SUMMARY CMI

Tamoxifen Sandoz^®

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 Tamoxifen Sandoz?

Tamoxifen Sandoz contains the active ingredient tamoxifen citrate. Tamoxifen Sandoz 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 Tamoxifen Sandoz? in the full CMI.

2. What should I know before I use Tamoxifen Sandoz?

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 Tamoxifen Sandoz? in the full CMI.

3. What if I am taking other medicines?

Some medicines may interfere with Tamoxifen Sandoz 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 Tamoxifen Sandoz?

• The usual dose is 20 mg of Tamoxifen Sandoz each day. This is two 10 mg Tamoxifen Sandoz tablets taken together or one 20 mg Tamoxifen Sandoz tablet taken once a day. Some people need to take 40 mg once a day.
• Swallow your Tamoxifen Sandoz tablets 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 Tamoxifen Sandoz? in the full CMI.

5. What should I know while using Tamoxifen Sandoz?

For more information, see Section 5. What should I know while using Tamoxifen Sandoz? 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

Tamoxifen Sandoz^®

Active ingredient(s): tamoxifen citrate

Consumer Medicine Information (CMI)

This leaflet provides important information about using Tamoxifen Sandoz. 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 Tamoxifen Sandoz.

Where to find information in this leaflet:

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

1. Why am I using Tamoxifen Sandoz?

Tamoxifen Sandoz contains the active ingredient tamoxifen citrate. Tamoxifen Sandoz 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.

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

Your doctor may prescribe this medicine for another use.

Tamoxifen Sandoz is not addictive.

2. What should I know before I use Tamoxifen Sandoz?

Warnings

Do not use Tamoxifen Sandoz if:

• you are allergic to tamoxifen citrate, 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-estrogen 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 Tamoxifen Sandoz 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 Tamoxifen Sandoz.
  It may not be safe for you to take Tamoxifen Sandoz 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 Tamoxifen Sandoz 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 Tamoxifen Sandoz from breast milk if you are breastfeeding.

Children

Do not give Tamoxifen Sandoz 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

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

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

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

4. How do I use Tamoxifen Sandoz?

How much to take

• Your doctor will decide how much Tamoxifen Sandoz you need to take.
• The usual dose is 20 mg of Tamoxifen Sandoz each day. This is two 10 mg Tamoxifen Sandoz tablets taken together or one 20 mg Tamoxifen Sandoz 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 Tamoxifen Sandoz whole, with a full glass of water. Do not chew or crush the tablets.

When to take Tamoxifen Sandoz

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

How long to take Tamoxifen Sandoz

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

If you forget to use Tamoxifen Sandoz

Tamoxifen Sandoz 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 Tamoxifen Sandoz

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

You should immediately:

• phone the Australian Poisons Information Centre
  (by calling 13 11 26), or the New Zealand National Poisons Information Centre (by calling 0800 POISONS or 0800 764766), 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 Tamoxifen Sandoz you may experience problems with the rhythm of your heart.

5. What should I know while using Tamoxifen Sandoz?

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

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

Things you should not do

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

Some patients may experience dizziness, fatigue or light headedness.

Looking after your medicine

• Keep your Tamoxifen Sandoz tablets in the blister pack until it is time to take them. If you take Tamoxifen Sandoz 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.

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.

Tamoxifen Sandoz 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 Tamoxifen Sandoz.

Less serious side effects

Serious side effects

Very serious side effects

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 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.

Tamoxifen Sandoz 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.

Tamoxifen Sandoz may cause or worsen symptoms of hereditary angioedema.

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

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 tamoxifen.

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 or to Medsafe at pophealth.my.site.com/carmreportnz/s/. 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 Tamoxifen Sandoz contains

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

What Tamoxifen Sandoz looks like

Tamoxifen Sandoz 10 mg – white, round, biconvex, film coated tablets (Aust R 80056).

Tamoxifen Sandoz 20 mg – white, round, biconvex, film coated tablets with a notch on one side (Aust R 80076).

Available in blisters of 30 and 60 tablets.

Not all strengths and pack sizes may be available in Australia and New Zealand.

Who distributes Tamoxifen Sandoz

Tamoxifen Sandoz is distributed in Australia by:

Sandoz Pty Ltd
100 Pacific Highway
North Sydney, NSW 2060
Australia
Tel 1800 726 369

Tamoxifen Sandoz is distributed in New Zealand by:

Sandoz New Zealand Limited
12 Madden Street
Auckland 1010
New Zealand
Tel: 0800 726 369

This leaflet was prepared in January 2025.

