EVISTA 60 mg Coated Tablets

Зміст інструкції

1. Evista 60 mg film-coated tablets
   1. What is Evista and what is it 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. Package contents and other information

Evista 60 mg film-coated tablets

raloxifene hydrochloride

Read this leaflet carefully before you start taking this medicine as 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. Do not pass it on to others even if their symptoms are the same as yours because it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell 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 you take 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 women after menopause. 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 (SERM). When a woman reaches menopause, the level of the female sex hormone,
estrogen, decreases. Evista reproduces 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 in the early stages the disease may
not be accompanied by symptoms, osteoporosis predisposes to fractures, especially of the
spine, hips and wrists and can cause 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 being treated or have been treated for the formation of 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 any of the other ingredients of this medicine (listed in section 6).
• If there is still a possibility that you may become pregnant, Evista could cause harm to the unborn child.
• If you have a liver disease (examples of liver disease are 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 investigations.
• If you have a malignant tumor in the uterus, as there is insufficient 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 immobilised for a certain period of time, for example if you are confined to a wheelchair, if you need to be hospitalised or stay in bed during post-operative recovery or 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 told you that you are at high risk of having one.
• If you have liver disease.
• If you have a malignant breast tumor, as there is insufficient experience with the use of Evista in women with this disease.
• If you are receiving oral estrogen therapy.

It is unlikely that Evista will cause vaginal bleeding. Therefore, vaginal bleeding is not expected to occur when taking Evista. Consult your doctor for investigations.
Evista does not relieve post-menopausal symptoms, such as hot flashes.
Evista lowers total cholesterol and LDL cholesterol (the "bad" cholesterol). Generally, it does not change the
triglyceride or HDL cholesterol (the "good" cholesterol) level. However, if you have taken estrogens in the
past and have had high increases in triglyceride levels, consult your doctor before taking
Evista.

Evista contains lactose
If your doctor has told you that you have an intolerance to lactose, a type of sugar, contact your doctor 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 available without a prescription.
If you are taking digitalis medicines for the heart or anticoagulants such as warfarin to improve
blood fluidity, your doctor may need to adjust the dosage of these medicines.
Tell your doctor if you are taking cholestyramine, which is mainly used as a medicine
that reduces blood fats, as Evista may not work optimally.

Pregnancy and breastfeeding
Evista is used exclusively in women after menopause and should not be taken by women who
may still be able to have children. Evista could cause harm to the unborn child.
Do not take Evista if you are breastfeeding as the medicine may pass into breast milk.

Driving and operating machinery
Evista has no effects, or negligible effects, on driving or operating machinery.

3. How to take Evista

Take this medicine following exactly the instructions of your doctor. If you have any doubts, you should
consult your doctor or pharmacist.
The dose is one tablet a day. It does not matter at what time of day you take the
tablet, but taking the tablet every day at the same time will help you remember to take it.
You can take it independently of meals.
The tablets are for oral use.
Swallow the tablet whole. If you prefer, you can swallow it with a glass of water. Do not cut or
crush the tablet before taking it. The cut or crushed tablet may have a bad
taste and there is a possibility that you may take an incorrect dose.
Your doctor will tell you how long you will need to continue taking Evista. Your doctor may also
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 you usually do. Do not take a
double dose to make up for the missed tablet.

If you stop taking Evista
Consult your doctor first.
It is important that you take Evista for the entire time prescribed by your doctor. Evista can treat or
prevent osteoporosis only if you continue to take the tablets.
If you have 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 of the side effects observed with Evista have been mild.
Very common side effects (which may affect more than 1 in 10 treated patients) are:

• Hot flushes (vasodilation)
• Flu-like syndrome
• Gastrointestinal symptoms such as nausea, vomiting, abdominal pain and digestive disorders
• Increased blood pressure

Common side effects (which may affect up to 1 in 10 treated patients) are:

• Headache, including migraine
• Leg cramps
• Swelling of the hands, feet and legs (peripheral edema)
• Gallstones
• Skin rash
• Mild breast symptoms such as pain, enlargement and tension

Uncommon side effects (which may affect up to 1 in 1,000 treated patients) 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 vein thrombosis)
• Red and painful skin around the vein (superficial venous thrombophlebitis)
• Formation of a blood clot in an artery (for example stroke, including increased risk of dying from stroke)
• Decreased number of platelets in the blood

In rare cases, during treatment with Evista, levels of liver enzymes in the
blood may increase.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor or pharmacist. You can also report side effects directly through the national
reporting system listed in Annex V. By reporting side effects you can help
to 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 which is stated on the pack after Exp. The expiry date refers to the last day of that month.
Store in the original package. Do not freeze.
Do not dispose of any medicine in waste water or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Evista contains

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

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

Description of the appearance of Evista and package contents
Evista are film-coated tablets, white, oval in shape. They are packaged in blisters or
in 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

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

For further information on this medicine, contact the local representative of the marketing
authorisation holder:

België/Belgique/ Belgien
SUBSTIPHARM
Tél/Tel: +32 474 62 24 24

Lietuva
SUBSTIPHARM
Tel: +33 1 43 18 13 00

България
SUBSTIPHARM
Тел.: +33 1 43 18 13 00

Luxembourg/Luxemburg
SUBSTIPHARM
Tél/Tel: +32 474 62 24 24

Česká republika
SUBSTIPHARM
Tel: +33 1 43 18 13 00

Magyarország
SUBSTIPHARM
Tel: +33 1 43 18 13 00

Danmark
SUBSTIPHARM
Tlf: +33 1 43 18 13 00

Malta
SUBSTIPHARM
Tel: +33 1 43 18 13 00

Deutschland
SUBSTIPHARM
Tel: +49 172-2802911

Nederland
SUBSTIPHARM
Tel: +31 657321695

Eesti
SUBSTIPHARM
Tel: +33 1 43 18 13 00

Norge
SUBSTIPHARM
Tlf: +33 1 43 18 13 00

Ελλάδα
ΦΑΡΜΑΣΕΡΒ ΕΛΛΑΣ
Τηλ: +30 210 620 8372

Österreich
SUBSTIPHARM
Tel: +43 6608044474

España
SUBSTIPHARM
Tel: +34 600 601 890

Polska
SUBSTIPHARM
Tel: +33 1 43 18 13 00

France
SUBSTIPHARM
Tél: +33 1 43 18 13 00

Portugal
SUBSTIPHARM
Tel: +35 19 24 42 39 34

Hrvatska
SUBSTIPHARM
Tel: +33 1 43 18 13 00

România
SUBSTIPHARM
Tel: +33 1 43 18 13 00

Ireland
SUBSTIPHARM
Tel: +33 9 71 35 39 06

Slovenija
SUBSTIPHARM
Tel: +33 1 43 18 13 00

Ísland
SUBSTIPHARM
Simi: +33 1 43 18 13 00

Slovenská republika
SUBSTIPHARM
Tel: +33 1 43 18 13 00

Italia
SUBSTIPHARM
Tel: +39 35 11 34 34 46

Suomi/Finland
SUBSTIPHARM
Puh./Tel: +33 1 43 18 13 00

Κύπρος
SUBSTIPHARM
Τηλ: +33 1 43 18 13 00

Sverige
SUBSTIPHARM
Tel: +33 1 43 18 13 00

Latvija
SUBSTIPHARM
Tel.: +33 1 43 18 13 00

United Kingdom (Northern Ireland)
SUBSTIPHARM
Tel: +33 1 43 18 13 00
Detailed information on this medicine is available on the website of the European Medicines Agency (EMA): http://www.ema.europa.eu