Risedronate Oral Tablets

What is this medication?

RISEDRONATE (ris ED roe nate) slows calcium loss from bones. It treats Paget's disease and osteoporosis. It may be used in other people at risk for bone loss.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

COMMON BRAND NAME(S): Actonel

What should I tell my care team before I take this medication?

They need to know if you have any of these conditions:

• bleeding disorder
• dental disease
• difficulty swallowing
• infection (fever, chills, cough, sore throat, pain or trouble passing urine)
• kidney disease
• low levels of calcium in the blood
• low red blood cell counts
• receiving steroids like dexamethasone or prednisone
• stomach or intestine problems
• trouble sitting or standing for 30 minutes
• an unusual or allergic reaction to risedronate, other drugs, foods, dyes or preservatives
• pregnant or trying to get pregnant
• breast-feeding

How should I use this medication?

Take this drug by mouth with a full glass of water. Take it as directed on the prescription label. If you take it once a day, take it at the same time every day. If you take it once a month, take it on the same day of each month. Take the dose right after waking up. Do not eat or drink anything before taking it. Do not take it with any other drink except water. Do not chew or crush the tablet. After taking it, do not eat breakfast, drink, or take any other drugs or vitamins for at least 30 minutes. Sit or stand up for at least 30 minutes after you take it. Do not lie down. Keep taking it unless your health care provider tells you to stop.

A special MedGuide will be given to you by the pharmacist with each prescription and refill. Be sure to read this information carefully each time.

Talk to your health care provider about the use of this drug in children. Special care may be needed.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

If you take your drug once a day, skip it. Take your next dose at the scheduled time the next morning. Do not take two doses on the same day.

If you take your drug once a month and the next scheduled dose is more than 7 days away, take the missed dose on the morning after you remember. Do not take two doses on the same day.

If you take your drug once a month and the next scheduled dose is only 1 to 7 days away, skip it. Take the next dose on the morning of the next scheduled dose. Do not take two doses on the same day.

What may interact with this medication?

• antacids like aluminum hydroxide or magnesium hydroxide
• aspirin
• calcium supplements
• iron supplements
• NSAIDs, medicines for pain and inflammation, like ibuprofen or naproxen
• thyroid hormones
• vitamins with minerals

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medication?

Visit your health care provider for regular checks on your progress. It may be some time before you see the benefit from this drug.

Some people who take this drug have severe bone, joint, or muscle pain. This drug may also increase your risk for jaw problems or a broken thigh bone. Tell your health care provider right away if you have severe pain in your jaw, bones, joints, or muscles. Tell you health care provider if you have any pain that does not go away or that gets worse.

You should make sure you get enough calcium and vitamin D while you are taking this drug. Discuss the foods you eat and the vitamins you take with your health care provider.

You may need blood work done while you are taking this drug.

Tell your dentist and dental surgeon that you are taking this drug. You should not have major dental surgery while on this drug. See your dentist to have a dental exam and fix any dental problems before starting this drug. Take good care of your teeth while on this drug. Make sure you see your dentist for regular follow-up appointments.

What side effects may I notice from receiving this medication?

Side effects that you should report to your doctor or health care provider as soon as possible:

• allergic reactions (skin rash, itching or hives; swelling of the face, lips, or tongue)
• bone pain
• changes in vision
• eye irritation, itching
• general ill feeling or flu-like symptoms
• heartburn (burning feeling in chest, often after eating or when lying down)
• increase in blood pressure
• infection (fever, chills, cough, sore throat, pain or trouble passing urine)
• jaw pain, especially after dental work
• joint pain
• low calcium levels (fast heartbeat; muscle cramps or pain; pain, tingling, or numbness in the hands or feet; seizures)
• muscle pain
• painful or difficulty swallowing
• redness, blistering, peeling, or loosening of the skin, including inside the mouth

Side effects that usually do not require medical attention (report to your doctor or health care provider if they continue or are bothersome):

• constipation
• depressed mood
• diarrhea
• dizziness
• headache
• nausea
• stomach pain
• swelling of the ankles, feet, hands
• trouble sleeping

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medication?

Keep out of the reach of children and pets.

Store at room temperature between 20 and 25 degrees C (68 and 77 degrees F). Throw away any unused drug after the expiration date.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.