^® Registered Trade Mark. The trade marks mentioned in this material are the property of their respective owners.

Published by MIMS April 2025

1 Name of Medicine

Tamoxifen citrate.

2 Qualitative and Quantitative Composition

Each Tamoxifen Sandoz 10 mg tablet contains 10 mg tamoxifen citrate.
Each Tamoxifen Sandoz 20 mg tablet contains 20 mg tamoxifen citrate.

List of excipients with known effect.

3 Pharmaceutical Form

Tamoxifen Sandoz 10 mg tablets.

Tamoxifen Sandoz 20 mg tablets.

4 Clinical Particulars

4.1 Therapeutic Indications

Treatment of breast cancer.

Primary reduction of breast cancer risk.

4.2 Dose and Method of Administration

Dosage.

Treatment of breast cancer.

Primary reduction of breast cancer risk.

4.3 Contraindications

Tamoxifen Sandoz must not be given during pregnancy (see Section 4.6 Fertility, Pregnancy and Lactation, Use in pregnancy). Premenopausal patients must be carefully examined before treatment for breast cancer to exclude the possibility of pregnancy.
Tamoxifen Sandoz 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, Tamoxifen Sandoz 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

An increased incidence of endometrial changes including hyperplasia, polyps and cancer and uterine sarcoma (mostly malignant mixed Mullerian tumours) has been reported in association with tamoxifen treatment. The incidence and pattern of this increase suggest that the underlying mechanism is related to the oestrogenic properties of tamoxifen. Any patients receiving or having previously received Tamoxifen Sandoz who report abnormal gynaecological symptoms, especially non-menstrual vaginal bleeding, should be promptly investigated.
In a large randomised trial in Sweden of adjuvant tamoxifen 40 mg/day for two to five years, an increased incidence of uterine cancer was noted. 23 of 1,372 patients randomised to receive tamoxifen versus 4 of 1,357 patients randomised to the observation group developed cancer of the uterus (relative risk = 5.6, range (1.9 to 16.2); p < 0.001).
One of the patients with cancer of the uterus who was randomised to receive tamoxifen never took the drug. After approximately 6.8 years of follow-up in the ongoing NSABP (National Surgical Adjuvant Breast and Bowel Project) B-14 trial, 15 of 1,419 women randomised to receive tamoxifen 20 mg/day for five years developed uterine cancer, and 2 of the 1,424 women randomised to receive placebo, who subsequently had recurrent breast cancer and were treated with tamoxifen, also developed uterine cancer. Most of the uterine cancers were diagnosed at an early stage, but deaths from uterine cancer have been reported. Patients receiving tamoxifen should have routine gynaecological care and report any abnormal vaginal bleeding to their doctor.
(The NSABP B-14 trial is undergoing reaudit and information from this study may be subject to change.)
In patients with hereditary angioedema, Tamoxifen Sandoz may induce or exacerbate symptoms of angioedema.
In an uncontrolled trial in 28 girls aged 2-10 with McCune Albright Syndrome (MAS), who received 20 mg once a day for up to 12 months duration, mean uterine volume increased after 6 months of treatment and doubled at the end of the one year study. While this finding is in line with the pharmacodynamic properties of tamoxifen, a causal relationship has not been established. Tamoxifen is not approved for treatment of McCune Albright Syndrome.
There is evidence of an increased incidence of thromboembolic events, including deep vein thrombosis and pulmonary embolism, during Tamoxifen Sandoz therapy. When Tamoxifen Sandoz is coadministered with chemotherapy, there may be a further increase in the incidence of thromboembolic effects. For treatment of breast cancer, the risks and benefits of Tamoxifen Sandoz should be carefully considered in women with a history of thromboembolic events.
In delayed microsurgical breast reconstruction, tamoxifen may increase the risk of microvascular flap complications.
A number of second primary tumours, occurring at sites other than the endometrium and the opposite breast, have been reported in clinical trials, following the treatment of breast cancer patients with tamoxifen. No causal link has been established and the clinical significance of these observations remains unclear.
Cases of visual disturbances, including infrequent reports of corneal changes, and common reports of retinopathy have been described in patients receiving tamoxifen therapy. Cataracts have commonly been reported in association with the administration of tamoxifen.
Tamoxifen should be used cautiously in patients with existing leucopenia or thrombocytopenia. Leucopenia has been observed following the administration of tamoxifen, sometimes in association with anaemia and/or thrombocytopenia. Neutropenia has been reported on rare occasions and can sometimes be severe and rarely cases of agranulocytosis have been reported. Decreases in platelet counts (usually to 50,000 to 100,000/mm³, infrequently lower) have been occasionally reported in patients taking tamoxifen for breast cancer. Periodic complete blood counts, including platelet counts, may be appropriate.
Tamoxifen at the recommended dose may prolong to QTc interval on the electrocardiogram (ECG) in patients with underlying risks for QT prolongation and cardiac comorbidities. ECG and electrolyte monitoring are recommended in such patients.

