CP.FIN.5T.28.RC.V3P2

FINASTERIDE 5MG TABLETS

Patient Information Leaflet: Information for the user

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 of the side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet:

1.    What Finasteride 5mg Tablets are and what they are used for

2.    What you need to know before you take Finasteride 5mg Tablets

3.    How to take Finasteride 5mg Tablets

4.    Possible side effects

5.    How to store Finasteride 5mg Tablets

6.    Contents of the pack and other information

1. WHAT FINASTERIDE 5MG TABLETS ARE AND WHAT THEY ARE USED FOR

Finasteride belongs to the group of medicines called 5-alpha reductase inhibitors.They act by reducing the size of the prostate gland in men.

Finasteride 5mg Tablets act by shrinking the enlarged prostate gland in men. Your doctor has prescribed the medicine for you to treat a condition known as benign prostatic hyperplasia or BPH.

The prostate gland which is near the bladder has become enlarged and is making it more difficult to pass urine. Finasteride 5mg Tablets will help to relieve these symptoms and will help reduce the risk of you developing a sudden inability to pass urine (known as acute urinary retention) and the need for surgery.

What is the prostate?

The prostate is a walnut-sized gland found only in men. It is located below the bladder and it surrounds the urethra, a tube that carries urine from the bladder out through the tip of the penis. The prostate's main function is to produce fluid for semen, the fluid that carries sperm.

What is Benign Prostatic Hyperplasia (BPH)?

BPH is a benign enlargement of the prostate gland which is common in men over 50 years old. Because the prostate is close to the bladder and surrounds part of the urethra, its enlargement may affect your ability to urinate. You may experience symptoms such as a need to urinate often, especially at night, a feeling that you must urinate right away, difficulty in starting to urinate, a weak or interrupted urinary stream, or a feeling that you cannot empty your bladder completely.

In some men, BPH can lead to serious problems, including urinary tract infections, and a sudden inability to pass urine at all as well as the need for surgery. For this reason, a man with symptoms of BPH should see his doctor.

2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE FINASTERIDE 5MG TABLETS

What else you should know before taking Finasteride 5mg Tablets:

BPH is not cancer and does not lead to cancer, but the two conditions can be present at the same time. Before starting you on finasteride, it is likely that your doctor will perform some simple tests to check whether you have prostate cancer. Your doctor will evaluate your symptoms and their possible causes. Talk to your doctor if you have any questions.

Finasteride 5mg Tablets are for use in men only.

Children

Finasteride should not be used in children.

Other medicines and Finasteride 5mg Tablets:

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

Taking Finasteride 5mg Tablets with food and drink:

Finasteride can be taken with or without food.

Pregnancy and breast-feeding:

Finasteride 5mg Tablets SHOULD NOT be taken by women.

Do not touch crushed or broken Finasteride 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 normal development of the baby's sex organs.

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

Driving and using machines

Finasteride 5mg Tablets are not likely to affect your ability to drive, use tools or machines.

Finasteride 5mg Tablets contain lactose

If you have been told by your doctor that you have an intolerance to some sugars, talk to your doctor or pharmacist before taking this medicine.

Talk to your doctor or pharmacist if you have any questions.

Do not take Finasteride 5mg Tablets:

•If you are allergic (hypersensitive) to finasteride or any of the other ingredients of Finasteride 5mg Tablets (see section 6)

•    If you are a woman (because this medicine is for men)

The condition for which Finasteride Tablets are prescribed occurs only in men. The tablets must not be taken by women or by children.

Warnings and precautions:

Talk to your doctor or pharmacist before taking Finasteride 5mg Tablets if:

•    Your partner is pregnant or planning to become pregnant. You should use a condom or other barrier method of contraception when taking this medicine. This is because your semen could contain a tiny amount of the drug and may affect the normal development of the baby's sex organs.

•    You are going to have a blood test called PSA. This is because Finasteride 5mg Tablets can affect the results of the test.

3. HOW TO TAKE FINASTERIDE 5MG TABLETS

Always take Finasteride 5mg Tablets exactly how your doctor has instructed you. You should check with your doctor or pharmacist if you are unsure. The usual dose is one tablet containing 5mg Finasteride to be taken by mouth once a day with or without food.

In order to treat your symptoms and control your BPH effectively, it is important that you continue to take Finasteride 5mg Tablets for as long as your doctor prescribes, even if you do not feel an immediate benefit.

Some patients show early improvements in symptoms, but you may need to take Finasteride 5mg Tablets for at least six months to see if it improves your symptoms.

Finasteride works best when it is taken long term.

Your doctor may prescribe Finasteride 5mg Tablets along with another medicine called doxazosin to help you control your BPH.

If you take more Finasteride 5mg Tablets than you should:

If you have taken too many tablets by mistake, contact your doctor immediately.

If you forget to take Finasteride 5mg Tablets

If you miss a dose, just carry on with the next one as usual. Do not take a double dose to make up for forgotten individual doses.

4. POSSIBLE SIDE EFFECTS

What else do you need to know about Finasteride 5mg Tablets?

Finasteride 5mg Tablets are not licensed to treat prostate cancer. Information collected for a clinical trial in men taking finasteride for 7 years showed:

•    The number of men who developed prostate cancer was lower in men taking finasteride compared with those taking nothing

•    The number of men who had a high score in a tumour grading system was higher in some of those taking finasteride compared to those taking nothing

•    The effect of long-term use of finasteride on tumours of this kind is not known

If you would like further information about the tumour grading system or this trial, please talk to your doctor.

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

If you have an allergic reaction, stop taking it and see your doctor straight away. The signs may include:

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

•    Swelling of your lips, tongue, throat and face.

Other side effects may include:

•    You may be unable to have an erection (impotence).

•    You may have less desire to have sex.

•    You may have 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.

These side effects above may disappear after a while if you continue taking this medicine. If not, they usually resolve after stopping taking this medicine.

Other side effects reported in some men are:

•    Breast swelling or tenderness

•    Palpitations (feeling your heartbeat)

•    Changes in the way your liver is working, which can be shown by a blood test

•    Pain in your testicles

•    An inability to have an erection which may continue after stopping the medication

•    Male infertility and/or poor quality of semen. Improvement in the quality of the semen has been reported after stopping medication

•    Depression

•    Decrease in sex drive that may continue after stopping the medication

•    Problems with ejaculation that may continue after stopping the medication

•    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.

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: 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 5MG TABLETS

Keep out of the sight and reach of children.

This medicinal product does not require any special storage conditions.

Do not use Finasteride 5mg Tablets after the expiry date, which is stated on the label after Exp. 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. CONTENTS OF THE PACK AND OTHER INFORMATION

What Finasteride 5mg Tablets contain

The active substance is finasteride. One film-coated tablet contains 5mg of finasteride.

The other ingredients are Tablet core - Lactose monohydrate, cellulose microcrystalline, starch pregelatinized, sodium starch glycolate (type-A), lauroyl macrogolglycerides and magnesium stearate.

Film coating - Hypromellose, titanium dioxide (E171), indigo carmine (E132) and macrogol 6000.

They are supplied in blister packs of 12, 28,

30 and 56 tablets and bottles of 50, 75 and 100 tablets.

Marketing Authorisation Holder & Manufacturer:

Relonchem Limited, Cheshire House, Gorsey Lane, Widnes, Cheshire, WA8 0RP, UK

Product Licence Number: PL 20395 / 0067

This leaflet was last revised in October 2014