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EVISTA

Evista tablets

Raloxifene Hydrochloride
Bone Metabolism Regulator

Patient Information for EVISTA

This information should answer some of the questions that you may have and help you to understand how to take Evista. If you still have any questions or concerns about taking this medication, talk to your doctor or pharmacist. Keep this information with your medicine in case you need to read it again.

What is Evista?
What is Osteoporosis?
How can osteoporosis be prevented or treated?
What should I do before taking Evista?
How should I take Evista?
Can I take other medicines with Evista?
Does Evista have side effects?
How should I store Evista?
What does Evista contain?

What is Evista?

Evista is the brand name of a substance called raloxifene made by Eli Lilly and Company. Your doctor may also refer to Evista as a Selective Estrogen Receptor Modulator or SERM. Evista is not a hormone, but it acts like estrogen in some parts of your body including the bones, but not like estrogen in other parts of the body. In the bones it promotes the building of new bones, either to prevent or treat osteoporosis.

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What is Osteoporosis?

Osteoporosis is a thinning and weakening of the bones making the bones more likely to break. It is common in women after the menopause or after the removal of the ovaries because of the decrease in estrogens. A variety of factors may promote osteoporosis. These include:

  • Caucasian or Asian descent
  • Slender build
  • Early menopause
  • Smoking
  • Drinking alcohol
  • A diet low in calcium
  • Lack of exercise
  • A family history of osteoporosis.

Initially osteoporosis usually does not cause any symptoms, but if left untreated may result in fractures. While most fractures are painful, fractures of the spine may not be noticed until they result in loss of height or a stooped posture. The fractures may occur as the result of normal every day activity or from minor injuries, which would ordinarily not result in broken bone.

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How can osteoporosis be prevented or treated?

  • Eat a balanced diet. Vitamin D and calcium are necessary for building strong bones. The requirement for vitamin D increases as you grow older. In the winter, when there is less sunlight, your skin produces less vitamin D. Discuss with your doctor the need to take vitamin D and calcium supplements.
  • Do not smoke.
  • Exercise. Bones need exercise to stay strong and healthy. Consult your doctor about an exercise program suitable to you.
  • While diet, exercise and vitamins are essential to good health, they may not be enough to offset the effects of estrogen decline in some women's bodies after menopause. Consequently, some people may require medications such as Evista to prevent or treat osteoporosis.

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What should I do before taking Evista?

Before starting Evista and to get the best possible treatment, be sure to tell your doctor if you:

  • are pregnant, breast-feeding, still have menstrual bleeds, or have had a menstrual bleed in the last year, as Evista is only for postmenopausal women.
  • have had an allergic reaction to any medicine you have taken
  • are intolerant to lactose because Evista contains lactose
  • have or ever have had liver problems
  • have or ever have had blood clots that have required a doctor's treatment. If you take warfarin (blood thinner) or other coumarin derivatives, Evista may not be suitable for you. It is contraindicated in women with an active or past history of blood clots in the veins. If you are taking the blood thinners for other reasons your doctor may need to check your prothrombin (blood clotting) time and adjust your medicine when you first begin taking Evista.
  • are currently on any other medications, prescription or non-prescription.

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How should I take Evista?

Take one Evista tablet, once-a-day, any time, with or without food. Evista comes in a 28-day blister pack that you start as soon as you fill your prescription. Each day of the week is printed above each tablet to make it easy to check if you've taken your pill that day.

You might find it helpful to take your tablet at the same time every day so that it's simply part of your routine. The efficacy of Evista is dependent upon your taking it regularly. Therefore, you should keep taking Evista until your doctor advises you otherwise.

If you miss a day of Evista take one pill as soon as you remember and resume 1 tablet once daily.

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Can I take other medicines with Evista?

Tell your doctor all the medicines that you are taking before starting to take Evista.

The effect of Evista is significantly reduced if taken with cholestyramine (products which contain cholestyramine include Questran, Questran Light, Alti-Cholestyramine Light, Novo-Cholamine, Novo-Cholamine Light, PMS-Cholestyramine). Therefore, you should not take cholestyramine while taking Evista.

It is not recommended that you combine Evista with hormone replacement therapy (ERT or HRT) since no studies have been done to look at the effectiveness or safety of this combination.

During clinical trials, Evista was taken with commonly prescribed medications such as acetaminophen, digoxin, nonsteroidal anti-inflammatory drugs (NSAIDs), and oral antibiotics with no observed problems. However, because each patient is different, you should always check with your doctor before taking any other medication.

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Does Evista have side effects?

During clinical trials, some women did have mild side effects such as hot flashes or leg cramps. However, most women did not find these side effects serious enough to stop taking Evista. Another common side effect is flu-like symptoms.

Similar to estrogen replacements, Evista may increase the risk of blood clots. Although this is a rare side effect, if you experience any unusual symptoms such as redness, swelling, heat or pain in your calves and legs, or sudden chest pain, shortness of breath, or a change in vision, talk to your doctor immediately. If you plan to be immobile, such as staying in bed after surgery, or taking a long plane trip, you should stop taking Evista at least 3 days before, as this may increase your risk of blood clots. When you are back on your feet, you may start taking Evista again.

Evista is not associated with adverse effects on the uterus, breast, or cognitive function. Therefore, any unexplained uterine bleeding, breast enlargement, breast pain, change in mood or deterioration of cognitive function should be reported to your doctor.

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How should I store Evista?

All medicines should be stored out of the reach of children. Evista should be stored in its original package at room temperature in a dry place.

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What does Evista contain?

Each tablet of Evista contains raloxifene as the active ingredient. Evista also contains the following inactive ingredients: anhydrous lactose, crospovidone, FD&C Blue No. 2 aluminum lake, hydroxypropyl methylcellulose, lactose monohydrate, magnesium stearate, polysorbate 80, povidone, macrogol 400 and titanium dioxide E171.

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