How does it work?

Evista tablets contain the active ingredient raloxifenehydrochloride, which is a type of medicine called a selective oestrogenreceptor modulator (SERM).

Oestrogen, the main female sex hormone, has many actionsthroughout the body. Bone tissue, cholesterol metabolism, breast tissue anduterine tissue are all affected by this hormone. At the menopause, blood levelsof oestrogen start to decrease and this affects the tissues that are normallyresponsive to oestrogen.

In terms of bone tissue, declining levels of oestrogen result inan increase in bone breakdown, which can lead to a loss of bone density. Boneloss is particularly rapid for the first ten years after the menopause and itmay lead to the development of osteoporosis - a condition in which the bonesare weak and break more easily.

Raloxifene is used to both prevent and treat osteoporosis inpostmenopausal women. It works by acting on oestrogen receptors in the bonetissue, where it mimicks the natural effects of oestrogen. This graduallyreverses the excessive breakdown of bone that happens at menopause and causesan increase in bone mineral density, making bones stronger. Raloxifene has beenshown to significantly reduce the risk of spinal fractures, but not hipfractures.

Raloxifene selectively mimicks the effects of oestrogen on bonetissue, but does not affect breast tissue or uterine tissue. This means thatlong-term use does not carry the increased risk of cancer of the lining of thewomb (endometrial cancer) or breast cancer that is associated with long-termuse of oestrogen-based hormone replacement therapy (HRT). However, raloxifeneis associated with an increased risk of developing blood clots in the veins(venous thromboembolism). This risk is similar to that associated with hormonereplacement therapy (HRT).

Due to its selective activity, raloxifene is not effective atrelieving other symptoms of oestrogen deficiency that occur during themenopause, for example hot flushes.

What is it used for?

• Prevention and treatment of osteoporosis in women who have passed the menopause.

Warning!

• This medicine may increase the risk of blood clots forming in the veins (eg deep vein thrombosis/pulmonary embolism). The risk is higher if you have existing risk factors (eg personal or family history, smoking, obesity, certain blood disorders - see cautions below) and needs to be weighed against the personal benefits to you of taking this medicine. Discuss these with your doctor before starting treatment. The risk of blood clots with raloxifene is similar to that associated with hormone replacement therapy (HRT).
• The risk of blood clots forming in the veins (thromboembolism) while taking this medicine may be temporarily increased if you have surgery, or experience major trauma or other illnesses or conditions that cause you to be immobile for prolonged periods of time. If you suffer an illness or condition that results in you becoming immobile for a prolonged time, you should stop taking this medicine as soon as possible and not start taking it again until you are moving around fully. If you know in advance that you will be immobile for some time, for example due to planned surgery, then your doctor will usually ask you to stop taking this medicine three days beforehand and not to restart it until you are fully mobile again. Discuss this with your doctor.
• If you experience any vaginal bleeding while taking this medicine you should consult your doctor so this can be investigated.

Use with caution in

• Women at risk of developing blood clots in the veins (eg deep vein thrombosis or pulmonary embolism) for example due to a family history of blood clots, smoking, obesity, or blood disorders such as antiphospholipid syndrome or factor V Leiden.
• Women with a history or risk of stroke or mini-stroke (transient ischaemic attack).
• Irregular heartbeat caused by very rapid contraction of the top two chambers of the heart (atrial fibrillation).
• Breast cancer (the manufacturer recommends that this medicine should not be used until any treatment for breast cancer is finished).
• Women who have had raised levels of a type of fat called triglycerides in their blood (hypertriglyceridaemia) as a result of taking an oral oestrogen-based medicine (eg the contraceptive pill or HRT). (If this applies to you, your blood triglyceride levels should be monitored while you are taking this medicine.)

