Evista 60 mg film-coated tablets

Package leaflet: Information for the user

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, as you may need to read it again.

• If you have any questions, ask your doctor or pharmacist.

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

• If you experience any adverse effects, talk to your doctor or pharmacist, even if the effects are not listed in this leaflet. See section 4.

Contents of the leaflet

1. What Evista is and what it is used for

2. What you need to know before taking Evista

3. How to take Evista

4. Possible side effects

5. How to store Evista

6. Contents of the pack and other information

1. What Evista is and what it is 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 women with postmenopausal osteoporosis. A reduction in the risk of hip fractures has not been demonstrated.

How Evista works

Evista belongs to a group of non-hormonal medicines called Selective Estrogen Receptor Modulators (international acronym 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 your bones to become thin and fragile; this condition is especially common in women after menopause. Osteoporosis, although it may not cause symptoms initially, makes you more prone to bone fractures (particularly of the spine, hip, and wrist) and may lead to back pain, loss of height, and curvature of the spine.

2. What you need to know before taking Evista

Do not take Evista

• If you are or have been receiving treatment for blood clots in the legs (deep vein thrombosis), in the lungs (pulmonary embolism), or in the eyes (retinal vein thrombosis).

• If you are allergic (hypersensitive) to raloxifene or to any of the other ingredients of this medicine (listed in section 6).

• If you could still become pregnant, as Evista may harm the fetus.

• If you have liver disease (some examples of liver disease are: cirrhosis, mild liver failure, or cholestatic jaundice).

• If you have severe kidney problems.

• If you experience unexplained vaginal bleeding. If this occurs, contact your doctor for evaluation.

• If you have active uterine cancer, as there is insufficient experience with the use of Evista in women with this condition.

Warnings and precautions

Talk to your doctor or pharmacist before starting to take Evista.

• If you are going to be immobile for a period of time, such as being wheelchair-bound, being hospitalized, or bedridden due to surgery or unexpected illness, as this may increase your risk of blood clots (deep vein thrombosis, pulmonary embolism, or retinal vein thrombosis).

• If you have had a stroke (e.g., ischemic 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 insufficient experience with the use of Evista in women with this condition.

• If you are undergoing treatment with oral estrogens.

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

Menopausal symptoms (e.g., hot flushes) do not improve with Evista.

Evista reduces total cholesterol and LDL cholesterol (“bad” cholesterol). In general, it does not affect triglycerides or HDL cholesterol (“good” cholesterol). However, if you previously took estrogens and experienced a marked increase in triglycerides, be sure to inform your doctor before taking Evista.

Evista contains lactose

If your doctor has informed you that you have an intolerance to lactose, a type of sugar, consult with your doctor before taking this medicine.

Other medicines and Evista

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

If you are taking digitalis medications for the heart or anticoagulants such as warfarin to thin the blood, 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 levels, as it may reduce the effectiveness of Evista.

Pregnancy and breastfeeding

Evista is intended only for postmenopausal women. It must not be used by women who could still become pregnant. 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 these are negligible, on the ability to drive or operate machinery.

3. How to take Evista

Follow exactly the instructions for taking this medicine as given 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 each day, you are more likely to remember. You may take it with or without food.

The tablets are taken orally.

Swallow the tablet whole. If desired, you may take it with a glass of water. Do not split or crush the tablet before taking it. A split or crushed tablet may have an unpleasant taste and you may receive 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 one tablet as soon as you remember and then continue as before. Do not take a double dose to make up for forgotten doses.

If you stop taking Evista

Consult your doctor first.

It is important that you continue taking Evista for as long as your doctor has prescribed the medicine.

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

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them. Most of the adverse effects observed with Evista have been mild.

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

• Hot flushes (vasodilation)

• Influenza-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 every 100 patients) are:

• Headache, including migraines

• Leg cramps

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

• Gallstones

• Rash

• Mild breast symptoms such as pain, enlargement, or tenderness

The uncommon adverse effects (affecting between 1 and 10 in every 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 venous thrombosis)

• Reddened and painful skin around a vein (superficial venous thrombophlebitis)

• Blood clots in an artery (e.g., stroke, including increased risk of death due to stroke)

• Decreased number of platelets in the blood

Rarely, liver enzyme levels in the blood may increase during treatment with Evista.

