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FINASTERIDE 5MG FILM COATED TABLETS

Active substance(s): FINASTERIDE

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Package Leaflet: Information for the user

Finasteride 5 mg film-coated tablets
Finasteride
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 or pharmacist.
• This medicine has been prescribed for you only. Do not pass it onto 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.
What is in this leaflet
1. What Finasteride 5 mg film-coated tablet (hereinafter:
Finasteride) is and what it is used for
2. What you need to know before you take Finasteride
3. How to take Finasteride
4. Possible side effects
5. How to store Finasteride
6. Contents of the pack and other information
1. WHAT FINASTERIDE IS AND WHAT IT IS USED FOR
Your doctor has prescribed Finasteride because you have a
condition known as benign prostatic hyperplasia or BPH.
Your prostate, a gland located near your urinary bladder that
produces a fluid in which the spermatozoids are transported,
has become bigger and is making it more difficult for you to
pass urine.
Finasteride reduces the size of the enlarged prostate and
relieves urinary symptoms, such as the need to urinate
frequently especially at night, painful urination, weak urine
stream, sensation that the urinary bladder is not completely
empty. Finasteride reduces the need for surgery.
2. What you need to know before you take
Finasteride
Do not take Finasteride
• If you are allergic to finasteride or any of the other
ingredients of this medicine (listed in section 6).
• Women and children should not take Finasteride. The
condition for which Finasteride is prescribed occurs only
in men.
Warnings and precautions
Talk to your doctor or pharmacist before taking Finasteride.
• Tell your doctor about any medical problems you have or
have had, and about any allergies.
• Finasteride is for use in men only in the treatment of BPH.
Women who are or may potentially be pregnant must not
use Finasteride, nor should they handle crushed or broken
tablets of Finasteride. If the active ingredient in Finasteride
is absorbed after oral use or through the skin by a woman
who is pregnant with a male fetus, then it is not known
whether the development of the external male organs in
the fetus may be adversely affected. If your sexual partner
is or may be pregnant then avoid exposing her to your
semen which could contain a small amount of finasteride e.g. by using a condom during sexual activity. If a woman
who is pregnant comes into contact with the active
ingredient in the tablet, a doctor should be
consulted. Finasteride tablets are coated and will prevent
contact with the active ingredient during normal handling,
provided that the tablets are not broken or crushed. If you
have any doubts, ask your doctor.

• BPH develops over a long period of time. Sometimes
symptoms improve promptly, but you may need to take
Finasteride for at least six months to see if it improves your
symptoms. Whether or not you notice any improvement or
change in symptoms, therapy with Finasteride may reduce
the risk of inability to pass urine and, therefore, the need
for surgery. You must visit your doctor regularly for
periodic checkups and an evaluation of your
progress. While BPH is not cancer and does not lead to
cancer, the two conditions can exist at the same time.
Only a doctor can evaluate your symptoms and their
possible causes.
• Finasteride can reduce the prostate-specific antigen levels
(PSA, a body substance which increases when the prostate
grows and can cause obstruction). If you have a PSA test
done, tell your doctor that you are taking Finasteride.
• Promptly report any changes in your breast tissue such as
lumps, pain, enlargement of your breast or nipple
discharge.
Children
Finasteride is contraindicated in children.
Other medicines and Finasteride
Tell your doctor or pharmacist if you are taking, have recently
taken or might take any other medicines.
Finasteride with food and drink
Finasteride tablet can be taken with or without food.
Pregnancy and breast-feeding
Finasteride is for use in men only. If a woman who is
pregnant comes into contact with the active ingredient
in the tablet, a doctor should be consulted. Finasteride
may harm the male fetus! Pregnant women should not
handle crushed or broken tablets of Finasteride.
If your sexual partner is or may be pregnant you should
minimise exposing her to your semen (e.g. by using a condom
during sexual activity) which could contain a small amount of
finasteride.
Driving and using machines
Finasteride should not affect your ability to drive or operate
machinery.
Finasteride contains lactose (milk sugar)
It should be taken into account that Finasteride contains
102.63 mg lactose. If your attention was drawn to intolerance
of certain kinds of sugar by your doctor, you should see your
doctor before you take this medicine.
3. HOW TO TAKE FINASTERIDE
Atake this medicine exactly as your doctor has told you. Check
with your doctor if you are not sure.
Do not change the doses or stop taking it without consulting
your doctor before.

