SUMMARY CMI

NOLVADEX^®

Consumer Medicine Information (CMI) summary

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

1. Why am I using NOLVADEX?

NOLVADEX contains the active ingredient tamoxifen citrate. NOLVADEX 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 using NOLVADEX? in the full CMI.

2. What should I know before I use NOLVADEX?

Do not use 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 use NOLVADEX? in the full CMI.

3. What if I am taking other medicines?

Some medicines may interfere with NOLVADEX 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.

4. How do I use NOLVADEX?

• The usual dose is 20 mg of NOLVADEX each day. This is two 10 mg NOLVADEX tablets taken together or one 20 mg NOLVADEX-D tablet taken once a day. Some people need to take 40 mg once a day.
• Swallow your NOLVADEX whole, with a full glass of water. Do not chew or crush the tablets.

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

5. What should I know while using NOLVADEX?

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

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.

FULL CMI

NOLVADEX^®

Active ingredient: tamoxifen citrate

Consumer Medicine Information (CMI)

This leaflet provides important information about using NOLVADEX. You should also speak to your doctor or pharmacist if you would like further information or if you have any concerns or questions about using NOLVADEX.

Where to find information in this leaflet:

1. Why am I using NOLVADEX?
2. What should I know before I use NOLVADEX?
3. What if I am taking other medicines?
4. How do I use NOLVADEX?
5. What should I know while using NOLVADEX?
6. Are there any side effects?
7. Product details

1. Why am I using NOLVADEX?

NOLVADEX contains the active ingredient tamoxifen citrate. NOLVADEX 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.

NOLVADEX 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 NOLVADEX for reducing the risk of breast cancer occurring, your knowledge of treatment risks becomes more important because you don't currently have breast cancer. NOLVADEX 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 gynaecological 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. NOLVADEX 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 NOLVADEX reduces, but does not eliminate, the risk of breast cancer.

Your doctor may prescribe this medicine for another use.

NOLVADEX is not addictive.

2. What should I know before I use NOLVADEX?

Warnings

Do not use NOLVADEX if:

• you are allergic to tamoxifen, or any of the ingredients listed at the end of this leaflet. Always check the ingredients to make sure you can use this medicine.
• you are allergic to other anti-oestrogen medicines
• you are allergic to any other medicines or substances, such as foods, preservatives or dyes. 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)

Check with your doctor if you:

• have any other medical conditions such as:
  - a history of hereditary angioedema (as NOLVADEX may cause or worsen symptoms of hereditary angioedema)
  - any unexplained vaginal bleeding
  - problems with your blood
  - 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 NOLVADEX.
  It may not be safe for you to take NOLVADEX if you have any of these conditions.
• take any medicines for any other condition

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 use NOLVADEX 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 NOLVADEX from breast milk if you are breastfeeding.

Children

Do not give NOLVADEX to children.

There is no experience of its 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.

Tell your doctor if you are taking:

• oral contraceptives ('the pill')
• hormone replacement therapy
• medicines used to thin your blood e.g. warfarin
• rifampicin
• chemotherapy
• any medicines that you buy at the chemist, supermarket or health food shop

NOLVADEX should not be taken with aromatase inhibitors such as anastrozole, letrozole or exemestane.

These medicines may affect the way NOLVADEX works or may not work as well. They could also cause side effects if you take them with NOLVADEX.

Check with your doctor or pharmacist if you are not sure about what medicines, vitamins or supplements you are taking and if these affect NOLVADEX.

4. How do I use NOLVADEX?

How much to take

• Your doctor will decide how much NOLVADEX you need to take.
• The usual dose is 20 mg of NOLVADEX each day. This is two 10 mg NOLVADEX tablets taken together or one 20 mg NOLVADEX-D tablet taken once a day.
• Some people need to take 40 mg once a day. Your doctor will tell you if this is necessary.
• Swallow your NOLVADEX whole, with a full glass of water. Do not chew or crush the tablets.

When to take NOLVADEX

• Take NOLVADEX at about the same time each day.
• It does not matter if you take NOLVADEX before, with or after food.

How long to take NOLVADEX

• Continue taking NOLVADEX for as long as your doctor or pharmacist tells you to.

