The United States Food

and Drug Administration (FDA) has approved Atelvia (risedronate sodium), a delayed-release version of Actonel (risedronate sodium) for the treatment of postmenopausal osteoporosis.

 

Atelvia Patient Information

 

Read this Patient Information Leaflet before you start taking Atelvia and each time you get a refill. There may be new information. This information does not take the place of talking with your healthcare provider about your medical condition or your treatment.

 

Important information about Atelvia

 

Atelvia may cause serious problems in your stomach and esophagus (the tube that connects your mouth and stomach, such as:

• trouble swallowing
• heartburn
• ulcers

You may feel pain in your bones, joints, or muscles.

Stop taking Atelvia and call your healthcare provider right away if you have:

• pain when swallowing
• trouble swallowing
• chest pain
• new or worse heartburn
• indigestion or heartburn that does not go away

You must take Atelvia exactly as your healthcare provider tells you to take it for Atelvia to work and to lower your chance of having serious side effects.

What is Atelvia?

Atelvia is a prescription medicine used to:

• treat osteoporosis in postmenopausal women
• 
  

Who should not take Atelvia?

 

Do not take Atelvia if you:

• take a medicine called risedronate sodium (Actonel). Atelvia and Actonel contain the same medicine
• have certain problems with your esophagus, the tube that connects your mouth and stomach
• cannot sit or stand up for at least 30 minutes
• have low blood calcium (hypocalcemia)
• have kidney problems
• are allergic to risedronate sodium or any of the other ingredients in Atelvia. See the end of this leaflet for a complete list of ingredients in Atelvia.
• 
  

Before taking Atelvia

 

Before you take Atelvia, tell your healthcare provider if you:

• have problems swallowing or other problems with your esophagus (the tube that connects your mouth and stomach)
• have kidney problems
• have any other medical conditions
• are pregnant or plan to become pregnant. It is not known if Atelvia can harm your unborn baby. Talk to your healthcare provider if you are pregnant or plan to become pregnant.
• are breastfeeding or plan to breastfeed. It is not known if Atelvia passes into your breast milk. You and your doctor should decide if you will take Atelvia or breastfeed. You should not do both.

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins and herbal supplements. Using Atelvia with certain other medicines may affect each other causing side effects.

Especially tell you healthcare provider if you take:

• Actonel or other medicines to treat osteoporosis
• calcium supplements
• antacids
• laxatives
• iron supplements

Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine.

 

How should I take Atelvia?

• Take Atelvia exactly as your healthcare provider tells you to take it.
• Take Atelvia 1 time a week right after breakfast. Choose a day of the week to take Atelvia that best fits your schedule.
• Take Atelvia with at least 4 ounces (about 1-half cup) of plain water.
• Take Atelvia while you are sitting up or standing. After taking Atelvia you must wait at least 30 minutes before lying down.
• Swallow Atelvia tablets whole. Do not chew, cut, or crush Atelvia tablets before swallowing. If you cannot swallow Atelvia tablets whole, tell your healthcare provider. You may need a different medicine.
• If you miss your weekly Atelvia dose, take Atelvia the morning after you remember then return to your usual schedule of 1 tablet on your chosen day of the week.
• You should not take 2 Atelvia tablets on the same day.
• If you take too much Atelvia, call your healthcare provider or go to the nearest emergency room right away.
• Your healthcare provider may tell you to take calcium and vitamin D supplements and to exercise.
• If you take calcium supplements and antacids they should be taken at a different time of the day from when you take Atelvia.