Details for: APO-RALOXIFENE
Company: APOTEX INC
| DIN | DIN name | Active Ingredient(s) | Strength | Dosage Form | Route of Administration |
|---|---|---|---|---|---|
| 02279215 | APO-RALOXIFENE | RALOXIFENE HYDROCHLORIDE | 60 MG | TABLET | ORAL |
Summary Reports
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.
- 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 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.
| 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