ACTONEL® (Risedronate) Synonyms: Pyridine N-oxide, Pyridostigmine bromide, Pyridostigmine bromine, Risedronate sodium tablets, Risedronic acid, Risofos Actonel (Risedronate) is used to treat or prevent osteoporosis in men and women. Actonel is also used to treat Paget's disease of bone.

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INDICATIONS AND USAGE

What is ACTONEL?

ACTONEL is a drug to treat and prevent osteoporosis. ACTONEL can reverse bone loss and help reduce the risk of breaking bones (fractures) by stopping further loss of bone and increasing bone mass. ACTONEL is not a hormone like estrogen (hormone replacement therapy used in postmenopausal women). Therefore, it does not have all the benefits and risks of estrogen.

What is Osteoporosis?

Osteoporosis is a disease that causes bones to become thinner. Thin bones can break easily. Most people think of their bones as being solid like a rock. Actually, bone is tissue, just like other parts of the body-your heart, brain, or skin, for example. Bone just happens to be a harder type of tissue. Bone is always changing. Your body keeps your bones strong and healthy by replacing old bone with new bone. When someone has osteoporosis, the body removes more bone than it replaces. This means that bones get weaker and are more likely to break. Osteoporosis is a bone disease that is quite common, especially in older women. However, young people and men can develop osteoporosis, too. Osteoporosis can be prevented, and with proper therapy it can be effectively managed.

How can osteoporosis affect me?

In the early stages of osteoporosis, people often have no pain or other symptoms. As bones become weaker, they are more likely to break when someone Falls or even without a fall. While osteoporosis can affect any bone, the spine, wrist, and hip are the bones most likely to break. People with osteoporosis may "shrink" (lose height), develop a curved back, or have severe back pain that forces them to limit their activities.

Who is at risk for osteoporosis?

Many things put people at risk for osteoporosis. Some are just part of who you are, like being a woman, going through menopause or already being postmenopausal, being Caucasian or Asian, being thin, or having a family history of osteoporosis. Other factors include not getting enough calcium or vitamin D, having an inactive lifestyle, smoking cigarettes, or drinking too much alcohol. Long-term use of cortisone-type medicines (such as prednisone) can also cause osteoporosis in both men and women of all ages.

How should I take ACTONEL?

Take ACTONEL once daily or as directed by your health care provider. It is important to take ACTONEL as recommended so that you can benefit from the medicine. Following these recommendations also helps ACTONEL work correctly and helps you avoid possible irritation of the esophagus, the tube connecting the mouth and the stomach. Take one ACTONEL tablet first thing in the morning while in an upright position (silting or standing) before you have anything to eat or drink (other than plain water). Do not eat or drink anything except plain water for 30 minutes after taking ACTONEL.

Who should not take ACTONEL?

Do not take ACTONEL if you have:

• low blood calcium (hypocalcemia)
• the inability to sit or stand upright for 30 minutes
• an allergy to ACTONEL
• severe kidney disease

If you are pregnant or nursing (breast-feeding), or have severe kidney disease, talk to your health care provider before taking ACTONEL.

• Take one ACTONEL tablet with 6 to 8 ounces (about 1 cup) of plain water (not coffee, tea, or juice, and especially not milk or other dairy
products). • After taking ACTONEL, wait at least 30 minutes before lying down. You may sit, stand, or do normal activities like read the newspaper, take a walk, etc.
• Swallow ACTONEL whole rather than chewing it or waiting for it to dissolve.
• If you take vitamins, calcium, and antacids, take them at a different time of the day from when you take ACTONEL, at least 30 minutes after you take ACTONEL,
• If you forget to take ACTONEL, do not double your next dose. Simply take ACTONEL as you normally would for your next dose.
• You should continue to take ACTONEL for as long as your health care provider recommends. ACTONEL can treat your osteoporosis or help keep you from getting osteoporosis only if you continue to take it.

CONTRAINDICATIONS

Foods and some supplements and medicines can stop your body from absorbing ACTONEL. Therefore, do not take these products at or near the time you take ACTONEL: food, milk, calcium supplements, or calcium-, aluminum-, or magnesium-containing medicines, such as antacids. Ask your health care provider if there is anything else you should avoid while taking this medicine.

PRECAUTIONS

ACTONEL can build bone mass in most people who take it, even though they won't be able to see or feel a difference. Your health care provider may measure the thickness (density) of your bones to check your progress. This is called a bone mineral density measurement.

ADVERSE REACTIONS

Most people have no problems with ACTONEL. However, ACTONEL may cause side effects. Adverse reactions from ACTONEL are usually mild. They generally do not cause patients to stop taking ACTONEL. In studies of ACTONEL in patients with osteoporosis, the most common side effects were reported about as often with ACTONEL as with placebo (sugar pill). They include upset stomach, abdominal (stomach area) pain, constipation, diarrhea, gas, and headache. This summary does not include all the possible side effects of ACTONEL. Talk to your health care provider about possible side effects. Tell your health care provider if you feel discomfort in your stomach or esophagus (the tube connecting the mouth and the stomach). Stop taking ACTONEL and tell your health care provider right away if swallowing is difficult or painful, if you have chest pain, or if you have severe or continuing heartburn.

Non-hormonal prescription medicine. Only Actonel is proven to reduce spinal fractures in the very first year.

If you've lost enough bone, you can be vulnerable to spinal fractures you may not always feel. Eventually, spinal fractures may cause your back to curve into dowager's hump. If you've seen that curve in your grandmother, mother or aunts, you may be at risk for osteoporosis. Some other risk factors include being Caucasian or Asian or smoking. Be aware, even extra calcium and exercise may not be enough to protect you from bone loss and fracture. In the battle against postmenopausal osteoporosis, your strongest ally is your doctor. Ask about Actonel. Not only can Actonel reverse bone loss, it helps your bones become more fracture resistant. You should not take Actonel if you have low blood calcium, severe kidney disease, or cannot sit or stand for 30 minutes. Stop taking Actonel and tell your doctor if you experience difficult or painful swallowing, chest pain or severe or continuing heartburn because these may be signs of serious upper digestive problems. Side effects are generally mild or moderate and may include stomach pain or upset, or constipation.