Tablets 5 mg

(finasteride, MSD)

 

PLEASE READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TO TAKE YOUR TABLETS, EVEN IF YOU HAVE JUST HAD A REPEAT PRESCRIPTION. SOME OF THE INFORMATION IN YOUR PREVIOUS LEAFLET MAY HAVE CHANGED.

Keep this leaflet. You may want to read it again.

THIS MEDICINE IS FOR USE ONLY IN MEN

WHAT IS IN YOUR TABLETS?

Active ingredient

The active ingredient in ‘Proscar’ tablets is finasteride. ‘Proscar’ is available as blue, apple shaped tablets, each containing 5 mg finasteride.

Other ingredients

Docasate sodium BP, Hydroxypropyl cellulose EP, Hypromellose EP, Indigo carmine aluminium lake E132, Lactose EP, Magnesium stearate EP, Microcrystalline cellulose E460, Pregelatinised maize starch BP, Sodium starch glycollate BP, Talc EP, Titanium dioxide E171, Yellow iron oxide E172.

‘Proscar’ tablets are supplied in blister packs of 28 tablets.

HOW DOES 'PROSCAR' WORK?

‘Proscar’ belongs to a group of medicines called 5-alpha reductase inhibitors. It works by shrinking the enlarged prostate gland in men.

WHO MAKES YOUR TABLETS?

Your tablets are made by Merck Manufacturing Division, Merck Sharp & Dohme Limited, Shotton Lane, Cramlington, Northumberland UK, for Merck Sharp & Dohme Limited, Hertford Road, Hoddesdon, Hertfordshire, UK, who hold the Product Licence in the UK.

WHY DO YOU NEED TO TAKE ‘PROSCAR’?

Your doctor has prescribed ‘Proscar’ for you because you have a condition known as benign prostate hyperplasia or BPH. Your prostate gland, which is near your bladder, has become bigger and is making it more difficult for you to pass water.

‘Proscar’ helps to shrink the enlarged prostate and relieves your symptoms,

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 (see diagram). The prostate’s main function is to produce fluid for semen, the fluid that carries sperm.

What is 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 such symptoms 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.

If left untreated, BPH can lead to serious problems, including urinary tract infections and the inability to pass urine at all. For this reason, a man with symptoms of BPH should see his doctor.

ARE THERE PATIENTS WHO SHOULD NOT TAKE THESE TABLETS?

Yes, do not take these tablets if you are allergic to any of the ingredients.

The condition for which ‘Proscar’ is prescribed occurs only in men.

The tablets must not be taken by women or children.

 

WHAT ELSE SHOULD YOU KNOW

BEFORE TAKING 'PROSCAR'?

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 ' Proscar', 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.

'Proscar' is for use in men only. However, it is very important that women who are already pregnant, or who could become pregnant, should not be exposed to 'Proscar', either by handling broken or crushed tablets or through sexual contact with a man taking Proscar, since the normal development of the sex organs of a male baby (exposed prior to birth) could be affected. Therefore, if your sexual partner is or may become pregnant you must avoid exposing her to your semen which could contain a tiny amount of the drug - for example, by using a condom during sexual activity. Whole 'Proscar' Tablets are coated to prevent contact. If you are unsure about this or if it will be a problem for you, talk to your doctor before taking the tablets

CAN YOU TAKE 'PROSCAR' WITH OTHER MEDICINES?

'Proscar' does not usually interfere with other medicines. However, you should always tell your doctor about all medicines you are taking or planning to take, including any obtained without a prescription.

HOW SHOULD YOU TAKE 'PROSCAR'?

You should take your tablets exactly as your doctor has told you. The dose is 1 tablet containing 5 mg 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 'Proscar' for as long as your doctor prescribes, even if you do not feel an immediate benefit. Some patients show early improvement in symptoms, but you may need to take 'Proscar' for at least six months to see if 'Proscar' helps you. 'Proscar' works best when taken long term.

WHAT IF YOU FORGET TO TAKE A TABLET OR TAKE TOO MANY?

If you miss a dose, just carry on with the next one as usual. Do not take an extra tablet to make up. If you take too many tablets by mistake, contact your doctor immediately

WHAT UNWANTED EFFECTS COULD 'PROSCAR' HAVE?

Like any medicine, 'Proscar' may have unintended or unwanted effects. These are uncommon and do not affect most men. Some men may notice changes in their sex lives - for example, impotence (an inability to have an erection) or decreased sex drive. Some men may have a decrease in the amount of semen released during sex. This does not appear to interfere with normal sexual function. In some men, such side effects disappear with time, even if 'Proscar' is continued .

In rare cases, .some men have reported breast swelling and/or tenderness, or allergic reactions such as lip swelling and rash.

If you experience these or any other unusual symptoms, go and see your doctor promptly

It will help if you make a note of what you experienced. when it started and how long it lasted.

If symptoms persist, they usually resolve upon discontinuing 'Proscar'.

HOW SHOULD YOUR TABLETS BE KEPT?

Keep your tablets out of the reach of children.

Store them in a dry place below 30ºC and protect from light.

Do not put the tablets into another container, they might get mixed up. If you have been given a calendar pack, do not remove the tablets from the blister until you are ready to take the medicine.

Do not take the tablets past the expiry date which is clearly marked on the pack.

REMEMBER: This medicine is for you. Do not share it with anyone else. It may not suit them.

This leaflet was revised in September 1995

 

HOW CAN YOU OBTAIN MORE INFORMATION

ABOUT 'PROSCAR'?

This leaflet gives you some of the most important patient information about 'Proscar'. If you have any questions after you have read it, ask your doctor or pharmacist, who will give you further information.

® denotes registered trademark of Merck & Co., Inc., Whitehouse Station, NJ, USA.

© Merck Sharp & Dohme Limited 1995. All rights reserved.

Merck Sharp & Dohme Limited

Hertford Road, Hoddesdon, Hertfordshire, EN11 9BU

Printed in England