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PACKAGE LEAFLET: INFORMATION FOR THE PATIENT

Finasteride 1 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 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

1.    WHAT FINASTERIDE TABLETS ARE AND WHAT THEY ARE uSED FOR

Finasteride tablet is used to treat early forms of male

pattern hair loss (also called androgenetic alopecia).

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

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.

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.

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.

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 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.

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, 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.

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.

5.    HOW TO STORE FINASTERIDE TABLETS

Keep this medicine out of sight and reach of children.

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.

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