Product Details

What you need to know before you take Tamoxifen

Do not take Tamoxifen: • If you are allergic to tamoxifen or any of the other ingredients of this medicine (listed in section 6). • If you are pregnant or think you might be pregnant (see ‘Pregnancy and breast-feeding’ in section 2 of this leaflet for further information). If you are a woman of child-bearing age, a pregnancy test should normally be taken to confirm if you are pregnant before starting treatment. • If you are taking another medicine for the treatment of breast cancer known as anastrozole • If you are taking any treatment for treating your infertility • If you have had blood clots in the past and the doctor did not know what caused them • If you have a family history of blood clots with the cause not known • If your doctor has told you that you have an illness which runs in the family that increases the risk of blood clots • If you are taking medicines used to prevent blood clots such as warfarin Do not take Tamoxifen if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before taking Tamoxifen. Warnings and precautions Talk to your doctor or pharmacist before taking Tamoxifen. When you take tamoxifen, you have a 2 to 3 times increased risk of a developing a blood clot in your vein. You should speak to your doctor before taking this medicine as the risk is greater if: • you are elderly • you or a member of your family have had a blood clot in the past • you are very overweight (obese), smoke (or have smoked in the past) or have heart or circulatory problems • you are being given chemotherapy for your 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 a history of hereditary angioedema as Tamoxifen 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. If your doctor considers that you are at risk of blood clots, they may give you an anticoagulant. This is a medicine that thins your blood and reduces your risk of forming a blood clot. When you take tamoxifen to treat breast cancer, you may stop having your monthly periods. Surgery and immobility If you are to have surgery, or you will be unable to move around for a long time, you should take the following precautions: • If you are taking tamoxifen for infertility: you should stop taking tamoxifen at least 6 weeks beforehand and you should not start taking tamoxifen again until you are fully mobile. • If you are taking tamoxifen for breast cancer: your doctor may decide that it is better to carry on taking tamoxifen. You may be given special stockings called compression stockings to wear whilst you are in hospital or they may give you an anticoagulant. These reduce the risk of a blood clot. Tamoxifen treatment 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 pelvic 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. Children This medicine is not for use in children. Other medicines and Tamoxifen Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription. Do not take tamoxifen if you are taking another medicine for the treatment of breast cancer such as anastrozole, letrozole and exemestane. Also, tell your doctor if you are taking: • Oral contraceptives • Hormone replacement therapy (HRT) • Paroxetine, fluoxetine (e.g. selective serotonin reuptake inhibitor (SSRI) antidepressants) • Bupropion (antidepressant or aid to smoking cessation) • Quinidine (for example used in the treatment of cardiac arrhythmia) • Cinacalcet (for treatment of disorders of the parathyroid gland) or the following: • anticoagulant medicines (to thin your blood), e.g. warfarin. Tamoxifen may increase the effects of these medicines. Your doctor will monitor your blood regularly, especially when you start or stop treatment • cytotoxic agents (used to treat cancer). These medicines increase the risk of a blood clot. Your doctor may give you another medicine to stop your blood clotting too easily. • rifampicin, an antibiotic used to treat infections such as tuberculosis (TB). Pregnancy and breast-feeding Do not take Tamoxifen if you are pregnant or breast-feeding as this medicine could harm your baby. If you are taking tamoxifen for the treatment of infertility, you must always take a pregnancy test before you start to take this medicine. If the result is positive, or you are not sure, do not take tamoxifen and talk to your doctor. If you are taking tamoxifen for the treatment of breast cancer and are of child-bearing age, a pregnancy test should normally be taken before you start to take this medicine to confirm that you are not pregnant. If you think you may be pregnant or are planning to have a baby, do not take tamoxifen and contact your doctor as soon as possible for advice. When you are taking tamoxifen, if you are sexually active, you should use a barrier method or other non-hormonal method of contraception (e.g. condom). You should not become pregnant while taking this medicine and for nine months after you stop taking it. Please see your doctor for contraception advice. Do not breast-feed your baby while taking this medicine and for nine months after stopping treatment. Tamoxifen may pass into breast milk. Driving and using machines Do not drive or operate machinery if you feel light-headed, or you have eyesight problems while taking this medicine. Tamoxifen contains sodium This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free’