Anterone 50

Anterone 50

Active ingredient(s): Cyproterone acetate

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Consumer Medicine Information (CMI)

This leaflet provides important information about using Anterone 50. You should also speak to your doctor or pharmacist if you would like further information or if you have any concerns or questions about using Anterone 50.

Where to find information in this leaflet:

1. Why am I using Anterone 50?
2. What should I know before I use Anterone 50?
3. What if I am taking other medicines?
4. How do I use Anterone 50?
5. What should I know while using Anterone 50?
6. Are there any side effects?
7. Product details

1. Why am I using Anterone 50?

Anterone 50 contains the active ingredient Cyproterone acetate. Anterone 50 tablets are an anti‐androgen medicine.

Androgens such as testosterone are natural male sex hormones which are also produced, to a slight extent, in females.

MEN:

In men, androgens may help cancer cells to grow in some types of prostate cancer. By blocking these hormones, Anterone 50 tablets may slow or stop the growth of cancer. Anterone 50 tablets may also be used in combination with other medicines or following surgical removal of the testes to treat side effects such as “hot flushes” or “sweats” and to prevent any initial worsening of the disease.

Anterone 50 tablets is also used to reduce abnormal sex drive in men.

WOMEN:

In women, androgens may increase hair growth, loss of scalp hair and secretion of oil from the sweat glands. By blocking these hormones, Anterone 50 tablets may slow or stop excessive hairiness, loss of scalp hair, acne, oily skin and dandruff.

2. What should I know before I use Anterone 50?

Warnings

Do not use Anterone 50 if:

• you are allergic to cyproterone acetate, or any of the ingredients listed at the end of this leaflet.

Some of the symptoms of an allergic reaction may include:
– shortness of breath
– wheezing or difficulty breathing
– swelling of the face, lips, tongue or other parts of the body
– rash, itching or hives on the skin

• Always check the ingredients to make sure you can use this medicine.
• you are a children and adolescents below 18 years of age or girls who have not completed puberty.
• you are pregnant or suspect you may be pregnant. It may affect your developing baby if you take it during pregnancy.
• you are breast‐feeding. The active ingredient in Anterone 50 tablets passes into breast milk and there is a possibility that your baby may be affected.
• you have liver disease, previous or existing liver tumours unless they are caused by metastases from prostate cancer (your doctor would have told you if you have this)
• you have Dubin‐Johnson or Rotor syndrome (your doctor would have told you if you have either of these conditions)
• you have history of jaundice (yellow skin or eyes), herpes or persistent itching during a previous pregnancy
• you have previous or existing benign brain tumour (meningioma)
• you have wasting disease (a disease causing muscle loss or loss of strength, with the exception of prostate cancer)
• you have severe and persistent depression
• you have previous or existing conditions relating to formation of blood clots
• you have severe diabetes with blood vessel changes (your doctor would have told you if you have this)
• you have sickle‐cell anaemia (your doctor would have told you if you have this).

Check with your doctor if you:

• have diabetes
• have history of blood clotting or sickle cell anaemia
• have osteoporosis, a family history of osteoporosis or risk factors for developing osteoporosis (such as smoking, a diet low in calcium, poor mobility, a slight build or treatment with steroid medicines)

Anterone 50 tablets tablets contain lactose monohydrate. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking Anterone 50 tablets.

During treatment, you may be at risk of developing certain side effects. It is important you understand these risks and how to monitor for them. See additional information under Section 6. Are there any side effects?

Pregnancy and breastfeeding

Check with your doctor if you are pregnant or intend to become pregnant.

If taken during pregnancy, Anterone 50 tablets may lead to signs of feminisation in the male foetus. Therefore, your doctor will check that you are not pregnant before you start taking Anterone 50 tablets. Women should use a reliable form of contraception while taking Anterone 50 tablets.

Talk to your doctor if you are breastfeeding or intend to breastfeed.

Tell your doctor if fertility after treatment is important.

For men it is recommended that a sperm count is taken to establish fertility before commencing Anterone 50 tablets. It can take 3‐20 months for fertile sperm production to be re‐established after stopping this medicine.

The long‐term effects of Anterone 50 tablets on female fertility are not known.

3. What if I am taking other medicines?

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

Your doctor and pharmacist may have more information on medicines to be careful with or avoid while taking this medicine.

Check with your doctor or pharmacist if you are not sure about what medicines, vitamins or supplements you are taking and if these affect Anterone 50.

