What is in this leaflet

This leaflet answers some common questions about Finasteride Viatris 5. It does not contain all the available information.

It does not take the place of talking to your doctor or pharmacist.

All medicines have risks and benefits. Your doctor has weighed the risks of you taking Finasteride Viatris 5 against the benefits they expect it will have for you.

If you have any concerns about taking this medicine, ask your doctor or pharmacist.

Keep this leaflet with the medicine. You may need to read it again.

What Finasteride Viatris 5 is used for

Finasteride Viatris 5 is for use by men only.

Finasteride Viatris 5 is used to treat a medical condition in men called benign prostatic hyperplasia or BPH. BPH is a condition where your prostate gland (which is near your bladder) has become bigger making it more difficult for you to pass urine.

This can lead to symptoms such as:

BPH occurs only in men and is common over the age of 50 years. In some men, BPH can lead to serious problems, including urinary tract infections and the sudden inability to pass urine at all. BPH can also lead to the need for surgery such as procedures to improve the flow of urine.

The prostate gland takes years to grow. Therefore, the symptoms of BPH take a long time to develop. Finasteride Viatris 5 works by slowly reducing the size of your prostate gland. This may lead to gradual improvement in your urine flow and other symptoms over several months. Finasteride Viatris 5 also helps reduce the risk of developing a sudden inability to pass urine (acute urinary retention) and the need for surgery. This may happen whether or not you notice any improvement or change in your symptoms.

Your doctor may have prescribed Finasteride Viatris 5 for another reason. Ask your doctor if you have any questions about why Finasteride Viatris 5 has been prescribed for you.

Finasteride Viatris 5 is not addictive.

Before you take Finasteride Viatris 5

When you must not take it

Do not take Finasteride Viatris 5 if:

Symptoms of an allergic reaction to Finasteride Viatris 5 may include skin rash, or swelling of the lips or face.

If you take this medicine after the expiry date has passed, it may not work.

If you are not sure whether you should start taking Finasteride Viatris 5, talk to your doctor.

Women who are pregnant or may be pregnant must not take Finasteride Viatris 5 or handle crushed or broken tablets.

If the active ingredient in Finasteride Viatris 5 is absorbed after swallowing the tablet or through the skin by a woman who is pregnant with a male baby, it may cause the male baby to be born with abnormalities of the sex organs. Finasteride Viatris 5 tablets are coated and will prevent contact with the active ingredient during normal handling, provided the tablets are not broken or crushed.

If a pregnant woman swallows Finasteride Viatris 5 or handles crushed or broken tablets, her doctor must be consulted immediately.

Do not give Finasteride Viatris 5 to children or women.

The condition for which Finasteride Viatris 5 is prescribed occurs only in men.

Before you start to take it

Tell your doctor if:

If you have not told your doctor about any of the above, tell them before you take any Finasteride Viatris 5.

Taking other medicines

Tell your doctor or pharmacist if you are taking any other medicines, including medicine that you buy without a prescription from your pharmacy, supermarket or health food shop.

Some medicines may affect the way other medicines work. However, Finasteride Viatris 5 has not been shown to interfere with other medicines.

How to take Finasteride Viatris 5

Follow all directions given to you by your doctor carefully.

They may differ from the information contained in this leaflet.

If you do not understand the instructions on the box, ask your doctor or pharmacist for help.

How much to take

Take Finasteride Viatris 5 only when prescribed by your doctor.

The usual dose in men is one tablet taken once each day.

How to take it

Swallow Finasteride Viatris 5 with a glass of water.

When to take it

Take Finasteride Viatris 5 once a day at about the same time each day.

This will help you to remember to take the tablets.

It does not matter if you take Finasteride Viatris 5 before or after food.

How long to take it

Finasteride Viatris 5 shrinks the prostate gland slowly. Therefore, you may need to take Finasteride Viatris 5 for 6 months or longer to see whether it helps you. If it does help your symptoms, you may need to take Finasteride Viatris 5 every day.

Continue taking Finasteride Viatris 5 for as long as your doctor prescribes. If you stop taking the medicine the prostate gland is likely to grow again.

