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What should I discuss with my healthcare provider before taking calcium carbonate and risedronate (Actonel with Calcium)?

Do not take a risedronate tablet if you cannot sit upright or stand for at least 30 minutes. Risedronate can cause serious problems in the stomach or esophagus (the tube that connects your mouth and stomach). You will need to stay upright for at least 30 minutes after taking this medication.

To make sure you can safely take risedronate, tell your doctor if you have any of these other conditions:

• low or high levels of calcium in your blood;
• kidney disease;
• trouble swallowing; or
• an ulcer in your stomach or esophagus.

Some people using medicines similar to risedronate have developed bone loss in the jaw, also called osteonecrosis of the jaw. Symptoms of this condition may include jaw pain, swelling, numbness, loose teeth, gum infection, or slow healing after injury or surgery involving the gums.

You may be more likely to develop osteonecrosis of the jaw if you have cancer or have been treated with chemotherapy, radiation, or steroids. Other conditions associated with osteonecrosis of the jaw include blood clotting disorders, anemia (low red blood cells), and dental surgery or pre-existing dental problems.

Talk with your doctor about the risks and benefits of using this medication.

FDA pregnancy category C. It is not known whether calcium carbonate and risedronate will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication.

It is not known whether calcium carbonate and risedronate passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

How should I take calcium carbonate and risedronate (Actonel with Calcium)?

Take exactly as prescribed by your doctor. Do not take in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label.

Actonel with Calcium is packaged as two separate medicines: 4 risedronate tablets and 24 calcium tablets. Take a risedronate tablet one day per week, first thing in the morning, at least 30 minutes before you eat or drink anything or take any other medicine. Take a calcium tablet with food every day for the 6 days in between your risedronate doses.

Take the risedronate tablet first thing in the morning, at least 30 minutes before you eat or drink anything or take any other medicine. Take the risedronate tablet on the same day each week and always first thing in the morning.

Take the risedronate tablet with a full glass (6 to 8 ounces) of water. Use only plain water (not mineral water) when taking a risedronate tablet.

Do not crush, chew, or suck the risedronate tablet. Swallow the pill whole.

After taking a risedronate tablet, carefully follow these instructions:

• Do not lie down or recline for at least 30 minutes.
• Do not eat or drink anything other than plain water.
• Do not take any other medicines including vitamins, calcium, or antacids for at least 30 minutes. It may be best to take your other medicines at a different time of the day. Talk with your doctor about the best dosing schedule for your other medicines.

Your bone mineral density will need to be checked often. Visit your doctor regularly.

Calcium carbonate and risedronate is only part of a complete program of treatment that may also include diet changes, exercise, and taking vitamin supplements. Follow your diet, medication, and exercise routines very closely.

Take only the amount of calcium that your doctor recommends. Do not use other calcium supplements unless your doctor has told you to.

Store at room temperature away from moisture and heat.

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