Consumer medicine information

ANASTROZOLE-SYNTHON

Anastrozole


Consumer Medicine Information

What is in this leaflet

This leaflet answers some of the common questions people ask about ANASTROZOLE-SYNTHON. 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 will have weighed the risks of you taking it 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 ANASTROZOLE-SYNTHON is used for

ANASTROZOLE-SYNTHON is used to treat breast cancer in women who no longer have their menstrual periods either naturally, due to their age or after surgery, radiotherapy or chemotherapy.

Itis a non-steroidal aromatase inhibitor, which reduces the amount of oestrogen (female sex hormone) made by the body. In some types of breast cancer, oestrogen can help the cancer cells grow. By blocking oestrogen, ANASTROZOLE-SYNTHON may slow or stop the growth of cancer.

Follow all directions given to you by your doctor. They may differ from the information contained in this leaflet.

Ask your doctor if you have any questions about why this medicine has been prescribed for you. Your doctor may have prescribed ANASTROZOLE-SYNTHON for another reason.

ANASTROZOLE-SYNTHON is only available with a doctor’s prescription.

It is not addictive.

Before you take it

When you must not take it

Do not take ANASTROZOLE-SYNTHON if you are pregnant or intend to become pregnant. It may affect your developing baby if you take it during pregnancy.

Do not breastfeed while taking ANASTROZOLE-SYNTHON. Your baby can take in ANASTROZOLE-SYNTHON from breast milk if you are breastfeeding.

Do not take ANASTROZOLE-SYNTHON if you have an allergy to:

  • Anastrozole, the active ingredient of ANASTROZOLE-SYNTHON.
  • Any of the other ingredients of ANASTROZOLE-SYNTHON listed at the end of this leaflet.
  • Other anti-oestrogen medicines.

Symptoms of an allergic reaction may include shortness of breath, wheezing or difficulty in breathing; swelling of the face, lips, tongue or any other parts of the body; rash, itching or hives on the skin.

Do not take ANASTROZOLE-SYNTHON if you are still having menstrual periods. ANASTROZOLE-SYNTHON should only be taken by women who are no longer having menstrual periods.

Do not take ANASTROZOLE-SYNTHON if you are a man. Men are not normally treated with ANASTROZOLE-SYNTHON.

Do not give this medicine to a child. ANASTROZOLE-SYNTHON is not recommended for use in children

Do not take ANASTROZOLE-SYNTHON after the use by (expiry) date printed on the pack. It may have no effect at all, or worse, an entirely unexpected effect if you take it after the expiry date.

Do not take ANASTROZOLE-SYNTHON if the packaging is torn or shows signs of tampering.

Do not use it to treat any other complaints unless your doctor tells you to.

Do not give this medicine to anyone else.

Before you start to take it

Tell your doctor if you have any allergies to the following:

  • Any medicines
  • Any other substances, such as foods, preservatives or dyes

Tell your doctor if you have or have had any of the following medical conditions:

  • liver problems
  • kidney problems
  • 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)

Aromatase inhibitors may decrease bone mineral density (BMD) in women who have been through menopause, with a possible increased risk of fractures.

If you have not told your doctor about any of the above, tell him/her before you start takingANASTROZOLE-SYNTHON.

Taking other medicines

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

Some medicines should not be taken with ANASTROZOLE-SYNTHON. These include:

  • Tamoxifen, a medicine used to treat breast cancer
  • Any medicine that contains oestrogen such as medicines used in Hormone Replacement Therapy (HRT) or oral contraceptives
  • Any health food products that contain natural oestrogens used for post-menopausal symptoms.
  • Medicines from a class called “Luteinising Hormone Releasing Hormone (LHRH) agonists”, such as goserelin or leuprorelin.

Talk to your doctor or pharmacist if you have any concerns or questions about taking. ANASTROZOLE-SYNTHON

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

How to take it

Follow all directions given to you by your doctor or pharmacist carefully. They may differ from the information contained in this leaflet.

Your doctor or pharmacist will tell you how many tablets you will need to take each day. This depends on your condition and whether or not you are taking any other medicines.

If you do not understand the instructions on the box, ask your doctor or pharmacist for help.

How much to take

The usual dose is one tablet every day.

When to take it

Take ANASTROZOLE-SYNTHON at about the same time each day. aking it at the same time each day will have the best effect. It will also help you remember when to take it.

Swallow ANASTROZOLE-SYNTHON tablets whole, with a glass of water.

It does not matter if you take it before, with or after food.

How long to take it

Continue taking ANASTROZOLE-SYNTHON for as long as your doctor or pharmacist tells you. ANASTROZOLE-SYNTHON helps to control your condition, but does not cure it. Therefore you must take it every day. Do not stop taking it unless your doctor tells you to – even if you feel better.

