Generic Name: risedronate (RIS-e-DROE-nate)
Brand Name: Actonel
Risedronate tablets are used for:
Treating and preventing osteoporosis in women who have been through menopause. It may also be used for other conditions as determined by your doctor.
Risedronate tablets are a bisphosphonate. It works by slowing bone loss.
Do NOT use risedronate tablets if:
- you are allergic to any ingredient in risedronate tablets
- you have certain esophagus problems (eg, narrowing, blockage)
- you are unable to stand or sit upright for at least 30 minutes
- you have low blood calcium levels or severe kidney problems
Contact your doctor or health care provider right away if any of these apply to you.
Before using risedronate tablets:
Some medical conditions may interact with risedronate tablets. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:
- if you are pregnant, planning to become pregnant, or are breast-feeding
- if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
- if you have allergies to medicines, foods, or other substances
- if you have a history of stomach or bowel problems (eg, inflammation, ulcer), esophagus problems (eg, narrowing, blockage, heartburn, reflux disease, severe irritation), or kidney problems, or if you have difficult or painful swallowing
- if you have low blood vitamin D levels, cancer, anemia, asthma, blood clotting problems, an infection, calcium metabolism problems, or nutrient absorption problems (eg, malabsorption syndrome), or you are unable to take calcium or vitamin D supplements
- if you have poor dental hygiene or other dental problems, or if you will be having a dental procedure (eg, tooth extraction)
- if you smoke or drink alcohol
- if you have had or will be having chemotherapy or radiation treatment
- if you have a mental disorder or other condition that may decrease your ability to follow the dosing instructions for risedronate tablets
- if you are taking any medicines that can cause jaw bone problems. There are many medicines that can do this. Ask your doctor or pharmacist if you are not sure
Some MEDICINES MAY INTERACT with risedronate tablets. Tell your health care provider if you are taking any other medicines, especially any of the following:
- Aspirin or nonsteroidal anti-inflammatory drugs (NSAIDs) (eg, ibuprofen, naproxen) because the risk of stomach or bowel problems may be increased
- Corticosteroids (eg, prednisone) or angiogenesis inhibitors (eg, bevacizumab) because the risk of jawbone problems may be increased
This may not be a complete list of all interactions that may occur. Ask your health care provider if risedronate tablets may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.
How to use risedronate tablets:
Use risedronate tablets as directed by your doctor. Check the label on the medicine for exact dosing instructions.
- Risedronate tablets comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get risedronate tablets refilled.
- Choose 2 days in a row during the month to take risedronate tablets. Take 1 tablet on the morning of the first day. Take the second tablet on the morning of the next day.
- Do not take more than 2 tablets of risedronate tablets per month unless your doctor tells you otherwise.
- Take risedronate tablets by mouth on an empty stomach in the morning at least 30 minutes before your first food, drink, or other medicine of the day. Do NOT take risedronate tablets at bedtime or before you get out of bed in the morning.
- Swallow risedronate tablets whole. Do not break, crush, chew, or suck on the tablet before swallowing.
- Take risedronate tablets with a full glass of plain water (8 oz/240 mL). Do not take risedronate tablets with mineral water, coffee, tea, milk, or juice.
- Take risedronate tablets while you are sitting up or standing. Do not lie down for 30 minutes after taking risedronate tablets and until you eat your first food of the day.
- Do not take antacids; products that contain calcium, aluminum, or magnesium; or certain vitamin products at the same time of day that you take risedronate tablets. Ask your pharmacist if you have questions about how to take any of these products with risedronate tablets.
- Be sure you understand how to take risedronate tablets. Contact your doctor or pharmacist if you have any questions.
- Continue to take risedronate tablets even if you feel well. Do not miss any doses.
- If you miss 1 or both doses of risedronate tablets and the next month's scheduled doses are less than 7 days away, skip the missed dose(s). Take your next doses as originally scheduled. If you miss 1 or both doses of risedronate tablets and the next month's scheduled doses are more than 7 days away, you should do the following:
- If only 1 tablet is missed, take it in the morning on the day after you remember.
- If both tablets are missed, take 1 tablet in the morning on the day after you remember. Take the other tablet in the morning on the next consecutive day. Do not take 2 doses on the same day.
Ask your health care provider any questions you may have about how to use risedronate tablets.
