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Active substance: FINASTERIDE

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Patient Information Leaflet: Information for the user

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, pharmacist or nurse.
• 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 of the side effects, talk to your doctor, pharmacist or nurse. This includes any
possible side effects not listed in this leaflet. See section 4.
What is in this leaflet:
1. What Finasteride 5mg Tablets are and what they are used for
2. What you need to know before you take Finasteride 5mg Tablets
3. How to take Finasteride 5mg Tablets
4. Possible side effects
5. How to store Finasteride 5mg Tablets
6. Contents of the pack and other information
Finasteride belongs to the group of medicines
called 5-alpha reductase inhibitors.They act
by reducing the size of the prostate gland in
Finasteride 5mg Tablets act by shrinking the
enlarged prostate gland in men. Your doctor
has prescribed the medicine for you to treat a
condition known as benign prostatic hyperplasia or BPH.
The prostate gland which is near the bladder
has become enlarged and is making it more
difficult to pass urine. Finasteride 5mg Tablets
will help to relieve these symptoms and will
help reduce the risk of you developing a
sudden inability to pass urine (known as acute
urinary retention) and the need for surgery.
What is the prostate?
The prostate is a walnut-sized gland found
only in men. It is located below the bladder
and it surrounds the urethra, a tube that
carries urine from the bladder out through the
tip of the penis. The prostate's main function
is to produce fluid for semen, the fluid that
carries sperm.
What is Benign Prostatic Hyperplasia
BPH is a benign enlargement of the prostate
gland which is common in men over 50 years
old. Because the prostate is close to the
bladder and surrounds part of the urethra, its
enlargement may affect your ability to urinate.
You may experience symptoms such as a
need to urinate often, especially at night, a
feeling that you must urinate right away,
difficulty in starting to urinate, a weak or
interrupted urinary stream, or a feeling that
you cannot empty your bladder completely.
In some men, BPH can lead to serious
problems, including urinary tract infections,
and a sudden inability to pass urine at all as
well as the need for surgery. For this reason,
a man with symptoms of BPH should see his
Do not take Finasteride 5mg Tablets:
•If you are allergic (hypersensitive) to
finasteride or any of the other ingredients of
Finasteride 5mg Tablets (see section 6)
• If you are a woman (because this medicine
is for men)
The condition for which Finasteride
Tablets are prescribed occurs only in
men. The tablets must not be taken by
women or by children.
Warnings and precautions:
Talk to your doctor or pharmacist before
taking Finasteride 5mg Tablets if:
• Your partner is pregnant or planning to
become pregnant. You should use a condom
or other barrier method of contraception
when taking this medicine. 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 5mg
Tablets can affect the results of the test.

What else you should know before taking
Finasteride 5mg Tablets:
BPH is not cancer and does not lead to
cancer, but the two conditions can be
present at the same time. Before starting
you on finasteride, it is likely that your doctor
will perform some simple tests to check
whether you have prostate cancer. Your
doctor will evaluate your symptoms and their
possible causes. Talk to your doctor if you
have any questions.
Finasteride 5mg Tablets are for use in men
Finasteride should not be used in children.
Other medicines and Finasteride 5mg
Tell your doctor or pharmacist if you are
taking, have recently taken or might take any
other medicines.
Taking Finasteride 5mg Tablets with food
and drink:
Finasteride can be taken with or without food.
Pregnancy and breast-feeding:
Finasteride 5mg Tablets SHOULD NOT be
taken by women.
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.
If a woman who is pregnant comes into
contact with crushed or broken tablets, speak
to your doctor.
Driving and using machines
Finasteride 5mg Tablets are not likely to affect
your ability to drive, use tools or machines.
Finasteride 5mg Tablets contain lactose
If you have been told by your doctor that you
have an intolerance to some sugars, talk to
your doctor or pharmacist before taking this
Talk to your doctor or pharmacist if you have
any questions.
Always take Finasteride 5mg Tablets exactly
how your doctor has instructed you. You
should check with your doctor or pharmacist if
you are unsure. The usual dose is one tablet
containing 5mg Finasteride to be taken by
mouth once a day with or without food.
In order to treat your symptoms and control
your BPH effectively, it is important that you
continue to take Finasteride 5mg Tablets for
as long as your doctor prescribes, even if you
do not feel an immediate benefit.
Some patients show early improvements in
symptoms, but you may need to take Finasteride 5mg Tablets for at least six months to
see if it improves your symptoms.

Finasteride works best when it is taken long
Your doctor may prescribe Finasteride 5mg
Tablets along with another medicine called
doxazosin to help you control your BPH.
If you take more Finasteride 5mg Tablets
than you should:
If you have taken too many tablets by
mistake, contact your doctor immediately.
If you forget to take Finasteride 5mg
If you miss a dose, just carry on with the next
one as usual. Do not take a double dose to
make up for forgotten individual doses.
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
Other side effects may include:
• You may be unable to have an erection
• 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 this medicine. If
not, they usually resolve after stopping taking
this medicine.
Other side effects reported in some men
• 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

What else do you need to know about
Finasteride 5mg Tablets?
Finasteride 5mg Tablets are 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
• 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.
Keep out of the sight and reach of
This medicinal product does not require any
special storage conditions.
Do not use Finasteride 5mg Tablets after the
expiry date, which is stated on the label after
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.
What Finasteride 5mg Tablets contain
The active substance is finasteride. One filmcoated tablet contains 5mg of finasteride.
The other ingredients are
Tablet core - Lactose monohydrate, cellulose
microcrystalline, starch pregelatinized, sodium
starch glycolate (type-A), lauroyl
macrogolglycerides and magnesium stearate.
Film coating - Hypromellose, titanium dioxide
(E171), indigo carmine (E132) and macrogol
They are supplied in blister packs of 12, 28,
30 and 56 tablets and bottles of 50, 75 and
100 tablets.
Marketing Authorisation Holder &
Relonchem Limited, Cheshire House, Gorsey
Lane, Widnes, Cheshire, WA8 0RP, UK
Product Licence Number: PL 20395 / 0067
This leaflet was last revised in October

• 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.
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 via
the Yellow Card Scheme at:
By reporting side effects you can help provide
more information on the safety of this

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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.