If you forget to take it

If you miss a dose, take it as soon as you remember, as long as it is 12 hours before the next dose is due. If it is less than 12 hours to the next dose, do not take the dose you have missed.

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

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

If you have trouble remembering when to take your medicine, 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 that you or anyone else may have taken too much anastrozole. Do this even if there are no signs of discomfort or poisoning.

You may need urgent medical attention.

While you are taking it

Things you must do

Tell any other doctors, dentists and pharmacists who are treating you that you are taking ANASTROZOLE-SYNTHON.

If you are about to be started on any new medicine, tell your doctor, dentist or pharmacist that you are taking ANASTROZOLE-SYNTHON.

Be sure to keep all your appointments with your doctor so your progress can be checked.

If you go into hospital, please let the medical staff know that you are taking ANASTROZOLE-SYNTHON.

Things you must not do

Do not give ANASTROZOLE-SYNTHON to anyone else, even if they have the same condition as you.

Do not take ANASTROZOLE-SYNTHON to treat any other complaints unless your doctor tells you to.

Do not stop taking ANASTROZOLE-SYNTHON unless you have discussed it with your doctor.

Things to be careful of

Be careful driving or operating machinery until you know how ANASTROZOLE-SYNTHON affects you. Some patients may occasionally feel weak or sleepy.

Side effects

Tell your doctor or pharmacist as soon as possible if you do not feel well while you are taking ANASTROZOLE-SYNTHON ANASTROZOLE-SYNTHON helps most postmenopausal women with breast cancer, 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. Side effects may happen at the start of treatment or they may happen after you have been taking your medicine for some time. You may need medical treatment if you get some of the side effects.

If you get any side effects do not stop taking ANASTROZOLE-SYNTHON without first talking to your doctor or pharmacist.

Ask your doctor or pharmacist to answer any questions you may have.

If any of the following happen tell your doctor immediately or go to Accident and Emergency at your nearest hospital:

  • Sudden signs of allergy such as shortness of breath, wheezing or difficulty in breathing; swelling of the face, lips, tongue or any other parts of the body; rash, itching or hives on the skin.
  • Extremely severe skin reactions (Stevens-Johnson syndrome) with lesions, ulcers or blisters.
  • Liver pain or swelling and/or a general feeling of unwell with or without jaundice (yellowing of the skin and eyes)

These are serious side effects. You may need urgent medical attention or hospitalisation.

Serious side effects are rare.

Tell your doctor if you notice any of the following and they worry you:

  • Hot flushes
  • Lack of energy
  • Joint pain or stiffness
  • Vaginal dryness
  • Thinning of hair
  • Mild skin rash
  • Feeling sick (nausea)
  • Diarrhoea
  • Headache

These are the more common side effects of ANASTROZOLE-SYNTHON. Mostly these are mild to moderate in nature.

Uncommon side effects can include vaginal bleeding, loss of appetite, vomiting, feeling sleepy and an increase in cholesterol levels or changes in blood test of liver function. These side effects are generally mild to moderate and often resolve themselves over time.

Tell your doctor if you notice anything else that is making you feel unwell. Other side effects not listed may occur in some people.

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 will not keep well.

Keep it in a cool dry place where the temperature stays below 30°C. Do not store it or any other medicine in the bathroom or near a sink. Do not leave it on a window-sill or in the car on hot days. Heat and dampness can destroy some medicines.

Keep it where young 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

Ask your pharmacist what to do with any tablets you have left over if your doctor tells you to stop taking them, or you find that the expiry date has passed.

Product description

What ANASTROZOLE-SYNTHON looks like

ANASTROZOLE-SYNTHON 1 mg is a round, biconvex, white, film-coated tablet with the following markings: “ANA” and “1” on one side.

ANASTROZOLE-SYNTHON comes in blister packs containing 10, 14, 20, 28, 30, 50, 56, 60, 84, 90, 98, 100 or 300 tablets and in hospital blisters of 28, 50, 84, 98, 300 or 500 tablets.

Not all pack sizes may be marketed.

Ingredients

Each tablet contains 1 mg of anastrozole as the active ingredient, and the following inactive ingredients:

  • Lactose
  • Povidone
  • Sodium starch glycollate
  • Magnesium stearate
  • Hypromellose
  • Macrogol (PEG 400)
  • Titanium dioxide CI 77891 (E171)

Supplier

Synthon AU Pty Ltd
Suite 201, 6-12 Atchison St
St Leonards NSW 2065
Australia

Australian Registration Number
ANASTROZOLE-SYNTHON 1mg film-coated tablet blister 155176

Date of most recent update 20 February 2011

Published by MIMS September 2012