Brand Name

Actonel {Warner Chilcott}

Generic Name

risedronate, pronounced rih SED ro nayt

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Drug Guide

The information contained in the following drug guide is intended as an educational resource only. This guide is not exhaustive and does not contain all available information about this drug.This guide is not intended as medical advice for individual conditions or treatment.

The information provided in this guide does not replace the need for the advice and services of medical professionals or the need for medical examination. Always talk to your physician or pharmacist before taking any prescription medication or over the counter drugs (including any supplements) or before making any changes to your treatment. Only your doctor, nurse or pharmacist can provide you with safe and effective advice regarding your drug treatment.

The use of the information in this guide is at your sole risk. This information is provided "AS IS" with no warranties to accuracy or timeliness.

**All trademarks and registered trademarks are the property of their respective owners.

What is Actonel?

Actonel treats and prevents osteoporosis in both women and men. Actonel is also used to treat Paget’s disease of bone in women and men.

Actonel may also be used for purposes not indicated in this medication guide.

Key Facts About Actonel

Actonel is in a group of medications called bisphosphonates, and it works by altering the cycle of both your bone formation and the breakdown of bone in your body. Actonel also slows bone loss while increasing your bone mass, which can help you to avoid future bone fractures.

You should not take Actonel if you cannot sit upright or stand for at least 30 minutes after taking your dose. If you cannot sit upright or stand for 30 minutes after taking the Actonel tablet you may experience serious problems in your stomach or esophagus.

Some patients who have used medications similar to Actonel have reported bone loss in their jaw, which is also called osteonecrosis of the jaw. The symptoms of this condition can include jaw pain, swelling, numbness, loose teeth, gum infections or a slow healing after injury or surgery involving your gums. You may be more likely to develop osteonecrosis of the jaw if you have cancer, have been treated with chemotherapy, radiation or steroids, have a blood clotting disorder, anemia or a pre-existing dental problem.

Tell your doctor if you are pregnant or plan to become pregnant. Actonel is in FDA pregnancy category C. Actonel is not known to harm an unborn baby. If you are breast-feeding you should ask your doctor about taking Actonel. We do not know if Actonel may affect a breast-feeding baby.

Before You Take Actonel

If you are allergic torisedronate, or if you have low levels of calcium in your blood (hypocalcemia) or a problem with the movement of muscles in your esophagus you should not take Actonel.

If you have trouble swallowing or a vitamin D deficiency you may not be a candidate to take Actonel.

Before taking Actonel, tell your doctor if you have kidney disease, an ulcer or another problem in your stomach or esophagus.

Do not take Actonel if you cannot sit upright or stand for at least 30 minutes after taking your dose.

You should avoid taking any other medications including vitamins, calcium, or antacids for at least 30 minutes after you take a Actonel tablet.

Actonel Drug Interactions

You should inform your doctor if you are taking any of the following:

• celecoxib (Celebrex)
• diclofenac (Arthrotec, Cambia, Cataflam, Voltaren, Flector Patch, Pennsaid, Solareze)
• diflunisal (Dolobid)
• ibuprofen (Motrin, Advil)
• indomethacin (Indocin)
• ketoprofen (Orudis)
• ketorolac (Toradol)
• meloxicam (Mobic)
• naproxen (Aleve, Naprosyn, Naprelan, Treximet)
• piroxicam (Feldene)

Other drugs you take that are not listed may interact with Actonel. You should tell your doctor about all of the medications you use. This includes prescription drugs, vitamins, supplements and herbal products, and over the counter medications. You should not begin taking a new medication without telling your doctor first.

Directions for Taking Actonel

You should take Actonel exactly as it is prescribed by your doctor. Your doctor may change your dose to make sure that you get the best results from Actonel. You should follow the instructions on your prescription label and not take Actonel for longer than recommended by your doctor, or in larger or smaller doses.