If you forget to take NOLVADEX

NOLVADEX should be used regularly at the same time each day. If you miss your dose at the usual time, 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, 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 you missed.

If you are not sure what to do, ask your doctor or pharmacist.

If you use too much NOLVADEX

If you think that you have used too much NOLVADEX, you may need urgent medical attention.

You should immediately:

• phone the Poisons Information Centre
  (by calling 13 11 26), 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.

If you take too much NOLVADEX you may experience problems with the rhythm of your heart.

5. What should I know while using NOLVADEX?

Things you should 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 NOLVADEX
• If you are about to be started on any new medicine, tell your doctor, dentist or pharmacist that you are taking NOLVADEX
• If you go into hospital, please let the medical staff know that you are taking NOLVADEX

Remind any doctor, dentist or pharmacist you visit that you are using NOLVADEX.

Things you should not do

• Do not get pregnant while you are taking NOLVADEX and for nine months after you stop taking NOLVADEX. Ask your doctor about reliable methods of contraception.
• Do not breastfeed while you are taking NOLVADEX.
• Do not take NOLVADEX to treat any other complaints unless your doctor tells you to.
• Do not stop taking NOLVADEX, 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 NOLVADEX 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 NOLVADEX affects you.

Some patients may experience dizziness, fatigue or light headedness.

Looking after your medicine

• Keep your NOLVADEX tablets in the blister pack until it is time to take them. If you take NOLVADEX out of the blister pack it will not keep well.
• Keep it in a cool, dry place where the temperature stays below 30°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 on hot days or on a windowsill.

Keep it where young children cannot reach it.

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.

It may have no effect at all, or worse, an entirely unexpected effect if you take it 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.

See the information below and, if you need to, ask your doctor or pharmacist if you have any further questions about side effects.

NOLVADEX 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 NOLVADEX.

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 gynaecological symptoms (such as pelvic pain or pressure) when you are taking NOLVADEX 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.

NOLVADEX 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.

NOLVADEX may cause or worsen symptoms of hereditary angioedema.

Increased risk of blood clots and ovarian cysts (in premenopausal women) have been seen with NOLVADEX.

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 NOLVADEX.

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 NOLVADEX contains

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

What NOLVADEX looks like

NOLVADEX 10 mg tablets are white to off-white, round film-coated tablets marked NOLVADEX 10 on one side (Aust R 11233).

NOLVADEX-D 20 mg tablets are white to off-white, octagonal (eight sided) film-coated tablets marked NOLVADEX-D on one side (Aust R 11232).

Each pack of NOLVADEX tablets contains 30 tablets in blister strips.

Who distributes NOLVADEX

AstraZeneca Pty Ltd
ABN 54 009 682 311
66 Talavera Road
MACQUARIE PARK NSW 2113
Telephone:- 1800 805 342

This leaflet was prepared in November 2024.

NOLVADEX and NOLVADEX-D are trademarks of the AstraZeneca group of companies

© AstraZeneca, 2024

[VV-RIM-01369998 v 10.0]

Published by MIMS February 2025

1 Name of Medicine

Tamoxifen citrate.

2 Qualitative and Quantitative Composition

Nolvadex tablets each contain tamoxifen citrate (15.2 mg) equivalent to 10 mg of tamoxifen.
Nolvadex-D tablets each contain tamoxifen citrate (30.4 mg) equivalent to 20 mg of tamoxifen.

Both Nolvadex and Nolvadex-D also contain an excipient with known effect.

3 Pharmaceutical Form

Nolvadex is presented as white to off-white, round, biconvex film coated tablets, impressed with "NOLVADEX 10" on one face, and plain on the reverse face.
Nolvadex-D is presented as white to off-white, octagonal shaped, biconvex film coated tablets, impressed with "NOLVADEX-D" on one face, and plain on the reverse face.

4 Clinical Particulars

4.1 Therapeutic Indications

Treatment of breast cancer.

Primary reduction of breast cancer risk.

4.2 Dose and Method of Administration

Adults.

Treatment of breast cancer.

Primary reduction of breast cancer risk.

Paediatric use.