4. How do I use Anterone 50?

How much to take

• Your doctor will advise of the most suitable dose for you to take.
• Follow the instructions provided and use Anterone 50 until your doctor tells you to stop.
• Do not alter the dose yourself.
• Your doctor will advise you if changing the dose is necessary.

MEN:

• Prostate cancer
  The usual daily dose is 50‐300 mg of Anterone 50 tablets. Your doctor may request you take Anterone 50 tablets with other medicines and/or change your dose during treatment.
• Reduction of abnormal sex drive
  Generally treatment is started with 50 mg of Anterone 50 tablets twice daily and may be increased to 100 mg twice daily or three times daily before reducing gradually to the lowest effective dose. Your doctor may change your dose during treatment.

WOMEN:

• If you are of childbearing age, you should commence your tablet taking on the 5^th day of your cycle (= 1st day of bleeding). If you have no menstrual periods (amenorrhoea) your treatment can start immediately. In this case, the first day of treatment is to be regarded as the 5th day of the cycle.
• Starting from day 1 take 50‐100 mg (as advised by your doctor) of Anterone 50 tablets daily from the 5th to the 14th day of the cycle (= for 10 days). Additionally, your doctor will advise the most appropriate contraceptive for you to take to provide the necessary contraceptive protection and to stabilise your cycle.
• If you are postmenopausal or have had a hysterectomy, Anterone 50 tablets may be administered alone. The usual dose is 25‐50 mg of Anterone 50 tablets once daily for 21 days, followed by a 7‐day tablet‐free interval.
• Shortness of breath may occur at high doses.

When to take Anterone 50

• Take your medicine after meals at about the same time each day.
• Taking it at the same time each day will have the best effect. It will also help you remember when to take it.
• Missed Anterone 50 tablets tablets may diminish the effectiveness of treatment and may lead to breakthrough bleeding in women.

How to take it

• Swallow the tablets whole with some liquid after meals.
• Continue taking your medicine for as long as your doctor tells you.
• This medicine helps to control your condition, but does not cure it. It is important to keep taking your medicine even if you feel well

If you forget to use Anterone 50

Anterone 50 should be used regularly as prescribed. If you miss your dose at the usual time, then take it as soon as you remember, and then go back to taking your medicine as you would normally.

If it is almost time for your next dose, skip the dose you missed and take your next dose when you are meant to.

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

If you are also taking an oral contraceptive and more than 12 hours has elapsed from the time Anterone 50 tablets was due to be taken, note that contraceptive protection in this cycle may be reduced and thus there is an increased risk of becoming pregnant.

If you are not sure what to do, ask your doctor or pharmacist.

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

If you use too much Anterone 50

If you think that you have used too much Anterone 50, you may need urgent medical attention.

You should immediately:

• phone the Poisons Information Centre
  (by calling 13 11 26), or
• contact your doctor, or
• go to the Emergency Department at your nearest hospital.

You should do this even if there are no signs of discomfort or poisoning.

5. What should I know while using Anterone 50?

Things you should do

If you are about to be started on any new medicine, remind your doctor and pharmacist that you are taking Anterone 50 tablets.

Tell any other doctors, dentists, and pharmacists who treat you that you are taking this medicine.

Keep all of your doctor’s appointments so that your progress can be checked.

Your doctor may do some tests from time to time to make sure the medicine is working and to prevent unwanted side effects.

Your doctor will check your liver function during treatment with Anterone 50 tablets and whenever any symptoms or signs suggesting liver problems are observed.

If you have diabetes, your doctor will monitor you to ensure that you receive the appropriate dose of oral antidiabetic or insulin whilst taking Anterone 50 tablets.

Your doctor will also check your red‐blood cell count to ensure you do not become anaemic during treatment with Anterone 50 tablets.

If you are a female taking an oral contraceptive during treatment, tell your doctor if your period does not occur during the tablet‐free / placebo interval.

Your doctor may need to check whether you are pregnant before you can continue treatment.

If you are a male taking Anterone 50 tablets to reduce abnormal sex drive, you should consider undertaking additional measures such as therapy or counselling in order to take advantage of the period of reduced drive.

These measures may assist in achieving personal and social re‐orientation.

Things you should not do

• Do not take Anterone 50 tablets to treat any other complaints unless your doctor tells you to.
• Do not give your medicine to anyone else, even if they have the same condition as you.
• Do not stop taking your medicine or lower the dosage without checking with your doctor.
• If you stop taking it suddenly, your condition may worsen or you may have unwanted side effects.

Driving or using machines

Be careful before you drive or use any machines or tools until you know how Anterone 50 affects you.

