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Finasteride 1 Mg Tablets

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Package leaflet: Information for the user Finasteride 1mg Tablets

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, pharmacist or nurse.

- 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, pharmacist or nurse. This includes any possible side effects not listed in this leaflet.

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 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 (because this medicine is for men)

Warnings and precautions

Talk to your doctor, pharmacist or nurse before taking Finasteride tablets

Children

Finasteride tablets should not be used in children.

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.

Other medicines and Finasteride tablets

Finasteride tablets can normally be taken with other medicines. Tell your pharmacist if you are taking, have recently taken or might take any other medicines.

Special precautions

Finasteride tablets are only intended for men.

Pregnancy, breast-feeding and fertility Finasteride tablets should not be taken by 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 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 contain lactose monohydrate

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 this medicine exactly as described in this leaflet or as your doctor, pharmacist or nurse has told you. Check with your doctor or pharmacist if you are not sure.

The recommended dose is 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 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.

If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.

4. Possible side effects

Like all medicines, this medicine 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 contact your doctor immediately if you develop any of the following symptoms of an allergic reaction:

•    Skin rashes, itching, or lumps under your skin (hives)

•    Swelling of your lips and face.

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.

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):

•    Inability to obtain an erection

•    Reduced sex drive

•    Problems with ejaculation, for example a decrease in the amount of semen released during

sex. This decrease in the amount of semen does not appear to affect normal sexual function.

•    Depression

These side effects above may disappear after a while if you continue taking Finasteride tablets. If these symptoms persist, they usually resolve after stopping Finasteride tablets.

Other side effects reported in men are:

•    Breast swelling or tenderness

•    Pain in the testicles

•    Palpitations

•    Change in liver function

•    Infertility

5. How to store Finasteride tablets

Keep out of the sight and reach of children.

Do not use this medicine 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.

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 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 600.

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 Caduceus Pharma Limited 6th Floor, 94 Wigmore Street London W1U 3RF

Manufacturer

Actavis hf, Reykjavikurvegur 78, IS-220 Hafnarfjordur, Iceland.

This leaflet was last revised in 11/2011