WHAT IS Actonel/Residronate TABLETS?

RISEDRONATE reduces calcium/Phoslo loss from bones. It helps make healthy bone and to slow bone loss in patients with Paget's disease and osteoporosis. It may be used in others at risk for bone loss. This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

WHERE SHOULD I KEEP Actonel/Residronate?

Keep out of the reach of children.

HOW SHOULD I USE Actonel/Residronate?

You must take this medication exactly as directed or you will lower the amount of medicine you absorb into your body or you may cause your self harm. Take this medicine by mouth first thing in the morning, after you are up for the day. Do not eat or drink anything before you take this medicine. Swallow the tablets with a full glass (6 to 8 fluid ounces) of plain water. Do not take the tablets with any other drink. Do not chew or crush the tablet. After taking this medicine, do not eat breakfast, drink, or take any other medicines or vitamins for at least 30 minutes. Stand or sit up for at least 30 minutes after you take this medicine; do not lie down. Do not take your medicine more often than directed.

A patient information sheet for the product will be given with each prescription and refill. Read this sheet carefully each time. This sheet may change.

Talk to your pediatrician regarding the use of this medicine 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 miss a dose, do not take it later in the day. Take your normal dose the next morning. Do not take double or extra doses.

WHAT SHOULD I WATCH FOR WHILE USING Actonel/Residronate?

Visit your doctor or health care professional for regular check ups. It may be some time before you see the benefit from this medicine. Your doctor or health care professional may order blood tests and other tests to see how you are doing.

You should make sure you get enough calcium/Phoslo and vitamin D while you are taking this medicine, unless your doctor tells you not to. Discuss the foods you eat and the vitamins you take with your health care professional.

Some people who take this medicine have severe bone, joint, and/or muscle pain. Tell your doctor if you have pain that does not go away or that gets worse.

WHAT MAY INTERACT WITH Actonel/Residronate?

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

This list may not describe all possible interactions. Give your health care providers 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 SIDE EFFECTS MAY I NOTICE FROM Actonel/Residronate?

Side effects that you should report to your doctor as soon as possible:

• jaw pain, especially after dental work
• redness, blistering, peeling, or loosening of the skin, including inside the mouth
• pain or difficulty when swallowing
• heartburn or stomach pain
• allergic reactions such as skin rash or itching, hives, swelling of the face, lips, throat, or tongue
• changes in vision
• black or tarry stools

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

• headache
• nausea or vomiting
• diarrhea or constipation
• bone, muscle, or joint pain
• changes in taste
• stomach gas or fullness
• eye pain or itching

This list may not describe all possible side effects.

WHAT SHOULD I TELL MY HEALTH CARE PROVIDERS BEFORE I TAKE Actonel/Residronate?

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

• low blood calcium/Phoslo
• kidney disease
• problems sitting or standing
• an unusual or allergic reaction to risedronate, other medicines, foods, dyes, or preservatives
• esophagus, stomach, or intestine problems, like acid reflux or GERD
• breast-feeding
• pregnant or trying to get pregnant
• trouble swallowing
• dental disease

What is the shelf life of the pills?

• The expiry date is mentioned on each blister. It is different for different batches. The shelf life is 2 years from the date of manufacture and would differ from batch to batch depending on when they were manufactured.