PMS-Risedronate: Uses, Side Effects and Dosage

What is pms-RISEDRONATE used for?

pms-RISEDRONATE is used in adults to:

• treat or prevent osteoporosis in postmenopausal women.
• increase bone density in men with osteoporosis.

How does pms-RISEDRONATE work?

pms-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. pms-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 pms-RISEDRONATE helps to increase bone density.

What are the ingredients in pms-RISEDRONATE? Medicinal ingredients: Risedronate Sodium (as risedronate sodium hemi-pentahydrate)

Non-medicinal ingredients: 35 mg: 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.

150 mg: Crospovidone, FD&C Blue #2 Indigo Carmine Aluminium Lake, Hydroxypropyl Cellulose, Hypromellose, Magnesium Stearate, Microcrystalline Cellulose, Polyethylene Glycol/Macrogol, Silica, Titanium Dioxide.

pms-RISEDRONATE comes in the following dosage forms:

Tablets: 35 mg and 150 mg

Do not use pms-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 pms-RISEDRONATE (see What are the ingredients in pms-RISEDRONATE?).

To help avoid side effects and ensure proper use, talk to your healthcare professional before you take pms-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 pms-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 pms-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 pms-RISEDRONATE incorrectly may cause you to experience problems with your esophagus. Stop taking pms-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 pms-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 pms-RISEDRONATE or until you have had your first meal of the day.
• do NOT take pms-RISEDRONATE at bedtime or before starting your day.

Eye Problems: Drugs like pms-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 pms-RISEDRONATE. Dental work should be done before you start treatment with pms-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 pms-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 pms-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 pms-RISEDRONATE:

• Vitamins, mineral supplements and antacids may contain substances that can stop your body from absorbing pms-RISEDRONATE. They include calcium, magnesium, aluminum and iron. Take these medicines at a different time of day than pms-RISEDRONATE. Talk to your healthcare professional about how and when to take these medications.
• Taking pms-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 non-steroidal anti-inflammatory drugs (NSAIDs) because they may upset your stomach.

How to take pms-RISEDRONATE:

• Take pms-RISEDRONATE exactly as your healthcare professional tells you to.

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

• Swallow each pms-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 pms-RISEDRONATE.

Usual dose:

To treat osteoporosis in women after menopause:

• 35 mg per week of pms-RISEDRONATE
• 150 mg per month of pms-RISEDRONATE

To prevent osteoporosis in women after menopause:

• 35 mg per week of pms-RISEDRONATE

To increase bone density in men with osteoporosis:

• 35 mg per week of pms-RISEDRONATE

Overdose:

If you take too much pms-RISEDRONATE, drink a full glass of milk, and tell your healthcare professional immediately. Do not make yourself vomit. Do not lie down.

Missed Dose:

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 pms-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 pms-RISEDRONATE within 7 days.

What are possible side effects from using pms-RISEDRONATE?

These are not all the possible side effects you may have when taking pms-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 pms-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

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

Storage:

• Store between 15°C and 30°C.
• Keep out of reach and sight of children.

If you want more information about pms-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 (https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html), or by contacting the sponsor 1-888-550-6060.

Last revised: February 1, 2023