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FINASTERIDE 5 MG TABLETS

Active substance(s): FINASTERIDE

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Artwork No.

300714/1

Colours Used

Customer

Relon Chem

Black
Keyline (not to print)

Description

Finasteride 5mg Leaflet

Market

UK

Language

English

Size

148 x 370 mm

Min. Font Size

9 pt

Page No.

1 of 1

Version No.

9

Date

10-10-16

Software

Illustrator 10

Packaging Development

FINASTERIDE 5 MG TABLETS
PATIENT INFORMATION LEAFLET: INFORMATION FOR THE USER

Quality Assurance (QA)

Quality Control (QC)

Production

Talk to your doctor or pharmacist if you have any
questions.

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.

3. HOW TO TAKE FINASTERIDE 5MG
2. WHAT YOU NEED TO KNOW BEFORE
Read all of this leaflet carefully before you
TABLETS
YO U TA K E F I N A S T E R I D E 5 M G
start taking this medicine because it contains
TABLETS
important information for you.
Reporting of side effects
Always take Finasteride 5mg Tablets exactly how
If you get any side effects, talk to your doctor,
!
Keep this leaflet. You may need to read it again.
your doctor has instructed you. You should check
Do not take Finasteride 5 mg Tablets:
pharmacist or nurse. This includes any possible
!
If you have any further questions, ask your
with your doctor or pharmacist if you are unsure.
!
If you are allergic (hypersensitive) to
side effects not listed in this leaflet. You can also
The usual dose is one tablet containing 5mg
doctor, pharmacist or nurse.
finasteride or any of the other ingredients of
report side effects directly via the Yellow Card
Finasteride to be taken by mouth once a day with
!
This medicine has been prescribed for you
Finasteride 5mg Tablets (see section 6)
Scheme
at: www.mhra.gov.uk/yellowcard
or without food.
only. Do not pass it on to others. It may harm
!
If you are a woman (because this medicine is
By reporting side effects you can help provide
In
order
to
treat
your
symptoms
and
control
your
them, even if their signs of illness are the same
for men).
more information on the safety of this medicine.
BPH effectively, it is important that you continue to
as yours.
Do not take Finasteride if any of the above applies
take Finasteride 5mg Tablets for as long as your
to you. If you are not sure, talk to your doctor or
!
If you get any of the side effects, talk to your
What else do you need to know about
doctor prescribes, even if you do not feel an
pharmacist.
doctor, pharmacist or nurse. This includes any
Finasteride
5mg Tablets?
immediate benefit. Some patients show early
possible side effects not listed in this leaflet.
Finasteride
5mg
Tablets are not licensed to treat
improvements in symptoms, but you may need to
The condition for which Finasteride Tablets
See section 4.
prostate cancer. Information collected for a clinical
take Finasteride 5mg Tablets for at least six months
are prescribed occurs only in men. The
trial in men taking finasteride for 7 years showed:
to see if it improves your symptoms.
tablets must not be taken by women or by
!
The number of men who developed prostate
Finasteride works best when it is taken long term.
What is in this leaflet:
children.
cancer was lower in men taking finasteride
1. What Finasteride 5mg Tablets are and what
compared with those taking nothing
Your doctor may prescribe Finasteride 5mg
they are used for
Warnings and precautions:
!
The number of men who had a high score in a
Tablets
along
with
another
medicine
called
2. What you need to know before you take
Talk to your doctor or pharmacist before taking
tumour grading system was higher in some of
doxazosin to help you control your BPH.
Finasteride 5mg Tablets
Finasteride 5mg Tablets if:
those taking finasteride compared to those
!
Your partner is pregnant or planning to
3. How to take Finasteride 5mg Tablets
taking nothing
If you take more Finasteride 5mg Tablets than
become
pregnant. You should use a condom or
4. Possible side effects
!
The
effect of long-term use of finasteride on
you should:
other barrier method of contraception when
5. How to store Finasteride 5mg Tablets
tumours
of this kind is not known.
If you have taken too many tablets by mistake,
taking this medicine. This is because your
6. Contents of the pack and other information
If you would like further information about the
contact your doctor immediately.
semen could contain a tiny amount of the drug
tumour grading system or this trial, please talk to
and may affect the normal development of the
your doctor.
1. WHAT FINASTERIDE 5 MG TABLETS
If you forget to take Finasteride 5mg Tablets
baby's sex organs
If you miss a dose, just carry on with the next one as
ARE AND WHAT THEY ARE USED FOR
!
You are going to have a blood test called PSA.
5. HOW TO STORE FINASTERIDE 5MG
usual. Do not take a double dose to make up for
This is because Finasteride 5mg Tablets can
TABLETS
forgotten individual doses.
Finasteride belongs to the group of medicines
affect the results of the test.
called 5-alpha reductase inhibitors. They act by
Keep out of the sight and reach of children.
4. POSSIBLE SIDE EFFECTS
reducing the size of the prostate gland in men.
If you are not sure, talk to your doctor or
!
This medicinal product does not require any
pharmacist before taking Finasteride.
Finasteride 5mg Tablets act by shrinking the
special storage conditions
Like all medicines, this medicine can cause side
enlarged prostate gland in men. Your doctor has
!
Do not use Finasteride 5 mg Tablets after the
effects, although not everybody gets them. The
What else you should know before taking
prescribed the medicine for you to treat a
expiry date, which is stated on the label after
following side effects may happen with this
