Teva-Raloxifene: Uses, Side Effects and Dosage

What the medication is used for:

TEVA-RALOXIFENE is used to treat or to prevent osteoporosis in postmenopausal women.

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 menopause or after removal of the ovaries because of the decrease in estrogens. A variety of risk 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

The greater the number of risk factors, the greater the probability of developing 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.

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 TEVA-RALOXIFENE to prevent or treat osteoporosis.

What it does:

TEVA-RALOXIFENE is a Selective Estrogen Receptor Modulator or SERM. TEVA-

RALOXIFENE 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 bone, either to prevent or treat osteoporosis.

When it should not be used:

Do not take TEVA-RALOXIFENE if:

• you have not passed menopause. TEVA-

  RALOXIFENE is for use only by women after menopause.

• you are pregnant or could become pregnant.

  TEVA-RALOXIFENE could harm your unborn child.

• you are nursing a baby. It is not known if

  TEVA-RALOXIFENE passes into breast milk or what effect it might have on the baby.

• you have or have had blood clots in the veins that required a doctor’s treatment. This may include clots in the legs, lungs or eyes. Taking TEVA-RALOXIFENE may increase the risk of getting these blood clots.
• you are allergic to raloxifene HCl or any of the other ingredients in TEVA-RALOXIFENE listed in the “nonmedicinal ingredients” section below.

What the medicinal ingredient is:

ABOUT THIS MEDICATION

raloxifene hydrochloride

What the nonmedicinal ingredients are: colloidal anhydrous silica, hypromellose, macrogol, magnesium stearate, microcrystalline cellulose, polydextrose, povidone, pregelatinized starch and titanium dioxide.

What dosage form it comes in

Tablet 60 mg.

WARNINGS AND PRECAUTIONS

Before starting TEVA-RALOXIFENE 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 TEVA-RALOXIFENE is only for postmenopausal women.

• have had an allergic reaction to any medicine

  you have taken.

• are intolerant to lactose because TEVA-

  RALOXIFENE contains lactose.

• have or ever had liver problems.

• have or ever had blood clots in the veins that

  have required a doctor’s treatment. If you take warfarin (blood thinner) or other coumarin derivatives, TEVA-RALOXIFENE may not be suitable for you. TEVA-RALOXIFENE 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 TEVA-

  RALOXIFENE.

• are currently on any other medications,

  prescription or non prescription.

• have had a stroke or have a history of other

  significant risk factors for stroke, such as “mini-stroke” (TIA/transient ischemic attack), or a type of irregular heartbeat (atrial fibrillation).

Being immobile for a long time can increase the risk of blood clots in the veins. TEVA-RALOXIFENE may add to this risk. If while taking TEVA-RALOXIFENE you plan to be immobile, such as staying in bed after surgery, or taking a long plane trip, you should stop taking TEVA-RALOXIFENE at least 3 days before, to reduce your risk of blood clots in the veins. When you are back on your feet, you may start taking TEVA-RALOXIFENE again (see

SIDE EFFECTS AND WHAT TO DO ABOUT THEM).

Tell your doctor all the medicines that you are taking before starting to take TEVA-RALOXIFENE.

The effect of TEVA-RALOXIFENE is significantly reduced if taken with cholestyramine (products which contain cholestyramine include Questran®, Questran Light®, Alti-Cholestyramine Light, Novo Cholamine, Novo-Cholamine Light, PMS-Cholestryramine).

Therefore, you should not take cholestyramine while taking TEVA-RALOXIFENE.

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

You should always check with your doctor before taking any other medication.

PROPER USE OF THIS MEDICATION

Usual dose:

Take one TEVA-RALOXIFENE 60 mg tablet, once-a-day, any time, with or without food. TEVA-RALOXIFENE comes in a 30-day blister pack that you start as soon as you fill your prescription.

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 TEVA-RALOXIFENE is dependent upon your taking it regularly. Therefore, you should keep taking TEVA-RALOXIFENE until your doctor advises you otherwise.

Overdose:

If you take too much TEVA-RALOXIFENE, immediately contact your doctor or go to your nearest hospital emergency department. Show your doctor the blister pack of medicine. Do this even if there are no signs of discomfort or poisoning.

For management of a suspected drug overdose, contact your regional Poison Control Centre.

Missed Dose:

INTERACTIONS WITH THIS MEDICATION

If you miss a day of TEVA-RALOXIFENE take one pill as soon as you remember and resume one tablet once daily. Do not take two doses at the same time.

SIDE EFFECTS AND WHAT TO DO ABOUT THEM

During clinical trials, some women did have mild side effects however most women did not find these side effects serious enough to stop taking raloxifene hydrochloride. The most common side effects of TEVA-RALOXIFENE are:

• hot flashes
• leg cramps

Another common side effect is f1u-like symptoms. Similar to estrogen replacements, TEVA-RALOXIFENE may increase the risk of blood clots in the veins. Although this is an uncommon side effect, if you experience any of the following unusual symptoms talk to your doctor immediately:

• redness, swelling, heat or pain in your calves and

  legs

• sudden chest pain or shortness of breath
• a sudden change in your vision

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

SERIOUS SIDE EFFECTS, HOW OFTEN THEY HAPPEN AND WHAT TO DO ABOUT THEM

* See “SIDE EFFECTS AND WHAT TO DO ABOUT THEM” for symptoms of blood clots in the veins. If you experience any of the listed symptoms talk to your doctor immediately.

**Women who have had a heart attack or are at risk for a heart attack may have an increased risk of dying from stroke when taking TEVA-RALOXIFENE.

This is not a complete list of side effects. For any unexpected effects while taking TEVA-RALOXIFENE, contact your doctor or pharmacist.

All medicines should be stored out of the reach of children. TEVA-RALOXIFENE should be stored in its original package at room temperature (between 15 to 30°C) in a dry place.

REPORTING SUSPECTED SIDE EFFECTS

You can report any suspected adverse reactions associated with the use of health products to the Canada Vigilance Program by one of the following 3 ways:

• Report online at

  www.healthcanada.gc.ca/medeffect

• Call toll-free at 1-866-234-2345

• Complete a Canada Vigilance Reporting Form and:

  • Fax toll-free to 1-866-678-6789, or

  • Mail to: Canada Vigilance Program Health Canada

    Postal Locator 0701D Ottawa, ON K1A 0K9

Postage paid labels, Canada Vigilance Reporting Form and the adverse reaction reporting guidelines are available on the MedEffect™ Canada Web site at www.healthcanada.gc.ca/medeffect.

NOTE: Should you require information related to the management of the side effect, please contact your health care provider before notifying Canada Vigilance. The Canada Vigilance Program does not provide medical advice.

MORE INFORMATION

This document plus the full product monograph, prepared for health professionals can be found by contacting Teva Canada Limited at: 1-800-268-4127 ext. 5005 (English); 1-877-777-9117 (French)

or druginfo@tevacanada.com

Teva Canada Limited

30 Novopharm Court

Toronto, Ontario

Canada, M1B 2K9

Last revised: July 25, 2011