Daiichi Sankyo Ireland Ltd

PACKAGE LEAFLET: INFORMATION FOR THE USER

EVISTA 60 mg film coated tablets
raloxifene hydrochloride

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

1. WHAT EVISTA IS AND WHAT IT IS USED FOR

EVISTA belongs to a group of non-hormonal medicines called Selective Oestrogen Receptor Modulators (SERMs). When a woman reaches the menopause, the level of the female sex hormone oestrogen goes down. EVISTA mimics some of the helpful effects of oestrogen after the menopause.

EVISTA is used to treat and prevent 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 shown.

Osteoporosis is a disease that causes your bones to become thin and fragile - this disease is especially common in women after the menopause. Although it may have no symptoms at first, osteoporosis makes you more likely to break bones, especially in your spine, hips and wrists and may cause back pain, loss of height and a curved back.

2. BEFORE YOU TAKE EVISTA

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.

3. How to take EVISTA

Always take this product exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

The dose is one tablet a day. It does not matter what time of day you take your tablet but taking the tablet at the same time each day will help you remember to take it. You may take it with or without food.

The tablets are for oral use.
Swallow the tablet whole. If you wish you may take a glass of water with it.

Your doctor will tell you how long you should continue to take EVISTA. The doctor may also advise you to take calcium and vitamin D supplements.

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.

4. POSSIBLE SIDE EFFECTS

Like all medicines, EVISTA can cause side effects although not everybody gets them. The majority of side effects seen with EVISTA have been mild.

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.

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.

5. HOW TO STORE EVISTA

Keep out of the reach and sight of children.

Do not use after the expiry date which is stated on the pack.

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. These measures will help to protect the environment.

6. FURTHER INFORMATION

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.

Marketing Authorisation Holder
Daiichi Sankyo Europe GmbH, Zielstattstrasse 48, D-81379 Munich, Germany.

Manufacturer

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

For any information about this medicinal product, please contact the representative in your country:

Belgique/België/Belgien Daiichi Sankyo Belgium N.V.-S.A Tél/Tel: +32-(0) 10 48 95 95	Luxembourg/Luxemburg Daiichi Sankyo Belgium N.V.-S.A Tél/Tel: +32-(0) 10 48 95 95
България ТП "Ели Лили Недерланд" Б.В. - България Тел: +359 2 491 41 40	Magyarország Lilly Hungária Kft. Tel: +36 1 328 5100
Česká republika Eli Lilly ČR, s.r.o. Tel: +420 234 664 111	Malta Charles de Giorgio Ltd. Tel: +356 25600 500
Danmark Eli Lilly Danmark A/S Tlf: +45 45 26 60 00	Nederland Daiichi Sankyo Nederland B.V. Tel: +31-(0) 20 4 07 20 72
Deutschland Daiichi Sankyo Deutschland GmbH Tel: +49-(0) 89 7808 0	Norge Eli Lilly Norge A.S. Tlf: +47 22 88 18 00
Eesti Eli Lilly Holdings Limited. Eesti filiaal Tel: +3726441100	Österreich Daiichi Sankyo Austria GmbH Tel: +43-(0) 1 485 86 420
Ελλάδα Φαρμασερβ-Λιλλυ Α.Ε.Β.Ε. Τηλ: +30 210 629 4600	Polska Eli Lilly Polska Sp. z o.o. Tel: +48 (0) 22 440 33 00
España Daiichi Sankyo España, S.A. Tel: +34- 91 539 99 11	Portugal Daiichi Sankyo Portugal, Lda. Tel: +351 21 4232010
France Daiichi Sankyo France SAS. Tél: +33-(0) 1 55 62 14 60	România Eli Lilly România S.R.L. Tel: +40 21 4023000
Ireland Daiichi Sankyo UK Ltd Tel: +44-(0) 1753 893 600	Slovenija Eli Lilly farmacevtska družba, d.o.o. Tel: +386 (0)1 580 00 10
Ísland Eli Lilly Danmark A/S, Útibú á Íslandi Tel: +354 520 34 00	Slovenská republika Eli Lilly Slovakia, s.r.o. Tel: +421 220 663 111
Italia Daiichi Sankyo Italia S.p.A. Tel: +39-06 85 2551	Suomi/Finland Oy Eli Lilly Finland Ab Puh/Tel: +358-(0) 9 85 45 250
Κύπρος Phadisco Ltd Τηλ: +357 22 715000	Sverige Eli Lilly Sweden AB Tel: +46-(0) 8 7378800
Latvija Eli Lilly Holdings Limited pārstāvniecība Latvijā Tel: +371 67364000	United Kingdom Daiichi Sankyo UK Ltd Tel: +44-(0) 1753 893 600
Lietuva Eli Lilly Holdings Limited atstovybė Tel: +370 (5) 2649600

This leaflet was last approved on:

Detailed information on this medicine is available on the European Medicines Agency (EMEA) web site: http://www.emea.europa.eu