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 - ORAL
COMMON BRAND NAME(S): Actonel
USES: 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.
HOW TO USE: 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 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. Take this medication by mouth, usually once a day or as directed by your doctor. Take it 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 (6-8 ounces or 180-240 milliliters) of plain water. 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 (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. Use this medication regularly in order to get the most benefit from it. Remember to take it at the same time each morning. Talk to your doctor about the risks and benefits of long-term use of this medication.
SIDE EFFECTS: Upset stomach 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 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 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.
PRECAUTIONS: Before taking risedronate, tell your doctor or pharmacist if you are allergic to it; or to other bisphosphonates (e.g., 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. This medication 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 blood calcium levels (hypocalcemia), inability to sit upright or stand for at least 30 minutes, severe kidney disease. Before using this medication, tell your doctor or pharmacist your medical history, especially of: esophagus problems (e.g., esophageal stricture, achalasia), difficult or painful swallowing, kidney problems, stomach/intestinal disorders (e.g., ulcers). Infrequently, people taking this class of medication (bisphosphonates) have had serious jawbone problems (osteonecrosis). Lack of proper dental hygiene, poorly fitting dentures, or certain dental procedures (such as tooth extraction, dental surgery) may increase your risk. Medical conditions (such as gum disease/infection, cancer, anemia) might also increase the risk. If you develop jaw pain, tell your doctor and dentist immediately. 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 not known. Discuss the risks and benefits with your doctor before starting treatment with risedronate. It is not known if this medication passes into breast milk. Consult your doctor before breast-feeding.
DRUG INTERACTIONS: 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. This medication 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.
OVERDOSE: 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.
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 (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, skip the missed dose. Do not take it later in the day. Resume your usual dosing schedule the following day. Do not double the dose to catch up.
STORAGE: Store the US product at room temperature between 68-77 degrees F (20-25 degrees C). Store the Canadian product at room temperature between 59-86 degrees F (15-30 degrees C). Store the medication away from light and moisture. 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 June 2012. Copyright(c) 2012 First Databank, Inc.