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FINASTERIDE 5 MG TABLETS

Active substance(s): FINASTERIDE / FINASTERIDE / FINASTERIDE

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FINASTERIDE 5 MG TABLETS

!
Decrease in sex drive that may continue after
stopping the medication
PATIENT INFORMATION LEAFLET: INFORMATION FOR THE USER
!
Problems with ejaculation that may continue
after stopping the medication
2. WHAT YOU NEED TO KNOW BEFORE
Read all of this leaflet carefully before you
!
You should promptly report to your doctor any
Finasteride 5mg Tablets contain lactose
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
changes
in your breast tissue such as lumps,
If you have been told by your doctor that you have
TABLETS
important information for you.
pain,
enlargement
or nipple discharge as these
an intolerance to some sugars, talk to your doctor
may be signs of a serious condition, such as
!
Keep this leaflet. You may need to read it again.
or pharmacist before taking this medicine.
Do not take Finasteride 5 mg Tablets:
breast cancer.
!
If you have any further questions, ask your
!
If you are allergic (hypersensitive) to
Talk to your doctor or pharmacist if you have any
doctor, pharmacist or nurse.
finasteride or any of the other ingredients of
If any of the side effects get serious, or if you notice
questions.
!
This medicine has been prescribed for you
Finasteride 5mg Tablets (see section 6)
any side effects not listed in this leaflet please tell
only. Do not pass it on to others. It may harm
!
If you are a woman (because this medicine is
your doctor or pharmacist. It will help if you make a
3. HOW TO TAKE FINASTERIDE 5MG
them, even if their signs of illness are the same
for men).
note of what happened, when it started and how
TABLETS
as yours.
Do not take Finasteride if any of the above applies
long it lasted.
to you. If you are not sure, talk to your doctor or
!
If you get any of the side effects, talk to your
Always take Finasteride 5mg Tablets exactly how
pharmacist.
doctor, pharmacist or nurse. This includes any
Reporting of side effects
your doctor has instructed you. You should check
possible side effects not listed in this leaflet.
If you get any side effects, talk to your doctor,
with your doctor or pharmacist if you are unsure.
The condition for which Finasteride Tablets
pharmacist or nurse. This includes any possible
See section 4.
The usual dose is one tablet containing 5mg
are prescribed occurs only in men. The
side effects not listed in this leaflet. You can also
Finasteride to be taken by mouth once a day with
tablets must not be taken by women or by
report side effects directly via the Yellow Card
or without food.
What is in this leaflet:
children.
Scheme at: www.mhra.gov.uk/yellowcard
In order to treat your symptoms and control your
1. What Finasteride 5mg Tablets are and what
By reporting side effects you can help provide
BPH effectively, it is important that you continue to
they are used for
Warnings and precautions:
more information on the safety of this medicine.
take Finasteride 5mg Tablets for as long as your
2. What you need to know before you take
Talk to your doctor or pharmacist before taking
doctor
prescribes,
even
if
you
do
not
feel
an
Finasteride 5mg Tablets
Finasteride 5mg Tablets if:
What else do you need to know about
immediate benefit. Some patients show early
!
Your partner is pregnant or planning to
3. How to take Finasteride 5mg Tablets
Finasteride 5mg Tablets?
improvements in symptoms, but you may need to
become pregnant. You should use a condom or
4. Possible side effects
Finasteride 5mg Tablets are not licensed to treat
take Finasteride 5mg Tablets for at least six months
other
barrier method of contraception when
5. How to store Finasteride 5mg Tablets
prostate cancer. Information collected for a clinical
to see if it improves your symptoms.
taking this medicine. This is because your
6. Contents of the pack and other information
trial in men taking finasteride for 7 years showed:
Finasteride works best when it is taken long term.
semen could contain a tiny amount of the drug
!
The number of men who developed prostate
and may affect the normal development of the
cancer was lower in men taking finasteride
1. WHAT FINASTERIDE 5 MG TABLETS
Your doctor may prescribe Finasteride 5mg
baby's sex organs
compared with those taking nothing
Tablets along with another medicine called
ARE AND WHAT THEY ARE USED FOR
!
You are going to have a blood test called PSA.
!
The
number of men who had a high score in a
doxazosin to help you control your BPH.
This is because Finasteride 5mg Tablets can
tumour grading system was higher in some of
Finasteride belongs to the group of medicines
affect the results of the test.
those taking finasteride compared to those
If you take more Finasteride 5mg Tablets than
called 5-alpha reductase inhibitors. They act by
taking nothing
you should:
reducing the size of the prostate gland in men.
Mood alterations and depression: Mood
!
The effect of long-term use of finasteride on
If you have taken too many tablets by mistake,
alterations such as depressed mood, depression
Finasteride 5mg Tablets act by shrinking the
tumours
of this kind is not known.
contact your doctor immediately.
and, less frequently, suicidal thoughts have been
enlarged prostate gland in men. Your doctor has
If you would like further information about the
reported in patients treated with Finasteride. If you
prescribed the medicine for you to treat a
tumour grading system or this trial, please talk to
If you forget to take Finasteride 5mg Tablets
experience
any of these symptoms contact your
your doctor.
condition known as benign prostatic hyperplasia or
If you miss a dose, just carry on with the next one as
