Risedronate (By mouth)

Introduction

Risedronate (ris-e-DROE-nate)

Prevents or treats osteoporosis (thinning of the bone) in women after menopause and treats osteoporosis in men. This medicine is also used to treat Paget's disease of bone and osteoporosis caused by steroid treatment.

Brand Name(s)

Actonel, Actonel with Calcium, Atelvia

There may be other brand names for this medicine.

How to Store and Dispose of This Medicine

• Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light.
• Ask your pharmacist, doctor, or health caregiver about the best way to dispose of any outdated medicine or medicine no longer needed.
• Keep all medicine away from children and never share your medicine with anyone.

Drugs and Foods to Avoid

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Make sure your doctor knows if you are using medicines that weaken your immune system, such as a steroid or cancer treatment.
• Wait at least 30 minutes after you take risedronate before taking calcium or mineral supplements, or antacids that contain aluminum, magnesium, or calcium (such as Maalox®, Mylanta®, or Tums®).
• This medicine may interact with the dye used for bone scans.
• Do not drink alcohol or smoke tobacco. Both alcohol and smoking can make your bone problems worse.

Warnings While Using This Medicine

• Make sure your doctor knows if you are pregnant or breastfeeding, or if you have kidney disease, stomach ulcers, heartburn, trouble swallowing, or any other kind of stomach or bowel problems.
• Tell your doctor if you have anemia, blood clotting problems, cancer, infection of any kind, any type of mineral imbalance, poor oral hygiene, or dental problems. Tell your doctor if you have trouble absorbing minerals in your stomach (malabsorption syndrome).
• This medicine can irritate your esophagus. If you think this medicine has started to damage your esophagus, stop taking this medicine and call your doctor. Some symptoms of damage to the esophagus are heartburn (either new or worse than usual), pain when swallowing, pain in the center of your chest, trouble swallowing, or feeling that food gets stuck on the way to your stomach.
• Your doctor will need to know if you have a history of problems with your mouth or teeth (such as gum disease). Make sure your doctor knows if you have been treated with a bisphosphonate medicine (such as alendronate, etidronate, ibandronate, or Fosamax®) in the past.
• You may need to have a dental exam before you start using this medicine.
• It is important that you tell your doctor or dentist that you are taking this medicine. If you are having dental procedures done, you may have an increased chance of getting a severe problem of your jaw.
• Make sure you tell your doctor about any new medical problems, especially with your teeth or jaws. Tell your doctor if you have severe bone, joint, or muscle pain while using this medicine.
• A small number of people who have Paget's disease may have new or increased bone pain when they first start using this medicine. If your symptoms get worse, call your doctor.
• Tell your doctor if you do weight-bearing exercises, or smoke and/or drink excessively. Your doctor will need to take these into consideration in deciding your dose.
• This medicine may increase your risk of developing fractures of the thigh bone. This may be more common if you use it for a long time. Check with your doctor right away if you have a dull or aching pain in the thighs, groin, or hips.
• Your doctor will need to check your progress at regular visits while you are using this medicine. Be sure to keep all appointments.

When This Medicine Should Not Be Used

You should not use this medicine if you have had an allergic reaction to risedronate, or if you have esophagus (the tube that runs from your throat to your stomach) problems, trouble swallowing, very low calcium in your blood (hypocalcemia), or severe kidney disease. You should not use this medicine if you are unable to sit upright or stand for at least 30 minutes after taking the medicine. This medicine should not be given to children.

