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Evista Tablets


Indicative Actions

EVISTA®

Raloxifene hydrochloride


Consumer Medicine Information

What is in this leaflet

This leaflet is designed to provide you with answers to somecommon questions about this medicine. It does not contain all theavailable information and does not take the place of talking withyour doctor.

All medicines have risks and benefits. Your doctor has moreinformation about this medicine than is contained in this leaflet.Also, your doctor has had the benefit of taking a full and detailedhistory from you and is in the best position to make an expert judgementto meet your individual needs.

If you have any concerns about taking this medicine, talk toyour doctor or pharmacist.

Keep this leaflet with this medicine. You may need to read it again.

What EVISTA is used for

EVISTA belongs to a group ofnon-hormonal medicines called SelectiveEstrogen Receptor Modulators (SERMs). When a woman reaches menopause,the level of the female sex hormone, oestrogen, goes down. EVISTAmimics some of the beneficial effects of oestrogen after menopause.

EVISTA is used to prevent and treat osteoporosis in women aftermenopause.

Osteoporosis causes your bones to become thin and fragile -it is especially common in women after menopause. While osteoporosismay have no symptoms at first, it makes your bones more likely tobreak, especially in your spine, hips and wrists. Osteoporosis mayalso cause back pain, loss of height and a curved back.

Fractures may occur during normal, everyday activity, such aslifting, or from minor injury that would not ordinarily fracture normalbone.

EVISTA is also used to reduce the risk of invasive breast cancerin women with osteoporosis after menopause and reduce the risk ofinvasive breast cancer in women at high risk of invasive breast cancerafter menopause.

Breast cancer is invasive when it has spread outside the milkduct or milk-making glands and has grown into normal tissue insidethe breast. Invasive cancers can spread cancer to other parts of thebody through the bloodstream and lymphatic system.

Your doctor may have prescribed EVISTA for another reason.

Ask your doctor if you have any questions about why EVISTA hasbeen prescribed for you.

This medicine is available only with a doctor's prescription.

Before you take EVISTA

Tell your doctor if you have any of the following conditionsor if you have ever experienced any of these conditions.

When you must not take EVISTA

Do not take EVISTA:

  • if you have not been through menopause. EVISTAis only for use by women after menopause and must not be taken bywomen who could still have a baby.
  • if you have had an allergic reaction to EVISTAor any of the ingredients listed at the end of this leaflet (see 'ProductDescription'). Signs of anallergic reaction may include a skin rash,itching, shortness of breath or swelling of the face,lips or tongue.
  • if you are being treated or have been treated forblood clots.
  • if the packaging is torn or shows signs of tampering,or if the tablets do not look quite right.
  • if the expiry date on the pack has passed. If youtake this medicine after the expiry date has passed, it may not workas well.

If you are not sure whether you should start taking EVISTA,talk to your doctor or pharmacist.

Before you start taking EVISTA

You must tell your doctor:

  • if you have any unexplained vaginal bleeding.
  • if you are at risk of blood clots.
  • if you are, or know you will be immobilised forsome time, e.g., being wheel-chair bound or having to stay in bedwhile recovering from an operation or illness.
  • if you have liver disease.
  • if you are intolerant of lactose. EVISTA containsa small amount of lactose (about 150 mg) which is unlikely to affectyou.
  • if you have menopausal symptoms, such as hot flushes.EVISTA does not treat hot flushes.
  • if you are breastfeeding.
  • if you are on oestrogen or hormone replacementtherapy (HRT).
  • if you have or have had high blood fats (triglycerides)caused by oestrogen.
  • if you have previously had a stroke, or if youhave ever had other risk factors for stroke such as a mini-stroke(transient ischaemic attack) or a type of irregular heartbeat calledatrial fibrillation
  • if you have had breast cancer. EVISTA has not beenfully studied in women who have a history of breast cancer.

Before starting and while taking EVISTA you should have breastexaminations and mammograms, as directed by your Doctor. EVISTA doesnot eliminate the chance of developing breast cancers, you need theseexaminations to find any breast cancers as early as possible.

EVISTA is not intended to be taken by men.

EVISTA has no known effect on driving or the ability to usemachinery.

Taking other medicines

Tell your doctor if you are taking any other medicines, includingany that you buy without a prescription from your pharmacy, supermarketor health food shop.

Some medicines and EVISTA may interfere with each other. Theseinclude:

  • medicines for your heart such as digitalis drugs(e.g. digoxin) or blood thinning drugs such as warfarin. Your doctormay need to adjust the dose of these medicines.
  • hormone replacement therapy (HRT) or oestrogens.
  • lipid-lowering drugs including cholestyramine.

Your doctor or pharmacist has more information on medicinesto be careful with or avoid while taking EVISTA.

Tell your doctor about these things before taking EVISTA.

How to take EVISTA

Carefully follow all directions given to you by your doctoror pharmacist. These may differ from the information contained in this leaflet.

How much to take

The usual dose of EVISTA is one tablet per day.

How to take it

EVISTA tablets should be swallowed whole with a glass of water.

When prescribed for the treatment or prevention of osteoporosis,EVISTA should be taken in conjunction with supplementary calcium ifdaily calcium intake is inadequate.

