Evista tablets contain the active ingredient raloxifene hydrochloride, which is a type of medicine called a selective oestrogen receptor modulator (SERM).
Oestrogen, the main female sex hormone, has many actions throughout the body. Bone tissue, cholesterol metabolism, breast tissue and uterine tissue are all affected by this hormone. At the menopause, blood levels of oestrogen start to decrease and this affects the tissues that are normally responsive to oestrogen.
In terms of bone tissue, declining levels of oestrogen result in an increase in bone breakdown, which can lead to a loss of bone density. Bone loss is particularly rapid for the first ten years after the menopause and it may lead to the development of osteoporosis - a condition in which the bones are weak and break more easily.
Raloxifene is used to both prevent and treat osteoporosis in postmenopausal women. It works by acting on oestrogen receptors in the bone tissue, where it mimicks the natural effects of oestrogen. This gradually reverses the excessive breakdown of bone that happens at menopause and causes an increase in bone mineral density, making bones stronger. Raloxifene has been shown to significantly reduce the risk of spinal fractures, but not hip fractures.
Raloxifene selectively mimicks the effects of oestrogen on bone tissue, but does not affect breast tissue or uterine tissue. This means that long-term use does not carry the increased risk of cancer of the lining of the womb (endometrial cancer) or breast cancer that is associated with long-term use of oestrogen-based hormone replacement therapy (HRT). However, raloxifene is associated with an increased risk of developing blood clots in the veins (venous thromboembolism). This risk is similar to that associated with hormone replacement therapy (HRT).
Due to its selective activity, raloxifene is not effective at relieving other symptoms of oestrogen deficiency that occur during the menopause, for example hot flushes.
This medicine should not be used if you are allergic to one or any of its ingredients. Please inform your doctor or pharmacist if you have previously experienced such an allergy.If you feel you have experienced an allergic reaction, stop using this medicine and inform your doctor or pharmacist immediately.
Certain medicines should not be used during pregnancy or breastfeeding. However, other medicines may be safely used in pregnancy or breastfeeding providing the benefits to the mother outweigh the risks to the unborn baby. Always inform your doctor if you are pregnant or planning a pregnancy, before using any medicine.
Medicines and their possible side effects can affect individual people in different ways. The following are some of the side effects that are known to be associated with this medicine. Because a side effect is stated here, it does not mean that all people using this medicine will experience that or any side effect.
The side effects listed above may not include all of the side effects reported by the drug's manufacturer.For more information about any other possible risks associated with this medicine, please read the information provided with the medicine or consult your doctor or pharmacist.
It is important to tell your doctor or pharmacist what medicines you are already taking, including those bought without a prescription and herbal medicines, before you start treatment with this medicine. Similarly, check with your doctor or pharmacist before taking any new medicines while taking this one, to ensure that the combination is safe.
Raloxifene has not been studied in combination with medicines used to treat breast cancer, and it is not known what effect it might have on these medicines. For this reason, women with breast cancer should only take raloxifene after their breast cancer treatment has been completed.
The manufacturer has not studied the effect of taking raloxifene in combination with medicines that contain oestrogen, eg HRT. For this reason, they recommend that women taking this medicine do not use oestrogen-containing medicines taken by mouth, injection, patch, gel, nasal spray or implant. Vaginal oestrogens (used to relieve the vaginal symptoms of the menopause) may be used.
The following medicines reduce the absorption of raloxifene from the gut and should not be taken at the same time as raloxifene:
This medicine may reduce the anti-blood-clotting effect of anticoagulant medicines such as warfarin. Women taking an anticoagulant should have their blood clotting time (INR) checked after starting treatment with this medicine; any effect on blood clotting time may develop over several weeks.
There are currently no other medicines available in the UK that contain raloxifene as the active ingredient.