4.3 Contraindications

Nolvadex must not be given during pregnancy. In premenopausal women, the possibility of pregnancy must be excluded before starting tamoxifen.
Nolvadex should not be given to patients who have experienced hypersensitivity to the product or any of its ingredients.
When considered for primary reduction of breast cancer risk, Nolvadex is contraindicated in women who require concomitant coumarin type anticoagulant therapy or in women with a history of deep vein thrombosis or pulmonary embolus.

4.4 Special Warnings and Precautions for Use

General precautions.

Additional precautions relating to primary reduction of breast cancer risk.

Use in premenopausal women.

Use in the elderly.

Paediatric use.

Effects on laboratory tests.

4.5 Interactions with Other Medicines and Other Forms of Interactions

When Nolvadex is used in combination with coumarin type anticoagulants, a significant increase in anticoagulant effect may occur. Where such coadministration is initiated for the treatment of breast cancer, careful monitoring of the patient is recommended. In women receiving tamoxifen for the primary reduction of breast cancer risk, the use of coumarin type anticoagulants is contraindicated (see Section 4.3 Contraindications).
When Nolvadex is used in combination with cytotoxic agents, there is increased risk of thromboembolic events occurring.
The use of tamoxifen in combination with an aromatase inhibitor as adjuvant therapy has not shown improved efficacy compared with tamoxifen alone.
The known principal pathway for tamoxifen metabolism in humans is demethylation, catalysed by CYP3A4 enzymes. Pharmacokinetic interaction with the CYP3A4 inducing agent rifampicin, showing a reduction in tamoxifen plasma levels, has been reported in the literature.
Pharmacokinetic interaction between CYP2D6 inhibitors and tamoxifen has been reported in literature. This showed a reduction in plasma level of active tamoxifen metabolite, 4-hydroxy-N-desmethyltamoxifen. Reduced efficacy on tamoxifen has been reported with concomitant usage of some SSRI antidepressants (e.g. paroxetine).
For the primary reduction of breast cancer risk, there is some evidence that hormone replacement therapy may reduce the effectiveness of tamoxifen, and the safety of concomitant use of tamoxifen and hormone replacement therapy or oral contraceptives is unknown. In women with breast cancer, the use of hormone replacement therapy or oral contraceptives to manage tamoxifen side effects is a relative contraindication.

4.6 Fertility, Pregnancy and Lactation

Effects on fertility.

4.7 Effects on Ability to Drive and Use Machines

Fatigue has been reported with the use of Nolvadex. Therefore, caution should be observed when driving or operating machinery while such symptoms persist.

