Risedronate is in the group of medicines called bisphosphonates (bis FOS fo nayts). It alters the cycle of bone formation and breakdown in the body. Risedronate slows bone loss while increasing bone mass, which may prevent bone fractures.

Calcium is a mineral that is needed for many functions of the body, especially bone formation and maintenance.

Risedronate is used to treat or prevent postmenopausal and steroid-induced osteoporosis. Risedronate is also used to treat Paget’s disease of bone.

Calcium carbonate is used to prevent and to treat calcium deficiencies.

Calcium carbonate and risedronate may also be used for purposes other than those listed in this medication guide.

Take calcium carbonate and risedronate exactly as it was prescribed for you. Do not use the medication in larger amounts or for longer than recommended by your doctor.

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.

Only the calcium tablet should be taken with food. Risedronate must be taken on an empty stomach.

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.

To be sure this medication is helping your condition, your bone mineral density will need to be tested on a regular basis. It is important that you not miss any scheduled visits to your doctor.

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 calcium carbonate and risedronate tablets at room temperature away from moisture and heat.

Antacids, supplements, or medicines that contain aluminum, calcium, magnesium, or other minerals can interfere with how your body absorbs risedronate. If you use these other medicines, do not that take them for at least 30 minutes after taking a risedronate tablet.

Before using calcium carbonate and risedronate, tell your doctor if you use any of the following drugs:

• levothyroxine (Synthroid);

• diuretics (water pills);

• steroids (prednisone and others);

• an antibiotic such as ciprofloxacin (Cipro), doxycycline (Doryx, Vibramycin), gatifloxacin (Tequin), levofloxacin (Levaquin), minocycline (Minocin), moxifloxacin (Avelox), ofloxacin (Floxin), sparfloxacin (Zagam), tetracycline (Sumycin, Achromycin, Robitet), and others; or

• aspirin or other NSAIDs (non-steroidal anti-inflammatory drugs) such as celecoxib (Celebrex), diclofenac (Voltaren), diflunisal (Dolobid), ibuprofen (Motrin, Advil), indomethacin, ketoprofen (Orudis), ketorolac (Toradol), naproxen (Aleve, Naprosyn), piroxicam (Feldene), and others.

There may be other drugs that can affect calcium carbonate and risedronate. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

Do not take any other medicines including vitamins, calcium, or antacids for at least 30 minutes after taking a risedronate tablet.

Do not lie down for at least 30 minutes after you take a risedronate tablet.

Do not take an iron supplement at the same time you take a calcium tablet. Take these minerals at separate times of the day.

Seek emergency medical attention if you think you have used too much risedronate. Drink a full glass of milk and call your local poison control center or emergency room right away. Do not make yourself vomit and do not lie down.

Symptoms of a risedronate overdose may include nausea, heartburn, stomach pain, diarrhea, muscle cramps, numbness or tingling, tight muscles in your face, seizure (convulsions), irritability, and unusual thoughts or behavior.

If you forget to take a risedronate tablet: If you forget to take this medicine first thing in the morning, do not take it later in the day. Wait until the following morning to take the medicine and skip the missed dose. Do not take take two (2) tablets in one day.

If you forget to take a calcium carbonate tablet: Take the missed dose as soon as you remember. If it is almost time for your next dose, skip the missed dose and take the medicine at the next regularly scheduled time. Do not take extra medicine to make up the missed dose.

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. Only the calcium tablet should be taken with food. Risedronate must be taken on an empty stomach.

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.

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

For at least the first 30 minutes after taking a risedronate tablet, do not lie down or recline, do not eat or drink anything other than plain water, and do not take any other medicines including vitamins, calcium, or antacids.

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 a pre-existing dental problem.

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.

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.

Before using calcium carbonate and risedronate, tell your doctor if you have:

• low or high levels of calcium in your blood;

• kidney disease;

• trouble swallowing; or

• an ulcer in your stomach or esophagus.

If you have any of these conditions, you may not be able to use calcium carbonate and risedronate, or you may need a dosage adjustment or special tests during treatment.

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.

FDA pregnancy category C. This medication may be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment.

It is not known whether this medication 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.

Your pharmacist has more information about calcium carbonate and risedronate written for health professionals that you may read.

Calcium carbonate and risedronate is available with a prescription under the brand name Actonel with Calcium. Other brand or generic formulations may also be available. Ask your pharmacist any questions you have about this medication, especially if it is new to you.