg TABLETS but will be
referred to as Proscar throughout the following leaflet.
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.

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

2. What you need to know before you take Proscar

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.

3. How to take Proscar

Children

4. Possible side effects

Proscar should not be used in children.

5. How to store Proscar

Taking other medicines

6. Contents of the pack and other information

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.

In this leaflet:
1. What Proscar is and what it is used for

1. WHAT PROSCAR IS AND WHAT IT IS USED FOR

Taking Proscar with food and drink

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

Proscar can be taken with or without food.

Proscar shrinks the prostate gland in men when it is swollen.



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.

The prostate gland is found underneath the bladder (but only in
men). It produces the fluid found in semen.

Pregnancy and breast feeding

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.



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.

121 LEAFLET Proscar 20171202

If you stop taking Proscar

Reporting of side effects

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.

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 in UK 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.

4. POSSIBLE SIDE EFFECTS

5. HOW TO STORE PROSCAR

Like all medicines, this medicine can cause side effects, although
not everybody gets them. The following side effects may happen
with this medicine:



KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.



Do not store above 25°C. Store in the original package. Keep
container tightly closed to protect from light and moisture.



If your doctor tells you to stop using the medicine, please take it
back to the pharmacist for safe disposal. Only keep the
medicine if your doctor tells you to.

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)





Do not use after the expiry date printed on the carton label or
blister strip.

Skin rashes, itching, or lumps under your skin (hives).



If the medicine becomes discoloured or shows any other signs
of deterioration, you should seek the advice of your pharmacist
who will tell you what to do.

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:

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


Each film-coated tablet contains 5mg of the active ingredient,
finasteride.



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

Product Licence holder



Problems with ejaculation that may continue after stopping the
medication

Procured from within the EU and repackaged by the Parallel Import
Product Licence holder: Chemilines Ltd, Chemilines House,
Alperton Lane, Wembley, Middlesex, HA0 1DX.

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.



Proscar Tablets also contain the following: talc, microcrystalline
cellulose, docusate sodium, lactose, magnesium stearate,
pregelatinised maize starch, sodium starch glycollate, yellow
iron oxide (E172), hydroxypropylcellulose, indigocarmine
aluminium lake (E132), hypromellose, and titanium dioxide
(E171).
What Proscar looks like and contents of the pack


Proscar tablets are blue, apple-shaped tablets marked ‘MSD 72’
on one side and 'Proscar' on the other.



Proscar Tablets are available as calendar blister packs of 28
tablets.

Manufacturer
This product is manufactured by Merck Sharp and Dohme Ltd,
Cramlington, Northumberland NE23 3JU, England.
POM

PL: 08747/0121

Leaflet revision date: 02 December 2017

Blind or partially sighted? Is
this leaflet hard to see or read?
Call 02087997607 to obtain the
leaflet in large print, tape, CD
or Braille.
Proscar® is a registered trade mark of Merck Sharp & Dohme Corp., USA.
121 LEAFLET Proscar 20171202

121 LEAFLET Finasteride 20171202

PACKAGE LEAFLET: INFORMATION FOR THE USER

2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE

FINASTERIDE TABLET
FINASTERIDE 5mg TABLETS
Your medicine is known as FINASTERIDE 5mg TABLETS but will
be referred to as Finasteride Tablet throughout the following leaflet.
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.

Do not take Finasteride Tablet:


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 Finasteride Tablet 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 Finasteride Tablet if:


your partner is pregnant or planning to become pregnant. You
should use a condom or other barrier method of contraception
when taking Finasteride Tablet. 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
Finasteride Tablet can affect the results of this test.

If you are not sure, talk to your doctor or pharmacist before taking
Finasteride Tablet.
Mood alterations and depression

2. What you need to know before you take Finasteride Tablet

Mood alterations such as depressed mood, depression and, less
frequently, suicidal thoughts have been reported in patients treated
with Finasteride Tablet. If you experience any of these symptoms
contact your doctor for further medical advice as soon as possible.

3. How to take Finasteride Tablet

Children

4. Possible side effects

Finasteride Tablet should not be used in children.

