Generic Name: risedronate (rih SED ro nayt)
Brand Names: Actonel, Atelvia

What is Atelvia?

Atelvia (risedronate) is in a 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.

Atelvia is a prescription medicine used to treat osteoporosis in women after menopause.

Atelvia may also be used for purposes not listed in this medication guide.

Important information about Atelvia

Do not take a Atelvia tablet if you cannot sit upright or stand for at least 30 minutes. Atelvia 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 the tablet.

Take the Atelvia tablet one time a week just after breakfast, with at least 4 ounces of water.

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Use only plain water (not mineral water) when taking a Atelvia tablet.

For at least the first 30 minutes after taking a Atelvia 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 Atelvia 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 pre-existing dental problems.

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

Before taking Atelvia

Do not take a Atelvia tablet if you cannot sit upright or stand for at least 30 minutes. Atelvia 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 Atelvia. You should not take Atelvia if you are allergic to risedronate, or if you have low levels of calcium in your blood (hypocalcemia), or a problem with the movement of muscles in your esophagus.

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

• low blood calcium (hypocalcemia);

• a vitamin D deficiency;

• kidney disease; or

• an ulcer in your stomach or esophagus.

Some people using medicines similar to Atelvia 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. It is not known whether Atelvia will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using Atelvia. It is not known whether risedronate passes into breast milk or if it could harm a nursing baby. You should not breast-feed while you are taking this medicine.

See also: Atelvia pregnancy and breastfeeding warnings (in more detail)

How should I take Atelvia?

Take Atelvia 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.

Take the Atelvia tablet one time a week just after breakfast, with at least 4 ounces of water.

Use only plain water (not mineral water) when taking the tablet.

After taking a Atelvia tablet, carefully follow these instructions:

• Do not lie down or recline for at least 30 minutes after taking Atelvia.

• 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 after taking Atelvia. 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.

Take Atelvia only once a week, take it on the same day each week, immediately after breakfast.

Do not crush, chew, or suck the tablet. Swallow the pill whole. The enteric coated pill has a special coating to protect your throat and stomach. Breaking the pill will damage this coating.

To be sure Atelvia is helping your condition, your bone mineral density will need to be tested on a regular basis. You may not need to take Atelvia for longer than 3 to 5 years if you take it for osteoporosis. Visit your doctor regularly. Visit your doctor regularly.

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

Store Atelvia at room temperature away from moisture and heat.

What happens if I miss a dose?

<<p>If you forget to take Atelvia on your scheduled day, take it first thing in the morning on the day after you remember the missed dose. Then return to your regular weekly schedule on your chosen dose day. Do not take two (2) tablets in one day.

What happens if I overdose?

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.

What should I avoid while taking Atelvia?

Avoid taking any other medicines including vitamins, calcium, or antacids for at least 30 minutes after taking a Atelvia tablet. Some medicines can make it harder for your body to absorb Atelvia.

Atelvia side effects

Get emergency medical help if you have any of these signs of an allergic reaction to Atelvia: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Stop using Atelvia and call your doctor at once if you have a serious side effect such as:

• chest pain;

• difficulty or pain when swallowing;

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

• new or worsening heartburn;

• severe or ongoing indigestion;

• severe joint, bone, or muscle pain;

• new or unusual pain in your thigh or hip; or

• jaw pain, numbness, or swelling.

Less serious Atelvia side effects may include:

• mild stomach pain or upset stomach;

• flu symptoms, muscle pain;

• diarrhea, constipation;

• mild joint or back pain; or

• headache.

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.

See also: Atelvia side effects (in more detail)

What other drugs will affect Atelvia?

Before using Atelvia, tell your doctor if you also use 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.

This list is not complete and other drugs may interact with Atelvia. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

Where can I get more information?

• Your pharmacist can provide more information about Atelvia.