Details for: ACT RALOXIFENE
Company: TEVA CANADA LIMITED
| DIN | DIN name | Active Ingredient(s) | Strength | Dosage Form | Route of Administration |
|---|---|---|---|---|---|
| 02358840 | ACT 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
ACT RALOXIFENE is used to treat or to prevent osteoporosis in postmenopausal women.
What is Ostepporosis?
- 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 ACT RALOXIFENE to prevent or treat osteoporosis.
What it does
ACT RALOXIFENE is a Selective Estrogen Receptor Modulator or SERM. ACT 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 ACT RALOXIFENE if:
- you have not passed menopause. ACT RALOXIFENE is for use only by women after menopause.
- you are pregnant or could become pregnant. ACT RALOXIFENE could harm your unborn child.
- you are nursing a baby. It is not known if ACT 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 ACT RALOXIFENE may increase the risk of getting these blood clots.
- you are allergic to raloxifene or any of the other ingredients in ACT RALOXIFENE listed in the “nonmedicinal ingredients” section below.
What the medicinal ingredient is
raloxifene hydrochloride
What the non-medicinal ingredients are
Citric acid monohydrate, dibasic calcium phosphate, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, poloxamer, polyethylene glycol, sodium starch glycolate, and titanium dioxide.
What dosage form it comes in
Tablet 60 mg.
Warnings and precautions
Serious Warnings and Precautions
Before starting ACT 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 ACT RALOXIFENE is only for postmenopausal women.
- have had an allergic reaction to any medicine you have taken.
- are intolerant to lactose because ACT RALOXIFENE contains lactose.
- have or ever had liver problems.
- have or ever had blood clots in the veins. If you take warfarin (blood thinner) or other coumarin derivatives, ACT RALOXIFENE may not be suitable for you. ACT 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 ACT 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 a “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. ACT RALOXIFENE may add to this risk. If while taking ACT RALOXIFENE you plan to be immobile, such as staying in bed after surgery, or taking a long plane trip, you should stop taking ACT 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 ACT RALOXIFENE again (see SIDE EFFECTS AND WHAT TO DO ABOUT THEM).
Interactions with this medication
You should always tell your doctor about all drugs you are taking or plan to take before starting to take ACT RALOXIFENE.
The effect of ACT 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 ACT RALOXIFENE.
It is not recommended that you combine ACT RALOXIFENE with hormone replacement therapy (ERT or HRT) since safety information is limited and no studies have been done to look at the effectiveness of this combination.
During clinical trials, ACT 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 ACT RALOXIFENE 60 mg tablet, once-a-day, any time, with or without food
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 ACT RALOXIFENE is dependent upon your taking it regularly. Therefore, you should keep taking ACT RALOXIFENE until your doctor advises you otherwise.
Overdose
If you take too much ACT RALOXIFENE, immediately contact your doctor or go to your nearest hospital emergency department. Show the 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 immediately.
Missed Dose
If you miss a day of ACT 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 ACT RALOXIFENE. The most common side effects of ACT RALOXIFENE are:
- hot flashes
- leg cramps
Another common side effect is flu-like symptoms.
Similar to estrogen replacements, ACT 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
ACT 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.
| Symptom / effect | Talk to your healthcare professional Only if severe | Talk to your healthcare professional In all cases | Stop taking drug and get immediate medical help |
|---|---|---|---|
| Uncommon | |||
| Blood clots in the veins* | ✔ | ||
| Rare | |||
| Blood clots in the lungs* | ✔ | ||
| Stroke fatality** | |||
*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 ACT RALOXIFENE
This is not a complete list of side effects. For any unexpected effects while taking ACT RALOXIFENE, contact your doctor or pharmacist.
How to store
All medicines should be stored out of the reach of children. ACT RALOXIFENE should be stored in its original package at room temperature (between 15 to 30°C) in a dry place.
Reporting side effects
You can report any suspected side effects associated with the use of health products to Health Canada by:
- Visiting the Web page on Adverse Reaction Reporting for information on how to report online, by mail or by fax; or
- Call toll-free at 1-866-234-2345
NOTE: Contact your health professional if you need information about how to manage your side effects. 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 by:
Phone: 1-800-268-4127 ext. 3;
Email: druginfo@tevacanada.com; or
Fax: 1-416-335-4472
This leaflet was prepared by:
Teva Canada Limited
30 Novopharm Court
Toronto, Ontario
M1B 2K9
Canada