FINTAST

Main information

  • Trade name:
  • FINTAST finasteride 5 mg tablet blister pack
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • FINTAST finasteride 5 mg tablet blister pack
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 210614
  • Last update:
  • 09-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

210614

FINTAST finasteride 5 mg tablet blister pack

ARTG entry for

Medicine Registered

Sponsor

Aurobindo Pharma Australia Pty Ltd

Postal Address

5 / 148 Spit Road,Mosman, NSW, 2088

Australia

ARTG Start Date

30/04/2014

Product category

Medicine

Status

Active

Approval area

Drug Safety Evaluation Branch

Conditions

Conditions applicable to all therapeutic goods as specified in the document "Standard Conditions Applying to Registered or Listed Therapeutic Goods

Under Section 28 of the Therapeutic Goods Act 1989" effective 1 July 1995.

Conditions applicable to the relevant category and class of therapeutic goods as specified in the document "Standard Conditions Applying to Registered

or Listed Therapeutic Goods Under Section 28 of the Therapeutic Goods Act 1989" effective 1 July 1995.

Products

1. FINTAST finasteride 5 mg tablet blister pack

Product Type

Single Medicine Product

Effective date

24/12/2015

Warnings

See Product Information and Consumer Medicine Information for this product

Standard Indications

Specific Indications

FINTAST is indicated for the treatment of patients with symptomatic benign prostatic hyperplasia (BPH) with an enlarged prostate.

Additional Product information

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

Blister Pack

PVC/PE/PVDC/Al

3 Years

Store below 25

degrees Celsius

Not recorded

Not recorded

Pack Size/Poison information

Pack Size

Poison Schedule

(S4) Prescription Only Medicine

(S4) Prescription Only Medicine

Components

1. FINTAST finasteride 5 mg tablet blister pack

Dosage Form

Tablet, film coated

Route of Administration

Oral

Visual Identification

Blue coloured, circular, biconvex, bevel edged film-coated tablets debossed

with 'E' on side and '61' on the other side

Active Ingredients

Finasteride

5 mg

© Commonwealth of Australia.This work is copyright.You are not permitted to re-transmit, distribute or commercialise the material without obtaining prior

written approval from the Commonwealth.Further details can be found at http://www.tga.gov.au/about/website-copyright.htm.

Public Summary

Page 1 of

Produced at 27.11.2017 at 09:16:43 AEDT

This is not an ARTG Certificate document.

The onus is on the reader to verify the current accuracy of the information on the document subsequent to the date shown.

Visit www.tga.gov.au for contact information

Patient Information leaflet

FINTAST™

Consumer Medicine Information

Finasteride 5 mg film-coated tablets

What is in this leaflet

This leaflet answers some common questions about FINTAST. 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 FINTAST

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 FINTAST is used for

FINTAST is for use by men only.

FINTAST, in the 5 mg strength, 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:

weak or interrupted stream of urine;

feeling that you cannot empty your bladder completely;

delay before you start to pass urine;

needing to pass urine often, especially at night; or

feeling that you must pass urine right away.

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.

How FINTAST works

FINTAST, in the 5 mg strength, 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.

FINTAST 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 FINTAST for another reason. Ask your doctor if you have any

questions about why FINTAST has been prescribed for you.

FINTAST is not addictive.

Before you take it

When you must not take it

Do not take FINTAST if:

you have an allergy to FINTAST or any of the ingredients listed at the end of this

leaflet

Symptoms of an allergic reaction to FINTAST may include skin rash, or swelling of the lips

or face;

the packaging is torn or shows signs of tampering; or

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 FINTAST, talk to your doctor.

Women who are pregnant or may be pregnant must not take FINTAST, handle crushed or

broken tablets.

If the active ingredient in FINTAST 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. FINTAST tablets are coated and will prevent contact with the

active ingredient during normal handling, provided that the tablets are not broken or crushed.

If a pregnant woman swallows FINTAST, handles crushed or broken tablets, her doctor

must be consulted immediately.

Do not give FINTAST to children or women.

Before you start taking it

Tell your doctor if:

1.

you have or have had any medical conditions; or

2.

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

FINTAST.

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, FINTAST has not been

shown to interfere with other medicines.

Driving and operating machinery

FINTAST should not affect your ability to drive or operate machinery.

How to take it

How much to take

Take FINTAST only when prescribed by your doctor.

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

Swallow FINTAST 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 FINTAST 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 FINTAST before or after food.

How long to take it

FINTAST shrinks the prostate gland slowly. Therefore, you may need to take FINTAST for 6

months or longer to see whether it helps you. If it does help your symptoms, you may need to take

FINTAST every day. Continue taking FINTAST 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 FINTAST. Do this

even if there are no signs of discomfort or poisoning.

While you are taking it

Things you must do

Go to your doctor for regular check-ups, 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.

FINTAST 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 FINTAST.

Things you must not do

Do not give FINTAST 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 FINTAST.

FINTAST 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) that continues after stopping FINTAST;

less desire for sex that continued after stopping FINTAST; or

problems with ejaculation that continued after stopping the medication.

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).

Male infertility and/or poor quality of semen have been reported infrequently. Improvement in the

quality of semen has been reported after stopping FINTAST.

These are the more common side effects of FINTAST. For the most part these have been mild. In

some cases, these side effects disappeared while the patient continued to take FINTAST. 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. In rare cases, male breast cancer has been reported;

breast lumps, pain or discharge from the nipples;

skin rash, itchiness;

hives or nettlerash (pinkish, itchy swellings on the skin);

testicle pain; or

depressions (feelings of severe sadness and unworthiness).

These are uncommon side effects that have been reported with FINTAST.

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

following happens:

swelling of the lips, tongue, throat or face.

These may be symptoms of a serious allergic reaction to FINTAST, 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 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 it

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.

Keep FINTAST in a cool dry place 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 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 the tablets have passed their expiry

date, ask your pharmacist what to do with any that are left over.

Product description

What it looks like

FINTAST (5 mg finasteride tablets) are supplied in pack sizes* of 28 or 30 tablets in blister packs.

FINTAST 5 mg finasteride tablets (AUST R: 210614)

Blue coloured, circular, biconvex, bevel edged film-coated tablets debossed with ‘E’ on side and

‘61’ on the other side.

Ingredients

Active ingredient

Finasteride 5 mg per tablet

Inactive ingredients

lactose;

microcrystalline cellulose;

pregelatinised maize starch;

sodium starch glycollate type A;

docusate sodium;

magnesium stearate; and

Opadry complete film coating system 20A50535 Blue contains.

*Some of these pack sizes are not marketed.

Sponsor/Marketing Authorisation Holder

Aurobindo Pharma Australia Pty Ltd

6 Eastern Road

South Melbourne

Victoria 3205

Australia

Distributed by Eris Pharmaceuticals (Australia) Pty Ltd

www.eris-pharma.com.au

Toll free telephone (Australia): 1800 233 588

This leaflet was prepared in December 2015

Version 3.0

4-7-2012

Danish Pharmacovigilance Update, 19 April 2012

Danish Pharmacovigilance Update, 19 April 2012

Among the topics covered in this issue of Danish Pharmacovigilance Update are: Split and crushed tablets containing finasteride may pose a risk for pregnant and fertile women.

Danish Medicines Agency

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