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Tamoxifen Sandoz

tamoxifen citrate tablets
Consumer Medicine Information
 

NOTICE: This Consumer Medicine Information (CMI) is intended for persons living in Australia. This page contains answers to some common questions about Tamoxifen Sandoz. It does not contain all the information that is known about Tamoxifen Sandoz. It does not take the place of talking to your doctor or pharmacist. All medicines have risks and benefits. Your doctor has weighed the risk of you using this medicine against the benefits he/she expects it will have for you. If you have any concerns about using this medicine, ask your doctor or pharmacist. Bookmark or print this page, 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, other anti-oestrogen medicines 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
aromatase inhibitors, such as anastrozole, letrozole or exemestane.
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 or joint pain
aching, tender or weak muscles not caused by exercise.
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
pain and reddening around the tumour
lumps anywhere in the body
unusual tiredness, shortness of breath and dizziness when exercising, looking pale
frequent infections, fever, severe chills, sore throat, mouth or nose 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)
changes or disturbances of vision
Cases of optic nerve diseases have been reported in patients receiving tamoxifen and, in a small number of cases, blindness has occurred.
If you have any unusual vaginal bleeding or other gynaecological symptoms (such as pelvic pain or pressure) when you are taking Tamoxifen Sandoz or anytime afterwards, tell your doctor. This is because a number of changes to the lining of the womb (endometrium) may occur, some of which may be serious and could include cancer.
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, hives or blistering on the skin.
Increased risk of blood clots and ovarian cysts (in premenopausal women) have been seen with Tamoxifen Sandoz.
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
54 Waterloo Road
Macquarie Park, NSW 2113
Australia
Tel: 1800 634 500
Novartis New Zealand Ltd
PO Box 99102
Newmarket
Auckland 1149
New Zealand
Tel: 0800 354 335
This leaflet was revised in January 2016.
Australian Register Number
20mg tablets: AUST R 80076