2. What should I know before I take GENOX?
Do not take if you have ever had an allergic reaction to tamoxifen citrate or any
of the ingredients listed at the end of the CMI.
Talk to your doctor if you have any other medical conditions, take any other medicines,
or are pregnant or plan to become pregnant or are breastfeeding.
3. What if I am taking other medicines?
Some medicines may interfere with GENOX and affect how it works.
4. How do I take GENOX?
The usual dose is 20 mg of GENOX each day. Your doctor may increase your dose to 40
mg a day depending in your condition and how you respond to the medicine.
Swallow your GENOX whole, with a full glass of water. Do not chew or crush the tablets.
5. What should I know while taking GENOX?
|
Things you should do
|
Tell any other doctors, dentists and pharmacists who are treating you that you are
taking GENOX.
Tell your doctor immediately if you notice any unusual gynecological symptoms, especially
vaginal bleeding or discharge, even if it occurs after treatment with GENOX has stopped.
If you go into hospital, please let the medical staff know that you are taking GENOX.
|
|
Things you should not do
|
Do not stop taking GENOX, or lower the dosage, unless you have discussed this with
your doctor.
Do not take GENOX to treat any other complaints unless your doctor tells you to.
Do not get pregnant while you are taking GENOX and for nine months after you stop
taking GENOX.
Do not breastfeed while you are taking GENOX.
|
|
Driving or using machines
|
Be careful driving or operating machinery until you know how GENOX affects you.
|
|
Looking after your medicine
|
Keep your GENOX tablets in the blister pack until it is time to take them.
Keep it in a cool, dry place where the temperature stays below 25°C.
|
6. Are there any side effects?
All medicines can have side effects. If you do experience any side effects, some may
be minor and temporary. However, some side effects may be serious. Tell your doctor
immediately if you have a skin rash, itching, hives or peeling skin, swelling of the
face, lips, tongue and/or throat, difficulty in swallowing or breathing (angioedema),
wheezing with difficulty breathing, 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. For more information, including what to do if you
have any side effects, see Section
6. Are there any side effects? in the full CMI.
Active ingredient(s):
tamoxifen (as citrate)
Full Consumer Medicine Information (CMI)
This leaflet provides important information about taking GENOX. You should also speak to your doctor or pharmacist if you would like further information
or if you have any concerns or questions about taking GENOX.
Where to find information in this leaflet:
1. Why am I taking GENOX?
GENOX contains the active ingredient tamoxifen citrate. GENOX blocks the actions of estrogen. Estrogen is a natural female sex hormone. In
some types of breast cancer, estrogen can help cancer cells to grow.
GENOX is used to either treat breast cancer or reduce the risk of breast cancer occurring
if you are at increased risk of breast cancer.
If you and your healthcare professional are considering using GENOX for reducing the
risk of breast cancer occurring, your knowledge of treatment risks becomes more important
because you don't currently have breast cancer. GENOX therapy may be uncommonly associated
with serious side effects such as deep vein thrombosis (DVT - blood clots in veins
of your leg), pulmonary embolus (blood clots in your lungs) and uterine cancer. In
some women, these events were fatal. Less serious side effects such as hot flushes,
vaginal discharge, menstrual irregularities and gynecological conditions may also
occur. Whether the benefits of treatment outweigh the risks depends on your age, health
history, your level of breast cancer risk and on your personal judgement. GENOX therapy
to reduce the risk of breast cancer may not be appropriate for all women at increased
risk of breast cancer. An assessment with your healthcare professional of the potential
benefits and risks prior to starting therapy for reduction in breast cancer risk is
essential. You should understand that GENOX reduces, but does not eliminate, the risk
of breast cancer.
Ask your doctor if you have any questions about why GENOX has been prescribed for
you.
Your doctor may prescribe this medicine for another use.
GENOX is not addictive.
2. What should I know before I take GENOX?
Warnings
Do not take GENOX if:
you are allergic to any medicines containing tamoxifen, or any of the ingredients
listed at the end of this leaflet.