Be careful driving or operating machinery until you know how Anterone 50 tablets affects you.

This medicine may cause tiredness and can impair the ability to concentrate. If you have any of these symptoms, do not drive, operate machinery or do anything else that could be dangerous.

Drinking alcohol

Tell your doctor if you drink alcohol.

Be careful when drinking alcohol while you are taking this medicine.

If you drink alcohol, tiredness and the ability to concentrate may be worse. Alcohol may prevent Anterone 50 tablets from working as well as it should in reducing abnormal sex drive.

Looking after your medicine

• Keep your tablets in the blister in the tablet pack carton until it is time to take them.
• If you take the tablets out of the blister they may not keep as well.
• Keep Anterone 50 tablets in a cool dry place where the temperature stays below 25°C.
• Heat and damp can destroy some medicines.
• A locked cupboard at least one‐and‐a‐half metres above the ground is a good place to store medicines.

Follow the instructions in the carton on how to take care of your medicine properly.

Store it in a cool dry place away from moisture, heat or sunlight; for example, do not store it:

• in the bathroom or near a sink, or
• in the car or on window sills.

Keep it where young children cannot reach it.

When to discard your medicine

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

Return any unused medicine to your pharmacist.

Getting rid of any unwanted medicine

If you no longer need to use this medicine or it is out of date, take it to any pharmacy for safe disposal.

Do not use this medicine after the expiry date.

6. Are there any side effects?

All medicines can have side effects. If you do experience any side effects, most of them are minor and temporary. However, some side effects may need medical attention.

See the information below and, if you need to, ask your doctor or pharmacist if you have any further questions about side effects.

If you were fertile before treatment, Anterone 50 tablets will normally prevent sperm production in men and ovulation in women. In men, fertility is usually regained within a few months of discontinuing therapy. The long term effects on female fertility are not known.

In men Anterone 50 tablets will also normally result in the inability to get or maintain an erection (impotence). This ability is usually also regained within a few months of discontinuing therapy.

Less serious side effects

Less serious side effects	What to do
More broad or affecting different parts of the body tiredness, fatigue weight change headache depressive mood nausea and other gastrointestinal complaints decreased sexual drive breast pain, change in breast size, breast swelling and/or tenderness breast enlargement in men menstrual cycle irregularity, spotting hot flushes, sweating shortness of breath osteoporosis	Speak to your doctor if you have any of these less serious side effects and they worry you.

Serious side effects

Serious side effects

What to do

More broad or affecting different parts of the body yellowing of the skin and/or eyes, light coloured bowel motions, dark coloured urine severe upper abdominal pain vomiting blood or material that looks like coffee grounds, bleeding from the back passage, black sticky bowel motions (stools) or bloody diarrhoea sudden severe headache, loss of vision, loss of coordination, slurred speech, shortness of breath, chest pain, numbness, heat or swelling in the arms and legs changes in vision (e.g. seeing double or blurriness), hearing loss or ringing in the ears, loss of smell, headaches that worsen with time, memory loss, seizures, weakness in your arms or legs

Call your doctor straight away, or go straight to the Emergency Department at your nearest hospital if you notice any of these serious side effects.

Tell your doctor or pharmacist if you notice anything else that may be making you feel unwell.

Other side effects not listed here may occur in some people.

Reporting side effects

After you have received medical advice for any side effects you experience, you can report side effects to the Therapeutic Goods Administration online at www.tga.gov.au/reporting-problems. By reporting side effects, you can help provide more information on the safety of this medicine.

Always make sure you speak to your doctor or pharmacist before you decide to stop taking any of your medicines.

7. Product details

This medicine is only available with a doctor’s prescription.

What Anterone 50 contains

Active ingredient (main ingredient)	cyproterone acetate
Other ingredients (inactive ingredients)	lactose monohydrate, starch‐maize, povidone, magnesium stearate, silica‐colloidal anhydrous, starch‐pregelatinised maize.

Do not take this medicine if you are allergic to any of these ingredients.

What Anterone 50 looks like

Anterone 50 tablets are white tablets containing 50 milligrams of the antiandrogenic substance, cyproterone acetate and presented in blister packs containing 20 and 50 tablets (AUST R 278777).

Who distributes Anterone 50

Cipla Australia Pty Ltd
Level 1, 132 – 136 Albert Road
South Melbourne VIC 3205
Phone no: 1 800 569 074
Email id: drugsafety@cipla.com

This leaflet was prepared in December 2020.