How does this medication work? What will it do for me?

Risedronate delayed-release belongs to the group of medications called bisphosphonates. It is used for the treatment and prevention of osteoporosis for post menopausal women and people using steroid medications. It is also used to treat osteoporosis and improve bone density in men and people with Paget's disease.

Risedronate delayed-release helps to slow bone loss by slowing down the cells that break down bone called osteoclasts. This allows the cells that build bone (called osteoblasts) to work more efficiently and increase the bone mineral density. By making bones stronger, risedronate delayed-release can help to reduce the risk of osteoporosis-related broken bones.

Your doctor may have suggested this medication for conditions other than those listed in these drug information articles. As well, some forms of this medication may not be used for all of the conditions discussed here. If you have not discussed this with your doctor or are not sure why you are taking this medication, speak to your doctor. Do not stop taking this medication without consulting your doctor.

Do not give this medication to anyone else, even if they have the same symptoms as you do. It can be harmful for people to take this medication if their doctor has not prescribed it.

What form(s) does this medication come in?

Each delayed-release, oval, yellow tablet with "EC 35" engraved on one face contains the equivalent of 35 mg of anhydrous risedronate sodium in the form of the hemi-pentahydrate with small amounts of monohydrate. Nonmedicinal ingredients: edetate disodium, ferric oxide yellow, magnesium stearate, methacrylic acid copolymer dispersion, silicified microcrystalline cellulose, polysorbate 80, simethicone, sodium starch glycolate, stearic acid, talc, and triethyl citrate.

How should I use this medication?

For preventing osteoporosis in women who are past menopause, the recommended dose of the delayed release formulation of risedronate is 35 mg once weekly.

The delayed release 35 mg tablet should be taken in the morning with breakfast to reduce the likelihood of experiencing upper abdominal pain.

This medication should be taken while sitting in an upright position and swallowed whole (not chewed) with at least a half glass of water (i.e., at least 120 mL). Do not lie down for at least 30 minutes after taking the medication to prevent any irritation to your esophagus (the tube connecting the mouth and stomach).

If you are taking calcium supplements or aluminum-, iron-, or magnesium-containing medications (e.g., antacids and mineral supplements), you should take them at a different time of day. When taken together with risedronate, they will decrease the amount of risedronate that is delivered from your stomach into your body and reduce the effectiveness of the risedronate.

If you are taking this medication on a once-weekly basis and you forget to take it on the regularly scheduled day, take one tablet on the day you first remember. Then, return to taking one tablet once a week on your regularly scheduled day. Do not take 2 tablets on the same day.

Store this medication at room temperature, protect it from light and moisture, and keep it out of the reach of children.

Do not dispose of medications in wastewater (e.g. down the sink or in the toilet) or in household garbage. Ask your pharmacist how to dispose of medications that are no longer needed or have expired.

Who should NOT take this medication?

Do not take this medication if you:

  • are allergic to risedronate or any ingredients of this medication
  • have hypocalcemia (low blood calcium levels)

What side effects are possible with this medication?

Many medications can cause side effects. A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent.

The side effects listed below are not experienced by everyone who takes this medication. If you are concerned about side effects, discuss the risks and benefits of this medication with your doctor.

The following side effects have been reported by at least 1% of people taking this medication. Many of these side effects can be managed, and some may go away on their own over time.

Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.

  • abdominal pain
  • constipation
  • diarrhea
  • headache
  • heartburn or acid reflux
  • joint, bone, or muscle pain
  • nausea
  • sore throat, or nose
  • vomiting

Although most of the side effects listed below don't happen very often, they could lead to serious problems if you do not seek medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

  • delayed healing and infection of mouth and jaw (usually after tooth extraction)
  • difficulty swallowing
  • eye pain, redness, or swelling
  • pain in the hip, groin, or thigh
  • sensitivity of eyes to light
  • severe pain in bones, muscles, or joints
  • signs of damage to the esophagus (e.g., pain in the esophagus [throat area] or behind the breastbone, chest pain, difficulty swallowing, pain when swallowing, or new or worsening heartburn)
  • signs of low levels of calcium in the blood (e.g., numbness, tingling, or muscle spasms)

Stop taking the medication and seek immediate medical attention if any of the following occur:

  • symptoms of a severe allergic reaction (e.g., hives; difficulty breathing; swelling of the face, mouth, tongue, or throat)
  • symptoms of a stomach or intestinal ulcer (e.g., nausea, vomiting, abdominal pain, loss of weight or appetite, black or bloody stools, or vomiting blood)
  • symptoms of thigh bone fracture (e.g., severe and sharp leg pain)

Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are taking this medication.

Are there any other precautions or warnings for this medication?

Before you begin using a medication, be sure to inform your doctor of any medical conditions or allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use this medication.

HEALTH CANADA ADVISORY

December 19, 2011

Health Canada has issued new restrictions concerning the use of Actonel DR® (risedronate delayed-release). To read the full Health Canada Advisory, visit Health Canada's web site at www.hc-sc.gc.ca.

Effects on the esophagus and stomach: Risedronate delayed-release may irritate the lining of the esophagus (the tube that connects the mouth and the stomach) and the stomach.

Esophagitis (inflammation of the esophagus lining), ulcers, and erosions have been reported by people who take risedronate delayed-release. To ease the passage of the medication to the stomach and thus reduce the risk of irritation of the esophagus, swallow risedronate delayed-release with at least 120 mL (4 ounces) of plain water with breakfast. Do not lie down for at least 30 minutes after taking the tablet.

If you experience problems swallowing, find it painful to swallow, develop pain behind the sternum (breastbone), or have new or worsening heartburn, stop taking this medication and contact your doctor.

Jaw problems: Some people taking this type of medication have developed a type of jaw problem called osteonecrosis of the jaw. This is more likely to occur if you have dental surgery, have cancer, are receiving chemotherapy or corticosteroids (e.g., prednisone), or already have dental health problems. It is important to practice good mouth care during treatment with this medication. Talk to your doctor to find out whether you might be at risk. Your doctor may ask you to see your dentist before you start this medication.

Kidney function: Risedronate may not be removed from the body at the expected rate if the kidneys are not working properly. This increases the risk of side effects for the person taking this medication. If you have reduced kidney function or kidney disease, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

If you have severely reduced kidney function, you should not take risedronate delayed-release.

Low calcium levels or vitamin D deficiency: Risedronate delayed-release may lower the calcium levels in your blood. If you have low blood calcium before you start taking this medication, it may get worse during treatment. Your low blood calcium must be treated before you take this medication. Most people with low blood calcium levels do not have symptoms, but some people may have symptoms.

Call your doctor right away if you have symptoms of low blood calcium such as spasms, twitches, or cramps in your muscles; or numbness or tingling in your fingers, toes, or around your mouth.

Your doctor may prescribe or suggest that you take calcium and vitamin D to help prevent low calcium levels in your blood, while you take risedronate delayed-release.

Musculoskeletal pain: Severe bone, muscle, and joint pain have been reported by some people taking this medication. If you experience any severe symptoms, talk to your doctor about whether you should continue taking this medication.

Other risedronate products: Do not take this medication if you are already taking a medication than contains risedronate.

Thigh bone fractures: Some people have developed fractures with little or no trauma in their thigh bone while taking this or similar medications. Symptoms of a fracture may include new or unusual pain in your hip, groin, or thigh. Call your doctor immediately if you have these symptoms.

Vision issues: Some people have developed inflammation of the eye after taking this or similar medication. If you develop any issues with your eye or vision, call your doctor immediately.

Pregnancy: Risedronate delayed-release is not intended to be taken by pregnant women and has not been studied for use by pregnant women.

Breast-feeding: Risedronate delayed-release is not intended to be taken by breast-feeding women. It is not known if risedronate passes into breast milk.

Children: The safety and effectiveness of this medication have not been established for children.

What other drugs could interact with this medication?

There may be an interaction between risedronate delayed-release and any of the following:

  • aluminum-containing products
  • antacids
  • calcium supplements
  • iron-containing products
  • magnesium-containing supplements or laxatives
  • proton pump inhibitors (PPIs; e.g., esomeprazole, omeprazole, pantoprazole)

If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:

  • stop taking one of the medications,
  • change one of the medications to another,
  • change how you are taking one or both of the medications, or
  • leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.

Medications other than those listed above may interact with this medication. Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.

All material copyright MediResource Inc. 1996 – 2017. Terms and conditions of use. The contents herein are for informational purposes only. Always seek the advice of your physician or other qualified health provider with any questions you may have regarding a medical condition. Source: www.medbroadcast.com/drug/getdrug/Actonel-DR