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 tamoxifen is used in combination with coumarin type anticoagulants, a significant increase in anticoagulant effect may occur. Where such coadministration is initiated, 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 tamoxifen 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 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 the 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 Tamoxifen Sandoz. 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, tumor pain and tumor flare; and those of a more general nature, e.g. gastrointestinal intolerance, headache, lightheadedness and occasionally, fluid retention and alopecia. In patients treated with tamoxifen 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 Tamoxifen Sandoz.
Although hypercalcaemia may occur in patients with advanced breast cancer, uncommonly patients with bony metastases have developed hypercalcaemia on initiation of therapy with tamoxifen.
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 tamoxifen. Vaginal polyps have rarely been observed in women receiving tamoxifen.
There is evidence of ischaemic cerebrovascular events and thromboembolic events, including deep vein thrombosis, microvascular thrombosis and pulmonary embolism, occurring commonly during tamoxifen therapy. When Tamoxifen Sandoz 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 with patients receiving Tamoxifen Sandoz.
Tamoxifen has been associated with changes in hepatic enzyme levels and, with a spectrum of more severe hepatic 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 Tamoxifen Sandoz.
Depression has been reported with frequency very common in association with the use of Tamoxifen Sandoz.
An increased incidence of endometrial cancer and other uterine sarcoma (mostly malignant mixed Mullerian tumours) has been reported in association with tamoxifen treatment.
Cutaneous lupus erythematosus has been observed very rarely in patients receiving tamoxifen.
Porphyria cutanea tarda has been observed very rarely in patients receiving tamoxifen.
Cases of optic neuropathy and optic neuritis have been rarely reported in patients receiving tamoxifen and, in a small number of patients, blindness has occurred.
Sensory disturbances (including paraesthesia and dysgeusia) have been reported commonly in patients receiving tamoxifen.
Fatigue has been reported very commonly in patients taking Tamoxifen Sandoz.
Radiation recall has been observed very rarely in patients receiving Tamoxifen Sandoz.

Primary reduction of breast cancer risk.

Women under 50 years old.

Gynaecological conditions and procedures.

Reporting suspected adverse effects.

4.9 Overdose

Symptoms.

Treatment.

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.

Bioavailability.

Distribution.

Protein binding.

Metabolism.

Excretion.

Clinical implications of pharmacokinetic data.

5.3 Preclinical Safety Data

Genotoxicity.

Carcinogenicity.

6 Pharmaceutical Particulars

6.1 List of Excipients

Tamoxifen tablets also contain lactose monohydrate, sodium starch glycollate, povidone, microcrystalline cellulose, magnesium stearate, titanium dioxide, hypromellose and macrogol 4000.

6.2 Incompatibilities

Incompatibilities were either not assessed or not identified as part of the registration of this medicine.
For information on interactions with other medicines and other forms of interaction, see Section 4.5 Interactions with Other Medicines and Other Forms of Interactions.

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

Tamoxifen Sandoz tablets should be stored below 25°C, protected from light and moisture.

6.5 Nature and Contents of Container

Tamoxifen Sandoz 10 mg tablets 60's*.
Tamoxifen Sandoz 20 mg tablets 60's.
* Not marketed in Australia.

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

Tamoxifen citrate is a white or almost white, crystalline powder, slightly soluble in water, soluble in methanol, slightly soluble in acetone.

Chemical structure.

CAS number.

7 Medicine Schedule (Poisons Standard)

Schedule 4 - Prescription Only Medicine.

Summary Table of Changes