Tamoxifen Citrate 20 mg tablets
Consumer Medicine Information
What is in this leaflet
This leaflet answers some of the common questions people ask about TAMOXEN 20. It does not contain all the information that is known about TAMOXEN 20.
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 TAMOXEN 20 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 TAMOXEN 20 is used for
TAMOXEN 20 is used to treat breast cancer.
TAMOXEN 20 blocks the actions of oestrogen. Oestrogen is a natural female sex hormone. In some types of breast cancer, oestrogen can help cancer cells to grow.
Your doctor will have explained why you are being treated with TAMOXEN 20 and told you what dose to take.
Follow all directions given to you by your doctor. They may differ from the information contained in this leaflet.
Your doctor may prescribe this medicine for another use. Ask your doctor if you want more information.
TAMOXEN 20 is not addictive.
Before you take TAMOXEN 20
When you must not use it
Do not use TAMOXEN 20 if you are pregnant, trying to become pregnant or are breastfeeding. We do not know if it is safe for you to take it while you are pregnant. It may affect your baby if you take it at any time during pregnancy.
Your baby may take in TAMOXEN 20 from breast milk if you are breastfeeding.
Do not use TAMOXEN 20 if you are allergic to tamoxifen or any of the other ingredients in TAMOXEN 20.
Do not give TAMOXEN 20 to children. There is no experience of its use in children.
Do not take 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 TAMOXEN 20 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, even if they have the same condition as you.
Before you take it
You must tell your doctor if:
- you have any allergies to:
- tamoxifen, the active ingredient in TAMOXEN 20
- any of the other ingredients in TAMOXEN 20 listed at the end of this leaflet
- other anti-oestrogen medicines
- any other medicines
- any other substances, such as foods, preservatives or dyes.
If you have an allergic reaction, you may experience a skin rash, hayfever, difficulty breathing or feel faint.
- you have or have ever had any of these medical conditions:
- any unexplained vaginal bleeding
- problems with your blood
- liver problems.
It may not be safe for you to take TAMOXEN 20 if you have any of these conditions.
Taking Other Medicines
Tell your doctor if you are taking any other medicines, including:
- medicines used to thin your blood eg. warfarin
- rifampicin
- Paroxetine, an SSRI antidepressant used to treat depression.
- chemotherapy
- any medicines that you buy at the chemist, supermarket or health food shop.
- TAMOXEN 20 should not be taken with aromatase inhibitors such as anastrozole, letrozole or exemestane.
These medicines may affect the way TAMOXEN 20 works.
Your doctor or pharmacist can tell you what to do if you are taking any of these medicines.
If you have not told your doctor about any of these things, tell them before you take any TAMOXEN 20.
Taking TAMOXEN 20
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.
If you do not understand the instructions on the box, ask your doctor or pharmacist for help.
How much to take
Your doctor will decide how much TAMOXEN 20 you need to take.
The usual dose is 20 mg of TAMOXEN 20 each day.
Some people need to take 40 mg once a day. Your doctor will tell you if this is necessary.
Swallow your TAMOXEN 20 whole, with a full glass of water. Do not chew or crush the tablets.
When to take it
Take TAMOXEN 20 at about the same time each day. It does not matter if you take TAMOXEN 20 before, with or after food.
How long to take it
Continue taking TAMOXEN 20 for as long as your doctor or pharmacist tells you to.
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 to take your medicine, ask your pharmacist for some hints.
Overdose
Immediately telephone your doctor or pharmacist or the Poisons Information Centre (telephone 13 11 26), or go to Accident and Emergency at your nearest hospital immediately if you think that you or anyone else may have taken too much TAMOXEN 20. Do this even if there are no signs of discomfort or poisoning.
If you take too much TAMOXEN 20 you may experience problems with the rhythm of your heart.
While you are using it
Things you must do
Be sure to keep all your appointments with your doctor so your progress can be checked.