4.8 Adverse Effects (Undesirable Effects)

The adverse reactions which have been reported are of two types: those associated specifically with the pharmacological action of the drug, e.g. hot flushes, vaginal bleeding, vaginal discharge, pruritus vulvae, tumour pain and tumour flare and those of a more general nature, e.g. gastrointestinal intolerance, headache, lightheadedness and, occasionally, fluid retention and alopecia. In patients treated with Nolvadex for metastatic breast cancer, the most frequent adverse reactions are hot flushes, nausea and vomiting. These may occur in up to one fourth of patients. Less frequently reported adverse reactions are vaginal bleeding, vaginal discharge, menstrual irregularities, alopecia and increased bone and tumour pain. Other adverse reactions which are seen infrequently are hypercalcaemia, peripheral oedema, pruritus vulvae, dizziness and lightheadedness. Infrequent cases of endometrial, ocular and haematological adverse effects have been reported (see Section 4.4 Special Warnings and Precautions for Use). When such adverse reactions are severe, it may be possible to control them by a simple reduction of dosage (within the recommended dose range) without loss of control of the disease. If adverse reactions do not respond to this measure, it may be necessary to stop the treatment.
Skin rashes (including isolated reports of erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, cutaneous vasculitis, and bullous pemphigoid) and commonly hypersensitivity reactions, including angioedema, have been reported.
Cases of exacerbation of angioedema have been reported in patients with hereditary angioedema receiving Nolvadex.
Although hypercalcaemia may occur in patients with advanced breast cancer, uncommonly patients with bony metastases have developed hypercalcaemia on initiation of therapy with Nolvadex.
Uterine fibroids, endometriosis and other endometrial changes including hyperplasia and polyps have been reported.
Cystic ovarian swellings have occasionally been observed in premenopausal women receiving Nolvadex. Vaginal polyps have rarely been observed in women receiving Nolvadex.
There is evidence of ischaemic cerebrovascular events and thromboembolic events, including deep vein thrombosis, microvascular thrombosis and pulmonary embolism, occurring commonly during Nolvadex therapy. When Nolvadex is used in combination with cytotoxic agents, there is increased risk of thromboembolic events occurring.
Uncommonly, cases of interstitial pneumonitis have been reported.
Leg cramps and myalgia have been reported commonly in patients receiving Nolvadex.
Nolvadex has been associated with changes in liver enzyme levels and with a spectrum of more severe liver abnormalities which in some cases were fatal, including fatty liver, cholestasis and hepatitis, liver failure, cirrhosis and hepatocellular injury (including hepatic necrosis).
Commonly, elevation of serum triglyceride levels, in some cases with pancreatitis, may be associated with the use of Nolvadex.
Depression has been reported with frequency very common in association with the use of Nolvadex.
An increased incidence of endometrial cancer and uterine sarcoma (mostly malignant mixed Mullerian tumours) has been reported in association with Nolvadex treatment.
Cutaneous lupus erythematosus has been observed very rarely in patients receiving Nolvadex.
Porphyria cutanea tarda has been observed very rarely in patients receiving Nolvadex.
Cases of optic neuropathy and optic neuritis have been rarely reported in patients receiving tamoxifen and, in a small number of cases, blindness has occurred.
Sensory disturbances (including paraesthesia and dysgeusia) have been reported commonly in patients receiving Nolvadex.
Fatigue has been reported very commonly in patients taking Nolvadex.
Radiation recall has been observed very rarely in patients receiving Nolvadex.

Primary reduction of breast cancer risk.

Women under 50 years old.

Gynaecological conditions and procedures.

Reporting suspected adverse effects.

4.9 Overdose

For information on the management of overdose, contact the Poison Information Centre on 131126 (Australia).
On theoretical grounds, an overdosage would be expected to cause enhancement of the pharmacological side effects mentioned above. Observations in animals show that extreme overdosage (100 to 200 times the equivalent of the recommended daily human dose) may produce oestrogenic effects.
There have been reports in the literature that Nolvadex given at several times the standard dose may be associated with prolongation of the QT interval of the ECG.
There is no specific antidote to overdosage, and treatment must be symptomatic.

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

Mechanism of action.

Clinical trials.

Concomitant use of hormone replacement therapy.

Effects of age and menopausal status.

Lobular carcinoma in situ and atypical hyperplasia.

5.2 Pharmacokinetic Properties

Absorption.

Distribution.

Protein binding.

Metabolism.

Half-life.

Excretion.

Clinical implications of pharmacokinetic data.

5.3 Preclinical Safety Data

Genotoxicity.

Carcinogenicity.

6 Pharmaceutical Particulars

6.1 List of Excipients

Both Nolvadex and Nolvadex-D include the following excipients: maize starch, lactose monohydrate, croscarmellose sodium, gelatin, magnesium stearate, hypromellose, macrogol 300, titanium dioxide.

6.2 Incompatibilities

Incompatibilities were either not assessed or not identified as part of the registration of the medicine.

6.3 Shelf Life

In Australia, information on the shelf life can be found on the public summary of the Australian Register of Therapeutic Goods (ARTG). The expiry date can be found on the packaging.

6.4 Special Precautions for Storage

Nolvadex and Nolvadex-D tablets should be protected from light. Store below 30°C.

6.5 Nature and Contents of Container

Nolvadex (10 mg): blister-packed in strips of 10, in containers of 30.*
Nolvadex-D (20 mg): blister-packed in strips of 10, in containers of 30.
*Not marketed.

6.6 Special Precautions for Disposal

In Australia, any unused medicine or waste material should be disposed of by taking to your local pharmacy.

6.7 Physicochemical Properties

Chemical structure.

CAS number.

7 Medicine Schedule (Poisons Standard)

Prescription only medicine (Schedule 4).

Summary Table of Changes