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FINASTERIDE 1 MG TABLETS

Active substance(s): FINASTERIDE

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Finasteride 1 mg
Film-coated Tablets

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT

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 on to 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 tablets are and what
they are used for
2. What you need to know before you take
Finasteride tablets
3. How to take Finasteride tablets
4. Possible side effects
5. How to store Finasteride tablets
6. Contents of the pack and other information

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Other medicines and Finasteride tablets
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, have recently taken or might take any
other medicines.

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.
Driving and using machines
There is no evidence to suggest that Finasteride
tablets affect the ability to drive or use machines.

1. WHAT FINASTERIDE TABLETS ARE AND
WHAT THEy ARE uSED FOR
Finasteride Tablets contains lactose

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

Finasteride tablet is used to treat early forms of male
pattern hair loss (also called androgenetic alopecia).

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

2. WHAT yOu NEED TO KNOW BEFORE
yOu TAKE FINASTERIDE TABLETS
Do not take Finasteride tablets if you
• are allergic to finasteride or any of the other
ingredients of this medicine(listed in section 6)
• are a woman

3. HOW TO TAKE FINASTERIDE TABLETS

Warnings and precautions

Talk to 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 taking
Finasteride tablets to exclude other obstructions
in the urinary tract.
• Finasteride is only intended for men.
• Finasteride should not be used in children under the
age of 18.

Always take this medicine exactly as your doctor or
pharmacist has told you. Check with your doctor or
pharmacist if you are not sure.
The recommended 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.

Artwork Proof Box
Ref: V012 –Safety update of SPC, PIL and labelling + RFI update
Proof no.
004.1
Colours:
Black

Date prepared:
09/03/2016

Font size:
7.5pt

none
none

Fonts:
Helvetica

Dimensions: 148 x 210 mm

If you stop taking Finasteride tablets
5. HOW TO STORE FINASTERIDE
Although an improvement is often noticed after a short
TABLETS
time, it may be necessary to continue the treatment for
Keep this medicine out of sight and reach
at least 6 months. Do not alter the dose or stop
of children.
treatment without asking your doctor.
If you take more Finasteride tablets than you
should
If you (or someone else) swallow a lot of the tablets at
the same time, or you think a child has swallowed any
of the tablets, contact your nearest hospital
casualty department or your doctor immediately.
If you forget to take Finasteride tablets
Do not take a double dose to make up for a forgotten
tablet. Just take the next one when it is due.

4. POSSIBLE SIDE EFFECTS

Like all medicines, this medicine can cause side
effects, although not everybody gets them.

Stop using Finasteride and immediately contact a
doctor if you experience any of the following
symptoms (angioedema): swelling of face, tongue
or throat; difficulty swallowing; hives and
breathing difficulties. The frequency is not known
(cannot be estimated from the available data).
you should promptly report to your doctor any
changes in the 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. The frequency is
not known (cannot be estimated from the available
data).

Please tell your doctor or pharmacist if you
notice any of the following effects or any side
effects not listed.
uncommon (occur in less than 1 in 100 users):
Reduced sex drive, difficulty ejaculating, reduced
amount of ejaculatory fluid, depressed mood
Not known (frequency cannot be estimated from the
available data): Allergic reactions, including rash,
itching, urticaria (itchy skin rash) and swelling of the
lips and face; irregular heartbeat; elevated liver
enzymes; breast tenderness and enlargement;
testicular pain; infertility; persistent difficulty having an
erection after discontinuation of treatment; persistent
decrease in sex drive after discontinuation of
treatment; persistent problems with ejaculation after
discontinuation of treatment.

Do not use this medicine after the expiry
date which is stated on the blister, carton
or bottle after ‘Exp’. The expiry date refers
to the last day of that month.

This medicinal product does not require any
special storage conditions.

Do not throw away any medicines via wastewater or
household waste. Ask your pharmacist how to throw
away medicines you no longer use.
These measures will help protect the environment.

6. CONTENTS OF THE PACK AND OTHER
INFORMATION
What Finasteride tablets contains
• the active substance is finasteride 1 mg
• the other ingredients are lactose monohydrate,
microcrystalline cellulose, pregelatinised starch,
lauroyl macrogolglycerides, sodium starch
glycolate (Type A), magnesium stearate,
hypromellose, titanium dioxide (E171), yellow
and red iron oxide (E172) and macrogol 600.

What Finasteride tablets looks like and contents
of the pack
Finasteride 1 mg Film-coated Tablets are round,
biconvex reddish-brown tablets, marked ‘F1’
They are supplied in:
Blister packs containing 28 tablets
Plastic bottles containing 28 tablets
Not all pack sizes may be marketed.

Marketing Authorisation Holder and
Manufacturer
Sandoz Ltd,
Frimley Business Park, Frimley,
Camberley, Surrey, GU16 7SR, UK.
Manufacturer
Actavis hf, Reykjavikurvegur 78,
IS-220 Hafnarfjordur, Iceland.

This leaflet was last revised in 03/2016.

Reporting of side effects
If you get any side effects, talk to your
doctor or pharmacist. This includes any
possible side effects not listed in this
leaflet. You can also report side effects
directly via the Yellow Card Scheme
website www.mhra.gov.uk/yellowcard.
By reporting side effects you can help
provide more information on the safety
of this medicine.

SZ00000LT000

Artwork Proof Box
Ref: V012 –Safety update of SPC, PIL and labelling + RFI update
Proof no.
004.1
Colours:
Black

Date prepared:
09/03/2016

Font size:
7.5pt

none
none

Fonts:
Helvetica

Dimensions: 148 x 210 mm

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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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