EVISTA

Package leaflet: Information for the user

Evista 60 mg film-coated tablets

raloxifene hydrochloride
Please read 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 questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Never give it to other people, even if they have the same symptoms as yours, because it could be harmful.
• If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this 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 is Evista and what is it used for?

Evista contains the active substance raloxifene hydrochloride.
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 demonstrated.

How Evista works:
Evista belongs to a group of non-hormonal medicines called Selective Estrogen Receptor Modulators (SERMs). When a woman reaches menopause, the level of the female sex hormone, estrogen, decreases. Evista mimics some of the beneficial effects of estrogen after menopause.

Osteoporosis is a disease that causes bones to become thin and fragile – this disease is particularly common in women after menopause. Although the disease may not cause symptoms in its early stages, osteoporosis increases the risk of fractures, especially in the spine, hips, and wrists, and may lead to back pain, loss of height, and a stooped posture.

2. What you should know before taking Evista

Do not take Evista:

• If you are currently being treated 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 to any of the other ingredients of this medicine (listed in section 6).
• If you could still become pregnant, as Evista may harm the unborn child.
• If you have liver disease (examples of liver disease include cirrhosis, moderate hepatic insufficiency, or cholestatic jaundice).
• If you have severe kidney problems.
• If you have unexplained vaginal bleeding. In this case, consult your doctor for further evaluation.
• If you currently have a malignant tumor of the uterus, as there is insufficient experience with the use of Evista in women with this condition.

Warnings and precautions
Consult your doctor or pharmacist before taking Evista.

• If you are immobilized for a period of time, for example if you are confined to a wheelchair, require hospitalization, or need bed rest during post-surgical recovery or due to an unexpected illness, as these conditions may increase the risk of thrombosis (deep vein thrombosis, pulmonary embolism, or retinal vein thrombosis).
• If you have had a stroke, or if your doctor has informed you that you are at high risk of having one.
• If you have liver diseases.
• If you have malignant breast cancer, as there is insufficient experience with the use of Evista in women with this condition.
• If you are receiving oral estrogen therapy.

It is unlikely that Evista causes vaginal bleeding. Therefore, vaginal bleeding is not expected when taking Evista. If it occurs, consult your doctor for further evaluation.
Evista does not relieve post-menopausal symptoms such as hot flushes.
Evista lowers total cholesterol and LDL cholesterol (the "bad" cholesterol). Generally, it does not alter triglyceride levels or HDL cholesterol (the "good" cholesterol). However, if you have previously taken estrogens and experienced marked increases in triglyceride levels, consult your doctor before taking Evista.
Evista contains lactose
If your doctor has informed you that you have lactose intolerance, a type of sugar intolerance, contact your doctor before taking this medicine.
Other medicines and Evista
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those not requiring a prescription.
If you are taking digitalis medications for the heart or anticoagulants such as warfarin to improve blood fluidity, your doctor may need to adjust the dosage of these medicines.
Inform your doctor if you are taking colestyramine, which is primarily used as a medicine to lower blood lipids, as Evista may not work optimally.
Pregnancy and breastfeeding
Evista is used exclusively in post-menopausal women and must not be taken by women who could still become pregnant. Evista may harm the unborn child.
Do not take Evista if you are breastfeeding, as the medicine may pass into breast milk.
Driving and using machines
Evista has no effects, or negligible effects, on the ability to drive vehicles or operate machinery.

3. How to take Evista

Take this medicine exactly as your doctor has told you. If you are unsure, consult your doctor or pharmacist.
The dose is one tablet daily. It does not matter at what time of day you take the tablet, but taking the tablet at the same time each day will help you remember to take it.
You may take it regardless of meals.
The tablets are for oral use.
Swallow the tablet whole. If preferred, you may take it with a glass of water. Do not cut or crush the tablet before taking it. A cut or crushed tablet may have an unpleasant taste and there is a risk that you may receive an incorrect dose.
Your doctor will tell you how long you should continue taking Evista. Your doctor may also recommend that you 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 prescribed, you may experience leg cramps and dizziness.
If you forget to take Evista
Take one tablet as soon as you remember, then continue as usual. Do not take a double dose to make up for the forgotten tablet.
If you stop taking Evista
Consult your doctor first.
It is important that you take Evista for the entire duration prescribed by your doctor. Evista can treat or prevent osteoporosis only if you continue taking the tablets.
If you have further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Most of the side effects observed with Evista have been mild.
Very common side effects (which may affect more than 1 in 10 people treated) are:

• Hot flushes (vasodilatation)
• Influenza-like illness
• Gastrointestinal symptoms such as nausea, vomiting, abdominal pain and digestive disorders
• Increased blood pressure

