Details for: RIVA-RISEDRONATE
Company: LABORATOIRE RIVA INC.
| DIN | DIN name | Active Ingredient(s) | Strength | Dosage Form | Route of Administration |
|---|---|---|---|---|---|
| 02341077 | RIVA-RISEDRONATE | RISEDRONATE SODIUM (RISEDRONATE SODIUM HEMIPENTAHYDRATE) | 35 MG | TABLET | ORAL |
Summary Reports
Summary Safety Review - Bisphosphonates - Assessing the Risk of Jaw Bone Loss (osteonecrosis of the jaw)
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
- To treat or prevent osteoporosis in postmenopausal women.
- To increase bone density in men with osteoporosis.
What it does
In osteoporosis, the body removes more bone than it replaces. This causes bones to get weaker and more likely to break or fracture (usually at the spine, wrist and hip). Spine fractures may result in a curved back, height loss or back pain. RIVA-RISEDRONATE slows down bone loss which can help to reduce the risk of fractures. In many people RIVA-RISEDRONATE helps to increase bone density.
It is not known how long RIVA-RISEDRONATE should be used for treating osteoporosis.
Keep talking to your doctor about whether RIVA-RISEDRONATE is still right for you.
RIVA-RISEDRONATE is not a pain reliever.
When it should not be used
- You have low levels of calcium in your blood (hypocalcemia).
- You are allergic to risedronate sodium or any of the other ingredients in RIVA-RISEDRONATE.
What the medicinal ingredient is
Medicinal Ingredients: Risedronate sodium
What the non-medicinal ingredients are
Non-medicinal ingredients: Colloidal Silicon Dioxide, Iron Oxide Yellow, Iron Oxide Red, Maltodextrin, Mannitol, Polyvinyl Alcohol, Polyethylene Glycol/Macrogrol, Povidone, Pregelatinized Starch, Sodium Starch Glycolate, Sodium Stearyl Fumarate, Talc, Titanium Dioxide.
What dosage form it comes in
Tablets: 35 mg
Warnings and precautions
To help avoid side effects and ensure proper use, talk to your healthcare professional before you take RIVA-RISEDRONATE. Talk about any health conditions or problems you may have, including if you:
- have had problems or disease in your kidneys, esophagus (the tube connecting the mouthand the stomach),
- have/had problems swallowing or have problems with your esophagus (the tube thatconnects your mouth to your stomach)
- have/had stomach or digestive problems
- have/had kidney problems
- cannot stand or sit upright for at least 30 minutes (see How to take RIVA-RISEDRONATE)
- are pregnant or breastfeeding
- have one of the following risk factors: cancer, diabetes, chemotherapy, radiotherapy ofthe head or neck, lowered immune system (immunosuppression), poor oral hygiene,treatment with corticosteroids or cancer drugs such as angiogenesis inhibitors (drugs thatslow down the growth of new blood vessels).
- had/have pain, swelling or numbness of the jaw or loosening of a tooth or any other oralsymptoms.
- have sores in the mouth. This can lead to osteonecrosis of the jaw.
Your doctor may check you if you:
- smoke
- have or have had teeth and/or gum disease
- have dentures that do not fit well
- have other relevant medical conditions at the same time, such as: low red blood cell count(called anemia) or if your blood cannot form clots in the normal way.
Your doctor may tell you to stop taking RIVA-RISEDRONATE until all sores in your mouth are healed.
Other warnings you should know about:
Your doctor should check your mouth and may ask you to see your dentist before you start taking RIVA-RISEDRONATE. Dental work should be done before you start RIVA-RISEDRONATE treatment. Take good care of your teeth and gums and see the dentist for regular checkups while taking RIVA-RISEDRONATE.
Calcium and vitamin D are also important for strong bones. Your doctor may ask you to take calcium and vitamin D while you are on RIVA-RISEDRONATE.
Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.
Interactions with this medication
Vitamins, mineral supplements and antacids may contain substances that can stop your body from absorbing RIVA-RISEDRONATE. They include calcium, magnesium, aluminum and iron. Take these medicines at a different time of day than RIVA-RISEDRONATE. Talk to your health care provider about how and when to take these medications.