Reporting of 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 leaflet. You may also report them directly through the national reporting system included in Appendix V. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Evista

Keep this medicine out of sight and reach of children.

Do not use this medicine after the expiry date stated on the packaging after EXP.

The expiry date refers to the last day of the month indicated.

Store in the original packaging. Do not freeze.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.

6. Pack contents 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 components are:

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

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

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

Appearance of the product and pack contents

Evista film-coated tablets are white, oval-shaped, and marked with the number 4165. They are available in blister packs or plastic bottles. Blister packs contain 14, 28 or 84 tablets. Bottles contain 100 tablets. Only certain pack sizes may be marketed.

Marketing Authorization Holder

SUBSTIPHARM, 24 rue Erlanger, 75016 Paris, France.

Manufacturer

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

For further information about this medicinal product, please contact the local representative of the Marketing Authorization Holder:

België/Belgique/Belgien   Lietuva
Daiichi Sankyo Belgium N.V.-S.A   Daiichi Sankyo Europe GmbH
Tél/Tel: +32-(0) 2 227 18 80   Tel: +49-(0) 89 7808 0

????????Luxembourg/Luxemburg
Daiichi Sankyo Europe GmbH   Daiichi Sankyo Belgium N.V.-S.A
???: +49-(0) 89 7808 0   Tél/Tel: +32-(0) 10 48 95 95

Česká republika   Magyarország
Daiichi Sankyo Europe GmbH   Goodwill Pharma Kft.
Tel: +49-(0) 89 7808 0   Tel: +36 62 443 571

Danmark   Malta
Daiichi Sankyo Europe GmbH   Charles de Giorgio Ltd.
Tlf: +49-(0) 89 7808 0   Tel: +356 25600 500

Deutschland   Nederland
Daiichi Sankyo Deutschland GmbH   Daiichi Sankyo Nederland B.V.
Tel: +49-(0) 89 7808 0   Tel: +31-(0) 20 4 07 20 72

Eesti   Norge
Daiichi Sankyo Europe GmbH   Daiichi Sankyo Europe GmbH
Tel: +49-(0) 89 7808 0   Tlf: +49-(0) 89 7808 0

Ελλάδα   Österreich
Pharmaserv-Lilly Α.Ε.Β.Ε.   Daiichi Sankyo Austria GmbH
Τηλ: +30 210 629 4600   Tel: +43-(0) 1 485 86 42 0

España   Polska
Daiichi Sankyo España, S.A.   Daiichi Sankyo Europe GmbH
Tel: +34 91 539 99 11   Tel: +49-(0) 89 7808 0

France   Portugal
Daiichi Sankyo France S.A.S.   Daiichi Sankyo Portugal, Unip. LDA
Tél: +33-(0) 1 55 62 14 60   Tel: +351 21 4232010

Hrvatska   România
Medis Adria d.o.o.   Terapia SA
Tel: +385-(0) 1 230 34 46   Tel: +40-(0) 26 45 01 502

Ireland   Slovenija
Daiichi Sankyo Ireland Ltd   Medis, d.o.o.
Tel: +353-(0) 1 489 3000   Tel: +386 1 589 69 00

Ísland   Slovenská republika
Daiichi Sankyo Europe GmbH   Daiichi Sankyo Europe GmbH
Simi: +49-(0) 89 7808 0   Tel: +49-(0) 89 7808 0

Italia   Suomi/Finland
Daiichi Sankyo Italia S.p.A.   Daiichi Sankyo Europe GmbH
Tel: +39-06 85 2551   Puh./Tel: +49-(0) 89 7808 0

Κύπρος   Sverige
Phadisco Ltd.   Daiichi Sankyo Europe GmbH
Τηλ: +357 22 715000   Tel: +49-(0) 89 7808 0

Latvija   United Kingdom
Daiichi Sankyo Europe GmbH   Daiichi Sankyo UK Ltd
Tel.: +49-(0) 89 7808 0   Tel: +44-(0) 800 028 5122

Date of the most recent review of this leaflet: Month YYYY

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