Risedronate is used to treat osteoporosis caused by menopause, or steroid use. risedronate 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 have problems with your esophagus, or low levels of calcium in your blood.

Do not take risedronate if you cannot sit upright or stand for at least 30 minutes after taking the medicine.

Risedronate can cause serious problems in the stomach or esophagus. Stop using risedronate and call your doctor at once if you have chest pain, new or worsening heartburn, or pain when swallowing.

Also call your doctor if you have muscle spasms, numbness or tingling (in hands and feet or around the mouth), new or unusual hip pain, or severe pain in your joints, bones, or muscles.

Risedronate comes as a tablet and a delayed-release tablet to take by mouth. The delayed-release tablets are usually taken once a week in the morning, immediately after breakfast. The tablets are usually taken on an empty stomach once a day in the morning, once a week in the morning, once monthly in the morning, or once monthly for two mornings in a row depending on your condition and the dosage prescribed by your doctor. If you are taking risedronate once a week, once monthly, or once monthly for 2 days in a row, take it on the same day every week or month or the same 2 days in a row every month. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take risedronate exactly as directed. Do not take more or less of it or take it more often or for a longer period of time than prescribed by your doctor.

Risedronate may not work properly and may damage the esophagus (tube that connects the mouth and stomach) or cause sores in the mouth if it is not taken according to the following instructions. Tell your doctor if you do not understand, you do not think you will remember, or you are unable to follow these instructions:

• You must take risedronate tablets immediately after you get out of bed in the morning and before you eat or drink anything. You must take risedronate delayed-release tablets immediately after breakfast. Never take risedronate at bedtime or before you wake up and get out of bed for the day.
• Swallow the tablets with a full glass (6 to 8 ounces [180 to 240 mL]) of plain water while you are sitting or standing. Swallow the delayed-release tablets with at least 4 ounces (120 mL) of plain water while you are sitting or standing. Never take risedronate with tea, coffee, juice, mineral water, milk, other dairy drinks, or any liquid other than plain water.
• Swallow the tablets and delayed-release tablets whole. Do not split, chew, or crush them. Do not suck on the tablets or hold them in your mouth for any length of time.
• After you take risedronate, do not eat, drink, or take any other medications for at least 30 minutes. Do not lie down for at least 30 minutes after you take risedronate. Sit upright or stand upright until at least 30 minutes have passed.

Risedronate controls osteoporosis and Paget's disease of bone but does not cure these conditions. Risedronate helps to treat and prevent osteoporosis only as long as it is taken regularly. Continue to take risedronate even if you feel well. Do not stop taking risedronate without talking to your doctor, but talk to your doctor from time to time about whether you still need to take risedronate.

Your doctor or pharmacist will give you the manufacturer's patient information sheet (Medication Guide) when you begin treatment with risedronate and each time you refill your prescription. Read the information carefully and ask your doctor or pharmacist if you have any questions. You can also visit the Food and Drug Administration (FDA) website (http://www.fda.gov/Drugs/DrugSafety/ucm085729.htm) or the manufacturer's website to obtain the Medication Guide.

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.

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 risedronate.

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.

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.

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom).

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

You should eat plenty of foods that are rich in calcium and vitamin D while you are taking risedronate. Your doctor will tell you which foods are good sources of these nutrients and how many servings you need each day. If you find it difficult to eat enough of these foods, tell your doctor. In that case, your doctor can prescribe or recommend a supplement.

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).

Risedronate may cause serious side effects. 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 of risedronate 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.

Keep all appointments with your doctor and the laboratory.

Before having any laboratory test or bone imaging study, tell your doctor and the laboratory personnel that you are taking risedronate.

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

• Actonel® with Calcium (containing Calcium, Risedronate)