Important safety information:
- Tell your doctor or dentist that you take risedronate tablets before you receive any medical or dental care, emergency care, or surgery.
- Talk to your doctor before you drink alcohol, smoke, or use other tobacco products while taking risedronate tablets.
- Follow the diet and exercise program given to you by your health care provider. Talk to your doctor about whether you should take a calcium and vitamin D supplement while you use risedronate tablets.
- Talk to your doctor about the use of weight-bearing exercises to help prevent weak bones.
- Certain fractures of the thigh bone (femur) have been reported in patients using bisphosphonates. It is unknown if bisphosphonates contributed to the fractures. Contact your doctor right away if you experience hip, thigh, or groin pain. Discuss any questions or concerns with your doctor.
- Risedronate tablets may cause jawbone problems in some patients. Your risk may be greater the longer you take risedronate tablets or if you have cancer, poor dental hygiene, ill-fitting dentures, or certain other conditions (eg, anemia, blood clotting problems, dental problems, infections). Your risk may also be greater if you have certain dental procedures or you use certain medicines or therapies (eg, chemotherapy, corticosteroids, radiation). Talk to your doctor about having a dental exam before you start to use risedronate tablets. Ask your doctor any questions you may have about dental treatment while you use risedronate tablets.
- Proper dental care is important while you use risedronate tablets. Brush and floss your teeth and visit the dentist regularly.
- Certain dental procedures should be avoided if possible while you are using risedronate tablets. Tell your doctor or dentist that you take risedronate tablets before you receive any medical or dental care, emergency care, or surgery.
- Worsening of asthma has been reported in patients taking medicines like this one. Discuss any questions or concerns with your doctor.
- A severe skin reaction (Stevens-Johnson syndrome/toxic epidermal necrolysis) may happen. It can cause serious health problems that may not go away, and sometimes death. Get medical help right away if you have signs like red, swollen, blistered, or peeling skin (with or without fever); red or irritated eyes; or sores in your mouth, throat, nose, or eyes.
- Risedronate tablets may interfere with certain lab tests. Be sure your doctor and lab personnel know you are taking risedronate tablets.
- Lab tests, including bone density and blood calcium levels, may be performed while you use risedronate tablets. These tests may be used to monitor your condition or check for side effects. Your doctor may also want to evaluate you periodically while you take risedronate tablets to assess the need to continue treatment. Be sure to keep all doctor and lab appointments.
- Risedronate tablets are not approved for use in children. Talk with the doctor.
- PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using risedronate tablets while you are pregnant. It is not known if this medicine is found in breast milk. Do not breast-feed while taking risedronate tablets.
Possible side effects of risedronate tablets:
All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:
Seek medical attention right away if any of these SEVERE side effects occur:
Constipation; diarrhea; dizziness; mild back, joint, or muscle pain; mild flu-like symptoms (eg, fever, headache, muscle aches, tiredness); mild stomach pain or upset; nausea.
Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, throat, or tongue; unusual hoarseness); black, tarry, or bloody stools; chest pain; coughing or vomiting blood; difficult or painful swallowing; mouth sores; new, worsening, or persistent heartburn; painful or difficult urination; severe bone, muscle, or joint pain (especially in the hip, groin, or thigh); severe headache, dizziness, or blurred vision; severe or persistent sore throat or stomach pain; swelling or pain in your jaw; symptoms of low blood calcium (eg, spasms, twitches, or cramps in your muscles; numbness or tingling in your fingers, toes, or around your mouth); unusual eye pain, swelling, redness, or sensitivity to light.
This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.
If OVERDOSE is suspected:
Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Do not lie down or try to vomit.Proper storage of risedronate tablets:
Store risedronate tablets at room temperature, between 68 and 77 degrees F (20 and 25 degrees C), in a tightly closed container. Store away from heat, moisture, and light. Do not store in the bathroom. Keep risedronate tablets out of the reach of children and away from pets.
- If you have any questions about risedronate tablets, please talk with your doctor, pharmacist, or other health care provider.
- Risedronate tablets are to be used only by the patient for whom it is prescribed. Do not share it with other people.
- If your symptoms do not improve or if they become worse, check with your doctor.
- Check with your pharmacist about how to dispose of unused medicine.
This information should not be used to decide whether or not to take risedronate tablets or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about risedronate tablets. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to risedronate tablets. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your health care provider for complete information about the risks and benefits of using risedronate tablets.
Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using this medicine.