Consumer medicine information

Finasta 1 mg

Finasteride

BRAND INFORMATION

Brand name

Finasta 1 mg

Active ingredient

Finasteride

Schedule

S4

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using Finasta 1 mg.

What is in this leaflet

This leaflet answers some common questions about FINASTA 1 mg. 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 FINASTA 1 mg 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 FINASTA 1 mg is used for

FINASTA 1 mg is for use by men only.

FINASTA 1 mg is used to treat men with male pattern hair loss to increase hair growth on the scalp and to prevent further hair loss.

Male pattern hair loss (also known as androgenetic alopecia) is a common condition in which men experience thinning of the hair on the scalp. This often results in a receding hair line and/or balding on the top of the head. These changes typically start to occur in some men in their 20s and become more common with age. Once hair loss has occurred over a long period of time, the hair may be permanently lost.

Male pattern hair loss is thought to be caused by a combination of family history (heredity) and production of a particular male hormone, called dihydrotestosterone (DHT). Men with male pattern hair loss have more DHT in the balding part of their scalp than in other parts, resulting in increased hair loss.

How FINASTA 1 mg works

FINASTA 1 mg specifically lowers the levels of DHT in the scalp, thus helping to reverse the balding process.

FINASTA 1 mg does not affect hair on other parts of the body.

Men with mild to moderate, but not complete, hair loss can expect to benefit from the use of FINASTA.

In women who were studied, FINASTA 1 mg was not effective in the treatment of hair loss (androgenetic alopecia).

There should be no need to change your usual hair care routine (for example, shampooing or haircuts) because you are taking FINASTA 1 mg.

FINASTA 1 mg is not addictive.

Before you take FINASTA 1 mg

When you must not take it

Do not take FINASTA 1 mg if:

  • You have an allergy to FINASTA 1 mg or any of the ingredients listed at the end of this leaflet.
    Symptoms of an allergic reaction to FINASTA 1 mg may include skin rash, or swelling of the lips or face.
  • 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 FINASTA, talk to your doctor.

Women who are pregnant or may be pregnant must not take FINASTA, handle crushed or broken tablets or handle tablets with wet hands. If the active ingredient in FINASTA 1 mg 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 FINASTA, handles crushed or broken tablets or handles tablets with wet hands, her doctor must be consulted immediately.

Do not give FINASTA 1 mg to children or women. FINASTA 1 mg 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 FINASTA 1 mg.

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, FINASTA 1 mg has not been shown to interfere with other medicines.

How to take FINASTA 1 mg

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 FINASTA 1 mg only when prescribed by your doctor.

The dose is one tablet taken once each day. FINASTA 1 mg will not work faster or better if you take it more than once a day.

How to take it

Swallow FINASTA 1 mg with a glass of water.

It does not matter if you take FINASTA 1 mg before or after food.

How long to take it

Male pattern hair loss is a condition that develops over a long period of time. Because it takes time for new hair to grow, you will not see immediate results. In general, daily use for 3 months or more may be necessary before you notice increased hair growth or prevention of further loss. Continue taking FINASTA 1 mg for as long as your doctor prescribes.

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.

If it is not nearly time for your next dose, 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 stop taking it

If you stop taking the tablets your hair loss is likely to resume.

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 FINASTA 1 mg. Do this even if there are no signs of discomfort or poisoning.

While you are taking FINASTA 1 mg

Things you must do

If you are about to be started on any new medicine tell your doctor and pharmacist that you are taking FINASTA 1 mg.

Things you must not do

Do not give FINASTA 1 mg 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 FINASTA 1 mg.

FINASTA 1 mg helps most men with male pattern hair loss, but it may have unwanted side effects in a few men. 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:

  • Difficulty in achieving an erection.
  • Less desire for sex.
  • Decreased amount of semen released during sex (this decrease does not appear to interfere with normal sexual function).

Each of these side effects occurred in less than two men in one hundred. It is important to understand that, in clinical trials, these unwanted effects disappeared in men who stopped taking FINASTA 1 mg, as well as in many men who continued treatment.

Also, tell your doctor if you notice problems with ejaculation and it worries you.

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

  • Breast swelling and/or tenderness.
  • Skin rash, itchiness.
  • Hives or nettlerash (pinkish, itchy swellings on the skin).
  • Testicle pain.

These are uncommon side effects that have been reported with FINASTA 1 mg.

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 FINASTA 1 mg, 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.

After taking FINASTA 1 mg

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 FINASTA 1 mg 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 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 that are left over.

Product description

What it looks like

FINASTA 1 mg comes as a reddish brown, round, biconvex, film coated tablets, marked ‘F1’ on one side and plain on the other.

A pack contains 28 tablets.

Ingredients

Active ingredient

FINASTA 1 mg tablet contains 1 mg of finasteride.

