FINASTERIDE 1 MG TABLETS

Active substance: FINASTERIDE

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SZ00000FL000

PACKAGE LEAFLET: INFORMATION FOR THE USER

Finasteride 1 mg
Film-coated Tablets
Finasteride
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 any further questions, ask your
doctor or pharmacist.
• This medicine has been prescribed for you. Do
not pass it on to others. It may harm them, even
if their symptoms are the same as yours.
• If any of the side effects gets serious, or if you
notice any side effects not listed in this leaflet,
please tell your doctor or pharmacist.
In this leaflet:
1. What Finasteride is and what it used for
2. Before you take Finasteride
3. How to take Finasteride
4. Possible side effects
5. How to store Finasteride
6. Further information

1. WHAT FINASTERIDE IS AND WHAT
IT IS USED FOR
Finasteride is used to treat early forms of male
pattern hair loss (also called androgenetic
alopecia).

Taking other medicines
Finasteride tablets can normally be taken with
other medicines. Please ask your doctor or
pharmacist before you take other medicines at the
same time or if you are taking or have recently
taken any other medicines, including medicines
obtained without a prescription.
Special precautions
Finasteride tablets are only intended for men.
Finasteride should not be used in children under
the age of 18.
Pregnancy
Women who are pregnant or may become
pregnant should not handle broken or crushed
Finasteride tablets. If finasteride is absorbed
through the skin or taken by mouth by a woman
pregnant with a male foetus, the child may be born
with malformed genital organs. The tablets are
film-coated, which prevents contact with finasteride
provided the tablets are not broken or crushed.
If your sexual partner is or may possibly be
pregnant, you must avoid exposing her to your
semen, which could contain a small amount of the
drug by using a condom. If you think a pregnant
woman has come into contact with finasteride, you
should consult a doctor.

2. BEFORE YOU TAKE FINASTERIDE
Do not take Finasteride tablets if you
• are allergic (hypersensitive) to finasteride or any
of the other ingredients in Finasteride tablets
(see section 6)
• are a woman

Driving and using machines
There is no evidence to suggest that Finasteride
tablets affect the ability to drive or use machines.
Important information about some of the
ingredients of Finasteride Tablets
Finasteride tablets contains lactose monohydrate.
If you have been told by your doctor that you have
an intolerance to some sugars, contact your doctor
before taking this medicine.

Check with your doctor or pharmacist before
taking Finasteride tablets if you
• have difficulty emptying your bladder
completely or a greatly reduced flow of urine.
Your doctor should examine you before you start Blood tests
Finasteride tablets can affect a blood test called
taking Finasteride tablets to exclude other
PSA. If you have a PSA test done, tell your doctor
obstructions in the urinary tract.
you are taking Finasteride tablets.

3. HOW TO TAKE FINASTERIDE
Always take Finasteride tablets exactly as your
doctor has told you. If you are not sure, check with
your doctor or pharmacist.
Usual dose is
1 mg (1 tablet) daily. The tablet should be
swallowed whole and should not be broken or
crushed. It may be taken with or without food.

You should promptly report to your
doctor any changes in your breast tissue
such as lumps,pain or nipple discharge
as these may be signs of a serious
condition, such as breast cancer.

5. HOW TO STORE FINASTERIDE
Keep out of reach and sight of children.
Do not use Finasteride tablets after the
expiry date which is stated on the blister,
carton or bottle after ‘Expiry date:’. The
expiry date refers to the last day of that
month.

If you stop taking Finasteride tablets
Although an improvement is often noticed after a
short time, it may be necessary to continue the
treatment for at least 6 months. Do not alter the dose
This medicinal product does not require any
or stop treatment without asking your doctor.
special storage conditions.
If you take more Finasteride tablets than you
Medicines should not be disposed of via
should
If you (or someone else) swallow a lot of the tablets wastewater or household waste. Ask your
at the same time, or you think a child has swallowed pharmacist how to dispose of medicines no longer
required. These measures will help to protect the
any of the tablets, contact your nearest hospital
environment.
casualty department or your doctor immediately.
If you forget to take Finasteride tablets
6. FURTHER INFORMATION
Do not take a double dose to make up for a forgotten
tablet. Just take the next one when it is due.
What Finasteride tablets contain
• the active substance is finasteride 1 mg
4. POSSIBLE SIDE EFFECTS
• the other ingredients are lactose monohydrate,
microcrystalline cellulose, pregelatinised starch,
Like all medicines, Finasteride tablets can cause
lauroyl macrogolglycerides, sodium starch
side effects, although not everybody gets them.
glycollate (Type A), magnesium stearate,
hypromellose, titanium dioxide (E171), yellow
Stop taking Finasteride tablets and contact
and red iron oxide (E172) and macrogol 600.
your doctor immediately if you develop any of
the following symptoms of an allergic reaction: What Finasteride tablets look like and contents
swelling of the face, tongue or lips or urticaria (itchy of the pack
skin rash).
Finasteride 1 mg Film-coated Tablets are round,
biconvex reddish-brown tablets, with the markings ‘F1’
Please tell your doctor or pharmacist if you
They are supplied in:
notice any of the following effects or any side
Blister packs containing 28 tablets
effects not listed.
Plastic bottles containing 28 tablets
Uncommon (occur in less than 1 in 100 users):
reduced sex drive, difficulty ejaculating, reduced
Not all pack sizes may be marketed.
amount of ejaculatory fluid, depressed mood
Not known (frequency cannot be estimated from
Marketing Authorisation Holder
the available data): Allergic reactions, including
Sandoz Ltd,
rash, itching, urticaria (itchy skin rash) and swelling Frimley Business Park, Frimley,
of the lips and face; irregular heartbeat; elevated
Camberley, Surrey, GU16 7SR, UK.
liver enzymes; breast tenderness and enlargement;
testicular pain; infertility.
Manufacturer
Actavis hf, Reykjavikurvegur 78,
The following undesirable effects have been
IS-220 Hafnarfjordur, Iceland.
reported in post-marketing use: breast tenderness
and enlargement; and testicular pain, persistence
This leaflet was last approved in 07/2011 (to be
of erectile dysfunction after discontinuation of
amended after approval).
treatment with Finasteride 1 mg; male breast
cancer.
SZ00000FL000

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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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