Some of the symptoms of an allergic reaction may include:
skin rash, itching or hives
swelling of the face, lips or tongue which may cause difficulty in swallowing or breathing
wheezing or shortness of breath.
Always check the ingredients to make sure you can use this medicine.
you are allergic to other anti-estrogen medicines
you are allergic to any other medicines, foods, dyes or preservatives. If you have
an allergic reaction, you may experience a skin rash, hay fever, difficulty breathing
or feel faint.
you are taking medicines used to prevent blood clots such as warfarin
you have had deep vein thrombosis (DVT - blood clots in veins of your leg) or pulmonary
embolus (blood clots in your lungs)
the expiry date printed on the pack has passed or the packaging is torn or shows signs
of tampering.
Tell your doctor if you:
have or have had any other medical conditions such as:
a history of hereditary angioedema (as GENOX may cause or worsen symptoms of hereditary
angioedema)
any unusual or unexplained vaginal bleeding or discharge
any blood disorder or problems such thrombocytopenia or leucopenia
liver problems
deep vein thrombosis (DVT - blood clots in veins of your leg) or pulmonary embolus
(blood clots in your lungs)
any heart conditions including heart rhythm problems (arrhythmia). The risk of heart
rhythm problems may be increased in such patients when using GENOX.
take any medicines for any other condition
are a premenopausal woman taking GENOX for reduction of breast cancer risk or for
breast cancer treatment, loss of the mineral content of bones may occur.
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
Do not take GENOX if you are pregnant or plan to become pregnant.
GENOX should not be used during pregnancy. A small number of unwanted complications,
such as birth defects, have been reported in the unborn baby of women who have taken
this medicine. However, it has not been shown whether these were due to GENOX. If
sexually active, your doctor may suggest you use a non-hormonal form of contraception
while you are taking GENOX and for nine months after you have stopped treatment with
it.
Men are recommended to use effective contraceptive measures and to not father a child
while receiving tamoxifen and for six months following completion of treatment.
Do not take GENOX if you are breastfeeding.
GENOX is not recommended during breastfeeding as your baby may take in GENOX from
breast milk.
Children
Do not give GENOX to children.
There is no experience of its use in children.
GENOX is not approved for use in children.
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.
Some medicines may be affected by GENOX, or may affect how well it works. These include:
oral contraceptives ('the pill')
hormone replacement therapy
other medicines used to treat cancer
medicines used to prevent blood clots e.g. warfarin
rifampicin, an antibiotic
chemotherapy
any medicines that you buy at the chemist supermarket or health food shop
GENOX should not be taken with aromatase inhibitors such as anastrozole, letrozole
or exemestane.
These medicines may affect the way GENOX works or may not work as well. They could
also cause side effects if you take them with GENOX.
Your doctor can tell you what to do if you are taking any of these medicines.
Your doctor and pharmacist have more information on medicines to be careful with or
avoid while taking GENOX.
Check with your doctor or pharmacist if you are not sure about what medicines, vitamins
or supplements you are taking and if these affect GENOX.
4. How do I take GENOX?
Follow all directions given to you by your doctor and pharmacist carefully.
They may differ from the information contained in this leaflet.
How much to take
The usual starting dose is 20 mg once a day. Your doctor may increase this dose to
40 mg a day, depending on your condition and how you respond to the medicine.
Patients with liver problems may need smaller doses.
How to take GENOX
Swallow the tablets with a glass of water at about the same time each day. Do not
chew or crush the tablets.
GENOX tablets can be taken with or without food.
How long to take GENOX
Keep taking GENOX for as long as your doctor recommends.
If you forget to take GENOX
If it is almost time for your next dose, skip the dose you missed and take your next
dose when you are meant to.
Otherwise, take the missed dose as soon as you remember, and then go back to taking
your tablets as you would normally.
Do not take a double dose to make up for the dose you missed.
If you are not sure what to do, ask your doctor of pharmacist.
If you use too much GENOX
If you think that you or anyone else has taken too much GENOX, urgent medical attention
maybe needed.