Tell any other doctors, dentists and pharmacists who are treating you that you are taking TAMOXEN 20.
If you are about to be started on any new medicine, tell your doctor, dentist or pharmacist that you are taking TAMOXEN 20.
If you go into hospital, please let the medical staff know that you are taking TAMOXEN 20.
Things you must not do
Do not get pregnant while you are taking TAMOXEN 20. Ask your doctor about reliable methods of contraception while you are taking TAMOXEN 20.
Do not take TAMOXEN 20 to treat any other complaints unless your doctor tells you to.
Do not stop taking TAMOXEN 20, or lower the dosage, unless you have discussed this with your doctor.
Things to be careful of
Be careful driving or operating machinery until you know how TAMOXEN 20 affects you. Some patients may experience dizziness or light headedness.
Side effects
Tell your doctor or pharmacist as soon as possible if you do not feel well while you are taking TAMOXEN 20. TAMOXEN 20 helps most people 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. 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 immediately if you notice any of the following:
- unusual pain or pressure around your pelvis, in your bones or anywhere in your body
- excessive thirst
- swelling of the hands, ankles and feet
- any changes in your vision
- pain and reddening around the tumour
- lumps anywhere in the body
- unusual tiredness, shortness of breath and dizziness when exercising, and looking pale
- frequent infection, fever, severe chills, sore throat or mouth ulcers
- unexplained bruising
- yellowing of the skin or eyes, dark coloured urine.
- 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 TAMOXEN 20 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.
Tell your doctor immediately or go to Accident and Emergency at your nearest hospital if any of the following happen.
- rash, itching or hives
- swelling of the face, lips, tongue and/or throat
- wheezing with difficulty breathing.
- Increased risk of blood clots and ovarian cysts (in premenopausal women) have been seen with TAMOXEN 20.
These are serious side effects. You may need urgent medical treatment. Serious side effects are rare.
Tell your doctor if you notice any of the following and they worry you:
- hot flushes
- nausea and vomiting
- unusual vaginal discharge
- any change in your periods
- itching around the vagina
- diarrhoea or constipation
- headache, dizziness or light headedness
- hair thinning or hair loss.
- leg cramps
- sudden onset of weakness or paralysis of the arms or legs, sudden difficulty with speaking, walking, difficulty in holding things or difficulty in thinking, any of which may occur because the blood supply in the blood vessels of the brain is reduced.
These symptoms could be signs of a stroke.
These are all mild side effects of TAMOXEN 20.
Rarely an increased level of triglycerides (increased levels of fats in the blood) sometimes with pancreatitis (pain or tenderness in the upper abdomen) has been seen with TAMOXEN 20.
Tell your doctor or pharmacist if you notice anything that is making you feel unwell. Some people may get other effects while taking TAMOXEN 20.
After using it
Storage
Keep your TAMOXEN 20 tablets in the blister pack until it is time to take them. If you take TAMOXEN 20 out of the blister pack it will not keep well.
Keep it in a cool dry place where the temperature stays below 30 degrees C. Protect from the light and moisture.
Do not store it or any other medicine in the bathroom or near a sink.
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.
Do not leave it on a window sill or in the car on hot days. Heat and dampness can destroy some 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 it looks like
TAMOXEN 20 20 mg tablets are an off-white, flat, bevel-edged tablet, with a breakline on one face and engraved “T UP>20” on the other.
Ingredients
Active ingredient
Tamoxifen Citrate.
Other ingredients (excipients)
lactose, maize starch, povidone, colloidal anhydrous silica, purified water, magnesium stearate.
TAMOXEN 20 does not contain sucrose, gluten, tartrazine or any other azo dyes.
Supplier
www.ascentpharma.com.au
Ascent Pharma Pty Ltd
151-153 Clarendon St
South Melbourne Vic. 3205
For further information call 1800 554 414
TAMOXEN 20 20 mg tablets AUST R 195636.
This leaflet was prepared in July 2012.
Published by MIMS September 2012