What is in this leaflet
This leaflet answers some common questions about Finasteride AN 1 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 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 1 mg tablets are used for
Finasteride AN 1 mg tablets are for use by men only.
It 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 20’s 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 (hereditary) 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 Finasteride AN works
Finasteride AN 1 mg tablets specifically lowers the levels of DHT in the scalp, thus helping to reverse the balding process.
It 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 this medicine.
In women who were studied, Finasteride AN 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 this medicine.
Finasteride AN 1mg tablets are not addictive.
Before You Take Finasteride AN 1 mg tablets
When you must not take it
Do not take Finasteride AN 1 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 1 mg tablets, talk to your doctor.
Women who are pregnant or may be pregnant must not take Finasteride AN 1 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 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 1 mg tablets has not been shown to interfere with other medicines.
How to take Finasteride AN 1 mg tablets
How much to take
Take Finasteride AN only when prescribed by your doctor.
The dose is one tablet taken once each day. Finasteride AN 1mg tablets will not work faster or better if you take it more than once a day.
How to take it
Swallow your tablet with a glass of water.
It does not matter if you take Finasteride AN before or after food.
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.
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.
Do not take a double dose to make up for the dose you missed.
If you are not sure what to do, ask your doctor or pharmacist.
If you have trouble remembering to take your tablets, ask your pharmacist for some hints.
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 Finasteride AN 1 mg tablets for as long as your doctor prescribes
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 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.
You may need urgent medical attention.
While you are taking Finasteride AN 1 mg tablets
Things you must do
If you are about to be started on any new medicine tell your doctor and pharmacist that you are taking Finasteride AN 1 mg tablets.
Things you must not do
Do not give Finasteride AN 1 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 1 mg tablets 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 Finasteride AN 1 mg tablets, 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 Finasteride AN 1 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.
After taking Finasteride AN 1 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 1 mg tablets are reddish brown, 7 mm, round, biconvex, film coated tablets, markef F1 on one side and plain on the other.
They are presented in Al blister packs of 28 tablets (AUST R 189272).
Ingredients
Active Ingredient:
Finasteride 1 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 03F34739 Pink
Finasteride AN 1 mg tablets do not contain gluten, sucrose, tartrazine or any other azo dyes.
Name and Address of the Sponsor
Amneal Pharma Australia Pty Ltd
12 River Street
SOUTH YARRA
VIC, 3141
Australia
Date of Preparation
October 2014