Finasteride 5mg Tablets
condition known as benign prostatic hyperplasia or
Exp. The expiry date refers to the last day of
medicine:
BPH is not cancer and does not lead to cancer, but
that month
BPH. The prostate gland which is near the bladder
the two conditions can be present at the same
!
Medicines should not be disposed of via
has become enlarged and is making it more difficult
Allergic reactions
time. Before starting you on finasteride, it is likely
wastewater or household waste. Ask your
If you have an allergic reaction, stop taking it and
to pass urine. Finasteride 5mg Tablets will help to
that your doctor will perform some simple tests to
pharmacist how to dispose of medicines no
see your doctor straight away. The signs may
relieve these symptoms and will help reduce the
check whether you have prostate cancer. Your
longer required. These measures will help to
include:
risk of you developing a sudden inability to pass
doctor will evaluate your symptoms and their
protect the environment.
!
Skin
rashes,
itching,
or
lumps
under
your
skin
urine (known as acute urinary retention) and the
possible causes. Talk to your doctor if you have any
(hives)
questions.
need for surgery.
6. CONTENTS OF THE PACK AND
!
Swelling of your lips, tongue, throat and face
OTHER INFORMATION.
difficulty swallowing and breathing difficulties
Finasteride 5mg Tablets are for use in men only.
What is the prostate?
(angioedema).
The prostate is a walnut-sized gland found only in
What Finasteride 5mg Tablets contain
Children
The active substance is finasteride. One filmmen. It is located below the bladder and it
Other side effects may include:
Finasteride should not be used in children.
coated tablet contains 5 mg of finasteride.
surrounds the urethra, a tube that carries urine
!
You may be unable to have an erection
(impotence)
from the bladder out through the tip of the penis.
Other medicines and Finasteride 5mg Tablets
The other ingredients are
!
You may have less desire to have sex
The prostate's main function is to produce fluid for
Tell your doctor or pharmacist if you are taking,
Tablet core- lactose monohydrate, cellulose
!
You
may
have
problems
with
ejaculation,
for
semen, the fluid that carries sperm.
have recently taken or might take any other
microcrystalline, starch pregelatinized, sodium
example a decrease in the amount of semen
medicines.
starch glycolate (type-A), lauroyl
released during sex. This decrease in the
What is Benign Prostatic Hyperplasia (BPH)?
macrogolglycerides, and magnesium stearate .
amount of semen does not appear to affect
Taking Finasteride 5 mg Tablets with food and
BPH is a benign enlargement of the prostate gland
normal sexual function.
drink:
which is common in men over 50 years old.
Film coating- Hypromellose , titanium dioxide (E
These side effects above may disappear after a
Finasteride can be taken with or without food.
Because the prostate is close to the bladder and
171), indigo carmine (E132), macrogol 6000.
while if you continue taking this medicine. If not,
surrounds part of the urethra, its enlargement may
they usually resolve after stopping taking this
Pregnancy and breast-feeding:
They are supplied in blister packs of 12, 28, 30
affect your ability to urinate. You may experience
medicine.
!
Finasteride 5mg Tablets SHOULD NOT be
and 56 tablets and bottles of 50, 75 and 100
symptoms such as a need to urinate often,
taken by women
tablets.
Other side effects reported in some men are:
especially at night, a feeling that you must urinate
!
Do not touch crushed or broken Finasteride
!
Breast
swelling
or
tenderness
right away, difficulty in starting to urinate, a weak
Tablets if you are a woman who is pregnant or
Marketing Authorisation Holder &
!
Palpitations (feeling your heartbeat)
or interrupted urinary stream, or a feeling that you
planning to become pregnant (whole tablets
Manufacturer:
!
Changes
in
the
way
your
liver
is
working,
cannot empty your bladder completely.
are coated to stop contact with the medicine
Relonchem Limited, Cheshire House, Gorsey
which can be shown by a blood test
In some men, BPH can lead to serious problems,
during normal use). This is because this
Lane, Widnes, Cheshire, WA8 0RP, UK
!
Pain in your testicles
medicine may affect the normal development
including urinary tract infections, and a sudden
Product Licence Number: PL 20395 / 0067
!
An inability to have an erection which may
of the baby's sex organs
inability to pass urine at all as well as the need for
continue after stopping the medication
!
If a woman who is pregnant comes into contact
surgery. For this reason, a man with symptoms of
This leaflet was last revised in October 2016
!
Male infertility and/or poor quality of semen.
with
crushed or broken tablets, speak to your
BPH should see his doctor.
Improvement in the quality of the semen has
doctor.
been reported after stopping medication
!
Depression
Driving and using machines
!
Decrease in sex drive that may continue after
Finasteride 5mg Tablets are not likely to affect your
stopping the medication
ability to drive, use tools or machines.
!
Problems with ejaculation that may continue
after stopping the medication
Finasteride 5mg Tablets contain lactose
!
You should promptly report to your doctor any
If you have been told by your doctor that you have
changes in your breast tissue such as lumps,
an intolerance to some sugars, talk to your doctor
pain, enlargement or nipple discharge as these
or pharmacist before taking this medicine.
may be signs of a serious condition, such as
breast cancer.

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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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