Take the Actonel tablet in the morning, at least 30 minutes before you eat or drink anything or take any other medications. If you take a Actonel tablet once a week you should take it on the same day each week and first thing in the morning, also 30 minutes before you eat or drink anything.

You should take each tablet of Actonel with a full 8 ounce glass of water. Do not use mineral water to take Actonel.

Swallow Actonel whole, being certain not to break, chew, crush or suck on the tablet.

You should not lie down or recline for at least 30 minutes after taking Actonel.

You should not take any other medication, vitamins, calcium or antacids for at least 30 minutes after taking Actonel.

You will need to visit your doctor to have your bone mineral density tested on a regular basis while taking Actonel.

Tell any dentist that treats you that you are taking Actonel, as you may need to stop taking this medication for a short time if you need extensive dental work or dental surgery.

Actonel is a part of a complete program of treatment that your doctor has prescribed to keep you healthy. Other aspects of this program may include dietary changes, exercise and taking calcium and vitamin supplements. Follow your diet, medication, and exercise routines exactly as your doctor has instructed you to.

Actonel needs to be stored at room temperature, and away from light, moisture and heat.

If you take Actonel tablets once daily and forget to take your dose first thing in the morning you should not take it later in the day. You must wait until the following morning to take the dose, and skip the dose you missed. Do not take two (2) tablets in one day.

If you take Actonel tablets once a week and forget to take Actonel on your scheduled day you should take it first thing in the morning on the day after you remember the missed dose. You should then return to your regular weekly schedule on the new day. Never take two (2) tablets in one day and attempt to take the dose you missed.

Actonel Side Effects

If you experience any of the following adverse effects you should stop taking Actonel and seek emergency medical help immediately:

• allergic reaction symptoms like breathing difficulties, hives, and swelling of your face,
• lips, throat or tongue
• burning or pain in your back or under your ribs
• chest pain
• coughing up blood
• difficulty or pain when swallowing
• fever, body aches and flu symptoms
• heartburn that is severe, new or worsening or burning pain in your upper stomach
• jaw pain, swelling or numbness
• new or unusual pain in your hip or thigh
• severe joint, bone or muscle pain

Less serious side effects of Actonel may include:

• bloating
• constipation
• diarrhea
• dizziness
• eye pain
• gas
• headache
• heartburn (mild)
• joint pain and swelling (mild)
• nausea
• stomach pain
• swelling in your feet and hands
• vomiting

It should be noted that this is not a complete list of possible side effects of Actonel. You should contact your physician for a complete list and medical advice regarding these effects.

Actonel Description and Dosing

Actonel is available as film-coated tablets in strengths of 5 mg, 35 mg, 75 mg and 150 mg.

The 5 mg tablets are oval and yellow with RSN on 1 face and 5 mg on the other.

The 30 mg tablets are oval and white with RSN on 1 face and 30 mg on the other.

The 35 mg tablets are oval and orange with RSN on 1 face and 35 mg on the other.

The 75 mg tablets are oval and pink with RSN on 1 face and 75 mg on the other.

The 150 mg tablets are oval and blue with RSN on 1 face and 150 mg on the other.

If you suspect that you have overdosed with Actonel you should seek emergency help immediately.

Ingredients in Actonel

The primary active ingredient in Actonel is risedronate sodium. Inactive ingredients include 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.

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The information contained in this drug guide is intended as an educational resource only. This guide is not exhaustive and does not contain all available information about this drug.This guide is not intended as medical advice for individual conditions or treatment.

The information provided in this guide does not replace the need for the advice and services of medical professionals or the need for medical examination. Always talk to your physician or pharmacist before taking any prescription medication or over the counter drugs (including any supplements) or before making any changes to your treatment. Only your doctor, nurse or pharmacist can provide you with safe and effective advice regarding your drug treatment.

The use of the information in this guide is at your sole risk. This information is provided "AS IS" with no warranties to accuracy or timeliness.

**All trademarks and registered trademarks are the property of their respective owners.