PACKAGE LEAFLET: INFORMATION FOR THE USER PROPECIA® 1 MG FILM-COATED TABLETS (finasteride)

This product will be referred to as Propecia throughout this leaflet.

This medicine is for use in men only

Read all of this leaflet carefully before you start taking this

medicine because it contains important information for you.

•    Keep this leaflet. You may want 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.

2. What you need to know before you take Propecia

Do not take Propecia:

•    if you are a woman (because this medicine is for men). It has been shown in clinical trials that Propecia does not work in women with hair loss.

•    if you are allergic (hypersensitive) to finasteride or any of the other ingredients of this medicine (listed in Section 6).

•    If you are already taking finasteride or dutasteride used for a prostate problem called benign prostatic hyperplasia (BPH).

Do not take Propecia if any of the above apply to you. If you are not

sure, talk to your doctor or pharmacist.

Warnings and Precautions

Talk to your doctor or pharmacist before taking Propecia if:

•    you are going to have a blood test for prostate cancer called PSA (prostatespecific antigen). This is because Propecia can affect the result of this test.

What is in this leaflet:

1.    What Propecia is and what it is used for

2.    What you need to know before you take Propecia

3.    How to take Propecia

4.    Possible side effects

5.    How to store Propecia

6.    Contents of the pack and other information

Propecia contains a medicine called finasteride. This belongs to a group of medicines called Type II '5-alpha reductase inhibitors'.

Propecia is used for the treatment of male pattern hair loss (also known as androgenetic alopecia). Propecia increases hair growth on the scalp and prevents further hair loss in men. Men with mild to moderate, but not complete hair loss, can benefit from using Propecia.

How does the hair on your head grow?

On average your hair grows about 1 centimetre (half an inch) each month. Hair grows from hair follicles, which are located under your skin.

A single scalp hair grows continuously for 2-4 years (growth phase) and then stops growing for 2-4 months (rest phase). After this the hair falls out. In its place a new healthy hair begins to grow, and the cycle is repeated. The hairs on your scalp are always in different stages of this cycle so it is normal to lose scalp hair every day.

What is male pattern hair loss?

Male pattern hair loss is a common condition in which men experience thinning of the hair on the scalp, often resulting in a receding hairline and/or balding on the top of the head. This condition is thought to be caused by a combination of genetic factors and a particular hormone, DHT (dihydrotestosterone).

DHT causes a decrease in the growth phase and thinning of the hair (see picture). This leads to male pattern hair loss. These changes can start to occur in some men in their 20s and become more common with age. Once hair loss has occurred over a long period of time, the hair may be permanently lost.

How does Propecia work?

Propecia lowers the levels of DHT in the scalp. This helps to reverse the balding process, leading to an increased hair growth and prevention of further hair loss.

Effects on fertility

Infertility has been reported in men who took finasteride for long time and had other risk factors that may affect fertility. Normalisation or improvement of seminal quality has been reported after discontinuation of finasteride.

Long-term clinical studies about the effects of finasteride on fertility in men have not been conducted.

Breast Cancer

See section 4.

Children and adolescents

Propecia should not be used in children.

There are no data demonstrating efficacy or safety of finasteride in children under the age of 18.

Other medicines and Propecia

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. Propecia does not usually affect other medicines.

•    Do not take Propecia if you are already taking finasteride or dustasteride, used for a prostate problem called benign prostatic hyperplasia (BPH).

•    No information is available about the use of Propecia with minoxidil, another type of medicine for male pattern hair loss which is applied to the head.

Pregnancy, breast feeding and fertility

Propecia is for the treatment of male pattern hair loss in men

only. For effects on fertility see section 2.

•    Propecia should not be taken by women.

•    Do not touch crushed or broken Propecia tablets if you are a woman who is pregnant or planning to become pregnant (whole tablets are coated to stop contact with the medicine during normal use). This is because this medicine may affect the baby's sex organs.

•    If a woman who is pregnant comes into contact with crushed or broken Propecia tablets, speak to your doctor.

Driving and using machines

Propecia is not likely to affect you being able to drive, use tools or machines.

Propecia contains Lactose

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

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 one tablet each day. The tablet can be taken with or without food.

If you take more Propecia than you should

If you take too many tablets by mistake, contact your doctor immediately. Propecia will not work faster or better if you take it more than once a day.