DrugindexOnline^{2nd edition}

Generic Name: Risedronate 75 mg Tablets (RIS-e-DROE-nate)
Brand Name: Actonel

Actonel is used for:

Treating and preventing osteoporosis in certain patients. 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 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 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, mental or mood problems, cancer, anemia, blood clotting problems, an infection, or calcium metabolism problems
• if you have poor dental hygiene or other dental problems, or if you will be having a dental procedure

Some MEDICINES MAY INTERACT with Actonel . However, no specific interactions with Actonel are known at this time.

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.

• An extra patient leaflet is available with Actonel . Talk to your pharmacist if you have questions about this information.
• 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.
• Swallow Actonel whole. Do not break, crush, chew, or suck on the tablet before swallowing.
• Take Actonel by mouth on an empty stomach in the morning at least 30 minutes before your first food or drink of the day. Do NOT take Actonel at bedtime or before you get out of bed in the morning.
• Do not take antacids, calcium, or vitamins for at least 30 minutes after you take Actonel . Take them at a different time of the day than Actonel .
• Take Actonel with a full glass of plain water (6 to 8 oz/180 to 240 mL). Do not take Actonel with mineral water, coffee, tea, milk, or juice. Do not lie down for 30 minutes after taking Actonel and until you eat your first food of the day.
• 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 a dose of Actonel and your next scheduled dose is less than 8 days away, skip the missed dose and go back to your regular dosing schedule. If you miss a dose of Actonel and your next scheduled dose is more than 7 days away, see the extra patient leaflet that comes with Actonel or contact your doctor or pharmacist for instructions. Do not take 2 doses at once.

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.
• Actonel may cause jaw bone problems in some patients. Your risk may be greater if you have cancer, poor dental hygiene, or certain other conditions (eg, anemia, blood clotting problems, infections, dental problems). Your risk may also be greater if 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.
• 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. Be sure to keep all doctor and lab appointments.
• Actonel should be used with extreme caution in CHILDREN; safety and effectiveness in children have not been confirmed.
• 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:

Back pain; constipation; diarrhea; dizziness; gas; headache; joint pain; 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, or tongue); black, tarry or bloody stools; chest pain; coughing or vomiting blood; difficult or painful swallowing; mouth sores; new, worsening, or severe heartburn; painful or difficult urination; sensitivity to light; severe bone, muscle, or joint pain; severe or persistent sore throat or stomach pain; swelling of the arms or legs; swelling or pain in your jaw; unusual eye pain or redness; vision changes.

This is not a complete list of all side effects that may occur. If you have questions or need medical advice about side effects, contact your doctor or health care provider. You may report side effects to the FDA at 1-800-FDA-1088 (1-800-332-1088) or at http://www.fda.gov/medwatch.

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/findyour.htm), or emergency room immediately. Do not lie down. Symptoms may include heartburn; pain upon swallowing; stomach upset or pain; ulcers.

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.

This information is a summary only. It does not contain all information about Actonel . If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.