You should immediately:
phone the Poisons Information Centre
(by calling 13 11 26) for advice, 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.
There have been reports of heart rhythm problems associated with an overdose of this
medicine.
5. What should I know while taking GENOX?
Things you should do
Tell any other doctors, dentists and pharmacists who are treating you that you are
taking GENOX
If you are about to be started on any new medicine, tell your doctor, dentist or pharmacist
that you are taking GENOX
If you go into hospital, please let the medical staff know that you are taking GENOX
Visit your doctor regularly so they can check on your progress.
You will need to have regular gynecological check-ups while you are taking GENOX.
Your doctor may also order regular blood tests to check your calcium levels, white
blood cell and platelet counts.
Call your doctor straight away if you:
notice any unusual gynecological symptoms, especially vaginal bleeding or discharge,
even if it occurs after the treatment with GENOX has stopped.
Unusual bleeding or discharge from the vagina are possible side effects of GENOX but
they may also be symptoms of uterine or endometrial cancer. These along with other
changes to the uterus lining (endometrium) have been reported in association with
the use of this medicine.
Things you should not do
For women: do not get pregnant while you are taking GENOX and for nine months after
you stop taking GENOX.
For Men: do not father a child while you are taking GENOX and for six months after
you stop taking GENOX. Ask your doctor about reliable methods of contraception.
Ask your doctor about reliable methods of contraception.
Do not breastfeed while you are taking GENOX.
Do not take GENOX to treat any other complaints unless your doctor tells you to.
Do not stop taking GENOX, or lower the dosage, unless you have discussed this with
your doctor.
Do not give this medicine to anyone else, even if they have the same condition as
you.
Do not take GENOX if the packaging is torn or shows signs of tampering.
Driving or using machines
Be careful before you drive or use any machines or tools until you know how GENOX
affects you.
Some patients may experience dizziness, fatigue or light headedness. If this occurs,
do not drive, operate machinery or do anything else that could be dangerous.
Looking after your medicine
Keep your GENOX tablets in the blister pack until it is time to take them. If you
take GENOX out of the blister pack it will not keep well.
Keep it in a cool, dry place where the temperature stays below 25°C.
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.
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.
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.
Some people, such as those who have not had menopause, may have a greater risk of
getting some of these side effects.
See the information below and, if you need to, ask your doctor or pharmacist if you
have any further questions about side effects.
GENOX helps most people with breast cancer, but it may have unwanted side effects
in a few people.
Tell your doctor or pharmacist as soon as possible if you do not feel well while you
are taking GENOX.
Less serious side effects
Serious side effects
Serious side effects are rare.
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.
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 an unusual vaginal bleeding or other gynecological symptoms (such as pelvic
pain or pressure) when you are taking GENOX 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.
GENOX may decrease bone density in premenopausal women. It is not known if this increases
the risk of fractures. Ask your doctor for advice about ways to maintain your bone
health.
GENOX may cause or worsen symptoms of hereditary angioedema.
Increased risk of blood clots and ovarian cysts (in premenopausal women) have been
seen with GENOX.
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 GENOX.
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 GENOX contains
|
Active ingredient
(main ingredient)
|
tamoxifen citrate 10 mg or 20 mg per tablet
|
|
Other ingredients
(inactive ingredients)
|
mannitol
maize starch
croscarmellose sodium
magnesium stearate
|
The tablets are gluten free.
Do not take this medicine if you are allergic to any of these ingredients.
What GENOX looks like
GENOX 10 - round, white tablet marked "TN" over "10" on one side and "G" on the other side. (AUST
R 40063)
GENOX 20 - round, white, scored tablet marked "TN" over "20" on one side and "G" on the other
side (AUST R 40065)
Each pack contains 30 or 60 tablets.
Who distributes GENOX
Alphapharm Pty Ltd trading as Viatris
Level 1, 30 The Bond
30-34 Hickson Road
Millers Point NSW 2000
Phone: 1800 274 276
This leaflet was prepared in August 2025.
GENOX® is a Viatris company trade mark
GENOX_cmi\Aug25/00