This product contains two separate medications: risedronate tablets and calcium tablets.

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 (such as prednisone) for a long 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 make sure you get enough calcium in addition to the calcium you get from a well-balanced diet.

Read the Patient Information Leaflet if available from your pharmacist before you start taking this product and each time you get a refill. Follow the instructions very closely to make sure you absorb as much of the drug as possible and reduce the risk of injury to your esophagus. If you have any questions, ask your doctor or pharmacist.

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

For risedronate: Take this medication by mouth as directed by your doctor, usually once a week. 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 of plain water (6 to 8 ounces or 180 to 240 milliliters). 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 (such as milk, yogurt), and calcium-enriched juice may interfere with absorption of risedronate. Medications such as quinapril, 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 as directed by your doctor, with food for best absorption, usually once daily except for the day you take risedronate. Calcium can interfere with the absorption of other drugs (such as levothyroxine, quinolone antibiotics such as ciprofloxacin, tetracycline antibiotics, iron, estramustine). Ask your pharmacist how and when to take these medications.

Use this product regularly in order to get the most benefit from it. Talk to your doctor about the risks and benefits of long-term use of this medication.

Upset stomach, nausea, constipation, gas, or bloating may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.

Remember that this medication has been prescribed because your doctor 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 right away if you have any serious side effects, including:

• increased or severe bone/joint/muscle pain
• new or unusual hip/thigh/groin pain
• jaw pain
• eye/vision problems

Risedronate may rarely cause irritation and ulcers in your stomach or esophagus. Get medical help right away 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 rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including:

• 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 or at www.fda.gov/medwatch.

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 (such as alendronate, etidronate, pamidronate); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this product, tell your doctor or pharmacist your medical history, especially of:

• low or high blood calcium levels (hypocalcemia or hypercalcemia)
• inability to sit upright or stand for at least 30 minutes
• esophagus problems (such as narrowing of the esophagus, achalasia)
• difficult or painful swallowing
• kidney problems (such as severe kidney disease, kidney stones)
• stomach/intestinal disorders (such as ulcers)

Some people taking risedronate may have serious jawbone problems. Your doctor should check your mouth before you start this medication. Tell your dentist that you are taking this medication before you have any dental work done. To help prevent jawbone problems, have regular dental exams and learn how to keep your teeth and gums healthy. If you have jaw pain, tell your doctor and dentist right away.

Before having any surgery (especially dental procedures), tell your doctor and dentist about this medication and all other products you use (including prescription drugs, nonprescription drugs, and herbal products). Your doctor or dentist may tell you to stop taking this medication before your surgery. Ask for specific instructions about stopping or starting this medication.

Tell your doctor if you are pregnant or plan to become pregnant. Risedronate may stay in your body for many years. You should not become pregnant while using risedronate. Discuss the risks and benefits with your doctor.

It is unknown if risedronate passes into breast milk. Consult your doctor before breastfeeding.

See also How to Use section.

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

This medication may interfere with certain lab tests (such as bone-imaging tests), possibly causing false test results. Make sure lab personnel and all your doctors know you use this drug.

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call 1-800-222-1222. Canada residents can call 1-844-764-7669.

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.

Lab and/or medical tests (x-rays, height, blood mineral levels) should be done while you are taking this medication. Keep all medical and lab appointments. 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. Keep 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. Take your next dose at the regular time. Do not double the dose of calcium to catch up unless your doctor directs you otherwise.

Store at room temperature away from light and moisture. Do not store in the bathroom. Keep all medications 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.