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Active substance(s): FINASTERIDE

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Finasteride 1 mg film-coated tablets
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 tablets are and what they are used for
2. Before you take Finasteride tablets
3. How to take Finasteride tablets
4. Possible side effects
5. How to store Finasteride tablets
6. Further information
1. What Finasteride tablets are and what they are used for
Finasteride is used to treat early forms of male pattern hair loss (also called androgenetic
2. Before you take Finasteride tablets:

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
- are giving to a child – Finasteride should not be used in children or adolescents under the
age of 18 years.
- are already taking medicines containing finasteride or dutasteride for a prostate problem
called benign prostatic hyperplasia (BPH) or any other conditions.
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 taking Finasteride tablets to exclude other
obstructions in the urinary tract.
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.
2. Special precautions
Finasteride tablets are only intended for men.
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.
You should promptly report to your doctor any changes in your 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

Driving and using machines
There is no evidence to suggest that Finasteride tablets affect the ability to drive or use
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
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.
3. How to take Finasteride tablets
Always take Finasteride tablets exactly as your doctor has told you. If you are not sure, check
with your doctor or pharmacist.
Usual doses are 1mg (1 tablet) daily.
The tablet should be swallowed whole and should not be broken or crushed. It may be taken
with or without food.

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 or stop 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

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
4. Possible side effects
Like all medicines, Finasteride tablets can cause side effects, although not everybody gets
Stop taking Finasteride tablets and contact your doctor immediately if you have allergic
reactions, symptoms of which may include:

Swelling of the face, tongue or lips
Skin rash, itching or urticaria (also known as hives or nettle rash)

Please tell your doctor or pharmacist if you notice any of the following effects or any side
effects not listed:

Inability to obtain an erection (impotence)
Reduced sex drive
Difficulty ejaculating
Reduced amount of ejaculatory fluid
Palpitations (feeling your heartbeat)
Testicular pain
Breast tenderness or enlargement
Changes in the way your liver is working (shown by a blood test)
Reduced fertility

You should promptly report to your doctor any changes in your breast tissue such as lumps,
pain, enlargement or nipple discharge as these may be signs of a serious condition, such as
breast cancer.
If any of these side effects gets serious, or if you notice any side effects not listed in this
leaflet, please tell your doctor or pharmacist.
5. How to store Finasteride tablets

Keep out of the 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.
This medicinal product does not require any special storage conditions.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist
how to dispose of medicines no longer required. These measures will help to protect the
6. Further information
What Finasteride tablets contain the active substance is finasteride 1 mg
the other ingredients are lactose monohydrate, microcrystalline cellulose, pregelatinised
starch, lauroyl macrogolglycerides, sodium starch glycollate Type A, magnesium stearate,
hypromellose, titanium dioxide (E171), yellow and red iron oxide (E172), and macrogol
What Finasteride tablets look like and contents of the pack
Finasteride 1mg film-coated tablets are round, biconvex reddish-brown tablets, with the
markings 'F1'
They are supplied in:
Blister packs containing 28 tablets
Plastic bottles containing 28 tablets
Marketing Authorisation Holder
Relonchem Limited,
27, Old Gloucester street, London, WC1 3XX.

Actavis hf, Reykjavikurvegur 78, IS-220 Hafnarfjordur, Iceland.
MA Number: PL 20395/0068
This leaflet was last approved in 05/2011
Revision Date: May 2011

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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.