Patient Medication Information: uses, side effects, how to take - Way-Risedronate
What is Way-Risedronate used for?
Way-Risedronate is used to treat osteoporosis in postmenopausal women.
How does Way-Risedronate work?
Way-Risedronate contains the medicinal ingredient risedronate sodium. Risedronate sodium belongs to a class of non-hormonal drugs called bisphosphonates. Bisphosphonates are similar to a molecule naturally made in your body that breaks down bone tissue. Way-Risedronate binds to the receptors in your body to prevent the bone from breaking down. This slows down bone loss which can help to reduce the risk of fractures. In many people Way-Risedronate helps to increase bone density.
What are the ingredients in Way-Risedronate?
Medicinal ingredients: risedronate sodium hemi-pentahydrate
Non-medicinal ingredients: colloidal silicon dioxide, crospovidone, hypromellose, indigo carmine, magnesium stearate, microcrystalline cellulose, polyethylene glycol, and titanium dioxide
Way-Risedronate comes in the following dosage forms:
Film-coated tablets: 150 mg (blue)
Do not use Way-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 Way-Risedronate (see What are the ingredients in Way-Risedronate?).
To help avoid side effects and ensure proper use, talk to your healthcare professional before you take Way-Risedronate. Talk about any health conditions or problems you may have, including if you:
- have or have had problems swallowing or have problems with your esophagus (the tube that connects your mouth to your stomach)
- have or have had stomach or digestive problems
- have or have had kidney problems
- cannot stand or sit upright for at least 30 minutes (see How to take Way-Risedronate)
are pregnant or breastfeeding
have one of the following risk factors for developing osteonecrosis (bone damage in the jaw):
- have cancer and/or are currently receiving chemotherapy
- are currently having or have had radiotherapy of the head or neck
- have an infection or a lowered immune system (immunosuppression)
- are taking corticosteroids (used to treat inflammation) or cancer drugs such as angiogenesis inhibitors (used to slow down the growth of new blood vessels)
- have diabetes (high blood sugar)
- have poor oral hygiene or dentures that do not fit well
- have or have had pain, swelling or numbness of the jaw or loosening of a tooth
- have sores in your mouth. Your healthcare professional may tell you not to take Way-Risedronate until all the sores in your mouth have healed.
- are or have been a smoker
- have or have had poor dental health, teeth or gum disease
- have anemia (low red blood cell count)
- have a blood disorder where your blood cannot form clots in the normal way
Other warnings you should know about:
Gastrointestinal Problems: Taking Way-Risedronate incorrectly may cause you to experience problems with your esophagus. Stop taking Way-Risedronate and talk to your healthcare professional if you experience difficulty or pain upon swallowing, chest/breastbone pain or new or worsening heartburn. To avoid problems with your esophagus and to allow the drug to reach the stomach, consider the following instructions:
- swallow each tablet of Way-Risedronate with a full glass of water.
- do NOT chew or suck the tablet.
- do NOT lie down for at least 30 minutes after taking Way-Risedronate or until you have had your first meal of the day.
- do NOT take Way-Risedronate at bedtime or before starting your day.
Eye Problems: Drugs like Way-Risedronate may cause vision problems. Different parts of your eye may experience inflammation or you may develop an eye infection. Your healthcare professional may end your treatment if they see symptoms of inflammation.
Oral Health: Your healthcare professional should check your mouth and may ask you to see your dentist before you start taking Way-Risedronate. Dental work should be done before you start treatment with Way-Risedronate. Tell your healthcare professional if you recently had any major dental procedures like an extraction or a root canal. Take good care of your teeth and gums and see the dentist for regular checkups while taking Way-Risedronate.
Calcium and Vitamin D: Calcium and vitamin D are also important for strong bones. Your healthcare professional may ask you to take calcium and vitamin D while you are on Way-Risedronate.
Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.
The following may interact with Way-Risedronate:
Vitamins, mineral supplements and antacids may contain substances that can stop your body from absorbing Way-Risedronate. They include calcium, magnesium, aluminum and iron. Take
- these medicines at a different time of day than Way-Risedronate. Talk to your healthcare professional about how and when to take these medications.
- Taking Way-Risedronate with corticosteroids or cancer drugs like angiogenesis inhibitors may increase your chance of jaw bone problems (osteonecrosis of the jaw).
- Talk to your healthcare professional before taking pain medication like ASA or other nonsteroidal anti-inflammatory drugs (NSAIDs) because they may upset your stomach.
How to take Way-Risedronate:
- Take Way-Risedronate exactly as your healthcare professional tells you to.
Take Way-Risedronate in the morning on an empty stomach, at least 30 minutes before you eat, drink or take other medicines.
- Swallow each Way-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 Way-Risedronate.
Usual dose: 150 mg per month of Way-Risedronate.
Overdose:
If you take too much Way-Risedronate, drink a full glass of milk and tell your healthcare professional immediately. Do not make yourself vomit. Do not lie down.
If you think that you or a person you are caring for have taken too much Way-Risedronate, contact your healthcare professional, hospital emergency department, regional poison control centre or Health Canada's toll-free number, 1-844 POISON-X (1-844-764-7669) immediately, even if there are no signs or symptoms.
Missed Dose:
If you forget to take your monthly dose of Way-Risedronate, take it next in the morning if your next dose 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 Way-Risedronate within 7 days.
What are possible side effects from using Way-Risedronate?
These are not all the possible side effects you may have when taking Way-Risedronate. If you experience any side effects not listed here, tell your healthcare professional.
Side effects may include:
- abdominal pain, heartburn, nausea
- diarrhea
- constipation
- flatulence (gas)
- headache
- lack of energy
When you take Way-Risedronate once a month, it may cause short-lasting, mild flu-like symptoms.
These symptoms usually decrease as you keep taking doses.
Serious side effects and what to do about them
| Symptom / effect | Talk to your healthcare professional | Stop taking drug and get immediate medical help | |
|---|---|---|---|
| Only if severe | In all cases | ||
| COMMON | |||
| Pain in bones, joints or muscles | √ | ||
| Esophagus and stomach problems: abdominal pain, pain or trouble swallowing, vomiting blood, heartburn, chest or breastbone pain, black or bloody stool | √ | ||
| UNCOMMON | |||
| Eye problems: 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 reactions: hives, rash (with or without blisters); swelling of the face, lips, tongue or throat; difficult or painful swallowing; trouble breathing | √ | ||
| Hypocalcemia (low levels of calcium in the blood): numbness, tingling or muscle spasms | √ | ||
| Atypical femur fractures: 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, tell your healthcare professional.
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 (canada.ca/drug-device-reporting) 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.
Storage:
Keep Way-Risedronate in the original package and store at room temperature (20-25°C).
Keep out of reach and sight of children.
If you want more information about Way-Risedronate:
- 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: (www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drugproduct-database.html); the manufacturer’s website www.waymade.ca, or by calling 1-800-970-8841.
Montreal, Quebec, H3Z2Y5.