doctor for further medical advice as soon as
BPH. The prostate gland which is near the bladder
usual. Do not take a double dose to make up for
possible.
5. HOW TO STORE FINASTERIDE 5MG
has become enlarged and is making it more difficult
forgotten individual doses.
TABLETS
to pass urine. Finasteride 5mg Tablets will help to
If you are not sure, talk to your doctor or
4. POSSIBLE SIDE EFFECTS
relieve these symptoms and will help reduce the
pharmacist before taking Finasteride.
Keep out of the sight and reach of children.
risk of you developing a sudden inability to pass
This medicinal product does not require any
!
Like
all
medicines,
this
medicine
can
cause
side
urine (known as acute urinary retention) and the
What else you should know before taking
special storage conditions
effects, although not everybody gets them. The
Finasteride 5mg Tablets
need for surgery.
Do not use Finasteride 5 mg Tablets after the
!
following side effects may happen with this
BPH is not cancer and does not lead to cancer, but
expiry date, which is stated on the label after
medicine:
the two conditions can be present at the same
What is the prostate?
Exp. The expiry date refers to the last day of
time. Before starting you on finasteride, it is likely
The prostate is a walnut-sized gland found only in
that month
Allergic reactions
that your doctor will perform some simple tests to
Medicines should not be disposed of via
!
men. It is located below the bladder and it
If you have an allergic reaction, stop taking it and
check whether you have prostate cancer. Your
wastewater or household waste. Ask your
surrounds the urethra, a tube that carries urine
see your doctor straight away. The signs may
doctor will evaluate your symptoms and their
pharmacist how to dispose of medicines no
include:
from the bladder out through the tip of the penis.
possible causes. Talk to your doctor if you have any
longer required. These measures will help to
!
Skin rashes, itching, or lumps under your skin
The prostate's main function is to produce fluid for
questions.
protect the environment.
(hives)
semen, the fluid that carries sperm.
!
Swelling of your lips, tongue, throat and face
Finasteride 5mg Tablets are for use in men only.
6. CONTENTS OF THE PACK AND
difficulty swallowing and breathing difficulties
What is Benign Prostatic Hyperplasia (BPH)?
OTHER INFORMATION.
(angioedema).
Children
BPH is a benign enlargement of the prostate gland
Finasteride should not be used in children.
which is common in men over 50 years old.
What Finasteride 5mg Tablets contain
Other side effects may include:
Because the prostate is close to the bladder and
The active substance is finasteride. One film!
You may be unable to have an erection
Other medicines and Finasteride 5mg Tablets
surrounds part of the urethra, its enlargement may
coated tablet contains 5 mg of finasteride.
(impotence)
Tell your doctor or pharmacist if you are taking,
affect your ability to urinate. You may experience
!
You may have less desire to have sex
have recently taken or might take any other
The other ingredients are
symptoms such as a need to urinate often,
!
You may have problems with ejaculation, for
medicines.
Tablet core- lactose monohydrate, cellulose
example a decrease in the amount of semen
especially at night, a feeling that you must urinate
microcrystalline, starch pregelatinized, sodium
released
during
sex.
This
decrease
in
the
right away, difficulty in starting to urinate, a weak
Taking Finasteride 5 mg Tablets with food and
starch glycolate (type-A), lauroyl
amount
of
semen
does
not
appear
to
affect
or interrupted urinary stream, or a feeling that you
drink:
macrogolglycerides, and magnesium stearate .
normal
sexual
function.
cannot empty your bladder completely.
Finasteride can be taken with or without food.
These side effects above may disappear after a
In some men, BPH can lead to serious problems,
Film coating- Hypromellose , titanium dioxide (E
while if you continue taking this medicine. If not,
Pregnancy and breast-feeding:
including urinary tract infections, and a sudden
171), indigo carmine (E132), macrogol 6000.
they usually resolve after stopping taking this
!
Finasteride 5mg Tablets SHOULD NOT be
inability to pass urine at all as well as the need for
medicine.
taken by women
surgery. For this reason, a man with symptoms of
They are supplied in blister packs of 12, 28, 30
!
Do not touch crushed or broken Finasteride
and 56 tablets and bottles of 50, 75 and 100
BPH should see his doctor.
Other side effects reported in some men are:
Tablets if you are a woman who is pregnant or
tablets.
!
Breast swelling or tenderness
planning to become pregnant (whole tablets
!
Palpitations (feeling your heartbeat)
are coated to stop contact with the medicine
Marketing Authorisation Holder &
!
Changes in the way your liver is working,
during normal use). This is because this
Manufacturer:
which can be shown by a blood test
medicine may affect the normal development
Relonchem Limited, Cheshire House, Gorsey
!
Pain in your testicles
of the baby's sex organs
Lane, Widnes, Cheshire, WA8 0RP, UK
!
An inability to have an erection which may
!
If a woman who is pregnant comes into contact
Product Licence Number: PL 20395 / 0067
continue after stopping the medication
with crushed or broken tablets, speak to your
!
Male infertility and/or poor quality of semen.
doctor.
This leaflet was last revised in August 2017
Improvement in the quality of the semen has
been reported after stopping medication
!
Depression
Driving and using machines
Finasteride 5mg Tablets are not likely to affect your
ability to drive, use tools or machines.

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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