Consumer Information for: DOM-RISEDRONATE

Consumer Information

Information about the product including what the product is used for, dosage, warnings, proper use and side effects. This summary will not tell you everything about the product. Contact your healthcare professional if you have any questions about the product.


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

Dom-RISEDRONATE is a bisphosphonate drug that helps to slow bone loss. In many people, Dom-RISEDRONATE helps to increase bone density. 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 or hip). Spine fractures may result in a curved back, height loss or back pain. Dom-RISEDRONATE corrects this imbalance by decreasing the elevated rate of bone removal. Dom-RISEDRONATE can therefore help reduce the risk of spine and non-spine fractures.

Since it is not known how long Dom-RISEDRONATE should be continued for patients with osteoporosis, you should discuss the need to stay on this medication with your doctor regularly to determine if Dom-RISEDRONATE is still right for you.

Your doctor may measure the thickness (i.e., density) of your bone through a bone mineral density (BMD) test or x-ray to check your progress against further bone loss or fracture.

Dom-RISEDRONATE is not a pain reliever. Your doctor may prescribe or recommend another medicine specifically for pain relief.

When it should not be used
  • If you have low blood calcium levels (hypocalcemia).
  • If you are allergic to risedronate sodium or any other ingredients in Dom-RISEDRONATE
What the medicinal ingredient is

Risedronate sodium

What the non-medicinal ingredients are

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

Before you use Dom-RISEDRONATE, talk to your doctor or pharmacist if you:

  • have had problems or disease in your kidneys, esophagus (the tube connecting the mouth and the stomach), stomach or intestines.
  • cannot carry out dosing instructions (see PROPER USE OF THIS MEDICATION).
  • are pregnant or nursing.
  • have one of the following risk factors: cancer, diabetes, chemotherapy, radiotherapy of the head or neck, immunosuppression, poor oral hygiene, treatment with corticosteroids or angiogenesis inhibitors (drugs that slow down the growth of new blood vessels and are used mostly to treat cancer).
  • had or have pain, swelling or numbness of the jaw or loosening of a tooth or any other oral symptoms.

Your doctor should inspect your mouth and may ask that you have a dental examination prior to treatment with Dom-RISEDRONATE. Dental work should be done before you receive treatment with Dom-RISEDRONATE, and dental procedures should be avoided during treatment. It is important that you practice good dental hygiene, routine dental care and have regular dental check-ups while being treated with Dom-RISEDRONATE. Immediately report any oral symptoms such as loosening of a tooth, pain, swelling, or non-healing sores or discharge (pus or oozing) during your treatment with Dom-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 Dom-RISEDRONATE therapy (see INTERACTIONS WITH THIS MEDICATION section).

Interactions with this medication

If taken with some other medicines, the effects of Dom-RISEDRONATE or the effects of other medicines may be changed. It is important to tell your healthcare providers, including doctors and dentists, about all medications you are taking, even if the medicine does not require a prescription (including vitamin and herbal supplements).

Vitamins, mineral supplements, antacids and other medications may contain substances (e.g., calcium, magnesium, aluminum, and iron) which can stop your body from absorbing or using Dom-RISEDRONATE. These medications should be taken at a different time of day than Dom-RISEDRONATE. Talk to your health care provider about how and when to take these medications.

Taking Dom-RISEDRONATE with corticosteroids or angiogenesis inhibitors may increase your chance of osteonecrosis of the jaw.

You should not take Dom-RISEDRONATE with food, as it may prevent your body from absorbing or using Dom-RISEDRONATE

You should take Dom-RISEDRONATE on an empty stomach. (See PROPER USE OF THIS MEDICATION for instructions)

Proper use of this medication

As with all medications, it is important to take as directed by your doctor.

