Consumer Medicines Information
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TAMOXIFEN SANDOZ®
tamoxifen citrate tablets
Consumer Medicine Information
WHAT IS IN THIS LEAFLET
This leaflet answers some common questions about Tamoxifen Sandoz.
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 this medicine 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 TAMOXIFEN SANDOZ IS USED FOR
This medicine is used to treat breast cancer.
It contains the active ingredient tamoxifen citrate.
Tamoxifen citrate belongs to a group of medicines called anti-oestrogens.
It works by blocking the actions of oestrogen. In some types of breast cancer, oestrogen can help cancer cells grow. By blocking the effect of oestrogen, Tamoxifen Sandoz stops or slows the growth of cancer cells.
Ask your doctor if you have any questions about why this medicine has been prescribed for you. Your doctor may have prescribed it for another reason.
This medicine is not addictive.
This medicine is available only with a doctor’s prescription.
BEFORE YOU TAKE TAMOXIFEN SANDOZ
When you must not take it
Do not take this medicine if you have an allergy to:
- tamoxifen citrate, the active ingredient, or to any of the other ingredients listed at the end of this leaflet under Product Description.
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.
Do not take this medicine if you are pregnant or trying to become pregnant. It may affect your developing baby if you take it during pregnancy.
Do not breastfeed if you are taking this medicine. It is unknown if the active ingredient in Tamoxifen Sandoz passes into breast milk, but there is a possibility that your baby may be affected.
Do not give this medicine to children. Safety and effectiveness in children have not been established.
Do not take this medicine after the expiry date printed on the pack or if the packaging is torn or shows signs of tampering. If it has expired or is damaged, return it to your pharmacist for disposal.
If you are not sure whether you should start taking this medicine, talk to your doctor.
Before you start to take it
Tell your doctor if you have allergies to any other medicines, foods, preservatives or dyes.
Tell your doctor if you have or have had any of the following medical conditions:
- any blood problems, such as low white blood cell counts (leucopenia) or low platelet counts (thrombocytopenia)
- unusual vaginal bleeding or discharge
- any liver problems.
Tell your doctor if you have not been through menopause.
If you have not told your doctor about any of the above, tell him/her before you start taking Tamoxifen Sandoz.
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 and Tamoxifen Sandoz may interfere with each other. These include:
- rifampicin, an antibiotic used to treat tuberculosis
- chemotherapy
- anticoagulants, such as warfarin, medicines used to prevent blood clots.
These medicines may be affected by Tamoxifen Sandoz or may affect how well it works. You may need different amounts of your medicines, or you may need to take different medicines.
Your doctor and pharmacist have more information on medicines to be careful with or avoid while taking this medicine.
HOW TO TAKE TAMOXIFEN SANDOZ
Follow all directions given to you by your doctor or pharmacist carefully. They may differ from the information contained in this leaflet.
If you do not understand the instructions, ask your doctor or pharmacist for help.
How much to take
Ask your doctor or pharmacist if you are unsure of the correct dose for you. They will tell you exactly how much to take.
Follow the instructions they give you. If you take the wrong dose, Tamoxifen Sandoz may not work as well and your problem may not improve.
The usual dose is one tablet (20mg) each day.
For some people, your doctor may recommend that you take two tablets (40mg) each day.
How to take it
Swallow the tablets whole with a full glass of water.
When to take Tamoxifen Sandoz
Take your medicine at about the same time each day. Taking it at the same time each day will help you remember when to take it. It does not matter if you take it before, with or after food.
How long to take Tamoxifen Sandoz
Continue taking your medicine for as long as your doctor tells you. It is important to keep taking your medicine even if you feel well.
If you forget to take it
Take your dose as soon as you remember, and continue to take it 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 that you missed. This may increase the chance of you getting an unwanted side effect.
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 take too much (overdose)
Immediately telephone your doctor or the Poisons Information Centre (telephone 13 11 26 or New Zealand 0800 POISON or 0800 764766) 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 Tamoxifen Sandoz. Do this even if there are no signs of discomfort or poisoning. You may need urgent medical attention.
Symptoms of an overdose may include problems with the rhythm of your heart.
WHILE YOU ARE TAKING TAMOXIFEN SANDOZ
Things you must do
If you are about to be started on any new medicine, remind your doctor and pharmacist that you are taking Tamoxifen Sandoz.