If you forget to take it

If it is almost time for your next dose, skip the dose you missed and take your next dose when you are meant to. Otherwise, take it as soon as you remember, and then go back to taking your tablet as you would normally.

If you are not sure whether to skip the dose, talk to your doctor or pharmacist.

Do not take a double dose to make up for the dose that you missed.

If you have trouble remembering to take your tablets, ask your pharmacist for some hints.

If you take too much (overdose)

Immediately telephone your doctor or Poisons Information Centre (telephone 13 11 26) for advice, if you think that you or anyone else may have taken too much Finasteride Viatris 5. Do this even if there are no signs of discomfort or poisoning.

While you are taking Finasteride Viatris 5

Things you must do

Go to your doctor for regular checkups, including a physical check for prostate cancer once a year if you are over 50.

While BPH is not cancer and does not lead to cancer, the two conditions can exist at the same time. Finasteride Viatris 5 is used for BPH not prostate cancer.

If you are having a blood test to measure your PSA (prostate-specific antigen) levels, tell your doctor you are taking Finasteride Viatris 5. Finasteride Viatris 5 can affect the results of this test.

If you are about to be started on any new medicine tell your doctor and pharmacist that you are taking Finasteride Viatris 5.

Things you must not do

Do not give Finasteride Viatris 5 to anyone else, even if they have the same condition as you.

Side effects

Tell your doctor or pharmacist as soon as possible if you do not feel well while you are taking Finasteride Viatris 5.

Finasteride Viatris 5 helps most men with BPH, but it may have unwanted side effects in a few people. All medicines can have side effects.

Sometimes they are serious, most of the time they are not. You may need medical treatment if you get some of the side effects.

Ask your doctor or pharmacist to answer any questions you may have.

Tell your doctor if you notice any of the following and they worry you:

These are the more common side effects of Finasteride Viatris 5. For the most part these have been mild. In some cases, these side effects disappeared while the patient continued to take Finasteride Viatris 5. If symptoms persisted, they usually resolved on stopping the tablets.

Tell your doctor immediately if you notice any of the following:

These are uncommon side effects that have been reported with Finasteride Viatris 5.

Tell your doctor immediately or go to accident and emergency at your nearest hospital if the following happens:

These may be symptoms of a serious allergic reaction to Finasteride Viatris 5, which may cause difficulty in swallowing or breathing. You may need urgent medical attention. Serious side effects are rare.

Other side effects not listed above may also occur in some patients. Tell your doctor if you notice any other effects.

Do not be alarmed by this list of possible side effects. You may not experience any of them.

After taking Finasteride Viatris 5

Storage

Keep your tablets in the blister pack until it is time to take them.

If you take the tablets out of the blister pack they may not keep well.

Never put the tablets in another box or container, as they might get mixed up.

Store Finasteride Viatris 5 where the temperature stays below 25°C. Do not store it or any other medicine in the bathroom or near a sink.

Do not leave it in the car or on window sills.

Heat and dampness can destroy some medicines.

Keep it where children cannot reach it.

A locked cupboard at least 1½ metres above the ground is a good place to store medicines.

Disposal

If your doctor tells you to stop taking the tablets or the tablets have passed their expiry date, ask your pharmacist what to do with any medicine that is left over.

Product description

What it looks like

Finasteride Viatris 5 comes as a blue, round, biconvex, film coated tablets, marked 'F5' on one side and plain on the other.

A pack contains 30 tablets.

Ingredients

Active ingredient

Finasteride Viatris 5 tablet contains 5 mg of finasteride.

Other ingredients:

Each tablet contains the following inactive ingredients:

Finasteride Viatris 5 tablet does not contain gluten, sucrose, tartrazine or any other azo dyes.

Australian Registration Numbers

Finasteride Viatris 5: AUST R 330152

Sponsor

Accord Healthcare Pty Ltd

Level 24, 570 Bourke Street

Melbourne VIC 3000

Email: ds@commercialeyes.com.au

Phone: 1800 134 988

This leaflet was prepared in April 2024.