Risedronate DR 35mg Tablets- 4 Tablet Pack (Greenstone)

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.

RISEDRONATE DELAYED-RELEASE - ORAL

(RIS-e-DROE-nate)

COMMON BRAND NAME(S): Atelvia

USES: Risedronate is used to prevent and treat certain types of bone loss (osteoporosis) in adults. Osteoporosis causes bones to become thinner and break 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. This effect helps maintain strong bones and reduce the risk of broken bones (fractures). Risedronate belongs to a class of medications called bisphosphonates.

HOW TO USE: Read the Medication Guide, and if available, the Patient Information Leaflet if available from your pharmacist before you start taking risedronate and each time you get a refill. If you have any questions, ask your doctor or pharmacist. Take this medication by mouth with or immediately after breakfast as directed by your doctor, usually once a week. Choose the day of the week that best fits your schedule and take it on the same day every week. Do not take it at bedtime or while you are still in bed. Take this medication with at least half a glass (4 ounces/120 milliliters) of plain water. Do not take it with any other beverages. Swallow the tablet whole. Do not cut, crush, chew, or suck on it. Then stay fully upright (sitting, standing or walking) and do not lie down for at least 30 minutes. Calcium or iron supplements, vitamins that contain minerals, and products that contain calcium/magnesium/aluminum (such as antacids, laxatives) 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. Take these products at a different time of the day from when you take risedronate. Wait at least 30 minutes after taking risedronate before you take these other products. Take this medication regularly in order to get the most benefit from it. Remember to take it on the same day each week. It may help to mark your calendar with a reminder. Talk to your doctor about the risks and benefits of long-term use of this medication.

SIDE EFFECTS: Stomach/abdominal pain, nausea, vomiting, or diarrhea may occur. If any of these effects persist or worsen, tell 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 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, painful/difficult 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.

PRECAUTIONS: Before taking risedronate, tell your doctor or pharmacist if you are allergic to it; 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: kidney disease, inability to sit upright or stand for 30 minutes, low level of calcium in the blood (hypocalcemia), disorders of the esophagus (such as esophageal stricture or achalasia), difficult or painful swallowing, 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 risedronate before your surgery. Ask for specific instructions about stopping or starting this medication. Caution is advised if you are pregnant or planning to become pregnant in the future. This medication may stay in your body for many years. Its effects on an unborn baby are unknown. Discuss the risks and benefits with your doctor before starting treatment with risedronate. It is unknown if this medication passes into breast milk. Consult your doctor before breast-feeding.

DRUG INTERACTIONS: 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. Products that may interact with this drug include: medications that decrease stomach acid (such as antacids, H2 blockers including ranitidine, proton pump inhibitors including omeprazole). This medication may interfere with bone-imaging agents. Make sure laboratory personnel and all your doctors know you use this medication.

OVERDOSE: 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 their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.

NOTES: 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. Laboratory and/or medical tests (such as 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.

MISSED DOSE: If you miss a dose, do not take it later in the day. Take it the next morning after you remember. Continue taking your weekly dose 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.

STORAGE: 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 for more details.

Information last revised July 2016. Copyright(c) 2016 First Databank, Inc.