Product Information for the User

Evista 60 mg Film-Coated Tablets

Hydrochloride of Raloxifene

Read this entire product information carefully before starting to take this medicine, as it contains important information for you.

• Keep this product information, as you may need to read it again.

• If you have any doubts, consult your doctor or pharmacist.

• This medicine has been prescribed only for you, and you must not give it to others, even if they have the same symptoms as you, as it may harm them.

• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this product information. See section 4.

1. What you need to know before starting to take Evista

1. How to take Evista

1. Possible adverse effects

1. Storage of Evista

1. Contents of the pack and additional information

Evista contains the active substance hydrochloride of raloxifene.

Evista is used for the treatment and prevention of osteoporosis in postmenopausal women. Evista reduces the risk of vertebral fractures in women with postmenopausal osteoporosis. No reduction in the risk of hip fractures has been demonstrated.

How Evista works

Evista belongs to a group of non-hormonal medications called Selective Estrogen Receptor Modulators (the international acronym is SERM). When a woman reaches menopause, the level of female sex hormones (estrogens) decreases. Evista produces some of the beneficial effects of estrogens after menopause.

Osteoporosis is a disease that causes bones to wear away and become fragile; this disease is especially common in women after menopause. Osteoporosis, although initially may not produce symptoms, predisposes you to bone fractures (especially of the spine, hip, and wrist) and can cause back pain, loss of height, and curvature of the spine.

Do not take Evista

• If you are or have been treated for blood clots in the legs (deep vein thrombosis), lungs (pulmonary embolism), or eyes (retinal vein thrombosis).
• If you are allergic (hypersensitive) to raloxifene or any of the other components of this medication (listed in section 6).
• If you may still become pregnant, as Evista could harm the fetus.
• If you have any liver disease (some examples of liver disease are: cirrhosis, mild liver insufficiency, or cholestatic jaundice).

• If you have severe kidney problems.
• If you observe unexplained vaginal bleeding. If this occurs, contact your doctor for further study..
• If you have active uterine cancer, as there is not enough experience with the use of Evista in women with this condition.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Evista.

• If you are to be immobilized for a certain period of time, such as being in a wheelchair, hospitalized, or recovering from surgery or an unexpected illness, as the risk of blood clots (deep vein thrombosis, pulmonary embolism, or retinal vein thrombosis) may be increased.
• If you have had a stroke (for example, cerebral hemorrhage) or if your doctor has told you that you are at high risk of having one.
• If you have liver disease.

• If you have breast cancer, as there is not enough experience with the use of Evista in women with this condition.
• If you are taking oral estrogen therapy.

It is unlikely that Evista will cause vaginal bleeding. Therefore, any vaginal bleeding that occurs during Evista treatment should be considered unexpected and should be investigated by your doctor.

Menopausal symptoms (such as hot flashes) do not improve with Evista.

Evista decreases total cholesterol and LDL ("bad") cholesterol. In general, it does not modify triglycerides or HDL ("good") cholesterol. However, if you have taken estrogens previously and they have excessively increased your triglycerides, inform your doctor before taking Evista.

Evista contains lactose

If your doctor has told you that you have lactose intolerance, consult with them before taking this medication.

Other medications and Evista

Inform your doctor or pharmacist if you are taking, have taken recently, or may take any other medication, including those purchased without a prescription.

If you are taking digitalis medications for the heart or anticoagulants such as warfarin to increase blood flow, your doctor may need to adjust the dose of your medication.

Inform your doctor if you are taking cholestyramine, which is a medication used to reduce fat content, as it may decrease the effectiveness of Evista.

Pregnancy and lactation

Only postmenopausal women should use Evista. Women who may still become pregnant should not use it. Evista could harm the fetus.

Do not take Evista during lactation as it may be excreted in breast milk.

Driving and operating machines

Evista has no effects, or these are insignificant, on the ability to drive or operate machines.

Follow exactly the administration instructions for this medication as indicated by your doctor. If in doubt, consult your doctor or pharmacist again.

The dose is one tablet per day. It does not matter at what time of day you take the tablet. However, if you take it at the same time every day, you will remember it more easily. You can take it with or without food.

The tablets are administered orally.

Swallow the tablet whole. If you wish, you can take it with a glass of water. Do not break or crush the tablet before taking it. A broken or crushed tablet may have an unpleasant taste and you may take an incorrect dose.

Your doctor will tell you for how long you should take Evista. Your doctor may advise you to take calcium and vitamin D supplements.

If you take more Evista than you should

Contact your doctor or pharmacist. If you take more Evista than you should, you may experience leg cramps and dizziness.

If you forgot to take Evista

Take a tablet as soon as you remember and continue as before..Do not take a double dose to make up for the missed doses.

If you interrupt treatment with Evista

Consult your doctor beforehand.

It is important that you continue to take Evista for as long as your doctor prescribes the medication.

Evista can only treat or prevent your osteoporosis if you continue to take the tablets.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Like all medications, this medication may produce adverse effects, although not all people will experience them. Most adverse effects observed with Evista have been mild.

