Proscar

• Relieves urinary symptoms of an enlarged prostate gland
• Intended solely for use in men
• Swallow tablet whole

PROSCAR tablets contain the active ingredient finasteride. This medicine belongs to a group of medicines called 5-alpha reductase inhibitors.

PROSCAR is used to relieve the urinary symptoms of an enlarged prostate gland (benign prostatic hyperplasia, BPH). This can lead to problems such as:

• Increased need to urinate.
• Weak flow of urine.
• Finding it difficult to start passing urine.
• Dribbling of urine after urinating.

If your prostate gland is swollen it can press on the tube that urine passes through on its way out of your body, causing the above-listed problems. PROSCAR shrinks the prostate gland in men when it is swollen, improves the flow of urine, and reduces other symptoms of an enlarged prostate.

The use of PROSCAR will reduce the risk that your urine flow will be completely blocked (acute urinary retention) and the need for surgery.

PROSCAR may also be used with another medicine called doxazosin to help control your BPH.

Always follow the instructions on the official package leaflet, unless the doctor advises otherwise. You should check with your doctor or pharmacist if you are not sure.

Dosage

• The usual dose is one 5mg tablet a day.

The tablet can be taken with or without food.

Your condition may show an early improvement after taking PROSCAR. However, it may take at least six months for the full effect to develop. Even if you do not feel any benefit straight away, PROSCAR can reduce the risk of acute urinary retention and the need for surgery.

Your doctor will perform tests to monitor the effects of this medicine.

Always take this medicine exactly as your doctor has told you. PROSCAR is only effective in treating the symptoms and controlling the disease if used for a long time.

Alcohol/driving

PROSCAR does not affect your reaction time. This medicine does not interact with alcohol.

If you take more or less PROSCAR than you should

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

If you forget to take a tablet, skip the missed dose. Take the next dose as usual. Do not take a double dose to make up for a forgotten one.

Always consult your doctor before stopping the treatment.

PROSCAR is not suitable for everyone. Do not take this medicine if:

• You are allergic to any of the ingredients in this medicine (see section ‘What PROSCAR contains').
• You are a women (this medicine is for men) or if your partner is pregnant or planning to become pregnant.
• You are a child.

When should this medicine be used with extreme caution?

There are warnings associated with PROSCAR.

• Before you begin using this medicine, be sure to inform your doctor of any medical conditions or allergies you may have or have had.
• Do not touch crushed or broken PROSCAR tablets if you are a woman who is pregnant or planning to become pregnant. This is because the active substance (finasteride) in 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 PROSCAR tablets, speak to your doctor immediately.
• If your partner is or may be pregnant, you must avoid exposing her to your semen. This is because your semen could contain a tiny amount of the active substance. Therefore, you should use a condom or other barrier method of contraception when taking PROSCAR.
• PROSCAR can affect the results of a blood test called PSA. If you are having a blood test for PSA, tell your doctor that you are taking PROSCAR.

Pregnancy and breastfeeding

In principle, PROSCAR is not intended for women. Seek medical advice from your doctor if you plan to take this medicine. It is not known if finasteride is excreted in the breast milk.

Do not touch crushed or broken PROSCAR tablets if you are a woman who is pregnant or planning to become pregnant. See section ‘When should this medicine be used with extreme caution?’.

Other medicines and PROSCAR

There are no known interactions with other medicines. However, be sure to tell your doctor if you are taking or have recently taken other medicines, including medicines obtained without a prescription.

Medicines can cause side effects, although some people may not experience any. PROSCAR is generally well tolerated, although the following side effects may occur:

• Sexual problems such as impotence or less desire to have sex (loss of libido).
• 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. In some cases, these side effects disappeared after a while, even in patients who continued taking PROSCAR. If not, they usually resolved after stopping with PROSCAR.
• Breast tenderness or soreness.
• Allergic reactions such as skin rash, itching, nettle rash, and swelling of the face and lips.
• Pain in the testicles.

You should promptly report to your doctor any abnormal changes or symptoms. If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

PROSCAR tablets contain the active substance finasteride. Each tablet contains 5 mg finasteride.

The other ingredients are: lactose, pregelatinised maize starch, sodium carboxymethyl starch, yellow iron oxide (E172), sodium dodecyl sulfate, microcrystalline cellulose, magnesium stearate, hypromellose, hydroxypropyl cellulose, titanium dioxide (E171), talc, indigo carmine aluminium lake (E132).

The manufacturer of PROSCAR 5 mg is:

Merck Sharp & Dohme BV
Postbus 581
Waarderweg 39
2003 PC Haarlem
The Netherlands

Read the package leaflet before use.