EVISTA 60 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Evista 60 mg Film-Coated Tablets

raloxifene hydrochloride

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• 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 only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.

• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

1. What is Evista and what is it used for

1. What you need to know before you take Evista

1. How to take Evista

1. Possible side effects

1. Storage of Evista

1. Contents of the pack and other information

1. What is Evista and what is it used for

Evista contains the active substance raloxifene hydrochloride.

Evista is used for the treatment and prevention of osteoporosis in postmenopausal women. Evista reduces the risk of vertebral fractures in postmenopausal women with osteoporosis. It has not been shown to reduce the risk of hip fractures.

How Evista works

Evista belongs to a group of non-hormonal medicines called Selective Estrogen Receptor Modulators (the international abbreviation 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 makes your bones waste away and become fragile; this disease is especially common in women after menopause. Osteoporosis, although it may not cause symptoms at first, 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.

2. What you need to know before you take Evista

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 ingredients of this medicine (listed in section 6).
• If you may still be able to become pregnant, as Evista may harm the fetus.
• If you have liver disease (some examples of liver disease are: cirrhosis, mild hepatic insufficiency, or cholestatic jaundice).

• If you have severe kidney problems.
• If you notice unexplained vaginal bleeding. If this happens, contact your doctor for examination.
• If you have active uterine cancer, as there is not enough experience with the use of Evista in women with this disease.

Warnings and precautions

Consult your doctor or pharmacist before taking Evista.

• If you are to be immobilized for a certain period, such as being in a wheelchair, hospitalized, or bedridden after surgery or 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 (e.g., stroke) 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 disease.
• If you are taking estrogen therapy by mouth.

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

Postmenopausal symptoms (e.g., hot flashes) do not improve with Evista.

Evista decreases total cholesterol and LDL ("bad") cholesterol. In general, it does not change triglycerides or HDL ("good") cholesterol. However, if you have taken estrogens before and they have excessively increased your triglycerides, do not fail to mention this to your doctor before taking Evista.

Evista contains lactose

If your doctor has told you that you have an intolerance to some sugars, contact them before taking this medicine.

Other medicines and Evista

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those obtained without a prescription.

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

Tell your doctor if you are taking colestyramine, a medicine used to reduce fat content, as it may decrease the effectiveness of Evista.

Pregnancy and breastfeeding

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

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

Driving and using machines

Evista has no effects, or negligible effects, on the ability to drive or use machines.

3. How to take Evista

Follow exactly the administration instructions of this medicine given by your doctor. If in doubt, consult your doctor or pharmacist again.

The dose is one tablet per day. It does not matter what time of day you take the tablet. However, if you take it every day at the same time, 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 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 forget 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 forgotten doses.

If you stop taking Evista

Consult your doctor beforehand.

It is important that you continue taking Evista for as long as your doctor prescribes it.

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

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. Most side effects seen with Evista have been mild.

The most common side 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

Common side effects (affecting between 1 and 10 in 100 patients) are:

• Headache, including migraines

• Leg cramps

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

• Gallstones

• Rash

• Mild breast symptoms, such as pain, increased size, or tenderness

Uncommon side 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 painful sensation of the skin 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 of side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Evista

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

Do not use this medicine after the expiry date which is stated on the carton after EXP.

The expiry date is the last day of the month stated.

Store in the original package. Do not freeze.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

Composition of Evista

• The active substance is raloxifene hydrochloride. Each tablet contains 60 mg of raloxifene hydrochloride, equivalent to 56 mg of raloxifene.

• The other ingredients are:

Core of the tablet: povidone, polysorbate 80, anhydrous lactose, lactose monohydrate, crospovidone, magnesium stearate.

Coating of the tablet: titanium dioxide (E 171), polysorbate 80, hypromellose, macrogol 400, carnauba wax.

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

Appearance and packaging

Evista film-coated tablets are white, oval, and engraved with the number 4165. They are available in blister packs or plastic bottles. The blister packs contain 14, 28, or 84 tablets. The bottles contain 100 tablets. Not all pack sizes may be marketed.

Marketing Authorisation Holder

SUBSTIPHARM, 24 rue Erlanger, 75016 Paris, France.

Manufacturer

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

You can request more information about this medicine from the local representative of the Marketing Authorisation Holder:

Belgium/België/BelgienLithuania

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

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

BulgariaLuxembourg/Luxemburg

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

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

Czech RepublicHungary

Daiichi Sankyo Europe GmbH Goodwill Pharma Kft.

Tel: +49-(0) 89 7808 0 Tel: +36 62 443 571

DenmarkMalta

Daiichi Sankyo Europe GmbH Charles de Giorgio Ltd.

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

GermanyNetherlands

Daiichi Sankyo Deutschland GmbH Daiichi Sankyo Nederland B.V.

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

EstoniaNorway

Daiichi Sankyo Europe GmbH Daiichi Sankyo Europe GmbH

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

GreeceAustria

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

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

SpainPoland

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

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

FrancePortugal

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

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

CroatiaRomania

Medis Adria d.o.o. Terapia SA

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

IrelandSlovenia

Daiichi Sankyo Ireland Ltd Medis, d.o.o.

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

IcelandSlovakia

Daiichi Sankyo Europe GmbH Daiichi Sankyo Europe GmbH

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

ItalyFinland

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

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

CyprusSweden

Phadisco Ltd. Daiichi Sankyo Europe GmbH

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

LatviaUnited Kingdom

Daiichi Sankyo Europe GmbH Daiichi Sankyo UK Ltd

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

Date of last revision of this leaflet: month YYYY

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