When to take it

It does not matter what time of day you take your tablet. However,it is best to take it at the same time each day as this will helpyou remember to take it.

The days of the week are printed on the blister foil to helpyou take your tablet each day.

You may take EVISTA with or without food.

How long do I take it

For maximum benefit, EVISTA is intended for long-term use.

Do not stop taking EVISTA without first talking to your doctor.

If you forget to take it

If it is almost time for your next dose, skip the tablet youmissed and take your next dose when you are meant to.

Otherwise, take it as soon as you remember then go back to takingyour medicine as you would normally.

Do not take a double dose to make up for the dose that you missed.

If you are not sure what to do, ask your doctor or pharmacist.

If you take too much

Immediately telephone your doctor or the Australian PoisonsInformation Centre (13 11 26), or the New Zealand National PoisonsInformation Centre (0800 POISON or 0800 764 766), or go to the Accidentand Emergency Department at your nearest hospital, if you think thatyou or anyone else has taken too much EVISTA.

Do this even if there are no signs of discomfort or poisoning.

In adults, symptoms of an overdose may include leg cramps anddizziness.

In children, symptoms of anoverdose may include coordinationproblems, dizziness, vomiting, rash, diarrhoea, repetitive shaking,and flushing.

While you are taking EVISTA

Things you must do

It is important that you remember to take EVISTA daily and atthe dose prescribed by your doctor.

Tell all doctors and pharmacists who are treating you that youare taking EVISTA.

While you are taking EVISTA, tell your doctor or pharmacistbefore you start any new medicine.

If you become pregnant while taking EVISTA, tell your doctor.

Tell your doctor if you are immobilised for some time, e.g.,being wheel-chair bound or having to stay in bed while recoveringfrom an operation or illness.

If you are going on a long plane or car trip, you should moveabout periodically.

Tell your doctor if you have any vaginal bleeding.

Things you must not do

Do not stop taking EVISTA without first checking with your doctor.

Do not give EVISTA to anyone else, your doctor has prescribedit specifically for you.

Side effects

Tell your doctor or pharmacist as soon as possible if youexperience any undesirable effect or feel unwell while you are takingEVISTA. Like other medicines, EVISTA may cause some unwanted sideeffects. These are likely to vary from patient to patient.

The majority of side effects seen with EVISTA have been mild.

Tell your doctor if you notice any of the following side effectsand they worry you:

  • hot flushes
  • leg cramps
  • muscle spasms
  • swelling of hands, feet and legs
  • flu-like symptoms

These are the more common side effects of EVISTA.

Tell your doctor immediately or go to the Accident and EmergencyDepartment at your nearest hospital if you notice any of the following:

  • severe pain or swelling in your legs
  • severe stomach pain
  • problems with your eyesight
  • shortness of breath or pain on breathing

In clinical trials of EVISTA, some women experienced blood clotsin the veins (venous thromboembolic events). This occurred in lessthan 1% of EVISTA patients. This is a serious side effect. You mayneed urgent medical attention or hospitalisation.

Tell your doctor if you notice anything unusual or if you areconcerned about any aspect of your health, even if you think the problemsare not associated with this medicine and are not referred to in thisleaflet.

Clinical trials using EVISTA have shown that:

  • Women taking EVISTA have less swelling, tendernessand pain in their breasts than women receiving oestrogen.
  • Unlike oestrogen, EVISTA has no effect on the uterusand is unlikely to cause vaginal bleeding or spotting.

After taking EVISTA

Storage

Keep your tablets in the blister pack until it is time to takethem.

Keep your tablets in a cool, dry place where the temperaturestays below 30 degrees C.

All medicines should be kept where young children cannot reachthem.

There will be an expiry date (month, year) on your EVISTA pack.

The medicine should not be taken after this date because itmay have lost some of its strength.

Disposal

If your doctor tells you to stop taking EVISTA or you find thatthe tablets have passed their expiry date, please return any leftover tablets to your pharmacist.

Product Description

What it looks like

EVISTA tablets are white, oval shaped and film coated. EachEVISTA tablet has the identicode number '4165' printed on it in blueink.

In Australia EVISTA tablets come in blister packs containing7 (sample pack) and 28 tablets.

In New Zealand EVISTA tablets are available in blister packscontaining 28 tablets.

Ingredients

Active Ingredient – raloxifene.

Each EVISTA tablet contains 60 mg of raloxifene hydrochloridewhich is equivalent to 56 mg raloxifene.

Inactive Ingredients – anhydrous lactose, lactose monohydrate,povidone, polysorbate 80, crospovidone, magnesium stearate,Colour Mixture WhiteYS-1-18027-A, carnauba wax and Edible Blue Ink.

Supplier

EVISTA is a product of:
Eli Lilly Australia Pty Limited
112 Wharf Road
West Ryde NSW 2114
AUSTRALIA

EVISTA is distributed in New Zealand by:
Eli Lilly andCompany (NZ) Limited
Level 3, Axon House
414-422 KhyberPass Road, Newmarket
PO Box 109 197, Newmarket
Auckland
NEW ZEALAND

Australian Registration Number:
AUST R 64709

This leaflet was revised in November 2008.

Published by MIMS March 2009