Details for: AURO-RISEDRONATE
Company: AURO PHARMA INC
| DIN | DIN name | Active Ingredient(s) | Strength | Dosage Form | Route of Administration |
|---|---|---|---|---|---|
| 02406306 | AURO-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.
- To treat or prevent osteoporosis in men or women who are taking steroid medicines such as prednisone.
- To treat men and women who have Paget’s disease of bone.
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. AURO-RISEDRONATE slows down bone loss which can help to reduce the risk of fractures. In many people AURO-RISEDRONATE helps to increase bone density. It is not known how long AURO-RISEDRONATE should be used for treating osteoporosis. Keep talking to your doctor about whether AURO-RISEDRONATE is still right for you. AURO-RISEDRONATE is not a pain reliever.
When it should not be used
Do not use AURO-RISEDRONATE if:
- You have low levels of calcium in your blood (hypocalcemia).
- You are allergic to risedronate sodium or any of the other ingredients in AURO-RISEDRONATE.
What the medicinal ingredient is
Risedronate sodium hemipentahydrate
What the non-medicinal ingredients are
Core tablet Ingredients:
5 mg, 30 mg & 35 mg:
Lactose Monohydrate, Cellulose Microcrystalline, Crospovidone XL, Hydroxy Propyl Cellulose, Magnesium stearate.
150 mg:
Cellulose Microcrystalline (Avicel PH 101 & 102), Crospovidone & Magnesium stearate.
Coating Ingredients:
5 mg: Hypromellose, Titanium Dioxide, Macrogol, Hydroxy propyl cellulose, Iron oxide yellow and Silica colloidal.
30 mg: Hypromellose, Hydroxy propyl cellulose, Macrogol, Titanium Dioxide.
35 mg: Hypromellose, Titanium Dioxide, Macrogol, Hydroxy propyl cellulose, Silica colloidal, Iron oxide yellow and
red.
150 mg: Hypromellose, Titanium Dioxide, Polyethylene glycol, Hydroxy propyl cellulose, FD & C Blue #2/Indigo
carmine Aluminium lake and Colloidal Silicon dioxide.
What dosage form it comes in
AURO-RISEDRONATE is available as tablets. Each tablet contains risedronate sodium hemipentahydrate 5 mg (yellow), 30 mg (white), 35 mg (orange) and 150 mg (blue).
Warnings and precautions
To help avoid side effects and ensure proper use, talk to your healthcare professional before you take AURO-RISEDRONATE. 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 AURO-RISEDRONATE)
- 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.
- 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.
Other warnings you should know about:
Your doctor should check your mouth and may ask you to see your dentist before you start taking AURO-RISEDRONATE. Dental work should be done before you start AURO-RISEDRONATE treatment. Take good care of your teeth and gums and see the dentist for regular checkups while taking AURO-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 AURO-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
The following may interact with AURO-RISEDRONATE:
Vitamins, mineral supplements and antacids may contain substances that can stop your body from absorbing AURO-RISEDRONATE.
They include calcium, magnesium, aluminum and iron. Take these medicines at a different time of
day than AURO-RISEDRONATE. Talk to your health care provider about how and when to take these medications.
Taking AURO-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.
Proper use of this medication
How to take AURO-RISEDRONATE:
As with all medications, it is important to take as directed by your doctor.
- Take AURO-RISEDRONATE in the morning on an empty stomach, at least 30 minutes before you eat, drink or take other medicines.
- Swallow each AURO-RISEDRONATE 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 AURO-RISEDRONATE.
Usual Dose
To treat osteoporosis in women after menopause:
- 5 mg per day of AURO-RISEDRONATE or
- 35 mg per week of AURO-RISEDRONATE or
- 150 mg per month of AURO-RISEDRONATE
- 5 mg per day of AURO-RISEDRONATE or
- 35 mg per week of AURO-RISEDRONATE
- 35 mg per week of AURO-RISEDRONATE
- 5 mg per day of AURO-RISEDRONATE
- 30 mg per day of AURO-RISEDRONATE
Overdose
Missed Dose
Daily dose (5 mg or 30 mg):
If you forget to take your dose, do not take two tablets on the same day. Skip the missed dose and take a tablet at your
next scheduled time.
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.
Monthly dose (150 mg):
If you forget to take your monthly dose of AURO-RISEDRONATE, take it next in the morning if it is more than 7
days away. Take your next dose on the regularly scheduled day.
If your next dose is less than 7 days away, wait until your next scheduled dose. Do not take more than 150 mg of
AURO-RISEDRONATE within 7 days.
Side effects and what to do about them
These are not all the possible side effects you may feel when taking AURO-RISEDRONATE. If you experience any
side effects not listed here, contact your healthcare professional.
Drugs like AURO-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 AURO-RISEDRONATE and tell your doctor right away. Remember to take
AURO-RISEDRONATE as directed.
The most common side effects reported with AURO-RISEDRONATE were:
- Abdominal pain, heartburn, nausea
- Diarrhea and headache (in studies of Paget’s disease)
When you take AURO-RISEDRONATE once a month, it may cause short-lasting, mild flu-like symptoms. These symptoms usually decrease as you keep taking doses.
Patients receiving AURO-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 with your doctor, nurse, or pharmacist only if severe | Talk with your doctor, nurse, or pharmacist 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
- 5 mg, 30 mg & 35 mg:
Store at room temperature between 15 and 30°C. Keep out of the reach of children. - 150 mg:
Store at room temperature (15°C to 30°C). Keep out of the reach of children.
Reporting side effects
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/healthcanada/services/drugs-health-products/medeffectcanada/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
If you want more information about AURO-RISEDRONATE:
- 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://health-products.canada.ca/dpd-bdpp/index-eng.jsp); the manufacturer’s website www.auropharma.ca, or by calling 1-855-648-6681.
Auro Pharma Inc.
3700 Steeles Avenue West, Suite # 402
Woodbridge, Ontario, L4L 8K8,
Canada.
Date of Revision: August 22, 2019