The most frequent adverse effects (affecting more than 1 in 10 patients) are:

• Hot flashes (vasodilation)

• Flu-like syndrome

• Gastrointestinal symptoms such as nausea, vomiting, abdominal pain, and stomach discomfort
• Increased blood pressure

The frequent adverse effects (affecting between 1 and 10 in 100 patients) are:

• Headache, including migraines

• Leg cramps

• Swelling of hands, feet, and legs (peripheral edema)

• Formation of gallstones

• Rash

• Mild symptoms in the breast, such as pain, enlargement, or sensitivity

The less frequent adverse effects (affecting between 1 and 10 in 1,000 patients) 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)

• Redness and pain around a vein (superficial venous thrombophlebitis)
• Blood clots in an artery (e.g., stroke, including increased risk of death from stroke)
• Decreased platelet count in the blood

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

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this prospectus. You can also report them directly through the national notification system included in Appendix V. By reporting adverse effects, you can contribute to providing more information about the safety of this medication.

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

Do not use this medication after the expiration date that appears on the packaging after CAD.

The expiration date is the last day of the month indicated.

Store in the original packaging. Do not freeze.

Medications should not be disposed of through drains or trash. Ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

Evista Composition

• The active ingredient is hydrochloride of raloxifeno. Each tablet contains 60 mg of hydrochloride of raloxifeno, which is equivalent to 56 mg of raloxifeno

• The other components are:

Tablet core: Povidone, polisorbate 80, anhydrous lactose, lactose monohydrate, crospovidone, magnesium stearate.

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

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

Product appearance and packaging contents

The coated Evista tablets are white, oval-shaped and have the number 4165 printed on them. They are presented in blisters or plastic bottles. The blister packs contain 14, 28 or 84 tablets. The bottles contain 100 tablets. Some packaging sizes may only be marketed.

Marketing Authorization Holder

SUBSTIPHARM, 24 rue Erlanger, 75016 Paris, France.

Responsible for Manufacturing

Lilly S.A., Avda. de la Industria 30, 28108 Alcobendas (Madrid), Spain.

For more information about this medicine, please contact the local representative of the marketing authorization holder:

België/Belgique/ BelgienLietuva

Daiichi Sankyo Belgium N.V.-S.ADaiichi Sankyo Europe GmbH

Tel: +32-(0) 2 227 18 80Tel: +49-(0) 89 7808 0

????????Luxembourg/Luxemburg

Daiichi Sankyo Europe GmbHDaiichi Sankyo Belgium N.V.-S.A

Tel: +49-(0) 89 7808 0Tel: +32-(0) 10 48 95 95

Ceská republikaMagyarország

Daiichi Sankyo Europe GmbHGoodwill Pharma Kft.

Tel: +49-(0) 89 7808 0Tel: +36 62443 571

DanmarkMalta

Daiichi Sankyo Europe GmbHCharles de Giorgio Ltd.

Tlf: +49-(0) 89 7808 0Tel: +356 25600 500

DeutschlandNederland

Daiichi Sankyo Deutschland GmbHDaiichi Sankyo Nederland B.V.

Tel: +49-(0) 89 7808 0Tel: +31-(0) 20 4 07 20 72

EestiNorge

Daiichi Sankyo Europe GmbHDaiichi Sankyo Europe GmbH

Tel: +49-(0) 89 7808 0Tlf: +49-(0) 89 7808 0

Ελλ?δαÖsterreich

Φαρμασερβ-Λιλλυ Α.Ε.Β.Ε.Daiichi Sankyo Austria GmbH

Tel: +30 210 629 4600Tel: +43-(0) 1 485 86 42 0

EspañaPolska

Daiichi Sankyo España, S.A.Daiichi Sankyo Europe GmbH

Tel: +34 91 539 99 11Tel: +49-(0) 89 7808 0

FrancePortugal

Daiichi Sankyo France S.A.S.Daiichi Sankyo Portugal, Unip. LDA

Tel: +33-(0) 1 55 62 14 60Tel: +351 21 4232010

HrvatskaRomânia

Medis Adria d.o.o.Terapia SA

Tel: +385-(0) 1 230 34 46Tel: +40-(0) 26 45 01 502

IrelandSlovenija

Daiichi Sankyo Ireland LtdMedis, d.o.o.

Tel: +353-(0) 1 489 3000Tel: +386 1 589 69 00

ÍslandSlovenská republika

Daiichi Sankyo Europe GmbHDaiichi Sankyo Europe GmbH

Tel: +49-(0) 89 7808 0Tel: +49-(0) 89 7808 0

ItaliaSuomi/Finland

Daiichi Sankyo Italia S.p.A.Daiichi Sankyo Europe GmbH

Tel: +39-06 85 2551Tel: +49-(0) 89 7808 0

Κ?προςSverige

Phadisco Ltd.Daiichi Sankyo Europe GmbH

Tel: +357 22 715000Tel: +49-(0) 89 7808 0

LatvijaUnited Kingdom

Daiichi Sankyo Europe GmbHDaiichi Sankyo UK Ltd

Tel: +49-(0) 89 7808 0Tel: +44-(0) 800 028 5122

Fecha de la última revisión de este prospecto: mes AAAA

The detailed information about this medicine is available on the website of the European Medicines Agency (EMA) :http://www.ema.europa.eu