Take one tablet of Finasteride every day, with or without food. • urticaria (hives),
Follow these instructions unless your doctor gave you different • fainting.
advice, otherwise Finasteride may not produce the desired
If you have any of these side effects, you may be having an
effect. Remember to take your medicine.
allergic reaction to finasteride. You should see a doctor
Although early improvement in symptoms may be seen,
immediately, so the doctor can assess how serious these side
sometimes you may need to take Finasteride for at least six
effects are.
months to achieve a beneficial response.
Reporting of side effects
Use in elderly patients and in patients with renal
If you get any side effects, talk to your doctor or pharmacist.
impairment
This includes any possible side effects not listed in this leaflet.
No dosage adjustment is required in the elderly or in patients You can also report side effects directly via Yellow Card
with varying degrees of renal insufficiency.
Scheme, Website:www.mhra.gov.uk/yellowcard.
By reporting side effects you can help provide more
Use in patients with liver impairment
information on the safety of this medicine.
There are no data available in patients with liver insufficiency.
If you take more Finasteride than you should
In case of overdose, contact your doctor immediately.

5. How TO STORE FINASTERIDE






• The active substance is: 5 mg of finasteride in each tablet.
• The other ingredients are:
Tablet core: magnesium stearate, talc, sodium starch glycolate
(type A), pregelatinised starch, microcrystalline cellulose,
lactose monohydrate.
Tablet coating: titanium dioxide (C.I.77891, E171), lactose
monohydrate, macrogol 6000, hyprolose, hypromellose.

Store in the original package in order to protect from light.
If you forget to take Finasteride
Do not take a double dose to make up for a forgotten dose. Just Keep out of the sight and reach of children.
take the next tablet as usual.
Do not take this medicine after the expiry date which is stated
on the carton and blisters after mm.yyyy (abbreviation used
If you stop taking Finasteride
for expiry date). The expiry date refers to the last day of that
You should not stop taking it without consulting your doctor
month.
before.
Leave your tablets in the foil. Only remove them when it is
If you have any further questions on the use of this product,
time to take your medicine.
ask your doctor or pharmacist.
Do not throw away any medicines via wastewater or household
waste.
Ask your pharmacist how to throw away medicines you
4. POSSIBLE SIDE EFFECTS
no longer use. These measures will help protect the
Like all medicines, this medicine can cause side effects,
environment.
although not everybody gets them.
6. Contents of the pack and other information
Finasteride can cause the following side effects:
What Finasteride contains
Common (may affect up to 1 in 10 people):
inability to have an erection (impotence),
decreased sex drive,
decreased amount of semen released during sex (this does
not appear to interfere with normal sexual function).

Uncommon (may affect up to 1 in 100 people):
• ejaculation disorder,
• breast enlargement or tenderness,
• skin rash.
Other side effects with frequency not known:
• increased level of hepatic enzymes,
• palpitation,
• pain in testicles,
• decreased sex drive that may continue after discontinuation
of therapy, depression,
• ejaculation disorder or inability to have an erection which
may continue after discontinuation of treatment,
• male infertility and/or poor seminal quality,
• allergic reactions such as itching, urticaria (hives), swelling
of lips, tongue, throat and face.

What Finasteride looks like and contents of the pack
White or almost white, rounded triangle shaped, slightly
biconvex film-coated tablets, with an imprinted mark “RG” on
one side.
Blister packs of hard aluminium foil and white, hard PVC foil
containing 7x, 10x, 14x, 15x, 28x, 30x, 50x, 56x, 90x, 98x,
100x, 105x, 120x tablets. Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
For any information about this medicinal product, please
contact the Marketing Authorisation Holder.

Marketing Authorisation Holder:
Gedeon Richter Plc., 1103 Budapest Gyömrői út 19-21.,
You should promptly report to your doctor any changes in your
Hungary
breast tissue such as lumps, pain, enlargement of the breast
tissue or nipple discharge as these may be signs of a serious
Manufacturer:
condition, such as breast cancer.
Gedeon Richter Plc., 1103 Budapest Gyömrői út 19-21.,
Hungary
In some cases, these side effects disappear while the patient
continues to take Finasteride. If symptoms persist, they usually Distributor:
resolve on discontinuing Finasteride treatment.
Consilient Health (UK) Limited. No.1 Church Road, Richmond
upon Thames, Surrey. TW9 2QE
If any of the following happen, stop taking Finasteride
and tell your doctor immediately or go to the casualty
department at your nearest hospital:
This leaflet was last revised in 02/2016
• swelling of the hands, feet, ankles, face, lips, mouth, or
throat which may cause difficulty in swallowing or
breathing,
P0421

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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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