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Risedronate tablets with calcium

Generic Name: risedronate tablets with calcium (RIS-e-DROE-nate/KAL-see-um)
Brand Name: Actonel with Calcium

Risedronate tablets with calcium 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 tablets with calcium 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 tablets with calcium if:

  • you are allergic to any ingredient in risedronate tablets with calcium
  • 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.

Slideshow: Flashback: FDA Drug Approvals 2013

Before using risedronate tablets with calcium:

Some medical conditions may interact with risedronate tablets with calcium. 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, 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 with calcium

Some MEDICINES MAY INTERACT with risedronate tablets with calcium. 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 tablets with calcium'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 tablets with calcium

Ask your health care provider if risedronate tablets with calcium 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 with calcium:

Use risedronate tablets with calcium as directed by your doctor. Check the label on the medicine for exact dosing instructions.

  • Risedronate tablets with calcium comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get risedronate tablets with calcium 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 tablets with calcium. 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 tablets with calcium 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 tablets with calcium.
  • 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 tablets with calcium 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 tablets with calcium.

Important safety information:

  • Risedronate tablets with calcium may cause dizziness. This effect may be worse if you take it with alcohol or certain medicines. Use risedronate tablets with calcium 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 tablets with calcium.
  • 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 with calcium.
  • 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 tablets with calcium may cause jawbone problems in some patients. Your risk may be greater the longer you take risedronate tablets with calcium 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 with calcium. Ask your doctor any questions you may have about dental treatment while you use risedronate tablets with calcium.
  • Proper dental care is important while you use risedronate tablets with calcium. Brush and floss your teeth and visit the dentist regularly.
  • Certain dental procedures should be avoided if possible while you are using risedronate tablets with calcium. Tell your doctor or dentist that you take risedronate tablets with calcium 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.
  • Risedronate tablets with calcium may interfere with certain lab tests. Be sure your doctor and lab personnel know you are taking risedronate tablets with calcium.
  • Lab tests, including bone density and blood calcium levels, may be performed while you use risedronate tablets with calcium. 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 with calcium to assess the need to continue treatment. Be sure to keep all doctor and lab appointments.
  • Risedronate tablets with calcium should not be used in CHILDREN; safety and effectiveness in children have not been confirmed. Risedronate tablets with calcium 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 tablets with calcium while you are pregnant. It is not known if risedronate tablets with calcium is found in breast milk. Do not breast-feed while taking risedronate tablets with calcium.

Possible side effects of risedronate tablets with calcium:

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:

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.

Seek medical attention right away if any of these SEVERE side effects occur:

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, 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 tablets with calcium:

Store risedronate tablets with calcium 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 tablets with calcium out of the reach of children and away from pets.

General information:

  • If you have any questions about risedronate tablets with calcium, please talk with your doctor, pharmacist, or other health care provider.
  • Risedronate tablets with calcium 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 tablets with calcium 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 with calcium. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to risedronate tablets with calcium. 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 tablets with calcium.

Issue Date: December 3, 2014
Database Edition 14.4.1.003
Copyright © 2014 Wolters Kluwer Health, Inc.

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.

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