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 150 MG – 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 more easily. Your chance of developing osteoporosis increases as you age, after menopause, or if you take corticosteroid medications (such as prednisone) for a long time.
This medication works by slowing bone loss to help maintain strong bones and reduces 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 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 as directed by your doctor, usually once a month. 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 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 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.
Take this medication regularly to get the most benefit from it. Choose the day of the month that best fits your schedule. Remember to take it on the same day each month. 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: Upset stomach may occur. Although uncommon, mild flu-like symptoms (such as fever, tiredness, muscle aches) may occur within several days of taking your first monthly dose, but usually last less than a week. 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 infrequently 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.
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 (such as alendronate); 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.
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 unknown if this drug 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.
This medication may interfere with certain lab tests (bone-imaging agents). Be sure to tell your doctor or laboratory personnel that you are taking this medication.
OVERDOSE: If overdose is suspected, contact a poison control center or emergency room immediately. 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 (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 your dose when you first get up for the day, do not take it later in the day. If you miss a dose and next month’s scheduled dose is more than 7 days away, take the missed dose the next day when you first get up. Then resume your usual dosing schedule. Do not take more than 1 dose within 7 days.
If you miss a dose and next month’s scheduled dose is less than 7 days away, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.
If you have any questions, ask your doctor or pharmacist.
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.
Information last revised March 2015. Copyright(c) 2015 First Databank, Inc.