Patient Medication Information: uses, side effects, how to take - Jamp Raloxifene
What JAMP Raloxifene is used for:
JAMP Raloxifene is used to treat or 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 the 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 everyday activity or from minor injuries, which would ordinarily not result in a 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 JAMP Raloxifene to prevent or treat osteoporosis.
What JAMP Raloxifene does:
JAMP Raloxifene is a Selective Estrogen Receptor Modulator or SERM. JAMP 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 JAMP Raloxifene should not be used:
Do not take JAMP Raloxifene if:
- You have not passed menopause. JAMP Raloxifene is for use only by women after menopause
You are pregnant or could become pregnant. JAMP Raloxifene could harm your unborn child
- You are nursing a baby. It is not known if JAMP 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 JAMP Raloxifene may increase the risk of getting these blood clots
- You are allergic to raloxifene or any of the other ingredients in JAMP Raloxifene listed in the “What the non-medicinal ingredients are:” section below.
What the medicinal ingredient is:
Raloxifene hydrochloride
What the non-medicinal ingredients are: Crospovidone, hypromellose, lactose anhydrous, lactose monohydrate, magnesium stearate, povidone, polysorbate 80, polyethylene glycol 400, titanium dioxide.
What dosage form JAMP Raloxifene comes in:
Tablet 60 mg.
Before starting JAMP Raloxifene and getting the best possible treatment, be sure to tell your doctor if you:
- Are pregnant, breastfeeding, still have menstrual bleeds, or have had a menstrual bleed in the last year, as JAMP Raloxifene is only for postmenopausal women
- Have had an allergic reaction to any medicine you have taken
- Are intolerant to lactose because JAMP 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, JAMP Raloxifene may not be suitable for you. JAMP 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 JAMP Raloxifene
- Are currently on any other medications, prescription or non-prescription
WARNINGS AND PRECAUTIONS
ABOUT THIS MEDICATION
- 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. JAMP Raloxifene may add to this risk. If while taking JAMP Raloxifene you plan to be immobile, such as staying in bed after surgery, or taking a long plane trip, you should stop taking JAMP 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 JAMP Raloxifene again (see “SIDE EFFECTS AND WHAT TO DO ABOUT THEM”).
You should always tell your doctor about all drugs you are taking or plan to take before starting to take JAMP Raloxifene.
The effect of JAMP Raloxifene is significantly reduced if taken with cholestyramine (products that contain cholestyramine include Questran®, Questran Light®, Alti-Cholestyramine Light, Novo-Cholamine, Novo-Cholamine Light, PMS-Cholestyramine). Therefore, you should not take cholestyramine while taking JAMP Raloxifene.
It is not recommended that you combine JAMP 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, 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.
Usual dose:
Take one JAMP 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 JAMP Raloxifene is dependent upon your taking it regularly. Therefore, you should keep taking JAMP Raloxifene until your doctor advises you otherwise.
Overdose:
Missed Dose:
If you miss a day of JAMP Raloxifene take one pill as soon as you remember and resume one tablet once daily.
Do not take two doses at the same time.
During clinical trials, some women did have mild side effects however most women did not find these side effects serious enough to stop taking JAMP Raloxifene. The most common side effects of JAMP Raloxifene are:
- Hot flashes
- Leg cramps.
Another common side effect is flu-like symptoms.
Similar to estrogen replacements, JAMP 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.
JAMP 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 AND WHAT TO DO ABOUT THEM
| Symptom / effect | Talk to your healthcare professional | Stop taking drug and get immediate medical help | ||
|---|---|---|---|---|
| Only if severe | In all cases | |||
| Uncommon | Blood clots in the veins* | ✓ | ||
| Rare | Blood clots in the lungs* | ✓ | ||
| Rare | 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 JAMP Raloxifene.
This is not a complete list of side effects. For any unexpected effects while taking JAMP Raloxifene, contact your doctor or pharmacist.
INTERACTIONS WITH THIS MEDICATION
PROPER USE OF THIS MEDICATION
SIDE EFFECTS AND WHAT TO DO ABOUT THEM
If you think you, or a person you are caring for, have taken too much JAMP Raloxifene, contact a healthcare professional, hospital emergency department, or regional poison control centre immediately, even if there are no symptoms.
JAMP Raloxifene should be stored at 15-30°C, in its original package, in a dry place.
Keep out of reach and sight of children.
If you want more information about JAMP Raloxifene:
- Talk to your healthcare professional
Find the full Product Monograph that is prepared for healthcare professionals and includes this Consumer Information by visiting the Health Canada website
(https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html); or by calling 1-866-399-9091
JAMP Pharma Corporation
1310 rue Nobel
Boucherville, Quebec
J4B 5H3, Canada
Last Authorized: August 21, 2023
HOW TO STORE IT
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 (https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/adverse-reaction-reporting.html) for information on how to report online, by mail or by fax; or
- Calling 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.