Actonel with Calcium

Actonel 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.

Actonel with Calcium is a bisphosphonate and mineral combination. The bisphosphonate works by slowing bone loss. Calcium helps the body to form bone normally.

Do NOT use Actonel with Calcium if:

• you are allergic to any ingredient in Actonel with Calcium
• 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 Actonel with Calcium :

Some medical conditions may interact with Actonel 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, 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
• if you smoke or drink alcohol
• if you take a corticosteroid (eg, prednisone), or 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 with Calcium

Some MEDICINES MAY INTERACT with Actonel with Calcium . Tell your health care provider if you are taking any other medicines, especially any of the following:

• Thiazide diuretics (eg, hydrochlorothiazide) because they may increase the risk of Actonel with Calcium 's side effects
• Corticosteroids (eg, prednisone) because they may decrease Actonel with Calcium 's effectiveness
• Quinolone antibiotics (eg, ciprofloxacin), tetracyclines (eg, doxycycline, minocycline), or thyroid hormones (eg, levothyroxine) because their effectiveness may be decreased by Actonel with Calcium

Ask your health care provider if Actonel 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 Actonel with Calcium :

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

• An extra patient leaflet is available with Actonel with Calcium . Talk to your pharmacist if you have questions about this information.
• 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 Actonel 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 Actonel 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, or until after you eat your first food of the day.
• Do not take antacids, calcium, or vitamins for at least 30 minutes after you take risedronate. Take them at a different time of the day than Actonel with Calcium .
• Take calcium by mouth with food.
• If you also take iron or tetracycline antibiotics (eg, doxycycline), ask your doctor or pharmacist how to take them with calcium.
• Continue to take Actonel 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 at once. 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 Actonel with Calcium .

Important safety information:

• Actonel with Calcium may cause dizziness. This effect may be worse if you take it with alcohol or certain medicines. Use Actonel 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 Actonel 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 Actonel with Calcium .
• Talk to your doctor about the use of weight-bearing exercises to help prevent weak bones.
• Actonel with Calcium 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, dental problems, infections). 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 with Calcium . Ask your doctor any questions you may have about dental treatment while you use Actonel with Calcium .
• Proper dental care is important while you use Actonel with Calcium . Brush and floss your teeth and visit the dentist regularly.
• Tell your doctor or dentist that you take Actonel with Calcium before you receive any medical or dental care, emergency care, or surgery.
• Actonel with Calcium may interfere with certain lab tests. Be sure your doctor and lab personnel know you are taking Actonel with Calcium .
• Lab tests, including bone density and blood calcium levels, may be performed while you use Actonel with Calcium . These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
• Actonel with Calcium 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 with Calcium while you are pregnant. It is not known if Actonel with Calcium is found in breast milk. Do not breast-feed while taking Actonel with Calcium .

Possible side effects of Actonel 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:

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. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects 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), or emergency room immediately. Symptoms may include increased thirst or urination; irregular heartbeat; loss of appetite; mental changes; muscle weakness; severe or persistent nausea; stomach pain; unusual or severe tiredness; vomiting.

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

General information:

• If you have any questions about Actonel with Calcium , please talk with your doctor, pharmacist, or other health care provider.
• Actonel 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.

This information is a summary only. It does not contain all information about Actonel with Calcium . 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.