Taking RIVA-RISEDRONATE with corticosteroids or cancer drugs may increase your chance of jaw bone problems (osteonecrosis of the jaw).
Talk to your doctor before taking pain medication like ASA or other non-steroidal anti-inflammatory drugs because they may upset your stomach on an empty stomach.
Proper use of this medication
As with all medications, it is important to take as directed by your doctor.
- Take RIVA-RISEDRONATE in the morning on an empty stomach, at least 30 minutesbefore you eat, drink or take other medicines.
- Swallow each ACTONE tablet whole, while you are sitting or standing in an uprightposition. Drink enough plain water (at least 120 mL or ½ cup) to make sure the tabletgets to your stomach. Do not chew, cut or crush the tablets.
- Do not lie down for at least 30 minutes after taking RIVA-RISEDRONATE.
Usual Dose:
To treat osteoporosis in women after menopause:
- 35 mg per week of RIVA-RISEDRONATE
To prevent osteoporosis in women after menopause:
- 35 mg per week of RIVA-RISEDRONATE
To increase bone density in men with osteoporosis:
- 35 mg per week of RIVA-RISEDRONATE
Overdose:
If you think you have taken too much RIVA-RISEDRONATE, drink a full glass of milk. Do not make yourself vomit. Contact your healthcare professional, hospital emergency room or regional poison control centre immediately, even if there are no symptoms.
Missed Dose:
If you missed your dose on your usual day, take one tablet in the morning after you remember. You can go back to your regular schedule for the next dose. If you have missed your dose by one week, do not take 2 tablets on the same day. Skip your missed dose and go back to your regular schedule.
Side effects and what to do about them
These are not all the possible side effects you may feel when taking RIVA-RISEDRONATE. If you experience any side effects not listed here, contact your healthcare professional.
Drugs like RIVA-RISEDRONATE may cause problems in your esophagus (the tube connecting the mouth and the stomach), stomach and intestines, including ulcers. If you have trouble or pain upon swallowing, heartburn, chest pain and black or bloody stools, stop taking RIVA-RISEDRONATE and tell your doctor right away. Remember to take RIVA-RISEDRONATE as directed.
The most common side effects reported with RIVA-RISEDRONATE were:
- Abdominal pain, heartburn, nausea
RIVA-RISEDRONATE may cause pain in bones, joints or muscles, rarely severe.
Patients receiving RIVA-RISEDRONATE or other drugs in this class have reported:
- Rarely, non-healing jaw wounds.
- Very rarely, unusual fractures in their thigh bone.
| 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 |
|---|---|---|---|
| Common | |||
| Pain in bones, joints, or muscles | ✔ | ||
| Abdominal pain | ✔ | ||
| Uncommon | |||
| Eye pain, redness or inflammation; sensitivity to light, decreased vision | ✔ | ||
| Rare | |||
| Painful tongue | ✔ | ||
| Osteonecrosis of the jaw: Jaw problems associated with numbness or feeling of heaviness in the jaw, poor healing of the gums especially after dental work, loose teeth, exposed bone in the mouth, sores, or non-healing sores in the mouth, swelling gum, infections, bad breath or pain in the mouth, teeth or jaw. | ✔ | ||
| Very rare | |||
| Allergic and skin reactions such as: hives; rash (with or without blisters); swelling of face, lips, tongue, or throat; difficult or painful swallowing; trouble breathing | ✔ | ||
| Symptoms of low blood calcium level such as numbness, tingling, muscle spasms | ✔ | ||
| New or unusual pain in hip, groin or thigh | ✔ | ||
If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, talk to your healthcare professional.
How to store
- Keep RIVA-RISEDRONATE and all other medications out of the reach of children.
- Store between 15 and 30°C.
- Do not keep medicine that is out of date or that you no longer need.
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.
More information
- Talk to your healthcare professional.
- Find the full product monograph that is prepared for healthcare professionals and includes this Patient Medication Information by visiting the Health Canada website(https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html); the manufacturer’s website www.labriva.com, orby calling 1-800-363-7988.
This leaflet was prepared by:
Laboratoire Riva Inc.
660 Boul. Industriel
Blainville, Quebec, Canada
J7C 3V4
www.labriva.com
Last revised: August 08, 2018