Risedronate Sodium

Risedronate is used to treat osteoporosis caused by menopause, or steroid use. This medicine is for use when you have a high risk of bone fracture due to osteoporosis.

Risedronate is also used to treat Paget's disease of bone.

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

You should not take risedronate if you are allergic to it, or if you have:

• low levels of calcium in your blood (hypocalcemia); or
• problems with the muscles in your esophagus (the tube that connects your mouth and stomach).

Do not take risedronate if you cannot sit upright or stand for at least 30 minutes. Risedronate can cause serious problems in the stomach or esophagus. You must stay upright for at least 30 minutes after taking this medicine.

Tell your doctor if you have ever had:

• trouble swallowing;
• problems with your stomach or digestion;
• hypocalcemia;
• a dental problem (you may need a dental exam before you begin taking risedronate);
• kidney disease; or
• any condition that makes it hard for your body to absorb nutrients from food (malabsorption).

This medicine may cause jaw bone problems (osteonecrosis). The risk is highest in people with cancer, blood cell disorders, pre-existing dental problems, or people treated with steroids, chemotherapy, or radiation. Ask your doctor about your own risk.

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

It is not known whether this medicine will harm an unborn baby. Stop taking risedronate and tell your doctor right away if you become pregnant, or think you may be pregnant.

You should not breastfeed while using risedronate.

Risedronate should not be given to a child younger than 18 years old.

Risedronate tablets come in different strengths (number of milligrams per pill) that are taken on different schedules. You may need to take a tablet once per day, once per week, once per month, or for 2 days in a row once per month.

Your dosing schedule will depend on why you are taking risedronate and in what tablet strength. If you change strengths, you may also need to change your schedule.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose. Use the medicine exactly as directed. Risedronate is often given for only 3 to 5 years.

Take the Actonel tablet first thing in the morning with a full glass (6 to 8 ounces) of water, at least 30 minutes before you eat or drink anything or take any other medicine.

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

Use only plain water when taking a risedronate tablet. Do not use coffee, tea, soda, juice, or mineral water.

Do not crush, chew, or suck on a risedronate tablet. Swallow it whole.

For at least 30 minutes after taking risedronate:

• Do not lie down or recline.
• Do not take any other medicine including vitamins, calcium, iron, antacids, or laxatives.

Take this medicine at the same time each day or on the same day each week or each month (depending on your dosing schedule).

Pay special attention to your dental hygiene while taking risedronate. Brush and floss your teeth regularly. If you need to have any dental work (especially surgery), tell the dentist ahead of time that you are using risedronate.

Risedronate is only part of a complete program of treatment that may also include diet changes, exercise, bone mineral density testing, and taking calcium and vitamin supplements. Follow your doctor's instructions very closely.

Store at room temperature away from moisture and heat. Keep unused effervescent tablets in the foil blister pack.

Once-daily dosing: If you forget to take risedronate first thing in the morning, do not take it later in the day. Wait until the following morning and skip the missed dose. Do not take two (2) doses in one day.

Once-per-week or once-per-month dosing: If you forget to take risedronate 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 or monthly schedule on your chosen dose day. Do not take 2 doses in one day.

Call your doctor for instructions if you miss more than 2 doses in a month.

Drink a full glass of milk and seek emergency medical attention or call the Poison Help line at 1-800-222-1222. Do not make yourself vomit and do not lie down.

Do not take two different brands or strengths of risedronate at the same time.

Avoid taking any other medicines for at least 30 minutes after taking risedronate. This includes vitamins, calcium, iron, antacids, or laxatives. Some medicines can make it harder for your body to absorb risedronate.

Avoid smoking, or try to quit. Smoking can reduce your bone mineral density, making fractures more likely.

Avoid drinking large amounts of alcohol. Heavy drinking can also cause bone loss.

Get emergency medical help if you have signs of an allergic reaction (hives, difficult breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning in your eyes, skin pain, red or purple skin rash that spreads and causes blistering and peeling).

Stop using risedronate 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 heartburn, burning pain in your upper stomach, or coughing up blood;
• new or unusual pain in your thigh or hip;
• jaw pain, numbness, or swelling;
• severe joint, bone, or muscle pain; or
• low calcium levels--muscle spasms or contractions, numbness or tingly feeling (around your mouth, or in your fingers and toes).

Common side effects may include:

• heartburn, diarrhea, indigestion;
• stomach pain;
• back pain, joint pain, muscle pain; or
• flu-like symptoms.

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 other medicines, especially:

• aspirin;
• calcium or iron supplements;
• antacids, laxatives; or
• NSAIDs (nonsteroidal anti-inflammatory drugs)--ibuprofen (Advil, Motrin), naproxen (Aleve), celecoxib, diclofenac, indomethacin, meloxicam, and others.

This list is not complete. Other drugs may affect risedronate, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.

Your pharmacist can provide more information about risedronate.