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Details for: APO-RALOXIFENE

Company: APOTEX INC

DIN DIN name Active Ingredient(s) Strength Dosage Form Route of Administration
02279215APO-RALOXIFENERALOXIFENE HYDROCHLORIDE60 MGTABLETORAL
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Summary Reports

Summary Safety Review - Hormone Replacement Therapy (Estrogenic and Progestogenic Agents) and Selective Estrogen Receptor Modulators (SERMs) - Assessing the Potential Risk of Ovarian Cancer

Consumer Information

This information was provided by the drug’s manufacturer when this drug product was approved for sale in Canada. It is designed for consumers and care givers. It is a summary of information about the drug and will not tell you everything about the drug. Contact your doctor or pharmacist if you have any questions about the drug.

What the medication is used for

APO-RALOXIFENE is used to treat or prevent osteoporosis in post-menopausal women.

This information should answer some of the questions that you may have and help you to understand how to take APO-RALOXIFENE. 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 it does

APO-RALOXIFENE is the brand name of a substance called raloxifene made by Apotex Inc. Your doctor may also refer to APO-RALOXIFENE as a Selective Estrogen Receptor Modulator or SERM. APO-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 bones, either to prevent or treat osteoporosis.

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 osteoprosis. 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.

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 take vitamin D and calcium supplements.

  1. Do not smoke.
  2. Exercise. Bones need exercise to stay strong and healthy. Consult your doctor about an exercise program suitable to you.
  3. 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 APO-RALOXIFENE to prevent or treat osteoporosis.
When it should not be used

Do not use APO-RALOXIFENE if:

  • You are allergic to raloxifene or any of the ingredients listed at the end of this information.
  • You are pregnant or planning to become pregnant as Apo-Raloxifene could hart the unborn child.
  • You are breastfeeding. It is not know if Apo- Raloxifene passes to breast milk and what effect it may have on the baby.
  • You have or have had blood clots in the veins that require a doctor's treatment. Taking APO-RALOXIFENE may increase the risk of blood clots.
What the medicinal ingredient is

Each tablet of APO-RALOXIFENE contains raloxifene as the active ingredient.

What the non-medicinal ingredients are

Anhydrous lactose, crospovidone, magnesium stearate, colloidal silicon dioxide, hydroxypropyl methyl cellulose, hydroxypropyl cellulose, polyethylene glycol and titanium dioxide.

What dosage form it comes in

60 mg tablets

Warnings and precautions

Before starting APO-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 APO-RALOXIFENE is only for postmenopausal women.
  • have had an allergic reaction to any medicine you have taken
  • are intolerant to lactose because APO-RALOXIFENE contains lactose
  • have or ever had liver problems
  • have or ever had blood clots that have required a doctor’s treatment, If you take warfarin (blood thinner) or other coumarin derivatives, APO-RALOXIFENE 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 APO-RALOXIFENE.
  • are currently on any other medications, prescription or non prescription
  • being immobile for a long time may increase the risk of blood clots in the vein. If while taking APO-RALOXIFENE you plan to be immobile, such as staying in bed after surgery, or taking a long plane trip, you should stop taking APO-RALOXIFENE 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 APO-RALOXIFENE again.
Interactions with this medication

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

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

It is not recommended that you combine APO-RALOXIFENE 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, APO-RALOXIFENE 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.

Proper use of this medication

Usual Dose

Take one APO-RALOXIFENE tablet, once-a-day, any time, with or without food. APO-RALOXIFENE 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 APO-RALOXIFENE is dependent upon your taking it regularly. Therefore, you should keep taking APO-RALOXIFENE until your doctor advises you otherwise.

If you miss a day of APO-RALOXIFENE take one pill as soon as you remember and resume one tablet once daily.

Overdose

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

Missed Dose

Take your prescribed dose at the same time each day. If you miss a dose of APO-RALOXIFENE by a few hours, take the dose when you remember. If most of the day has passed, wait until your next scheduled dose and try not to miss any more. Do not take 2 doses at once.

Side effects and what to do about them

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 APO-RALOXIFENE. Another common side effect is flu-like symptoms.

Similar to estrogen replacements, APO-RALOXIFENE 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.

APO-RALOXIFENE 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.

Serious side effects, how often they happen and what to do about them
Symptom / effect Talk with your doctor or pharmacist only if severe Talk with your doctor or pharmacist in all cases Stop taking drug and call your doctor or pharmacist
Blood clots in the veins  

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

How to store

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

Reporting side effects

To monitor drug safety, Health Canada collects information on serious and unexpected effects of drugs. If you suspect you have had a serious or unexpected reaction to this drug you may notify Health Canada by:

toll-free telephone: 866-234-2345
toll-free fax 866-678-6789
By email: cadrmp@hc-sc.gc.ca

By regular mail:
Canadian Adverse Drug Reaction Monitoring Program
(CADRMP)
Health Canada
Address Locator: 0201C2
Ottawa, ON K1A 1B9

NOTE:Before contacting Health Canada, you should contact your physician or pharmacist.

More information

For more information, please contact your doctor, pharmacist or other healthcare professional. This leaflet plus the full product monograph, prepared for health professionals, can be obtained by contacting DISpedia, Apotex's Drug Information Service, at 1- 800-667-4708. This leaflet can also be found at http://www.apotex.ca/products.

This leaflet was prepared by Apotex Inc., Toronto, Ontario, M9L 1T9.

Date of Revision: March 24, 2006

Date modified: