This product contains two separate medications, risedronate and calcium.

Risedronate is used to prevent and treat certain types of bone loss (osteoporosis) in adults. Osteoporosis causes bones to become thinner and break (fracture) more easily. Your chance of developing osteoporosis increases as you age, after menopause, or if you are taking corticosteroid medications (e.g., prednisone) for long periods of time. This medication works by slowing bone loss to help maintain strong bones and reduce the risk of fractures. Risedronate belongs to a class of medications called bisphosphonates.

Calcium is a mineral needed to form healthy bones and to keep them strong. Calcium supplements are used to ensure an adequate intake of calcium in addition to the calcium you get from a well-balanced diet.

Read the Patient Information Leaflet provided by your pharmacist before you start this product and each time you get a refill. Follow the instructions very closely to maximize the amount of drug absorbed and reduce the risk of injury to your esophagus. Consult your doctor or pharmacist if you have any questions.

This product package contains both risedronate and calcium tablets. Calcium can decrease the absorption of risedronate if taken within 30 minutes after it. The manufacturer has indicated on the package instructions to take risedronate and calcium on separate days to avoid this drug interaction.

For risedronate: Take this medication by mouth, usually once a week or as directed by your doctor. Take it after getting up for the day, before taking your first food, beverage or other medication. Do not take it at bedtime or while you are still in bed. Take this medication with a full glass (6-8 ounces or 180-240 milliliters) of plain water. Do not take it with any other beverages. Swallow the tablet whole. Do not chew or suck on it. Then stay fully upright (sitting, standing or walking) for at least 30 minutes, and do not lie down until after your first food of the day. Wait at least 30 minutes after taking risedronate before you eat or drink anything other than plain water and before taking any other medication by mouth.

Iron supplements, vitamins with minerals, antacids containing calcium/magnesium/aluminum, dairy products (e.g., milk, yogurt), and calcium-enriched juice may interfere with absorption of risedronate. Medications such as quinapril, certain forms of didanosine (chewable/dispersible buffered tablets or pediatric oral solution), sucralfate, and bismuth subsalicylate may also interfere with absorption. Do not take these products for at least 30 minutes after taking risedronate.

For calcium: Take the calcium in this product with food for best absorption, usually once daily except for the day you take risedronate, or as directed by your doctor. Calcium can interfere with the absorption of other drugs (e.g., levothyroxine, quinolone antibiotics such as ciprofloxacin, tetracycline antibiotics, iron, estramustine). Consult your pharmacist for details on the proper times to take these medications to minimize this interaction.

Use this product regularly in order to get the most benefit from it.

Upset stomach, nausea, constipation, gas, bloating, or headache may occur. If any of these effects persist or worsen, notify your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if any of these unlikely but serious side effects occur: bone/joint/muscle pain, jaw pain, eye/vision problems, symptoms of a kidney stone (e.g., lower abdominal/back/side pain, frequent urination, blood in the urine, fever/chills).

Risedronate may infrequently cause irritation and ulcers in your stomach or esophagus. Seek immediate attention if any of these serious side effects occur: new/severe/worsening heartburn, chest pain, difficult or painful swallowing, severe stomach/abdominal pain, black/tarry stools, vomit that looks like coffee grounds.

A very serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction may include: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Before taking risedronate with calcium, tell your doctor or pharmacist if you are allergic to either of these drugs; or to other bisphosphonates (e.g., alendronate, etidronate, pamidronate); or if you have any other allergies.

This product should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have the following conditions: low or high blood calcium levels (hypocalcemia or hypercalcemia), inability to sit upright or stand for at least 30 minutes, severe kidney disease.

Before using this product, tell your doctor or pharmacist your medical history, especially of: esophagus problems (e.g., esophageal stricture), difficult or painful swallowing, kidney problems (e.g., kidney stones), stomach/intestinal disorders (e.g., ulcers).

Infrequently, serious jawbone problems (osteonecrosis) have occurred in people taking medications similar to risedronate. Most people were also using other medications or had conditions that actually caused the jawbone problem. If you have cancer, anemia, blood clotting disorders, infections in the mouth or other diseases of the mouth, or poor dental hygiene, see your dentist for a full examination/treatment before you start risedronate. Make sure your dentist knows your entire medical history, including any cancer radiation treatments. Also tell your dentist of all the medications you are using, especially corticosteroids such as prednisone, cancer chemotherapy, and risedronate. Consult your dentist for more details.

Caution is advised if you are pregnant or planning to become pregnant in the future. Risedronate may stay in your body for many years. Its effects on an unborn baby are not known. Discuss the risks and benefits with your doctor before starting treatment with risedronate.

It is not known if risedronate passes into breast milk. Consult your doctor before breast-feeding.

See also the How to Use section.

Your healthcare professionals (e.g., doctor or pharmacist) may already be aware of any possible drug interactions and may be monitoring you for it. Do not start, stop or change the dosage of any medicine before checking with them first.

Before using this product, tell your doctor or pharmacist of all prescription and nonprescription/herbal products you may use, especially of: certain "water pills" (thiazide diuretics such as hydrochlorothiazide).

Check the labels on all your medicines because they may contain aspirin or nonsteroidal anti-inflammatory drugs (NSAIDs such as ibuprofen, naproxen) that could cause stomach irritation/ulcers. Ask your pharmacist about the safe use of those products. Low-dose aspirin, as prescribed by your doctor for specific medical reasons such as heart attack or stroke prevention (usually these dosages are 81-325 milligrams per day), should be continued. Consult your doctor or pharmacist for more details.

Risedronate may affect the results of certain lab tests (bone-imaging agents). Be sure to tell your doctor or laboratory personnel that you are taking this medication.

This document does not contain all possible interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist.

If overdose is suspected, contact your local poison control center or emergency room immediately. US residents can call the US national poison hotline at 1-800-222-1222. Canadian residents should call their local poison control center directly.

Do not share this product with others.

Lifestyle changes that help promote healthy bones include increasing weight-bearing exercise, stopping smoking, limiting alcohol, and eating well-balanced meals that contain adequate calcium and vitamin D. Since you may also need to take calcium and vitamin D supplements and make lifestyle changes, consult your doctor for specific advice.

Laboratory and/or medical tests (x-rays, height, blood mineral levels) should be performed periodically to monitor your progress or check for side effects. Consult your doctor for more details.

If you miss a dose of risedronate, do not take it later in the day. Take it the next morning after you remember. Take that day's calcium at a later time, with food. Continue taking your weekly dose of risedronate on your originally scheduled day of the week. Do not take two doses on the same day. Consult your doctor or pharmacist if you have any questions.

If you miss a dose of calcium, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose of calcium to catch up unless your doctor directs you otherwise.

Store at room temperature between 68-77 degrees F (20-25 degrees C) away from light and moisture. Brief storage between 59-86 degrees F (15-30 degrees C) is permitted. Do not store in the bathroom. Keep all medicines away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.

Information last revised October 2009 Copyright(c) 2009 First DataBank, Inc.