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Active substance(s): FINASTERIDE

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Finasteride 5mg 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:
What Finasteride tablets are and what they are used for
Before you take Finasteride tablets
How to take Finasteride tablets
Possible side effects
How to store Finasteride tablets
Further information
What Finasteride tablets are and what they are used for
Finasteride belongs to a group of medicines called 5-alpha reductase inhibitors. They act by reducing the
size of the prostate gland in men.
Finasteride is used in the treatment and control of benign (not cancerous) enlargement of the prostate.

Before you take Finasteride tablets
Do not take Finasteride tablets if you
are allergic (hypersensitive) to finasteride or any other ingredients in Finasteride tablets (see
section 6)
are a woman who is pregnant, or who may potentially be pregnant

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.

Finasteride tablets are not recommended for use in women or children
Mood alterations and depression
Mood alterations such as depressed mood, depression and, less frequently, suicidal thoughts have been
reported in patients treated with Finasteride tablets. If you experience any of these symptoms contact your
doctor for further medical advice as soon as possible.
Taking other medicines
Finasteride tablets can normally be taken with other medicines. However, 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
Pregnancy and breast-feeding
- Finasteride tablets are not recommended for use in women.




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
baby, 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. The use of a condom is recommended. If you think a pregnant
woman has come into contact with finasteride, you should consult a doctor.
It is not known whether finasteride is excreted in human milk.

Driving and using machines
There is no evidence to suggest that Finasteride tablets affect the ability to drive or use machines.
Sugar intolerance
Finasteride tablets contain lactose monohydrate. If you do not tolerate some types of sugar, contact your
doctor before you take 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.
Finasteride tablets are not recommended for use in children.
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.
The usual dose is 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 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, Finasteride tablets can cause side effects, although not everybody gets them.
The following side effects may happen with this medicine:
Allergic reactions
Stop taking Finasteride tablets and immediately contact a doctor if you experience any of the
following symptoms of an allergic reaction:
• Skin rashes, itching, or lumps under your skin (hives)
• Swelling of your lips, face, tongue or throat; difficulty swallowing; breathing difficulties (angioedema).
Common (occurs in less than 1 of 10, but more than 1 of 100 patients treated)
• Inability to obtain an erection (impotence)
• Reduced sex drive (libido)

• A decrease in the amount of semen released during sex.
Impotence and reduced libido may occur soon after starting treatment but usually resolve with continued
Uncommon (less than 1 of 100, but more than 1 of 1000 patients treated)
• Skin rash
• Ejaculation disorders
• Breast tenderness
• Breast enlargement
Other side effects reported in men are:
• Palpitations
• Itching
• Lumps under your skin (hives)
• Change in liver function
• Testicular pain
• Sexual dysfunction – erectile and ejaculation problems that may continue after stopping the medication
• Male breast cancer
• Male infertility and/or poor seminal quality – normalization or improvement in seminal quality has been
reported after stopping this medication
• depression, decreased libido that continued after discontinuation of treatment
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.
Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects
not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at:
By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store Finasteride tablets
Keep out of the sight and reach of children. There are no special storage precautions. Use before the expiry
date which is stated on the package. The expiry date refers to the last day of that month.
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 environment.
6. Further information
What Finasteride tablets contain
– The active substance (the ingredient which makes the medicine work) is finasteride 5mg
– The other ingredients are lactose monohydrate, cellulose microcrystalline, pregelatinised starch, lauroyl
macrogolglycerides, sodium starch glycolate (type A), magnesium stearate. The film coating contains
hypromellose, macrogol 6000, titanium dioxide (E171) and indigocarmine lake (E132).
What Finasteride tablets look like and contents of the pack
The tablets are film-coated, blue, round, biconvex.
They are supplied in:
Blister packs containing 12, 28 or 30 or 56 tablets.
Plastic bottles containing 50, 75 or 100 tablets.
Not all pack sizes may be available.
Marketing Authorisation Holder
Accord Healthcare Limited

Sage House
319 Pinner Road
North Harrow
United Kingdom
Actavis Group hf
Reykjavíkurvegur 76-78
220 Hafnarfjørdur
Actavis Group PTC ehf
Reykjavíkurvegur 76-78
IS-220 Hafnarfjörður
This leaflet was last revised in February 2018
Pil Spec no

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Further information

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