Not to be used in

• Women with a blood clot in a vein, eg blood clot in a vein of the leg (deep vein thrombosis), in the lungs (pulmonary embolism), or in the eye (retinal vein thrombosis), or a history of these conditions.
• Women with signs or symptoms of cancer of the lining of the womb (endometrial cancer).
• Severely decreased kidney function.
• Decreased liver function.
• Failure of the normal flow of bile from the liver to the intestines (cholestasis)which can result in jaundice.
• Vaginal bleeding of unknown cause.
• Pregnancy.
• Women who could get pregnant (a woman is considered fertile for two years after her last menstrual period if she is under 50, or for one year if over 50).
• Breastfeeding.
• Rare hereditary problems of galactose intolerance, the Lapp lactase deficiency, or glucose-galactose malabsorption (Evista tablets contain lactose).

This medicine should not be used if you are allergic to one orany of its ingredients. Please inform your doctor or pharmacist if you havepreviously experienced such anallergy.If you feel you haveexperienced an allergic reaction, stop using this medicine and inform yourdoctor or pharmacist immediately.

Pregnancy and Breastfeeding

Certain medicines should not be used during pregnancy orbreastfeeding. However, other medicines may be safely used in pregnancy orbreastfeeding providing the benefits to the mother outweigh the risks to theunborn baby. Always inform your doctor if you are pregnant or planning apregnancy, before using any medicine.

• This medicine must not be used during pregnancy, or by women who could get pregnant, as it may be harmful to a developing foetus. (A woman is considered fertile for two years after her last menstrual period if she is under 50, or for one year if over 50. If you fall into this group, you should make sure you use adequate methods of contraception to prevent pregnancy while taking this medicine.) Consult your doctor immediately if you get pregnant during treatment.
• It is not known if this medicine passes into breast milk. It should not be used by breastfeeding women, because of the potential harm it may cause to nursing infants. Seek medical advice from your doctor.

Side effects

Medicines and their possible side effects can affect individualpeople in different ways. The following are some of the side effects that areknown to be associated with this medicine. Because a side effect is statedhere, it does not mean that all people using this medicine will experience thator any side effect.

• Hot flushes
• Flu-like symptoms
• Leg cramps
• Swelling of the legs and ankles due to excess fluid retention (peripheral oedema)
• Blood clots in the veins (eg, DVT, pulmonary embolism, retinal vein thrombosis - see warnings above)
• Decreased numbers of platelets in the blood
• Abdominal pain
• Indigestion (dyspepsia)
• Nausea and vomiting
• Migraine
• Headache
• Rash
• Rise in blood pressure
• Breast pain, englargement or tenderness
• Blood clot in an artery (eg stroke)

The side effects listed above may not include all of the sideeffects reported by the drug'smanufacturer.For moreinformation about any other possible risks associated with this medicine,please read the information provided with the medicine or consult your doctoror pharmacist.

How can this medicine affect other medicines?

It is important to tell your doctor or pharmacist what medicinesyou are already taking, including those bought without a prescription andherbal medicines, before you start treatment with this medicine. Similarly,check with your doctor or pharmacist before taking any new medicines whiletaking this one, to ensure that thecombination is safe.

Raloxifene has not been studied in combination with medicinesused to treat breast cancer, and it is not known what effect it might have onthese medicines. For this reason, women with breast cancer should only takeraloxifene after their breast cancer treatment has been completed.

The manufacturer has not studied the effect of taking raloxifenein combination with medicines that contain oestrogen, eg HRT. For this reason,they recommend that women taking this medicine do not use oestrogen-containingmedicines taken by mouth, injection, patch, gel, nasal spray or implant.Vaginal oestrogens (used to relieve the vaginal symptoms of the menopause) maybe used.

The following medicines reduce the absorption of raloxifene fromthe gut and should not be taken at the same time as raloxifene:

• cholestyramine
• colestipol.

This medicine may reduce the anti-blood-clotting effect ofanticoagulant medicines such as warfarin. Women taking an anticoagulant shouldhave their blood clotting time (INR) checked after starting treatment with thismedicine; any effect on blood clotting time may develop over severalweeks.

Other medicines containing the same active ingredient

There are currently no other medicines available in the UK thatcontain raloxifene as the active ingredient.