5. How to store Finasteride Tablet

Taking other medicines

6. Contents of the pack and other information

Tell your doctor or pharmacist if you are taking, have recently taken
or might take any other medicines. Finasteride Tablet does not
usually affect other medicines.

In this leaflet:
1. What Finasteride Tablet is and what it is used for

1. WHAT FINASTERIDE TABLET IS AND WHAT IT IS

USED FOR
Finasteride Tablet contains a medicine called finasteride. This
belongs to a group of medicines called ‘5-alpha reductase
inhibitors’.
Finasteride Tablet shrinks the prostate gland in men when it is
swollen.

Taking Finasteride Tablet with food and drink
Finasteride Tablet can be taken with or without food.
Pregnancy and breast feeding


Finasteride Tablet should not be taken by women.



Do not touch crushed or broken Finasteride Tablet 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.

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 a woman who is pregnant comes into contact with crushed or
broken Finasteride tablets, speak to your doctor.
Driving and using machines

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.

Finasteride Tablet is not likely to affect you being able to drive, use
tools or machines.
Finasteride Tablet contains

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:

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 FINASTERIDE TABLET
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



urinary tract infections





The usual dose is one tablet each day.

a sudden inability to pass urine



Take this medicine by mouth.



Your doctor may prescribe Finasteride Tablet along with
another medicine (called doxazosin) to help control your BPH.

 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 Finasteride Tablet, 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.

If you take more Finasteride Tablet than you should
If you take too many tablets by mistake, contact your doctor
immediately.
If you forget to take Finasteride Tablet


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.

121 LEAFLET Finasteride 20171202

If you stop taking Finasteride Tablet

Reporting of side effects

Your condition may show an early improvement after taking
Finasteride Tablet. However, it may take at least six months for the
full effect to develop. It is important to keep taking Finasteride
Tablet for as long as your doctor tells you, even if you do not feel
any benefit straight away.

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 in UK 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.

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. The following side effects may happen
with this medicine:
Allergic reactions
Stop using Finasteride Tablet 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 Finasteride Tablet. If not, they usually resolve after
stopping Finasteride Tablet. Other side effects reported in some
men are:

5. HOW TO STORE FINASTERIDE TABLET


KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.



Do not store above 25°C. Store in the original package. Keep
container tightly closed to protect from light and moisture.



If your doctor tells you to stop using the medicine, please take it
back to the pharmacist for safe disposal. Only keep the
medicine if your doctor tells you to.



Do not use after the expiry date printed on the carton label or
blister strip.



If the medicine becomes discoloured or shows 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. CONTENTS OF THE PACK AND OTHER INFORMATION
What Finasteride Tablet contains


Each film-coated tablet contains 5mg of the active ingredient,
finasteride.



Finasteride Tablets also contain the following: talc,
microcrystalline cellulose, docusate sodium, lactose,
magnesium stearate, pregelatinised maize starch, sodium
starch glycollate, yellow iron oxide (E172),
hydroxypropylcellulose, indigocarmine aluminium lake (E132),
hypromellose, and titanium dioxide (E171).
What Finasteride Tablet looks like and contents of the pack



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



Finasteride tablets are blue, apple-shaped tablets marked ‘MSD
72’ on one side and 'Finasteride Tablet' on the other.



Male infertility and/or poor quality of semen. Improvement in the
quality of the semen has been reported after stopping
medication



Finasteride Tablets are available as calendar blister packs of 28
tablets.



Depression

Product Licence holder



Decrease in sex drive that may continue after stopping the
medication



Problems with ejaculation that may continue after stopping the
medication

Procured from within the EU and repackaged by the Parallel Import
Product Licence holder: Chemilines Ltd, Chemilines House,
Alperton Lane, Wembley, Middlesex, HA0 1DX.

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 Finasteride Tablet?
Finasteride Tablet (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.

Manufacturer
This product is manufactured by Merck Sharp and Dohme Ltd,
Cramlington, Northumberland NE23 3JU, England.
POM

PL: 08747/0121

Leaflet revision date: 02 December 2017

Blind or partially sighted? Is
this leaflet hard to see or read?
Call 02087997607 to obtain the
leaflet in large print, tape, CD
or Braille.
121 LEAFLET Finasteride 20171202

+ Expand Transcript

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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