Risedronate Delayed-Release Weekly Tablets

What is this medication?

RISEDRONATE (ris ED roe nate) treats osteoporosis. It works by making your bones stronger and less likely to break (fracture). It belongs to a group of medications called bisphosphonates.

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

COMMON BRAND NAME(S): Atelvia

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
• Cancer
• Dental disease
• Difficulty swallowing
• Infection
• Kidney disease
• Low levels of calcium in the blood
• Low red blood cell levels
• Stomach or intestine problems
• Taking steroids, such as dexamethasone or prednisone
• Trouble sitting or standing for 30 minutes
• An unusual or allergic reaction to risedronate, other medications, foods, dyes, or preservatives
• Pregnant or trying to get pregnant
• Breast-feeding

How should I use this medication?

Take this medication by mouth with a full glass of water. Take it as directed on the prescription label on the same day of each week. Take the dose right after breakfast. Do not take it with any other drink except water. Do not chew or crush the tablet. After taking it, do not take any other medications 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 care team 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 care team about the use of this medication 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, take the missed dose on the morning after you remember. Do not take two doses on the same day.

What may interact with this medication?

• Aluminum hydroxide
• Antacids
• Aspirin
• Calcium supplements
• Iron supplements
• Magnesium supplements
• NSAIDS, medications for pain and inflammation, such as ibuprofen or naproxen
• Stomach acid blockers, such as cimetidine, famotidine, omeprazole
• 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 care team for regular checks on your progress. It may be some time before you see the benefit from this medication.

Some people who take this medication have severe bone, joint, or muscle pain. This medication may also increase your risk for jaw problems or a broken thigh bone. Tell your care team right away if you have severe pain in your jaw, bones, joints, or muscles. Tell your care team 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 medication. Discuss the foods you eat and the vitamins you take with your care team.

Tell your dentist and dental surgeon that you are taking this medication. You should not have major dental surgery while on this medication. See your dentist to have a dental exam and fix any dental problems before starting this medication. Take good care of your teeth while on this medication. 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 care team as soon as possible:

• Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat
• Low calcium level—muscle pain or cramps, confusion, tingling, or numbness in the hands or feet
• Osteonecrosis of the jaw—pain, swelling, or redness in the mouth, numbness of the jaw, poor healing after dental work, unusual discharge from the mouth, visible bones in the mouth
• Pain or trouble swallowing
• Severe bone, joint, or muscle pain
• Stomach bleeding—bloody or black, tar-like stools, vomiting blood or brown material that looks like coffee grounds

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

• Back pain
• Diarrhea
• Joint pain
• Stomach pain
• Upset stomach

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). Get rid of any unused medication after the expiration date.

To get rid of medications that are no longer needed or have expired:

• Take the medication to a take-back program. Check with your pharmacy or law enforcement to find a location.
• If you cannot return the medication, check the label or package insert to see if the medication should be thrown out in the garbage or flushed down the toilet. If you are not sure, ask your care team. If it is safe to put it in the trash, empty the medication out of the container. Mix the medication with cat litter, dirt, coffee grounds, or other unwanted substance. Seal the mixture in a bag or container. Put it in the trash.

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.