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, oestrogen, goes down. EVISTA mimics some of the beneficial effects of oestrogen after menopause.
EVISTA is used to prevent and treat osteoporosis in women after menopause.
Osteoporosis causes your bones to become thin and fragile - it is especially common in women after menopause. While osteoporosis may have no symptoms at first, it makes your bones more likely to break, especially in your spine, hips and wrists. Osteoporosis may also cause back pain, loss of height and a curved back.
Fractures may occur during normal, everyday activity, such as lifting, or from minor injury that would not ordinarily fracture normal bone.
EVISTA is also used to reduce the risk of invasive breast cancer in women with osteoporosis after menopause and reduce the risk of invasive breast cancer in women at high risk of invasive breast cancer after menopause.
Breast cancer is invasive when it has spread outside the milk duct or milk-making glands and has grown into normal tissue inside the breast. Invasive cancers can spread cancer to other parts of the body 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 has been prescribed for you.
This medicine is available only with a doctor's prescription.
Tell your doctor if you have any of the following conditions or if you have ever experienced any of these conditions.
Do not take EVISTA:
If you are not sure whether you should start taking EVISTA, talk to your doctor or pharmacist.
You must tell your doctor:
Before starting and while taking EVISTA you should have breast examinations and mammograms, as directed by your Doctor. EVISTA does not eliminate the chance of developing breast cancers, you need these examinations 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 use machinery.
Tell your doctor if you are taking any other medicines, including any that you buy without a prescription from your pharmacy, supermarket or health food shop.
Some medicines and EVISTA may interfere with each other. These include:
Your doctor or pharmacist has more information on medicines to be careful with or avoid while taking EVISTA.
Tell your doctor about these things before taking EVISTA.
Carefully follow all directions given to you by your doctor or pharmacist.
These may differ from the information contained in this leaflet.
The usual dose of EVISTA is one tablet per day.
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 if daily calcium intake is inadequate.
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 help you remember to take it.
The days of the week are printed on the blister foil to help you take your tablet each day.
You may take EVISTA with or without food.
For maximum benefit, EVISTA is intended for long-term use.
Do not stop taking EVISTA without first talking to your doctor.
If it is almost time for your next dose, skip the tablet you missed and take your next dose when you are meant to.
Otherwise, take it as soon as you remember then go back to taking your 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.
Immediately telephone your doctor or the Australian Poisons Information Centre (13 11 26), or the New Zealand National Poisons Information Centre (0800 POISON or 0800 764 766), or go to the Accident and Emergency Department at your nearest hospital, if you think that you 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 and dizziness.
In children, symptoms of an overdose may include coordination problems, dizziness, vomiting, rash, diarrhoea, repetitive shaking, and flushing.
It is important that you remember to take EVISTA daily and at the dose prescribed by your doctor.
Tell all doctors and pharmacists who are treating you that you are taking EVISTA.
While you are taking EVISTA, tell your doctor or pharmacist before 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 recovering from an operation or illness.
If you are going on a long plane or car trip, you should move about periodically.
Tell your doctor if you have any vaginal bleeding.
Do not stop taking EVISTA without first checking with your doctor.
Do not give EVISTA to anyone else, your doctor has prescribed it specifically for you.
Tell your doctor or pharmacist as soon as possible if you experience any undesirable effect or feel unwell while you are taking EVISTA.
Like other medicines, EVISTA may cause some unwanted side effects. 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 effects and they worry you:
These are the more common side effects of EVISTA.
Tell your doctor immediately or go to the Accident and Emergency Department at your nearest hospital if you notice any of the following:
In clinical trials of EVISTA, some women experienced blood clots in the veins (venous thromboembolic events). This occurred in less than 1% of EVISTA patients. This is a serious side effect. You may need urgent medical attention or hospitalisation.
Tell your doctor if you notice anything unusual or if you are concerned about any aspect of your health, even if you think the problems are not associated with this medicine and are not referred to in this leaflet.
Clinical trials using EVISTA have shown that:
Keep your tablets in the blister pack until it is time to take them.
Keep your tablets in a cool, dry place where the temperature stays below 30 degrees C.
All medicines should be kept where young children cannot reach them.
There will be an expiry date (month, year) on your EVISTA pack.
The medicine should not be taken after this date because it may have lost some of its strength.
If your doctor tells you to stop taking EVISTA or you find that the tablets have passed their expiry date, please return any left over tablets to your pharmacist.
EVISTA tablets are white, oval shaped and film coated. Each EVISTA tablet has the identicode number '4165' printed on it in blue ink.
In Australia EVISTA tablets come in blister packs containing 7 (sample pack) and 28 tablets.
In New Zealand EVISTA tablets are available in blister packs containing 28 tablets.
Active Ingredient - raloxifene.
Each EVISTA tablet contains 60 mg of raloxifene hydrochloride which is equivalent to 56 mg raloxifene.
Inactive Ingredients - anhydrous lactose, lactose monohydrate, povidone, polysorbate 80, crospovidone, magnesium stearate, Colour Mixture White YS-1-18027-A, carnauba wax and Edible Blue Ink.