How to Use This Medicine

Tablet

• Your doctor will tell you how much of this medicine to use and how often. Do not use more medicine or use it more often than your doctor tells you to.
• This medicine comes with patient instructions. Read and follow these instructions carefully. Ask your doctor or pharmacist if you have any questions.
• Depending on why you are receiving this medicine, you will take it either each day, once each week, once a month, or on two consecutive days (two days in a row) each month.
• If you take the medicine once a week, choose a day of the week that best fits your activity schedule and will be easy for you to remember.
• If you take the medicine on two consecutive days each month, choose two days in a row that best fits your activity schedule and will be easy for you to remember. Take the first tablet in the morning of your first chosen day. Take the second tablet in the morning of the following day. Then take two tablets on the same consecutive days each month. Do not take more than two tablets within 7 days.
• If you take the medicine once a month, choose a day of the month that best fits your activity schedule and will be easy for you to remember.
• If any of this medicine stays in your esophagus, it may cause serious damage. The esophagus is the tube that carries food from your mouth to your stomach when you swallow. To lower the risk of this problem, take the tablets exactly as directed below.
• Take this medicine as soon as you get out of bed in the morning, before you eat or have anything to drink. Swallow the tablet whole with a large glass (8 ounces) of plain water only (not mineral water, coffee, tea, soda, juice, or any other liquid). Do not chew or suck on the tablet. Do not take the medicine while you are still in bed, and do not take it at bedtime.
• Wait at least 30 minutes after you swallow the tablet before you eat or drink anything or take any other medicines. This will help your body absorb the medicine.
• Do not lie down for at least 30 minutes after taking this medicine, and do not lie down until after you have eaten some food.
• Carefully follow your doctor's instructions about any special diet. It is especially important that you get enough calcium and vitamin D in your diet.
• Follow your dosing instructions given to you by your doctor closely. It may affect the way this medicine works if you do not. Do not stop using this medicine suddenly without asking your doctor.
• This medicine should come with a Medication Guide. Read and follow these instructions carefully. Ask your doctor or pharmacist if you have any questions. Ask your pharmacist for the Medication Guide if you do not have one.

If a dose is missed:

• For patients taking the medicine each day: If you miss a dose or forget to use your medicine in the morning, skip the missed dose and take your medicine the next morning. Do not take two tablets on the same day. Return to your regular schedule the next day.
• For patients taking the medicine once a week: If you miss a dose or forget to take your medicine in the morning, skip the missed dose and take your medicine the next morning. Return to your regular schedule the following week.
• For patients taking the medicine on two consecutive days each month, and the next month's scheduled doses are more than 7 days away: If both tablets are missed, take the first tablet on the morning after the day it is remembered. Take the second tablet on the next morning. If only one tablet is missed, take the missed tablet on the morning after the day it is remembered. Return to your regular schedule the following month. Do not take more than two tablets within 7 days.
• For patients taking the medicine on two consecutive days each month, and the next month's scheduled doses are 1 to 7 days away: Wait until the next month and take the tablets on the scheduled days. Return to your regular schedule the following month. Do not take more than two tablets within 7 days.
• For patients taking the medicine once a month, and the next month's scheduled dose is more than 7 days away: If you miss a dose or forget to take your medicine in the morning, skip the missed dose and take your medicine the next morning. Return to your regular schedule the following month. Do not take more than one tablet within 7 days.
• For patients taking the medicine once a month, and the next month's scheduled dose is 1 to 7 days away: Wait until the next month and take the tablet on the scheduled day. Return to your regular schedule the following month. Do not take more than one tablet within 7 days.
• Follow all of the usual instructions about taking the medicine on an empty stomach and not lying down for at least 30 minutes. Do not use extra medicine to make up for a missed dose.

Possible Side Effects While Using This Medicine

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Blistering, peeling, or itchy skin rash.
• Blood in the urine, lower back pain, side pain, or sharp back pain just below the ribs.
• Blurred vision, eye problems.
• Change in how much or how often you urinate, painful urination.
• Chest pain, heartburn, or burning in your throat.
• Difficult or painful swallowing.
• Eye pain or redness.
• Fever, chills, cough, sore throat, and body aches.
• Heavy jaw feeling.
• Loosening of a tooth.
• Pain, swelling, or numbness in the mouth or jaw.
• Severe bone, joint, or muscle pain.
• Swelling in your hands, ankles, or feet.
• Tooth problems.
• Unusual or severe stomach pain.
• Unusual tiredness or weakness.

If you notice these less serious side effects, talk with your doctor:

• Depression.
• Headache or dizziness.
• Mild back pain, neck pain, or joint pain.
• Mild nausea, gas, diarrhea, constipation, stomach pain or upset.
• Mild skin rash.
• Runny or stuffy nose.

If you notice other side effects that you think are caused by this medicine, tell your doctor

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088