Usual dose

Treatment of postmenopausal osteoporosis:
1 tablet (35 mg) per week

Prevention of postmenopausal osteoporosis:
1 tablet (35 mg) per week

Treatment of Osteoporosis in Men, to Improve Bone Mineral Density:
1 tablet (35 mg) per week

Dosing Instructions

  • Dom-RISEDRONATE should be taken in the morning on an empty stomach at least 30 minutes before consuming the first food, drink (other than plain water) and/or any other medication of the day. Food, medication or drink other than plain water can interfere with the absorption of risedronate sodium.
  • Each Dom-RISEDRONATE tablet should be swallowed whole while you are in an upright position and with sufficient plain water (≥ 120 mL or ½ cup) to facilitate delivery to the stomach.
  • You should not lie down for at least 30 minutes after taking the medication. You may sit, stand or do normal activities like read the newspaper, take a walk, etc.
  • Dom-RISEDRONATE tablets should not be chewed, cut, or crushed.

These recommendations help Dom-RISEDRONATE work correctly and help you avoid possible irritation of the esophagus (the tube connecting the mouth and the stomach).

The effects of Dom-RISEDRONATE may change if you take it with food. Talk to your health care professional to ensure that you are clear on the dosage you have been prescribed.

Once weekly dosing (35 mg per week):

  • Choose a day of the week to take your tablet.
  • On your chosen day, take one Dom-RISEDRONATE tablet first thing in the morning with plain water before you have anything to eat or drink.

Missed Dose

Weekly dose (35 mg tablet): If you forget to take your dose on the regularly scheduled day, simply take 1 tablet on the day you first remember having missed your dose. Then resume your schedule by taking 1 tablet on the originally chosen day of the week. If you've missed your dose by exactly one week, do not take 2 tablets on the same day. Simply take 1 tablet as you normally would have on this day and resume your usual weekly schedule.

Overdose

If you take too many tablets on any given day, contact your doctor, or a Poison Control Centre, or an emergency room of the nearest hospital immediately.

For Dom-RISEDRONATE overdose, drink a full glass of milk. Do not induce vomiting.

Side effects and what to do about them

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

Dom-RISEDRONATE side effects: In clinical studies of osteoporosis with risedronate sodium, the most commonly reported side effects were abdominal pain, heartburn and nausea.

Dom-RISEDRONATE may cause pain in bones, joints or muscles, rarely severe. Pain may start as soon as one day or up to several months after starting Dom-RISEDRONATE.

Dom-RISEDRONATE at monthly doses may cause short-lasting, mild flu-like symptoms. These symptoms usually decrease after subsequent doses.

Rarely patients have reported non-healing jaw wounds while receiving risedronate sodium or other drugs in this class. Consult your doctor if you experience persistent pain in your mouth, teeth or jaw, or if your gums or mouth heal poorly.

Very rarely patients have reported unusual fractures in their thigh bone while receiving drugs in this class. Consult your doctor if you experience new or unusual pain in your hip, groin, or thigh.

Serious side effects, how often they happen and what to do about them
Symptom / effect Talk with your doctor or pharmacist Only if severe Talk with your doctor or pharmacist In all cases Stop taking drug and seek immediate emergency medical attention.
Common (more than 1 in 100)
Pain in bones, joints, or muscles ✔    
Abdominal pain ✔    
Uncommon (less than 1 in 100)
Eye pain, redness or inflammation; sensitivity to light, decreased vision     ✔
Rare (less than 1 in 1,000)
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 (less than 1 in 10,000)
Allergic and skin reactions such as: hives (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   ✔  

This is not a complete list of side effects. For any unexpected effects while taking Dom-RISEDRONATE, contact your doctor or pharmacist.

How to store
  • Keep Dom-RISEDRONATE and all other medications out of the reach of children.
  • Store at room temperature (15°C - 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:

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

This document plus the full product monograph, prepared for health professionals, can be obtained by contacting the sponsor, Dominion Pharmacal at, 1-888-550-6060.

This leaflet was prepared by
        Dominion Pharmacal
        Montreal Canada
        H4P 2T4

Last revised: February 24, 2017

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