Generic Name: risedronate tablets with calcium (RIS-e-DROE-nate/KAL-see-um)
Brand Name: Actonel with Calcium
Risedronate is used for:
Treating and preventing osteoporosis in women who are past menopause. It may also be used for other conditions as determined by your doctor.
Risedronate is a bisphosphonate and mineral combination. The bisphosphonate works by slowing bone loss. The calcium works by helping the body to form bone normally.
Do NOT use risedronate if:
- you are allergic to any ingredient in risedronate
- you have certain esophagus problems (eg, narrowing, blockage)
- you are unable to stand or sit upright for at least 30 minutes
- you have low or high 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:
Some medical conditions may interact with risedronate. 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 (including calcium supplements)
- if you have allergies to medicines, foods, or other substances
- if you have a history of stomach or bowel problems (eg, inflammation, low stomach acid levels, ulcer), esophagus problems (eg, blockage, heartburn, narrowing, reflux disease, severe irritation), or kidney problems or kidney stones, or if you have difficult or painful swallowing
- if you have very poor health, low blood iron or vitamin D levels, high urine calcium levels, cancer, anemia, 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
Some MEDICINES MAY INTERACT with risedronate. 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) because the risk of jawbone problems may be increased
- Thiazide diuretics (eg, hydrochlorothiazide) because they may increase the risk of risedronate's side effects
- Iron, quinolone antibiotics (eg, ciprofloxacin), tetracyclines (eg, doxycycline, minocycline), or thyroid hormones (eg, levothyroxine) because their effectiveness may be decreased by risedronate
Ask your health care provider if risedronate 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:
Use risedronate as directed by your doctor. Check the label on the medicine for exact dosing instructions.
- Risedronate comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get risedronate refilled.
- Risedronate is usually taken 1 time each week. Take the calcium on the other 6 days of the week. Be sure you understand how to take risedronate. Contact your doctor or pharmacist if you have any questions.
- Take the risedronate by mouth on an empty stomach in the morning at least 30 minutes before your first food, drink, or other medication of the day. DO NOT take it at bedtime or before you get out of bed in the morning.
- Swallow risedronate whole. Do not break, crush, chew, or suck on the tablet before swallowing.
- Take risedronate with a full glass of plain water (8 oz/240 mL). Do not take it with mineral water, coffee, tea, milk, or juice.
- Take the risedronate while you are sitting up or standing. Do not lie down for 30 minutes after taking it and until after 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. Ask your pharmacist if you have questions about how to take any of these products with risedronate.
- Take calcium by mouth with food.
- If you also take iron, quinolone antibiotics (eg, ciprofloxacin), tetracycline antibiotics (eg, doxycycline), or thyroid hormones (eg, levothyroxine), ask your doctor or pharmacist how to take them with calcium.
- Continue to take risedronate even if you feel well. Do not miss any doses.
- If you miss a dose of risedronate, do not take it later in the day. Take it the morning after you remember, and then go back to your regular dosing schedule. Do not take 2 doses on the same day. If you miss a dose of the calcium tablet and remember later in the day, you may take it with food. If you miss a dose of the calcium tablet the entire day, and you remember the next day, you may take two tablets in that day at separate times with food. Do not take more than 2 calcium tablets on the same day, unless recommended by your health care provider.
Ask your health care provider any questions you may have about how to use risedronate.
Important safety information:
- Risedronate may cause dizziness. This effect may be worse if you take it with alcohol or certain medicines. Use risedronate with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
- Talk to your doctor before you drink alcohol, smoke, or use other tobacco products while taking risedronate.
- 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.
- 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 not known 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 may cause jawbone problems in some patients. Your risk may be greater 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. Ask your doctor any questions you may have about dental treatment while you use risedronate.
- Proper dental care is important while you use risedronate. Brush and floss your teeth and visit the dentist regularly.
- Certain dental procedures should be avoided if possible while you are using risedronate. Tell your doctor or dentist that you take risedronate before you receive any medical or dental care, emergency care, or surgery.
- Risedronate may interfere with certain lab tests. Be sure your doctor and lab personnel know you are taking risedronate.
- Lab tests, including bone density and blood calcium levels, may be performed while you use risedronate. 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 to assess the need to continue treatment. Be sure to keep all doctor and lab appointments.
- Risedronate should not be used in CHILDREN; safety and effectiveness in children have not been confirmed. Risedronate is not approved for use in children.
- PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of taking risedronate while you are pregnant. It is not known if risedronate is found in breast milk. Do not breast-feed while taking risedronate.
Possible side effects of risedronate:
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; gas; 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 back pain; 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 or 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 ( http://www.aapcc.org), or emergency room immediately. Symptoms may include increased thirst or urination; irregular heartbeat; loss of appetite; mental changes; muscle cramps, spasms, twitches, or weakness; numbness or tingling in the fingers or toes, or around the mouth; seizures; severe or persistent nausea or heartburn; stomach pain; unusual or severe tiredness; vomiting.Proper storage of risedronate:
Store risedronate at room temperature, between 68 and 77 degrees F (20 and 25 degrees C). Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Store away from heat, moisture, and light. Do not store in the bathroom. Keep risedronate out of the reach of children and away from pets.
- If you have any questions about risedronate, please talk with your doctor, pharmacist, or other health care provider.
- Risedronate is 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 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. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to risedronate. 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 risedronate.
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.