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Evista 60mg film-coated tablets 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. 2. 3. 4. 5. 6. What EVISTA is and what it is used for Before you take EVISTA How to take EVISTA Possible side effects How to store EVISTA Further information
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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.
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Do not take EVISTA if you are breast-feeding as it might be excreted in mother's milk.
The most common side effects (affects more than 1 user in 10) are:
Hot flushes (vasodilatation) Flu syndrome
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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.
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).
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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/Belgi/Belgien Daiichi Sankyo Belgium N.V.-S.A Tl/Tel:+32-(0) 10 48 95 95 " " .. - :+359 2 491 41 40 esk republika Eli Lilly R, s.r.o. Tel:+420 234 664 111 Danmark Eli Lilly Danmark A/S Tlf:+45 45 26 60 00 Deutschland Daiichi Sankyo Deutschland GmbH Tel:+49-(0) 89 7808 0 Eesti Eli Lilly Holdings Limited. Eesti filiaal Tel:+3726441100 - .... :+30 210 629 4600 Espaa Daiichi Sankyo Espaa, S.A. Tel:+34- 91 539 99 11 France Daiichi Sankyo France SAS. Tl:+33-(0) 1 55 62 14 60 Ireland Daiichi Sankyo UK Ltd Tel:+44-(0) 1753 893 600 sland Eli Lilly Danmark A/S tib slandi Tel:+354 520 34 00 Italia Daiichi Sankyo Italia S.p.A. Tel:+39-06 85 2551 Phadisco Ltd :+357 22 715000 Latvija
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Eli Lilly Holdings Limited prstvniecba Latvij Tel:+371 67364000 Lietuva Eli Lilly Holdings Limited atstovyb Tel:+370 (5) 2649600 Luxembourg/Luxemburg Daiichi Sankyo Belgium N.V.-S.A Tl/Tel:+32-(0) 10 48 95 95 Magyarorszg Lilly Hungria Kft. Tel:+36 1 328 5100 Malta Charles de Giorgio Ltd. Tel:+356 25600 500 Nederland Daiichi Sankyo Nederland B.V. Tel:+31-(0) 20 4 07 20 72 Norge Eli Lilly Norge A.S. Tlf:+47 22 88 18 00 sterreich Daiichi Sankyo Austria GmbH Tel:+43-(0) 1 485 86 420 Polska Eli Lilly Polska Sp. z o.o. Tel:+48 (0) 22 440 33 00 Portugal Daiichi Sankyo Portugal, Lda. Tel:+351 21 4232010 Romnia Eli Lilly Romnia S.R.L. Tel:+40 21 4023000 Slovenija Eli Lilly farmacevtska druba, d.o.o. Tel:+386 (0)1 580 00 10 Slovensk republika Eli Lilly Slovakia, s.r.o. Tel:+421 220 663 111 Suomi/Finland Oy Eli Lilly Finland Ab Puh/Tel:+358-(0) 9 85 45 250 Sverige Eli Lilly Sweden AB Tel:+46-(0) 8 7378800 United Kingdom Daiichi Sankyo UK Ltd Tel:+44-(0) 1753 893 600 This leaflet was last approved in: August 2008 Detailed information on this medicine is available on the European Medicines Agency (EMEA) web site: http://www.emea.europa.eu
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