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Details for: AURO-RISEDRONATE

Company: AURO PHARMA INC

DIN DIN name Active Ingredient(s) Strength Dosage Form Route of Administration
02406306AURO-RISEDRONATERISEDRONATE SODIUM (RISEDRONATE SODIUM HEMIPENTAHYDRATE)35 MGTABLETORAL
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Summary Reports

Summary Safety Review - Bisphosphonates - Assessing the Potential Risk of Severe Bone Damage (osteonecrosis)
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.
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 AURO-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 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
To prevent osteoporosis in women after menopause:
  • 5 mg per day of AURO-RISEDRONATE or
  • 35 mg per week of AURO-RISEDRONATE
To increase bone density in men with osteoporosis:
  • 35 mg per week of AURO-RISEDRONATE
To treat or prevent osteoporosis in men or women who are taking steroid medicines (e.g., prednisone):
  • 5 mg per day of AURO-RISEDRONATE
To treat men and women who have Paget’s disease of bone:
  • 30 mg per day of AURO-RISEDRONATE

Overdose

If you think you have taken too much AURO-RISEDRONATE, contact your healthcare professional, hospital emergency department or regional Poison Control Centre immediately, even if there are no symptoms.

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)
AURO-RISEDRONATE may cause pain in bones, joints or muscles, rarely severe.

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.

Serious side effects, how often they happen and what to do about them
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:

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:

This leaflet was prepared by:
Auro Pharma Inc.
3700 Steeles Avenue West, Suite # 402
Woodbridge, Ontario, L4L 8K8,
Canada.
Date of Revision: August 22, 2019

Date modified: