Tamoxifen-EGIS 20mg Tablets

What Tamoxifen Tablets are used for

• Tamoxifen Tablets are used to treat breast cancer

• Tamoxifen Tablets also to treat infertility in women caused by a failure to produce and release eggs (ovulate) properly

• Tamoxifen Tablets can also reduce the risk of developing breast cancer occurring in those women who have an increased likelihood of developing breast cancer (your risk). It is important that your healthcare professional calculates your risk of developing breast cancer and discusses the result with you before commencing treatment. There are a number of specific tools available to calculate breast cancer risk, based on information such as your age, family history, genetics, reproductive factors (e.g. age when periods started and stopped, had children or not, taken or taking hormonal replacement therapy and/or oral contraceptive pill) and history of breast disease. Although the tools can estimate your risk, it doesn’t mean you will get breast cancer, being at increased risk means you have a higher chance of developing breast cancer. If you and your healthcare professional are considering using Tamoxifen Tablets for this, it is important to understand the benefits as well as the side effects of taking Tamoxifen Tablets because you don't currently have breast cancer and tamoxifen reduces, but does not stop the risk of developing breast cancer.

If you want to know more about how to decide whether tamoxifen is right for you, there is more information for patients on the National Institute for Health and Care Excellence website. Ask your doctor to talk to you about the information which is available for patients.

How Tamoxifen Tablets work

Oestrogen is a natural substance in your body known as a ‘sex hormone’. Some breast cancers need oestrogen to grow and tamoxifen works by blocking the effects of oestrogen.

Warnings and precautions

Talk to your doctor or pharmacist before taking Tamoxifen Tablets.

If you have a history of hereditary angioedema as Tamoxifen Tablets may cause or worsen symptoms of hereditary angioedema. If you experience symptoms such as swelling of the face, lips, tongue and/or throat with difficulty in swallowing or breathing, contact a doctor immediately.

In delayed breast reconstruction operation (weeks to years after the primary breast operation when your own tissue is moved to shape a new breast) Tamoxifen Tablets may increase the risk of the formation of blood clots in the small vessels of the tissue flap which may lead to complications.

Tamoxifen therapy may be used to reduce the risk of breast cancer and it can be associated with serious side effects such as blood clots in the veins of your leg (deep vein thrombosis), blood clots in your lungs (pulmonary embolus) and uterine cancer, all of which can be fatal. Other less serious side effects such as hot flushes, vaginal discharge, menstrual irregularities and pelvis pain 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 therapy to reduce the risk of breast cancer may not be appropriate for all women at increased risk. All assessments with your healthcare professional of the potential benefits and risks prior to starting therapy are essential. You should understand that tamoxifen reduces, but does not eliminate the risk of breast cancer.

Serious skin reactions including Stevens-Johnson syndrome and toxic epidermal necrolysis, have been reported in association with tamoxifen treatment. Stop using tamoxifen and seek medical attention immediately if you notice any of the symptoms related to these serious skin reactions described in section 4.

If you have or have had heart problems or an irregular heartbeat (arrhythmia), you may be at a higher risk of changes in your heart’s electrical activity (known as QT prolongation) when using tamoxifen. QT prolongation can be seen on a heart test called an electrocardiogram (ECG) and may increase the risk of serious heart rhythm problems. If you are at an increased risk, your doctor should check your blood for important blood salts and minerals (electrolytes) and check your heart activity with an ECG before and during treatment with Tamoxifen Tablets.

Studies in premenopausal women who took tamoxifen for reduction of breast cancer risk or for treatment of breast cancer have reported decreases in bone density. If you are a premenopausal woman undergoing treatment with Tamoxifen Tablets, ask your doctor for advice about ways to maintain your bone health.

Children

This medicine is not for use in children.

Other medicines and Tamoxifen Tablets

Contraception

Women who can become pregnant should use adequate non-hormonal contraception (e.g., barrier contraception) during treatment with tamoxifen and for an additional two months after stopping treatment.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy

• Do not take Tamoxifen Tablets if you are pregnant. This is because it may affect your unborn baby

• You should not become pregnant while taking Tamoxifen Tablets. Please see your doctor for advice on what contraceptive precautions you should take, as some may be affected by Tamoxifen Tablets

• You should see your doctor immediately if you think you may have become pregnant after starting to take Tamoxifen Tablets.

