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Risedronate delayed-release tablets

Pronunciation

Generic Name: risedronate (RIS-e-DROE-nate)
Brand Name: Atelvia

Risedronate delayed-release tablets is used for:

Treating osteoporosis (weak bones) in women who have gone through menopause. It may also be used for other conditions as determined by your doctor.

Risedronate delayed-release tablets is a bisphosphonate. It works by slowing bone loss.

Do NOT use risedronate delayed-release tablets if:

  • you are allergic to any ingredient in risedronate delayed-release tablets
  • you have certain esophagus problems (eg, narrowing, blockage)
  • you are unable to stand or sit upright for at least 30 minutes
  • you are unable to swallow risedronate delayed-release tablets whole
  • you have low blood calcium levels or severe kidney problems
  • you are taking an H2 blocker (eg, ranitidine) or a proton pump inhibitor (PPI) (eg, omeprazole)
  • you are taking another medicine that contains risedronate

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 delayed-release tablets:

Some medical conditions may interact with risedronate delayed-release 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), digestion problems, 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 delayed-release tablets

Some MEDICINES MAY INTERACT with risedronate delayed-release 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
  • H2 blockers (eg, ranitidine) or proton pump inhibitors (PPIs) (eg, omeprazole) because they may decrease risedronate delayed-release tablets's effectiveness
  • Corticosteroids (eg, prednisone) 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 delayed-release 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 delayed-release tablets:

Use risedronate delayed-release tablets as directed by your doctor. Check the label on the medicine for exact dosing instructions.

  • Risedronate delayed-release tablets comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get risedronate delayed-release tablets refilled.
  • Take risedronate delayed-release tablets by mouth in the morning immediately after breakfast. Do NOT take risedronate delayed-release tablets before breakfast.
  • Swallow risedronate delayed-release tablets whole. Do not break, crush, or chew before swallowing.
  • Take risedronate delayed-release tablets while you are sitting up or standing. Do not lie down or take other medicines for 30 minutes after taking risedronate delayed-release tablets.
  • Take risedronate delayed-release tablets with at least 4 oz (120 mL) of plain water. Do not take risedronate delayed-release tablets with mineral water, coffee, tea, milk, or juice.
  • Do not take antacids, calcium, certain vitamin products, iron, or products that contain magnesium (eg, certain laxatives) at the same time of day that you take risedronate delayed-release tablets. Ask your pharmacist if you have questions about how to take any of these products with risedronate delayed-release tablets.
  • Risedronate delayed-release tablets is usually taken 1 time each week. Be sure you understand how to take risedronate delayed-release tablets. Contact your doctor or pharmacist if you have any questions.
  • Continue to take risedronate delayed-release tablets even if you feel well. Do not miss any doses.
  • If you miss a dose of risedronate delayed-release tablets, take 1 tablet on the morning after you remember, then go back to taking risedronate delayed-release tablets on your regularly scheduled 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 delayed-release tablets.

Important safety information:

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

Possible side effects of risedronate delayed-release 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:

Constipation; diarrhea; dizziness; mild flu-like symptoms (eg, fever, headache, muscle aches, tiredness); mild joint, back, or muscle pain; mild stomach pain or upset; nausea; vomiting.

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; severe bone, muscle, or joint pain (especially in the groin, hip, 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. Do not lie down or try to vomit. Symptoms of overdose may include muscle weakness, spasms, twitching, or cramps; numbness or tingling in the fingers or toes, or around the mouth; seizures; severe heartburn; stomach pain or upset.

Proper storage of risedronate delayed-release tablets:

Store risedronate delayed-release tablets at room temperature, between 68 and 77 degrees F (20 and 25 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep risedronate delayed-release tablets out of the reach of children and away from pets.

General information:

  • If you have any questions about risedronate delayed-release tablets, please talk with your doctor, pharmacist, or other health care provider.
  • Risedronate delayed-release tablets 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 delayed-release 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 delayed-release tablets. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to risedronate delayed-release 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 healthcare provider for complete information about the risks and benefits of using risedronate delayed-release tablets.

Issue Date: September 3, 2014
Database Edition 14.3.1.003
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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