Genox

The full CMI on the next page has more details. If you are worried about taking this medicine, speak to your doctor or pharmacist.

GENOX contains the active ingredient tamoxifen citrate. 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.

For more information, see Section 1. Why am I taking GENOX? in the full CMI.

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.

For more information, see Section 2. What should I know before I take GENOX? in the full CMI.

Some medicines may interfere with GENOX and affect how it works.

A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI.

More instructions can be found in Section 4. How do I take GENOX? in the full CMI.

For more information, see Section 5. What should I know while taking GENOX? in the full CMI.

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)

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:

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.

Your doctor may want to take special care if you have any of these conditions.

If you have not told your doctor about any of the above, tell them before you start taking GENOX.

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?

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.

Do not give GENOX to children.

There is no experience of its use in children.

GENOX is not approved for use in children.

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:

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.

Follow all directions given to you by your doctor and pharmacist carefully.

They may differ from the information contained in this leaflet.

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 think that you or anyone else has taken too much GENOX, urgent medical attention maybe needed.

You should immediately:

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.

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.

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:

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.

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.

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.

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.

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.

This medicine is only available with a doctor's prescription.

The tablets are gluten free.

Do not take this medicine if you are allergic to any of these ingredients.

Each pack contains 30 or 60 tablets.

Alphapharm Pty Ltd trading as Viatris

Level 1, 30 The Bond

30-34 Hickson Road

Millers Point NSW 2000

www.viatris.com.au 

Phone: 1800 274 276

This leaflet was prepared in May 2025.

GENOX® is a Viatris company trade mark

GENOX_cmi\May25/00