Other ingredients

Each tablet contains the following inactive ingredients:

  • Lactose monohydrate.
  • Microcrystalline cellulose.
  • Pregelatinised starch.
  • Lauroyl macrogolglycerides.
  • Sodium starch glycolate (Type A).
  • Magnesium stearate.
  • Opadry complete film coating system 03F34739 Pink.

FINASTA 1 mg does not contain gluten, sucrose, tartrazine or any other azo dyes.

Australian Registration Numbers

FINASTA: AUST R 330148

Sponsor

Sandoz Pty Ltd
54 Waterloo Road
Macquarie Park, NSW 2113
Australia
Tel: 1800 726 369

This leaflet was prepared in August 2020.

Published by MIMS November 2020

BRAND INFORMATION

Brand name

Finasta 1 mg

Active ingredient

Finasteride

Schedule

S4

 

1 Name of Medicine

Finasteride.

2 Qualitative and Quantitative Composition

Finasta 1 mg film-coated tablets contain 1 mg of finasteride.
List of excipients with known effects. Lactose monohydrate.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Finasta 1 mg film-coated tablets are reddish-brown, round, biconvex, film-coated tablet, marked 'F1' on one side and plain on the other.

4 Clinical Particulars

4.9 Overdose

In clinical studies, single doses of finasteride up to 400 mg and multiple doses of finasteride up to 80 mg/day for three months did not result in side effects.
No specific treatment for overdosage with Finasta 1 mg is recommended.
For information on the management of overdose, contact the Poisons Information Centre on 13 11 26 (Australia).

5 Pharmacological Properties

5.3 Preclinical Safety Data

Genotoxicity. No evidence of mutagenicity was observed in an in vitro bacterial mutagenesis assay, a mammalian cell mutagenesis assay, or in an in vitro alkaline elution assay. In an in vitro chromosome aberration assay, when Chinese hamster ovary cells were treated with high concentrations (450-550 micromol) of finasteride, there was a slight increase in chromosome aberrations. These concentrations are in excess of the peak plasma concentrations in men given a total dose of 1 mg and are not achievable in a biological system. In an in vivo chromosome aberration assay in mice, no treatment-related increases in chromosome aberration were observed with finasteride at the maximum tolerated dose.
Carcinogenicity. In a 24-month carcinogenicity study in rats there was an increase in the incidence of thyroid follicular adenomas in male rats receiving 160 mg/kg/day finasteride (statistically significant trend test). This oral dose produced an exposure in rats of more than 800 times that observed in humans at the recommended dose (based on AUC(0-24 hrs) values). The effect of finasteride on the thyroid in rats appears to be due to an increased rate of thyroxine clearance and not a direct effect of the medicine. These observations seen in the rat are thought not relevant to man.
In a 19-month carcinogenicity study in mice, a statistically significant (p ≤ 0.05) increase in the incidence of testicular Leydig cell adenoma was observed at an oral dose of 250 mg/kg/day (estimated exposure of more than 1,700 times that observed in humans at the recommended dose); no adenomas were seen in mice given 2.5 or 25 mg/kg/day.
In mice at an oral dose of 25 mg/kg/day (estimated exposure about 90 times that in humans at the recommended dose) and in rats at an oral dose of ≥ 40 mg/kg/day, (estimated exposure about 300 times that in humans at the recommended dose) an increase in the incidence of Leydig cell hyperplasia was observed. A positive correlation between the proliferative changes of the Leydig cells and the increase in serum luteinising hormone (LH) levels (2-3 fold above control) has been demonstrated in both rodent species treated with high doses of finasteride. This suggests the Leydig cell changes are secondary to elevated serum LH levels and not due to a direct effect of finasteride.
No medicine-related Leydig cell changes were seen in either rats or dogs treated with finasteride for one year at respective oral doses of 20 mg/kg/day (estimated exposure more than 220 times that in humans at the recommended dose) and 45 mg/kg/day (estimated exposure more than 2,600 times that in humans at the recommended dose) or in mice treated for 19 months at an oral dose of 2.5 mg/kg/day (estimated exposure about 9 times that in humans at the recommended dose).

6 Pharmaceutical Particulars

6.7 Physicochemical Properties

Finasteride is a white, crystalline solid with a molecular weight of 372.55. It is freely soluble in chloroform and in lower alcohol solvents but is practically insoluble in water.
Chemical structure.
https://stagingapi.mims.com/au/public/v2/images/fullchemgif/CSFINAST.gif Chemical Name: N-(1,1-dimethylethyl)-3-oxo-4-aza-5α-androst-1-ene-17β-carboxamide.
Molecular Formula: C23H36N2O2.
Molecular Weight: 372.55.
CAS number. 98319-26-7.

7 Medicine Schedule (Poisons Standard)

Schedule 4 - Prescription Only Medicine.

Summary Table of Changes

https://stagingapi.mims.com/au/public/v2/images/fulltablegif/FINSTAST.gif