Common side effects (which may affect from 1 to 10 in 100 people treated) are:

• Headache, including migraine
• Leg cramps
• Swelling of the hands, feet and legs (peripheral oedema)
• Gallstones
• Rash
• Mild breast symptoms such as pain, enlargement and tenderness

Uncommon side effects (which may affect from 1 to 10 in 1,000 people treated) are:

• Increased risk of blood clots forming in the veins of the legs (deep vein thrombosis)
• Increased risk of blood clots forming in the lungs (pulmonary embolism)
• Increased risk of blood clots forming in the eyes (retinal venous thrombosis)
• Red, painful skin around a vein (superficial venous thrombophlebitis)
• Formation of a blood clot in an artery (e.g. stroke, including increased risk of death from stroke)
• Decrease in the number of platelets in the blood

In rare cases, during treatment with Evista, liver enzyme levels in the blood may increase.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist.
You can also report side effects directly via the national reporting system listed in Annex V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Evista

Keep this medicine out of the sight and reach of children.
Do not use Evista after the expiry date stated on the carton after Exp. The expiry date refers to the
last day of that month.
Store in the original packaging. Do not freeze.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to
dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Evista contains

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

Tablet core: Povidone, polysorbate 80, anhydrous lactose, monohydrate lactose, crospovidone,
magnesium stearate.
Tablet coating: Titanium dioxide (E 171), polysorbate 80, methylhydroxypropylcellulose,
macrogol 400.

Description of the appearance of Evista and pack sizes

Evista tablets are white, oval, film-coated tablets. They are packaged in blisters or in plastic bottles. Blister packs contain 14, 28 or 84 tablets. Bottles contain 100 tablets. Not all pack sizes may be marketed.

Marketing Authorisation Holder

SUBSTIPHARM, 24 rue Erlanger, 75016 Paris, France.

Manufacturer

• INPHARMASCI, ZI N°2 de Prouvy-Rouvignies, 1 rue de Nungesser, 59121 Prouvy, France.

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

België/Belgique/ Belgien Lietuva
SUBSTIPHARM SUBSTIPHARM
Tél/Tel: +32 474 62 24 24 Tel: +33 1 43 18 13 00
България Luxembourg/Luxemburg
SUBSTIPHARM SUBSTIPHARM
Тел.: +33 1 43 18 13 00 Tél/Tel: +32 474 62 24 24
Česká republika Magyarország
SUBSTIPHARM SUBSTIPHARM
Tel: +33 1 43 18 13 00 Tel: +33 1 43 18 13 00
Danmark Malta
SUBSTIPHARM SUBSTIPHARM
Tlf: +33 1 43 18 13 00 Tel: +33 1 43 18 13 00
Deutschland Nederland
SUBSTIPHARM SUBSTIPHARM
Tel: +49 172-2802911 Tel: +31 657321695
Eesti Norge
SUBSTIPHARM SUBSTIPHARM
Tel: +33 1 43 18 13 00 Tlf: +33 1 43 18 13 00
Ελλάδα Österreich
PHARMASERV ELLAS SUBSTIPHARM
Tel: +30 210 620 8372 Tel: +43 6608044474
España Polska
SUBSTIPHARM SUBSTIPHARM
Tel: +34 600 601 890 Tel: +33 1 43 18 13 00
France Portugal
SUBSTIPHARM SUBSTIPHARM
Tél: +33 1 43 18 13 00 Tel: +35 19 24 42 39 34
Hrvatska România
SUBSTIPHARM SUBSTIPHARM
Tel: +33 1 43 18 13 00 Tel: +33 1 43 18 13 00
Ireland Slovenija
SUBSTIPHARM SUBSTIPHARM
Tel: +33 9 71 35 39 06 Tel: +33 1 43 18 13 00
Ísland Slovenská republika
SUBSTIPHARM SUBSTIPHARM
Simi: +33 1 43 18 13 00 Tel: +33 1 43 18 13 00
Italia Suomi/Finland
SUBSTIPHARM SUBSTIPHARM
Tel: +39 35 11 34 34 46 Puh./Tel: +33 1 43 18 13 00
Κύπρος Sverige
SUBSTIPHARM SUBSTIPHARM
Tel: +33 1 43 18 13 00 Tel: +33 1 43 18 13 00
Latvija United Kingdom (Northern Ireland)
SUBSTIPHARM SUBSTIPHARM
Tel.: +33 1 43 18 13 00 Tel: +33 1 43 18 13 00

This summary of product characteristics was last revised in month YYYY.

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