Actonel with Calcium (risedronate and calcium) is packaged as two separate medicines: 4 Actonel tablets and 24 calcium tablets. 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 fractise.

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

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

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

Actonel with Calcium may also be used for purposes not listed in this medication guide.

You should not use Actonel with Calcium if you have low levels of calcium in your blood (hypocalcemia), or a problem with the movement of muscles in your esophagus.

Do not take an Actonel 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).

Take Actonel with Calcium exactly as prescribed by your doctor. Follow all directions on your prescription label. Do not take this medicine in larger or smaller amounts or for longer than recommended.

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. Actonel must be taken on an empty stomach.

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

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

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

After taking an Actonel 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.

Actonel with Calcium 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.

Your bone mineral density will need to be checked often. You may not need to take this medication for longer than 3 to 5 years if you take it for osteoporosis.

Store Actonel with Calcium at room temperature away from moisture and heat.

Usual Adult Dose for Osteoporosis:

Prevention and treatment of osteoporosis in postmenopausal women:

risedronate: 35 mg orally once a week.
calcium carbonate: 1250 mg orally with food once daily on each of the remaining 6 days of the week.

You should not use Actonel with Calcium if you are allergic to calcium carbonate or risedronate, or if you have:

• low levels of calcium in your blood (hypocalcemia); or

• a problem with the movement of muscles in your esophagus.

Do not take an Actonel 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 Actonel with Calcium is safe for you, 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.

In rare cases, this Actonel with Calcium may cause bone loss (osteonecrosis) in the jaw. Symptoms include jaw pain or numbness, red or swollen gums, loose teeth, or slow healing after dental work. The longer you use Actonel with Calcium, the more likely you are to develop this condition.

Osteonecrosis of the jaw may be more likely if you have cancer or received chemotherapy, radiation, or steroids. Other risk factors include blood clotting disorders, anemia (low red blood cells), and a pre existing dental problem.

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

It is not known whether Actonel with Calcium will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

It is not known whether calcium carbonate and risedronate passes into breast milk or if it could harm a nursing baby. Tell your doctor if you are breast-feeding a baby.

If you forget to take an Actonel 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 two (2) tablets in one day.

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

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. 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.

Overdose symptoms 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.

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

Get emergency medical help if you have signs of an allergic reaction to Actonel with Calcium: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using this medication and call your doctor at once if you have:

• chest pain, new or worsening heartburn;

• difficulty or pain when swallowing;

• pain or burning under the ribs or in the back;

• severe joint, bone, or muscle pain;

• new or unusual pain in your thigh or hip;

• jaw pain, numbness, or swelling; or

• severe skin reaction--fever, sore throat, swelling in your face or tongue, burning in your eyes, skin pain followed by a red or purple skin rash that spreads (especially in the face or upper body) and causes blistering and peeling.

Common Actonel with Calcium side effects may include:

• mild heartburn, nausea, or stomach upset;

• diarrhea, gas, or constipation;

• muscle, joint, or back pain;

• pain or burning with urination;

• mild skin rash; or

• headache or depressed mood.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Tell your doctor about all your current medicines and any you start or stop using, especially:

• levothyroxine or other thyroid medicine;

• a diuretic or "water pill";

• an iron supplement;

• steroids (prednisone and others);

• an antibiotic--ciprofloxacin, doxycycline, levofloxacin, minocycline, moxifloxacin, ofloxacin, tetracycline, and others; or

• aspirin or other NSAIDs (nonsteroidal anti-inflammatory drugs)--ibuprofen (Advil, Motrin), naproxen (Aleve), celecoxib, diclofenac, indomethacin, meloxicam, and others.

This list is not complete. Other drugs may interact with Actonel with Calcium, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.