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Finasteride AN tablets

Finasteride AN tablets 5 mg


Consumer Medicine Information

What is in this leaflet

This leaflet answers some common questions about Finasteride AN 5 mg tablets.

It does not contain all of the available information. It does not take the place of talking to your doctor or pharmacist.

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

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

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

What Finasteride AN 5 mg tablets are used for

Finasteride AN 5 mg tablets are for use by men only.

Finasteride AN 5 mg tablets are 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:

  • Weak or interrupted stream of urine
  • Feeling that you cannot empty your bladder completely
  • A delay before you start to pass urine
  • Needing to pass urine often, especially at night
  • Feeling that you must pass urine right away

BHP 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-GA 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-GA 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 AN 5 mg tablets for another reason. Ask your doctor if you have any questions about why Finasteride AN 5 mg tablets has been prescribed for you.

Finasteride AN is not addictive.

Before you take Finasteride AN 1 mg tablets

When you must not take it

Do not take Finasteride AN 5 mg tablets if:

  • You have an allergy to Finasteride or to any of the ingredients listed at the end of this leaflet
    Symptoms of an allergic reaction may include skin rash, or swelling of the face and lips.
  • The packaging is torn or shows signs of tampering
  • The expiry date on the pack has passed
    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 AN 5 mg tablets, talk to your doctor.

Women who are pregnant or may be pregnant must not take Finasteride AN 5 mg tablets, handle crushed or broken tablets or handle tablets with wet hands.

If the active ingredient in the tablet 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.

Whole tablets are coated to prevent contact with the active ingredient during normal handling, provided that the tablets haven’t been crushed or broken.

If a pregnant woman swallows Finasteride AN, handles crushed or broken tablets or handles tablets with wet hands, her doctor must be consulted immediately.

Do not give Finasteride AN to children or women.

Finasteride AN 5 mg tablets is for use by men only.

Before you start to take it

Tell your doctor if:

  • You have or have had any medical conditions
  • You have any allergies to any other medicines or any other substances, such as foods, preservatives or dyes.

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

Taking other medicines

Tell your doctor if you are taking any other medicines, including medicines 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 AN 5 mg tablets has not been shown to interfere with other medicines.

How to take Finasteride AN 5 mg tablets

How much to take

Take Finasteride AN 5 mg tablets only when prescribed by your doctor.

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

How to take it

Swallow your tablet with a glass of water.

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.

When to take it

Take Finasteride AN 5 mg tablets once a day at about the same time each day. This will help you remember to take the tablets.

It does not matter if you take Finasteride AN 5 mg tablets before or after food.

How long to take it

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

Continue taking this medicine 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 the missed dose as soon as you remember, and then go back to taking your tablets 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 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 the Poisons Information Centre (telephone 13 11 26) for advice, or go to Accident and Emergency at the nearest hospital, if you think you or anyone else may have taken too much Finasteride AN. Do this even if there are no signs of discomfort or poisoning.

While you are taking Finasteride AN 5 mg tablets

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 AN 5 mg tablets are 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 AN. Finasteride AN 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 AN.

Things you must not do

Do not give Finasteride AN 5 mg tablets 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 AN. Finasteride AN 5 mg tablets 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:

  • Impotence - (inability to have an erection)
  • Less desire for sex
  • Changes or problems with ejaculation, such as decreased amount of semen released during sex (this decrease does not appear to interfere with normal sexual function)

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

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

  • Breast swelling and/or tenderness
  • Breast lumps, pain or discharge from the nipples
  • Skin rash, itchiness
  • Hives or nettle rash (pinkish, itchy swellings on the skin)
  • Testicle pain

These are uncommon side effects that have been reported with Finasteride AN 5 mg tablets.

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

  • swelling of the lips or face.
    These may be symptoms of a serious allergic reaction to Finasteride AN 1 mg tablets 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 occur in some men. Tell your doctor or pharmacist if you notice any other unwanted effects.

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

After taking Finasteride AN 5 mg tablets

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 AN tablets where the temperature stays below 25 degrees 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 one-and-a-half metres above the ground is a good place to store medicines.

Disposal

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

Product description

What it looks like

Finasteride AN 5 mg tablets are blue, 7 mm, round, biconvex, film coated tablets, marked F5 on one side and plain on the other.

They are presented in PVC/PVDC/Al blister packs of 30 tablets (AUST R 189273).

Ingredients

Active Ingredient:
Finasteride 5 mg per tablet

Other Ingredients:

  • microcrystalline cellulose
  • lactose
  • lauroyl macrogoglycerides
  • magnesium stearate
  • pregelatinised maize starch
  • sodium starch glycolate type A
  • Opadry complete film coating system 03F20404 Blue

Finasteride AN 5 mg tablets do not contain gluten, sucrose, tartrazine or any other azo dyes.

Name and Address of the Sponsor

Scentia Pharmaceuticals Pty Ltd
8 - 12 Ordish Road
Dandenong South,
VIC - 3175
Australia

Date of Preparation

February 2014

Doc ID: 61.AN.M.1.0

Published by MIMS November 2014

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