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Stop taking Tamoxifen Tablets and tell your doctor straight away if you notice any of the following side effects – you may need urgent medical treatment:

• Symptoms of a blood clot. These include swelling of the calf or leg, chest pain, being short of breath or suddenly feeling weak

• Symptoms of a stroke. These include sudden onset of the following: weakness or paralysis of the arms or legs, being unable to move the arms or legs, sudden difficulty with speaking, walking, difficulty in holding things or difficulty in thinking. These symptoms are caused by a reduced blood supply in the brain

• Difficulty in breathing

• Swelling of the face, lips, tongue or throat which may make it difficult to swallow

• Swelling of the hands, feet or ankles

• Nettle rash (also called ‘hives’ or ‘urticaria’)

• Reddish non-elevated, target-like or circular patches on the trunk, often with central blisters, skin peeling, ulcers of mouth, throat, nose, genitals and eyes. These serious skin rashes can be preceded by fever and flu-like symptoms [Stevens-Johnson syndrome, toxic epidermal necrolysis] – these side effects occur rarely

• Swelling of the face, lips, tongue or throat, difficulty in swallowing or breathing (angioedema). Tamoxifen Tablets may cause or worsen symptoms of hereditary angioedema.

Tell your doctor straight away if you notice any of the following:

• Unusual bleeding from your vagina

• Irregular periods, especially if associated with heavier bleeding as this could be a warning sign for a certain type of cancer affecting the lining of your womb (endometrial cancer)

• Vaginal discharge

• A feeling of discomfort in the lower tummy (pelvis) such as pain or pressure.

These effects may mean that there have been changes to the lining of your womb (the endometrium). Sometimes these effects are serious and could include cancer. They can happen during or after treatment with Tamoxifen Tablets.

Other possible side effects:

Very common: may affect more than 1 in 10 people

• Nausea

• Fluid retention

• Skin rash

• Hot flushes

• Tiredness.

Common: may affect up to 1 in 10 people

• Anaemia (a blood problem which means you have too few red blood cells)

• Changes in vision due to cataracts or changes to the retina of your eye

• Increased amounts of fats in your blood (shown by blood tests)

• Allergic reactions

• Leg cramp

• Changes in the womb (including changes to its lining and benign growths)

• Headache

• Feeling light-headed

• Itching of the genitals

• Thinning of the hair

• Vomiting

• Diarrhoea

• Constipation

• Changes in blood tests of liver function

• Formation of fatty liver cells

• Muscle pain

• Sensory changes (including taste disorder and numbness or tingling in the skin)

• Increased risk of blood clots (including clots in small vessels).

Uncommon: may affect up to 1 in 100 people

• Blood problems. This can make you bruise more easily, get serious infections, or feel very tired or breathless

• Changes to your vision and difficulty seeing

• Swelling of the pancreas. This may cause moderate to severe pain in the stomach

• Changes in the amount of calcium in your blood. The signs may include feeling very sick, being sick a lot or being thirsty. Tell your doctor if this happens because he or she may want you to have blood tests

• Inflammation of the lungs. The symptoms may be like pneumonia (such as feeling short of breath and coughing)

• Liver cirrhosis (problems with your liver).

Rare: may affect up to 1 in 1,000 people

• Severe blood problems. This can make you bruise more easily, get serious infections, or feel very tired or breathless

• Changes to the cornea of your eye

• Problems with the nerve that connects your retina to your brain

• Swelling of the optic nerve

• On occasions more severe liver diseases have occurred from which some patients have died. These liver diseases include inflammation of the liver, liver cirrhosis, liver cell damage, reduced bile formation, and failure of the liver. Symptoms may include a general feeling of being unwell, with or without jaundice (yellowing of the skin and eyes)

• Damage to blood vessels causing red or purple dots in the skin

• Severe skin disorder. The symptoms include redness, blistering and peeling

• Cells normally only found in the lining of the womb found elsewhere in your body, cysts on the ovaries, and cancer (the signs of this are given above)

• Non-cancerous mass in the inner lining of the vagina (called vaginal polyp)

• At the beginning of treatment, a worsening of the symptoms of your breast cancer such as an increase in pain and/or an increase in the size of the affected tissue may occur (known as tumour flare)

• Changes in the electrical activity of the heart (ECG QT prolonged).

Very rare: may affect up to 1 in 10,000 people

• Inflammation of the skin characterized by rash or erythema, very often on areas exposed to light (a condition called cutaneous lupus erythematosus)

• A skin condition characterised by skin blisters in areas exposed to the light, this is due to the increased liver production of a special group of cell pigments (called porphyrins)

• Radiation recall - skin rash involving redness, swelling, and/or blistering (like severe sunburn) of the skin after receiving radiation therapy.

Not Known (frequency cannot be estimated from the available data):

Decreased bone mineral density in premenopausal women.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the yellow card scheme at www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

By reporting side effects you can help provide more information on the safety of this medicine.

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton and foil. The expiry date refers to the last day of that month.

Do not use this medicine if you notice visible signs of deterioration such as discoloration. Do not store above 25°C.

Store in the original container or package in order to protect from light and moisture. Do not transfer the tablets to another container. Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.