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Details for: TEVA-RISEDRONATE

Company: TEVA CANADA LIMITED

DIN DIN name Active Ingredient(s) Strength Dosage Form Route of Administration
02298376TEVA-RISEDRONATERISEDRONATE SODIUM (RISEDRONATE SODIUM MONOHYDRATE)5 MGTABLETORAL
02298384TEVA-RISEDRONATERISEDRONATE SODIUM (RISEDRONATE SODIUM MONOHYDRATE)30 MGTABLETORAL
02298392TEVA-RISEDRONATERISEDRONATE SODIUM (RISEDRONATE SODIUM MONOHYDRATE)35 MGTABLETORAL
02413809TEVA-RISEDRONATERISEDRONATE SODIUM (RISEDRONATE SODIUM MONOHYDRATE)150 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. TEVA-RISEDRONATE slows down bone loss which can help to reduce the risk of fractures. In many people TEVA-RISEDRONATE helps to increase bone density.

It is not known how long TEVA-RISEDRONATE should be used for treating osteoporosis. Keep talking to your doctor about whether TEVA-RISEDRONATE is still right for you.

TEVA-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 TEVA-RISEDRONATE.
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:

5 mg: D&C yellow #10 lake, hydroxypropyl methylcellulose, iron oxide yellow, polyethylene glycol, polysorbate and titanium dioxide.

30 mg: Hydroxypropyl methylcellulose, polyethylene glycol, polysorbate and titanium dioxide.

35 mg: FD&C yellow #6/sunset yellow FCF aluminium lake, hydroxypropyl methylcellulose, iron oxide red, iron oxide yellow, polyethylene glycol, polysorbate and titanium dioxide.

150 mg: Carmine, FD&C blue #2/Indigo carmine aluminium lake, macrogol, polyvinyl alcohol, talc and titanium dioxide

What dosage form it comes in

TEVA-RISEDRONATE is available as tablets. Each tablet contains: risedronate sodium 5 mg (yellow), 30 mg (white), 35 mg (orange), or 150 mg (blue).

Warnings and precautions

To help avoid side effects and ensure proper use, talk to your healthcare professional before you take TEVA-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 TEVA-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 TEVA-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 TEVA-RISEDRONATE. Dental work should be done before you start TEVA-RISEDRONATE treatment. Take good care of your teeth and gums and see the dentist for regular check-ups while taking TEVA-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 TEVA-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 TEVA-RISEDRONATE. They include calcium, magnesium, aluminum and iron.
Take these medicines at a different time of day than TEVA-RISEDRONATE. Talk to your health care provider about how and when to take these medications.

Taking TEVA-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 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 TEVA-RISEDRONATE in the morning on an empty stomach, at least 30 minutes before you eat, drink or take other medicines.
  • Swallow each TEVA-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 TEVA-RISEDRONATE

Usual dose

To treat osteoporosis in women after menopause:

  • 5 mg per day of TEVA-RISEDRONATE or
  • 35 mg per week of TEVA-RISEDRONATE or
  • 150 mg per month of TEVA-RISEDRONATE

To prevent osteoporosis in women after menopause:

  • 5 mg per day of TEVA-RISEDRONATE or
  • 35 mg per week of TEVA-RISEDRONATE

To increase bone density in men with osteoporosis:

  • 35 mg per week of TEVA-RISEDRONATE

To treat or prevent osteoporosis in men or women who are taking steroid medicines (e.g. prednisone):

  • 5 mg per day of TEVA-RISEDRONATE

To treat men and women who have Paget’s disease of bone:

  • 30 mg per day of TEVA-RISEDRONATE

Overdose

If you think you have taken too much TEVA-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

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 TEVA-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 TEVA-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 TEVA-RISEDRONATE. If you experience any side effects not listed here, contact your healthcare professional.

Drugs like TEVA-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 TEVA-RISEDRONATE and tell your doctor right away. Remember to take TEVA-RISEDRONATE as directed.

The most common side effects reported with TEVA-RISEDRONATE were:

  • Abdominal pain, heartburn, nausea
  • Diarrhea and headache (in studies of Paget’s disease)

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

When you take TEVA-RISEDRONATE once a month, it may cause short-lasting, mild flu-like symptoms. These symptoms usually decrease as you keep taking doses.

Patients receiving TEVA-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 and What to do About Them
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 TEVA-RISEDRONATE 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:

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.tevacanada.com; or by calling 1-800-268-4127 ext. 3; or email druginfo@tevacanada.com.

This leaflet was prepared by Teva Canada Limited, Toronto, Ontario M1B 2K9

Last Revised: January 12, 2018

Date modified: