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ACTONEL- risedronate sodium tablet, film coated


  1. Actonel Is A Prescription Medicine Used:
  2. Do Not Take Actonel If You:
  3. The Following Instructions Apply To All Patients Taking Actonel:
  4. What Is My Actonel Schedule?
  5. What Should I Avoid While Taking Actonel?
  6. Stop Taking Actonel And Tell Your Healthcare Provider Right Away If:
  7. Possible Serious Side Effects May Include:
  8. Common Side Effects Include The Following:
  9. Other Possible Side Effects May Include:
  10. How Should I Store Actonel?
  11. General Information About Actonel:
  12. What If I Have Other Questions About Actonel?
  13. What Are The Ingredients Of Actonel?
  14. Actonel (inactive Ingredients):
  15. Patient Information
  16. Instruct Patients About Missing Actonel Doses As Follows:
  17. Distributed By:

Actonel Is A Prescription Medicine Used: ⮝

  • to prevent and treat osteoporosis in postmenopausal women.
  • to increase bone mass in men with osteoporosis.
  • to prevent and treat osteoporosis in men and women that is caused by treatment with steroid medicines such as prednisone.
  • to treat Paget s disease of bone in men and women. The treatment for Paget s disease is very different than for osteoporosis and uses a different dose of ACTONEL. This leaflet does not cover using ACTONEL for Paget s disease. If you have Paget s disease, ask your healthcare provider how to use ACTONEL.

ACTONEL may reverse bone loss by stopping more loss of bone and increasing bone strength in most people who take it, even though they won t be able to

Do Not Take Actonel If You: ⮝

  • have problems of the esophagus which delay emptying
  • have low blood calcium (hypocalcemia)
  • cannot sit or stand up for 30 minutes
  • have kidneys that work poorly
  • have an allergy to ACTONEL. The active ingredient in ACTONEL is risedronate sodium. (

The Following Instructions Apply To All Patients Taking Actonel: ⮝

  • Take ACTONEL exactly as prescribed by your healthcare provider.
  • Take ACTONEL first thing in the morning before you eat or drink anything except plain water.
  • Take ACTONEL while you are sitting up or standing.
  • Take ACTONEL with 6 to 8 ounces (about 1 cup) of plain water. Donottake it with any other drink besides plain water.
  • Swallow ACTONEL whole.Do not chewthe tablet or keep it in your mouth to melt or dissolve.
  • After taking ACTONEL you must wait at least 30 minutesBEFORE:
    • lying down. You may sit, stand, or do normal activities like read the newspaper or take a walk.
    • eating or drinking anything except plain water.
    • taking vitamins, calcium, or antacids. Take vitamins, calcium, and antacids at a different time of the day from when you take ACTONEL.
  • Keep taking ACTONEL for as long as your healthcare provider tells you.
  • For ACTONEL to treat your osteoporosis or keep you from getting osteoporosis, you have to take it exactly as prescribed.
  • If you miss a dose of ACTONEL, call your healthcare provider for instructions.
  • If you take more than your prescribed dose of ACTONEL, call your healthcare provider right away.
  • Your healthcare provider may tell you to take calcium and vitamin D supplements and to exercise.

What Is My Actonel Schedule? ⮝

ACTONEL tablets are made in 4 different dosages (amounts). How often you should take your tablet depends upon the dosage that your doctor has prescribed (recommended) for you.

  • 5 mg tablets are yellow. One tablet should be taken every day in the morning.
  • 35 mg tablets are orange. One tablet should be taken once a week in the morning.
  • 75 mg tablets are pink. One tablet should be taken in the morning two days in a row every month.
  • 150 mg tablets are blue. One tablet should be taken once a month in the morning.

If you miss your dose in the morning, do not take it later in the day. You should call your healthcare provider for instructions.

What Should I Avoid While Taking Actonel? ⮝

  • Do not eat or drink anything except water before you take ACTONEL and for at least 30 minutes after you take it.

Stop Taking Actonel And Tell Your Healthcare Provider Right Away If: ⮝

  • swallowing is difficult or painful
  • you have chest pain
  • you have very bad heartburn or it doesn t get better

Possible Serious Side Effects May Include: ⮝

  • esophagus or stomach problems, including ulcers, pain, or trouble swallowing. Tell your healthcare provider if you have pain or discomfort in your stomach or esophagus.
  • low calcium and other mineral disturbances. If you already have one (or more) of these problems, it should be corrected before taking ACTONEL.
  • pain in bones, joints or muscles, sometimes severe. Pain may start as soon as one day or up to several months after starting ACTONEL.
  • jaw-bone problems in some people, which may include infection and slower healing after teeth are pulled. Tell your healthcare providers, including your dentist, right away if you have these symptoms.

Common Side Effects Include The Following: ⮝

  • back and joint pain
  • upset stomach and abdominal (stomach area) pain
  • short-lasting, mild flu-like symptoms, which are reported with the monthly doses and usually get better after the first dose.

Other Possible Side Effects May Include: ⮝

  • Allergic and severe skin reactions.Tell your healthcare provider if you develop any symptoms of an allergic reaction including: rash (with or without blisters), hives, or swelling of the face, lips, tongue, or throat.Get medical help right away if you have trouble breathing or swallowing.
  • Eye inflammation.Tell your healthcare provider if you get any eye pain, redness, or if your eyes become more sensitive to light.


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

How Should I Store Actonel? ⮝

  • Store ACTONEL between 68 F to 77 F (20 C to 25 C).
  • Keep ACTONEL and all medicines out of the reach of children.

General Information About Actonel: ⮝

Medicines are sometimes prescribed for conditions that are not mentioned in patient information leaflets. Do not use ACTONEL for a condition for which it was not prescribed. Do not give ACTONEL to other people, even if they have the same symptoms you have. It may harm them.

What If I Have Other Questions About Actonel? ⮝

This leaflet summarizes the most important information about ACTONEL for osteoporosis. If you have more questions about ACTONEL, ask your healthcare provider or pharmacist. They can give you information written for healthcare professionals. For more information, call 1-877-ACTONEL(toll-free) or visit our web site at www.actonel.com.

What Are The Ingredients Of Actonel? ⮝

ACTONEL (active ingredient): risedronate sodium.

Actonel (inactive Ingredients): ⮝

All dose strengths contain: crospovidone, hydroxypropyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, silicon dioxide, titanium dioxide.

Dose-strength specific ingredients include: 5 mg ferric oxide yellow, lactose monohydrate; 30 mg lactose monohydrate; 35 mg ferric oxide red, ferric oxide yellow, lactose monohydrate; 75 mg ferric oxide red; 150 mg FD&C blue #2 aluminum lake.


ACTONELis marketed by:
Warner Chilcott Pharmaceuticals Inc.,
Mason, OH 45040


March 2010


To report SUSPECTED ADVERSE REACTIONS, contact Warner Chilcott at 1-800-836-0658 or FDA at 1-800-FDA-1088 orwww.fda.gov/medwatch.

Warner Chilcott logo

Patient Information ⮝

See FDA-approved patient labeling (Medication Guide)

Instruct patients to read the Medication Guide before starting therapy with ACTONEL and to re-read it each time the prescription is renewed.

Instruct patients that Atelvia and ACTONEL contain the same active ingredient and if they are taking Atelvia, they should not take ACTONEL [seeWarnings and Precautions (5.1)].

Instruct patients to pay particular attention to the dosing instructions as clinical benefits may be compromised by failure to take the drug according to instructions. Specifically, ACTONEL should be taken at least 30 minutes before the first food or drink of the day other than water.

Instruct patients to take ACTONEL while in an upright position (sitting or standing) with a full glass of plain water (6 to 8 ounces) to facilitate delivery to the stomach, and thus reduce the potential for esophageal irritation.

Instruct patients not to lie down for 30 minutes after taking the medication [seeWarnings and Precautions (5.1)].

Instruct patients not to chew or suck on the tablet because of a potential for oropharyngeal irritation.

Instruct patients that if they develop symptoms of esophageal disease (such as difficulty or pain upon swallowing, retrosternal pain or severe persistent or worsening heartburn) they should consult their physician before continuing ACTONEL.

Instruct Patients About Missing Actonel Doses As Follows: ⮝

  • If a dose of ACTONEL 35 mg once-a-week is missed, they should take 1 tablet on the morning after they remember and return to taking 1 tablet once-a-week, as originally scheduled on their chosen day. Patients should not take 2 tablets on the same day.
  • If one or both tablets of ACTONEL 75 mg on two consecutive days per month are missed, and the next month s scheduled doses are more than 7 days away, the patient should be instructed as follows:
    • If both tablets are missed, take one ACTONEL 75 mg tablet in the morning after the day it is remembered and then the other tablet on the next consecutive morning.
    • If only one ACTONEL 75 mg tablet is missed, take the missed tablet in the morning after the day it is remembered.
    • Patients should then return to taking their ACTONEL 75 mg on two consecutive days per month as originally scheduled. Patients should not take more than two 75 mg tablets within 7 days.
  • If one or both tablets of ACTONEL 75 mg on two consecutive days per month are missed, and the next month's scheduled doses are within 7 days, patients should wait until their next month s scheduled doses and then continue taking ACTONEL 75 mg on two consecutive days per month as originally scheduled.
  • If the dose of ACTONEL 150 mg once-a-month is missed, and the next month s scheduled dose is more than 7 days away, the patient should be instructed to take the missed tablet in the morning after the day it is remembered. Patients should then return to taking their ACTONEL 150 mg once-a-month as originally scheduled. Patients should not take more than one 150 mg tablet within 7 days.
  • If the dose of ACTONEL 150 mg once-a-month is missed, and the next month's scheduled dose is within 7 days, patients should wait until their next month s scheduled dose and then continue taking ACTONEL 150 mg once-a-month as originally scheduled.

Instruct patients to take supplemental calcium and vitamin D if dietary intake is inadequate [seeWarnings and Precautions (5.3)]. Weight-bearing exercise should be considered along with the modification of certain behavioral factors, such as excessive cigarette smoking, and/or alcohol consumption, if these factors exist.

Instruct patients to take calcium supplements or calcium-, aluminum-, and magnesium-containing medications at a different time of the day than ACTONEL as these medications may interfere with the absorption of ACTONEL.

Remind patients to give all of their healthcare providers an accurate medication history. Instruct patients to tell all of their healthcare providers that they are taking ACTONEL. Patients should be instructed that any time they have a medical problem they think may be from ACTONEL, they should talk to their doctor.

Distributed By: ⮝

Allergan USA, Inc.

Irvine, CA 92612

2018 Allergan. All rights reserved.

All trademarks are the property of their respective owners.

73443US10

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