Details for: RISEDRONATE-35
Company: SIVEM PHARMACEUTICALS ULC
| DIN | DIN name | Active Ingredient(s) | Strength | Dosage Form | Route of Administration |
|---|---|---|---|---|---|
| 02411407 | RISEDRONATE-35 | RISEDRONATE SODIUM (RISEDRONATE SODIUM MONOHYDRATE) | 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
- Treatment and prevention of osteoporosis in postmenopausal women.
- Treatment of osteoporosis in men, to improve bone mineral density.
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. RISEDRONATE-35 slows down bone loss which can help to reduce the risk of fractures. In many people RISEDRONATE-35 helps to increase bone density.
It is not known how long RISEDRONATE-35 should be used for treating osteoporosis. Keep talking to your doctor about whether RISEDRONATE-35 is still right for you.
RISEDRONATE-35 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 RISEDRONATE-35.
What the medicinal ingredient is
Risedronate sodium
What the non-medicinal ingredients are
Colloidal silicon dioxide, lactose monohydrate, magnesium stearate, pregelatinized starch, sodium stearyl fumarate, starch and film-coating containing the following: FD&C yellow #6/sunset yellow FCF aluminium lake, hydroxypropyl methylcellulose, iron oxide red, iron oxide yellow, polyethylene glycol, polysorbate and titanium dioxide.
What dosage form it comes in
RISEDRONATE-35 is available as tablets. Each orange tablet contains: risedronate sodium 35 mg.
Warnings and precautions
To help avoid side effects and ensure proper use, talk to your healthcare professional before you take RISEDRONATE-35. Talk about any health conditions or problems you may have, including if you:
- have/had problems swallowing or have problems with your esophagus (the tube that connects 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 RISEDRONATE-35)
- are pregnant or breastfeeding
- have one of the following risk factors: cancer, diabetes, chemotherapy, radiotherapy of the head or neck, lowered immune system (immunosuppression), poor oral hygiene, treatment with corticosteroids or cancer drugs such as angiogenesis inhibitors (drugs that slow down the growth of new blood vessels)
- had/have pain, swelling or numbness of the jaw or loosening of a tooth or any other oral symptoms
- 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 RISEDRONATE-35 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 RISEDRONATE-35. Dental work should be done before you start RISEDRONATE-35
treatment. Take good care of your teeth and gums and see the dentist for regular check-ups while
taking RISEDRONATE-35.
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 RISEDRONATE-35.
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 RISEDRONATE-35. They include calcium, magnesium, aluminum and iron.
Take these medicines at a different time of day than RISEDRONATE-35. Talk to your health
care provider about how and when to take these medications.
Taking RISEDRONATE-35 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 antiinflammatory
drugs because they may upset your stomach.
Proper use of this medication
As with all medications, it is important to take as directed by your doctor.
- Take RISEDRONATE-35 in the morning on an empty stomach, at least 30 minutes before you eat, drink or take other medicines.
- Swallow each RISEDRONATE-35 tablet whole, while you are sitting or standing in an upright position. Drink enough plain water (at least 120 mL or ½ cup) to make sure the tablet gets to your stomach. Do not chew, cut or crush the tablets.
- Do not lie down for at least 30 minutes after taking RISEDRONATE-35
Usual Dose
To treat osteoporosis in women after menopause:
- 1 tablet (35 mg) per week
To prevent osteoporosis in women after menopause:
- 1 tablet (35 mg) per week
To increase bone density in men with osteoporosis:
- 1 tablet (35 mg) per week
Overdose
Missed Dose
Weekly dose (35 mg):
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 that you may feel when taking RISEDRONATE-35. If you experience any side effects not listed here, contact your healthcare professional.
Drugs like RISEDRONATE-35 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 RISEDRONATE35 and tell your doctor right away. Remember to take RISEDRONATE-35 as directed.
The most common side effects reported with RISEDRONATE-35 were:
RISEDRONATE-35 may cause pain in bones, joints or muscles, rarely severe.
Patients receiving RISEDRONATE-35 or other drugs in this class have reported:
| 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 swelling, sensitivity to light, decreased vision | ✔ | ||
| RARE | |||
| Pain in your tongue | ✔ | ||
| Jaw bone problems (osteonecrosis). Numbness or a feeling of heaviness in the jaw; poor healing of gums; loose teeth; exposed bone in the mouth; sores in the mouth; discharge; dry mouth; swelling gums; infections; bad breath; pain in the mouth, teeth or jaw. | ✔ | ||
| VERY RARE | |||
| Allergic and skin reactions such as hives, rash (with or without blisters); swelling of the face, lips, tongue or throat; difficult or painful swallowing; trouble breathing. | ✔ | ||
| Symptoms of low levels of calcium in the blood such as numbness, tingling or muscle spasms. | ✔ | ||
| New or unusual pain in the 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 RISEDRONATE-35 in the original package and store at controlled room temperature (15°C – 30°C). Protect from light.
Keep out of reach and sight of children.
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 (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 (health-products.canada.ca/dpd-bdpp/index-eng.jsp); the manufacturer’s website http://www.sivem.ca; or by calling 1-855-788-3153.
This leaflet was prepared by:
Sivem Pharmaceuticals ULC
4705 Dobrin Street
Saint-Laurent, Québec
H4R 2P7
Last Revised: August 29, 2018