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

Actonel is 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.

Actonel is a bisphosphonate. It works by slowing bone loss.

Do NOT use Actonel if:

  • you are allergic to any ingredient in Actonel
  • 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.

Slideshow: 2014 Update: First Time Brand-to-Generic Switches

Before using Actonel:

Some medical conditions may interact with Actonel. 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, 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 Actonel

Some MEDICINES MAY INTERACT with Actonel. 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

This may not be a complete list of all interactions that may occur. Ask your health care provider if Actonel 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 Actonel:

Use Actonel as directed by your doctor. Check the label on the medicine for exact dosing instructions.

  • Actonel comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get Actonel refilled.
  • Choose 2 days in a row during the month to take Actonel. 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 Actonel per month unless your doctor tells you otherwise.
  • Take Actonel 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 Actonel at bedtime or before you get out of bed in the morning.
  • Swallow Actonel whole. Do not break, crush, chew, or suck on the tablet before swallowing.
  • Take Actonel with a full glass of plain water (8 oz/240 mL). Do not take Actonel with mineral water, coffee, tea, milk, or juice.
  • Take Actonel while you are sitting up or standing. Do not lie down for 30 minutes after taking Actonel 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 Actonel. Ask your pharmacist if you have questions about how to take any of these products with Actonel.
  • Be sure you understand how to take Actonel. Contact your doctor or pharmacist if you have any questions.
  • Continue to take Actonel even if you feel well. Do not miss any doses.
  • If you miss 1 or both doses of Actonel 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 Actonel 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 Actonel.

Important safety information:

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

Possible side effects of Actonel:

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 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 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. Drink a full glass (8 oz/240 mL) of milk. Symptoms of overdose may include muscle weakness, spasms, twitching, or cramps; numbness or tingling in the fingers, toes, or around the mouth; seizures; severe heartburn; stomach pain or upset.

Proper storage of Actonel:

Store Actonel 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 Actonel out of the reach of children and away from pets.

General information:

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

Issue Date: July 2, 2014
Database Edition 14.3.1.001
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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