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Package leaflet: Information for the user

Finasteride 5 mg Film-coated Tablets

Finasteride

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 5 mg Tablets are and what they are used for

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

3.    How to take Finasteride 5 mg Tablets

4.    Possible side effects

5.    How to store Finasteride 5 mg Tablets

6.    Contents of the pack and other information

1. What Finasteride 5 mg 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 shrinks the prostate glad in men when it is swollen. Finasteride is used in the treatment and control of benign (i.e., non-cancerous) enlargement of the prostate (benign prostatic hyperplasia - BPH). The prostate gland is found underneath the bladder (but only in man). It produces the fluid found in semen. A swollen prostate gland can lead to a condition called 'benign prostatic hyperplaia' (BPH). Finasteride causes shrinkage of the enlarged prostate, improves urinary flow and symptoms caused by BPH, and reduces the risk of you developing a sudden inability to pass urine (known as acute urinary retention) and the need for surgery.

What is BPH?

If you have BPH it means that your prostate gland is swollen. It can press on the tube that urine passes through, on its way out of your body.

This can lead to problems such as

-    Feelling like you need to pass urine more often, especially at night

-    Feeling that you must pass urine right away

-    Finding it difficult to pass urine

-    When you pass urine the flow of urine is weak

-    When you pass urine the flow stops and starts

-    Feeling that you cannot empty your bladder completely

In some men, BPH can lead to more serious problems, such as:

-    Urinary tract infections

-    A sudden inability to pass urine

-    The need for surgery

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

Do not take Finasteride 5 mg Tablets:

-    If you are allergic (hypersensitive) to finasteride or any of the other ingredients of Finasteride

5 mg Tablets.

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

-    If you are a child

Do not take finasteride if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist.

Take special care with Finasteride 5 mg Tablets:

-    If you have a large amount of residual urine in your bladder after urinating and/or severely reduced urinary flow. If this is the case, you should be closely monitored for narrowing of the urinary tract

-    If you have impaired liver function. The level of finasteride in your blood may be increased if so

-    If your sexual partner is or may potentially be pregnant, you should avoid exposing her to your semen which could contain a tiny amount of the drug.

-    If you have a blood test called PSA (test used to detect prostate cancer). Tell your doctor that you are taking finasteride. Finasteride can affect the blood levels of the substance being tested, PSA.

Tell your doctor if any of the above applies to you now or in the past.

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.

Children

Finasteride should not be used in children.

Taking other medicines:

Finasteride does not usually interfere with other medicines. No significant drug interactions have been identified. Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

Taking Finasteride 5 mg Tablets with food and drink:

Finasteride can be taken with or without food.

Pregnancy and breast-feeding:

Finasteride 5 mg Tablets are only intended for men. Finasteride should not be taken by women. Women who are or may potentially be pregnant should not handle Finasteride 5 mg Tablets especially if broken or crushed. If finasteride is absorbed through the skin or taken by mouth by women pregnant with a male foetus, the child may be born with malformed genital organs. If a women who is pregnant comes into contact with crushed or broken Finasteride tablets, speak to you doctor.

When the patient's sexual partner is or may become pregnant, the patient should either avoid exposure of his partner to semen (e.g. by use of a condom) or discontinue treatment with finasteride.

Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines:

There is no information to suggest that Finasteride affects the ability to drive and use machines.

Important information about some of the ingredients of Finasteride 5 mg Tablets:

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

3. How to take Finasteride 5 mg Tablets

Always take Finasteride 5 mg Tablets exactly as your doctor has told you.

You should check with your doctor or pharmacist if you are not sure.

The usual dose is one tablet daily (equivalent to 5 mg finasteride).

The film-coated tablets can either be taken on an empty stomach or with a meal. This medicine should be taken by mouth, swallowed whole and should not be divided or crushed. Your doctor may prescribe finasteride along with another medicine (called doxazosin) to help control your BPH.

Although early improvement may be seen, treatment for at least six months may be necessary to assess whether a beneficial response has been achieved.

Your doctor will tell you how long you should continue to take Finasteride 5 mg Tablets. Do not interrupt treatment early or the symptoms may come back.

•    Patients with impaired liver function

There is no experience of the use of Finasteride in patients with impaired liver function (see also 'Take special care with Finasteride 5 mg Tablets').

•    Patients with impaired kidney function

No dosage adjustment is required. The use of Finasteride in patients who have to undergo haemodialysis has not been investigated yet.

•    Elderly patients

No dosage adjustment is required.

Please speak to your doctor or pharmacist if you feel that the effects of Finasteride 5 mg Tablets is too strong or too weak.

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

If you have taken more tablets than you were told to, or if someone else has taken any tablets, contact accident and emergency department of your nearest hospital. Take any left over tablets or empty box with you for easier identification.

If you forget to take Finasteride 5 mg Tablets:

If you forget to take a dose of Finasteride 5 mg Tablets, you can take it as soon as you remember unless it is time for the next dose, in which case you should continue with your medication as prescribed. Do not take a double dose to make up for a forgotten dose.

If you stop taking Finasteride 5 mg Tablets:

Your condition may show an early improvement after taking Finasteride. However, it may take at least six months for the full effect to delevop. It is important to keep taking Finasteride for as long as your doctor tells you, even if you do not feel any benefit straight away.

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

4. Possible side effects

Like all medicines, Finasteride 5 mg Tablets can cause side effects, although not everybody gets them.

For the assessment of side effects, the following descriptions of frequency have been used -

Very common - occur in more than 1 in 10 patients

Common - occur in more than 1 in 100 patients,

but in less than 1 in 10 patients

Uncommon - occur in less than 1 in 100 patients,

but in more than 1 in 1000 patients

Rare - occur in less than 1 in 1000 patients, but

in more than 1 in 10000 patients

Very rare - occur in less than 1 in 10000 patients,

including isolated reports