Read all of this leaflet carefully before you start taking your medicine.

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

In this leaflet:

• 1. What EVISTA is and what it is used for
• 2. Before you take EVISTA
• 3. How to take EVISTA
• 4. Possible side effects
• 5. How to store EVISTA
• 6. Further information

Do not take EVISTA:

• If you are allergic (hypersensitive) to raloxifene or any of the ingredients of EVISTA.
• If there is still a possibility that you can get pregnant, EVISTA could harm your unborn child.
• If you are being treated or have been treated for blood clots (deep vein thrombosis, pulmonary embolism or retinal vein thrombosis).
• If you have liver disease (examples of liver disease include cirrhosis, mild hepatic impairment or cholestatic jaundice).
• If you have any unexplained vaginal bleeding. This must be investigated by your doctor.
• If you have active uterine cancer, as there is insufficient experience of EVISTA use in women with this disease.
• If you have severe kidney problems.

Take special care with EVISTA

The following are reasons why this product may not be suitable for you. If any of them apply to you, talk to your doctor before you take the medicine.

• If you are immobilised for some time such as being wheel-chair bound, needing to be admitted to a hospital or having to stay in bed while recovering from an operation or an unexpected illness.
• If you are receiving oral oestrogen therapy.
• If you are suffering from breast cancer, as there is insufficient experience of EVISTA use in women with this disease.
• If you have had a cerebrovascular accident (e.g. stroke), or if your doctor has told you that you are at high risk of having one.

It is unlikely that EVISTA will cause vaginal bleeding. So any vaginal bleeding while you take EVISTA is unexpected. You should have this investigated by your doctor.

EVISTA does not treat postmenopausal symptoms, such as hot flushes.

EVISTA lowers total cholesterol and LDL ("bad") cholesterol. In general, it does not change triglycerides or HDL ("good") cholesterol. However, if you have taken oestrogen in the past and had extreme elevations in triglycerides, you should talk to your doctor before taking EVISTA.

Taking other medicines

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

If you are taking digitalis medicines for your heart or anticoagulants like warfarin to thin your blood, your doctor may need to adjust your dose of these medicines.

Tell your doctor if you are taking cholestyramine which is mainly used as lipid-lowering medicine.

Pregnancy and breast-feeding

EVISTA is for use only by postmenopausal women and must not be taken by women who could still have a baby. Evista could harm your unborn child.

Do not take EVISTA if you are breast-feeding as it might be excreted in mother's milk.

Driving and using machines

EVISTA has no known effects on driving or using machines.

Important information about some ingredients of EVISTA

If you have been told by your doctor that you have an intolerance to lactose, a type of sugar, contact your doctor before taking this medicinal product.

If you stop taking EVISTA

You should talk to your doctor first.

If you have the impression that the effect of this product is too strong or too weak, talk to your doctor or pharmacist.

If you forget to take EVISTA

Take a tablet as soon as you remember and then continue as before.

If you take more EVISTA than you should

Tell your doctor or pharmacist.

The most common side effects (affects more than 1 user in 10) are:

• Hot flushes (vasodilatation)
• Flu syndrome

Common side effects (affects 1 to 10 users in 100) are:

• Leg cramps
• Swelling of hands, feet and legs (peripheral oedema)
• Gallstones

Uncommon side effects (affects 1 to 10 users in 1000) are:

• Increased risk of blood clots in the legs (deep vein thrombosis)
• Increased risk of blood clots in the lungs (pulmonary embolism)
• Increased risk of blood clots in the eyes (retinal vein thrombosis)
• Skin around the vein is red and painful (superficial vein thrombophlebitis)

Very rare side effects (affects less than 1 user in 10,000) are:

• Rash
• Gastrointestinal symptoms such as nausea, vomiting, abdominal pain and stomach upset
• Increased blood pressure
• Decrease in the number of the platelets in the blood
• Blood clot in an artery (for example stroke)
• Headache including migraine
• Mild breast symptoms such as pain, enlargement and tenderness

In rare cases, blood levels of liver enzymes may increase during treatment with EVISTA.

What EVISTA contains

• The active substance is raloxifene hydrochloride. Each tablet contains 60 mg of raloxifene hydrochloride, which is equivalent to 56 mg raloxifene.
• The other ingredients of EVISTA tablets are:

Tablet Core: Povidone, polysorbate 80, anhydrous lactose, lactose monohydrate, crospovidone, magnesium stearate.

Tablet coating: Titanium dioxide (E 171), polysorbate 80, hypromellose, macrogol 400, carnauba wax.

Ink: Shellac, propylene glycol, indigo carmine (E 132).

What EVISTA looks like and contents of the pack

EVISTA are white, oval, film coated tablets which are marked with the number 4165. They are packed in blisters or in plastic bottles. The blister boxes contain 14, 28 or 84 tablets. The bottles contain 100 tablets. Not all pack sizes may be marketed.

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