FINASTERIDE 5MG TABLETS

Active substance: FINASTERIDE

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121 LEAFLET Proscar 20131105

PACKAGE LEAFLET: INFORMATION FOR THE USER

PROSCAR 5mg TABLETS
(finasteride)
Your medicine is known by above names 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.



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:

If you have any further questions, ask your doctor or
pharmacist.



2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE
PROSCAR



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.
Children

In this leaflet:

Proscar should not be used in children.

1. What Proscar is and what it is used for

Taking other medicines

2. What you need to know before you take Proscar

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

3. How to take Proscar
4. Possible side effects
5. How to store Proscar
6. Contents of the pack and other information

Proscar can be taken with or without food.
Pregnancy and breast feeding


Proscar should not be taken by women.



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

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.



A swollen prostate gland can lead to a condition called ‘benign
prostatic hyperplasia’ or BPH.

If a woman who is pregnant comes into contact with crushed or
broken Proscar tablets, speak to your doctor.

Driving and using machines

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.

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.

Proscar is not likely to affect you being able to drive, use tools or
machines.
Proscar 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

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.

In some men, BPH can lead to more serious problems, such as:


urinary tract infections



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.

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 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 20131105

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 get any side effects, talk to your anaesthetist or other doctor.
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.

If you have any further questions on the use of this medicine, ask
your doctor or pharmacist.

United Kingdom: Yellow Card Scheme Website:
www.mhra.gov.uk/yellowcard

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
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, tongue, throat and face.
Other side effects may include:


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.

Post-Licensing Directorate, 203 Level 3, Rue D’Argens,
GŻR-1368 Gżira Website: www.medicinesauthority.gov.mt,
e-mail: postlicensing.medicinesauthority@gov.mt

5. HOW TO STORE PROSCAR


KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.



Do not store above 25°C. Store in a closed container protected
from light.



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.

You may be unable to have an erection (impotence)



Malta: ADR Reporting, The Medicines Authority,

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.



Breast swelling or tenderness



Palpitations (feeling your heartbeat)



Changes in the way your liver is working, which can be shown
by a blood test

6. FURTHER INFORMATION



Pain in your testicles





An inability to have an erection which may continue after
stopping the medication

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





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



Depression



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).

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.

What Proscar contains

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.

Product Licence holder
Procured from within the EU and repackaged by the Parallel Import
Product Licence holder: Chemilines Ltd, Chemilines House,
Alperton Lane, Wembley, Middlesex, HA0 1DX.
Manufacturer
This product is manufactured by Merck Sharp and Dohme Ltd,
Cramlington, Northumberland NE23 3JU, England.
POM

PL No: 08747/0121

Leaflet revision date: 5 November 2013
Proscar is a registered trade mark of Merck & Co Inc, USA.
121 LEAFLET Proscar 20131105

121 LEAFLET Finasteride 20131105

PACKAGE LEAFLET: INFORMATION FOR THE USER

FINASTERIDE 5mg TABLETS
(finasteride)
Your medicine is known by above names but will be referred to as
Finasteride 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.



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:


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 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 if:

If you have any further questions, ask your doctor or
pharmacist.



2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE
FINASTERIDE



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

If you are not sure, talk to your doctor or pharmacist before taking
Finasteride.
Children

In this leaflet:

Finasteride should not be used in children.

1. What Finasteride is and what it is used for

Taking other medicines

2. What you need to know before you take Finasteride

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

3. How to take Finasteride
4. Possible side effects
5. How to store Finasteride
6. Contents of the pack and other information

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


Finasteride should not be taken by women.



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

Do not touch crushed or broken Finasteride 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.



A swollen prostate gland can lead to a condition called ‘benign
prostatic hyperplasia’ or BPH.

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

Driving and using machines

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

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.

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

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.

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 Finasteride, 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.

3. HOW TO TAKE FINASTERIDE
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 Finasteride along with another
medicine (called doxazosin) to help control your BPH.

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


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 20131105

If you stop taking Finasteride

Reporting of side effects

Your condition may show an early improvement after taking
Finasteride. However, it may take at least six months for the full
effect to develop. It is important to keep taking Finasteride 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 anaesthetist or other doctor.
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.

If you have any further questions on the use of this medicine, ask
your doctor or pharmacist.

United Kingdom: Yellow Card Scheme Website:
www.mhra.gov.uk/yellowcard
Malta: ADR Reporting, The Medicines Authority,

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

Post-Licensing Directorate, 203 Level 3, Rue D’Argens,
GŻR-1368 Gżira Website: www.medicinesauthority.gov.mt,
e-mail: postlicensing.medicinesauthority@gov.mt

5. HOW TO STORE FINASTERIDE

If you have an allergic reaction, stop taking it and see your doctor
straight away. The signs may include:



KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.





Do not store above 25°C. Store in a closed container protected
from light.



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.

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

 Swelling of your lips, tongue, throat 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 Finasteride. If not, they usually resolve after
stopping Finasteride. 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.



Breast swelling or tenderness



Palpitations (feeling your heartbeat)

6. FURTHER INFORMATION



Changes in the way your liver is working, which can be shown
by a blood test

What Finasteride contains



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 Finasteride?
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.



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 looks like and contents of the pack


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



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

Product Licence holder
Procured from within the EU and repackaged by the Parallel Import
Product Licence holder: Chemilines Ltd, Chemilines House,
Alperton Lane, Wembley, Middlesex, HA0 1DX.
Manufacturer
This product is manufactured by Merck Sharp and Dohme Ltd,
Cramlington, Northumberland NE23 3JU, England.
POM

PL No: 08747/0121

Leaflet revision date: 5 November 2013
121 LEAFLET Finasteride 20131105

Expand view ⇕

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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