Risedronate Sodium

IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

Before taking risedronate, tell your doctor or pharmacist if you are allergic to it; 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 medication, tell your doctor or pharmacist your medical history, especially of: esophagus problems (such as heartburn, narrowing of the esophagus, achalasia), difficult or painful swallowing, low levels of calcium in the blood (hypocalcemia), inability to sit upright or stand for at least 30 minutes, stomach/intestinal disorders (such as ulcers), severe kidney disease.

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 risedronate 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 this drug 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 medication 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.

This section contains uses of this drug that are not listed in the approved professional labeling for the drug but that may be prescribed by your health care professional. Use this drug for a condition that is listed in this section only if it has been so prescribed by your health care professional.

This drug may also be used for certain types of bone loss (osteoporosis) in adults. Osteoporosis causes bones to become thinner and break more easily. Your chance of getting osteoporosis goes up as you age, after menopause, or if you are taking corticosteroid medications (such as prednisone) for a long time.

Read the Medication Guide and, if available, the Patient Information Leaflet provided by your pharmacist before you start using risedronate 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.

Take this medication by mouth, after getting up for the day and 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 beverage. 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.

Calcium or iron supplements, vitamins with minerals, antacids containing calcium/magnesium/aluminum, dairy products (such as milk, yogurt), and juice with added calcium 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.

Use this medication regularly to get the most benefit from it. For the treatment of Paget's disease, remember to take it at the same time each morning, usually for 2 months.

This drug may also be prescribed once weekly for osteoporosis. Check your prescription label carefully, and ask your doctor or pharmacist if you are uncertain about your dosing schedule. Talk to your doctor about the risks and benefits of long-term use of this medication.

Upset stomach may occur. If this effect lasts or gets 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.

This medication 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 MedWatch: The FDA Safety Information and Adverse Event Reporting Program.

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

If you take this medication once a day and miss a dose, skip the missed dose. Do not take it later in the day. Take your next dose at the regular time the following day. Do not double the dose to catch up.

If you take this medication once a week and miss a dose, skip the missed dose. Do not take it later in the day. Take it the next morning after you remember. Keep taking your weekly dose on your originally scheduled day of the week. Do not take 2 doses on the same day. Ask your pharmacist if you have any questions.