FINASTERIDE 5 MG TABLETS

Active substance: FINASTERIDE

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Finasteride 5mg Tablets

condom during sexual activity. If a woman who is pregnant
comes in contact with the active ingredient finasteride, a
doctor should be consulted. Whole Finasteride 5mg
tablets are coated to prevent contact with the active
ingredient during normal handling.

PACKAGE LEAFLET: INFORMATION FOR THE USER
Read all of this leaflet carefully before you start
taking this medicine.
• Keep this leaflet. You may need to read it again.
• If you have further questions, please ask your
doctor or your pharmacist.
• This medicine has been prescribed for you
personally and you should not pass it on to others.
It may harm them, even if their symptoms are the
same as yours.

pass urine at all as well as the need for surgery. For this
reason, a man with symptoms of BPH should see his
doctor.

In this leaflet:
1. What Finasteride 5mg Tablets are and what they are
used for
2. Before you take Finasteride 5mg Tablets
3. How to take Finasteride 5mg Tablets
4. Possible side effects
5. Storing Finasteride 5mg Tablets
6. Further Information

If you have been told by your doctor that you have an
intolerance to some sugars, contact your doctor before
taking this medicinal product.

1. WHAT FINASTERIDE 5mg TABLETS ARE
AND WHAT THEY ARE USED FOR

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?

Talk to your doctor if you have any questions.
3. HOW TO TAKE FINASTERIDE 5mg TABLETS

2. BEFORE YOU TAKE FINASTERIDE 5mg TABLETS

Always take Finasteride 5mg tablets exactly as 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.

Do not take Finasteride 5mg Tablets if you are
hypersensitive to finasteride or any of the other
ingredients of Finasteride 5mg Tablets.

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 term.

The condition for which Finasteride tablets are
prescribed occurs only in men. The tablets must
not be taken by women or by children.
Taking Finasteride 5mg Tablets with other
medicines
Finasteride 5mg tablets do not usually interfere with
other medicines. However, you should always inform
your doctor or pharmacist if you are taking or have
recently taken any other medicines even if not
prescribed.

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.

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.

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.

Finasteride 5mg tablets are for use in men only.

What is Benign Prostatic Hyperplasia (BPH) ?

If you forget to take FINASTERIDE 5mg Tablets
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.

If the active ingredient finasteride is absorbed by a
woman who is pregnant with a male baby, it may affect
the normal development of the baby's sex organs.
Therefore, women who are or may potentially be
pregnant should not be exposed to Finasteride 5mg
tablets. They should not take Finasteride 5mg Tablets. In
addition, they should not handle broken or crushed
tablets or be exposed to the drug through sexual contact
with a man taking Finasteride 5mg tablets. Therefore, if
your sexual partner is or may potentially be pregnant, you
must avoid exposing her to your semen which could
contain a tiny amount of the drug for example, by using a

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

4. POSSIBLE SIDE EFFECTS

Like all medicines, Finasteride 5mg Tablets can have side
effects. These are uncommon and do not affect most
men. Side effects due to finasteride may include:
impotence (an inability to have an erection) or less desire
to have sex. Some men may have changes or problems
with ejaculation, such as a decrease in the amount of
semen released during sex. This decrease in the amount
of semen does not appear to interfere with normal sexual
function. In some men, such side effects disappeared
while the patient continued to take Finasteride 5mg
tablets. If symptoms persist, they usually resolve on
discontinuing Finasteride 5mg Tablets.

Finasteride 5mg tablets can affect a blood test called PSA.
If you have a PSA test done, tell your doctor you are
taking Finasteride 5mg tablets.

In addition, some men may have breast swelling and/or
tenderness. Some men have reported testicular pain and
allergic reactions such as rash, itching, hives and swelling
of the lips and face.

CP.FIN.5T.28.RC.V2P1

Customer: RC

CP.FIN.5T.28.RC.V2P1

Designer: CP

Colours

Product: Finasteride 5 mg Tablets
Dimensions: 148mm x 210mm
Item Code: CP.FIN.5T.28.RC.V2P1
Proof No and Date: 4

17/10/2012

Revision: RC Address Update
ARTWORK FOR SUBMISSION
Supersedes: n/a

Pantone Blue
280 C

You should promptly report to your doctor any changes
in your breast tissue such as lumps, pain, enlargement of
the breast tissue or nipple discharge as these may be signs
of a serious condition, such as breast cancer.
A large scale clinical trial was conducted in which men
were taking tablets containing the active ingredient
finasteride or placebo for 7 years to study the prevention
of prostate cancer (finasteride is not licensed for this
treatment). The results showed that the number of men
who developed prostate cancer was lower in the group
treated with finasteride. However the number of men
with a high score in a tumour grading system was higher in
those men treated with finasteride than in men treated
with placebo. The relationship between long-term use of
finasteride and tumours of this kind is unknown.
If you experience any of these or any other unusual
symptoms, go and see your doctor promptly.
It will help if you make a note of what you experienced
and for how long it lasted.
If you notice any side effects not mentioned in this leaflet,
please inform your doctor or pharmacist.
5. STORING FINASTERIDE 5mg TABLETS

Keep out of the reach and sight of children
There are no special storage instructions
Do not use after the expiry date stated on the carton.
Unused tablets should be taken back to the pharmacist for
safe disposal.
6. FURTHER INFORMATION

What Finasteride 5mg Tablets contain
• The active substance is finasteride. Each tablet
contains 5mg of finasteride.
• The film coated tablets also contain lactose
monohydrate,
cellulose
microcrystalline,
pregelatinised starch, lauroyl macrogolglycerides,
sodium starch glycolate (type A), magnesium
stearate, hypromellose 6 cps., titanium dioxide
(E171), indigocarmine-lake (E132) and macrogol
6000. They are supplied in blister packs of 12, 28, 30
and 56 tablets and bottles of 50, 75 and 100 tablets.
• The tablets are film-coated, blue, round biconvex
tablets with a diameter of 7mm, marked “F5” on
one side.
Marketing Authorisation Holder & Manufacturer:
Relonchem Limited, Cheshire House, Gorsey Lane,
Widnes, Cheshire, WA8 0RP U.K.
,
Distributor: Kent Pharmaceuticals Limited, Repton Road,
Measham, DE12 7DT, U.K.
Product Licence Number: PL 20395 / 0067
This leaflet was last revised in October 2012

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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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