Tell any other doctors, dentists, and pharmacists who treat you that you are taking this medicine.
If you become pregnant while taking this medicine or within two months of stopping therapy with Tamoxifen Sandoz, tell your doctor immediately. Talk to your doctor about the risks to your developing baby if you become pregnant while taking this medicine or within two months after stopping Tamoxifen Sandoz.
Keep all of your doctor’s appointments so that your progress can be checked. Your doctor may do some tests (gynaecological checks, blood tests) from time to time to make sure the medicine is working and to prevent unwanted side effects.
Things you must not do
Do not take Tamoxifen Sandoz 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.
Do not fall pregnant while you are taking Tamoxifen Sandoz. Talk to your doctor about reliable methods of contraception while you are taking Tamoxifen Sandoz.
Things to be careful of
Be careful driving or operating machinery until you know how Tamoxifen Sandoz affects you. This medicine may cause dizziness and light-headedness in some people. If you have any of these symptoms, do not drive, operate machinery or do anything else that could be dangerous.
SIDE EFFECTS
Tell your doctor or pharmacist as soon as possible if you do not feel well while you are taking Tamoxifen Sandoz. All medicines can have side effects. Sometimes they are serious, most of the time they are not. You may need medical attention if you get some of the side effects.
Do not be alarmed by the following lists of side effects. You may not experience any of them.
Ask your doctor or pharmacist to answer any questions you may have.
Tell your doctor or pharmacist if you notice any of the following and they worry you:
- nausea and vomiting
- hot flushes
- any change in your periods
- itching around the vagina
- unusual vaginal discharge
- diarrhoea or constipation
- headaches, dizziness or light-headedness
- hair thinning or hair loss
- leg cramps.
These are mild side effects of the medicine.
Tell your doctor immediately if you notice any of the following:
- unusual pain or pressure in your bones or anywhere in your body
- excessive thirst
- swelling of the hands, ankles and feet
- changes or disturbance of vision
- pain and reddening around the tumour
- unusual tiredness, shortness of breath and dizziness when exercising, looking pale
- frequent infections, fever, severe chills, sore throat or mouth ulcers
- unexplained bruising
- yellowing of the skin or eyes, dark coloured urine
- unusual vaginal bleeding or other gynaecological symptoms (such as pelvic pain or pressure).
The above list includes serious side effects that may require medical attention.
If any of the following happen, tell your doctor immediately or go to Accident and Emergency at your nearest hospital:
- sharp, stabbing pain the leg, groin or chest
- signs of a stroke, such as sudden onset of weakness or paralysis of the arms or legs, sudden difficulty with speaking, walking or difficulty thinking
- 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.
The above list includes very serious side effects. You may need urgent medical attention or hospitalisation. These side effects are rare.
Tell your doctor or pharmacist if you notice anything else that is making you feel unwell. Other side effects not listed above may also occur in some people.
Some side effects (for example, changes in liver function, triglyceride levels or blood cells counts) can only be found when your doctor does tests from time to time to check your progress.
AFTER TAKING TAMOXIFEN SANDOZ
Storage
Keep your medicine in the original container.
If you take it out of its original container it may not keep well.
Keep your medicine in a cool dry place where the temperature stays below 25°C.
Do not store Tamoxifen Sandoz or any other medicine in the bathroom or near a sink. Do not leave it on a window sill or in the car.
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 this medicine or the expiry date has passed, ask your pharmacist what to do with any medicine that is left over.
PRODUCT DESCRIPTION
What it looks like
Tamoxifen Sandoz 20mg – white, round tablets with a notch on one side.
Available in blisters of 60 tablets.
Ingredients
Active ingredient:
- Tamoxifen Sandoz 20mg – 20mg tamoxifen (as citrate)
Inactive ingredients:
- lactose
- sodium starch glycollate
- povidone
- microcrystalline cellulose
- magnesium stearate
- titanium dioxide
- hypromellose
- macrogol 4000.
Supplier
Sandoz Pty Ltd
ABN 60 075 449 553
Level 4, 100 Harris St
Pyrmont NSW 2009
Tel: 1800 634 500
Novartis New Zealand Ltd
Private Bag 65904 Mairangi Bag
Auckland 0754
New Zealand
Tel: 0800 354 335
This leaflet was revised in February 2010.
Australian Register Number
20mg tablets: AUST R 80076
Published by MIMS/myDr November 2010
