ACTONEL

INDICATIONS

Actonel (risedronate sodium) tablets is a pyridinyl bisphosphonate that inhibits osteoclast-mediated bone resorption and modulates bone metabolism. Risedronic acid (INN) or risedronate sodium (USAN) is a bisphosphonate used to strengthen bone, treat or prevent osteoporosis, and treat Paget’s disease of bone.

INSTRUCTIONS  

Take Actonel exactly as your doctor prescribes. Do not take a Actonel tablet if you cannot sit upright or stand for at least 30 minutes. Actonel can cause serious problems in the stomach or esophagus (the tube that connects your mouth and stomach). You will need to stay upright for at least 30 minutes after taking this medication.

Take the Actonel tablet first thing in the morning with a full glass (6 to 8 ounces) of water, at least 30 minutes before you eat or drink anything or take any other medicine.

Before taking risedronate, tell your doctor or pharmacist if you are allergic to it; or to other bisphosphonates (e.g., alendronate, etidronate, pamidronate); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems.

To make sure you can safely take Actonel, tell your doctor if you have any of these other conditions:
low blood calcium (hypocalcemia);
a vitamin D deficiency;
kidney disease;
an ulcer in your stomach or esophagus.

STORAGE 

Store Actonel at 77 degrees F (25 degrees C). Keep away from heat, moisture, and light. Do not store in the bathroom. Keep Actonel out of the reach of children and away from pets.

Stop using Actonel if:

Stop using risedronate and call your doctor at once if you have any of these serious side effects: chest pain; difficulty or pain when swallowing; pain or burning under the ribs or in the back; new or worsening heartburn; severe joint, bone, or muscle pain; jaw pain, numbness.

Do not take two different strengths of Actonel tablet at the same time.

If you take Actonel only once a week, take it on the same day and time each week.

Do not crush, chew, or suck the Actonel tablet. Swallow the pill whole. The enteric coated pill has a special coating to protect your throat and stomach. Breaking the pill will damage this coating.

If you need to have any dental work (especially surgery), tell the dentist ahead of time that you are using Actonel. You may need to stop using the medicine for a short time.

To be sure this medication is helping your condition, your bone mineral density will need to be tested on a regular basis. Visit your doctor regularly.

Actonel is only part of a complete program of treatment that may also include diet changes, exercise, and taking calcium and vitamin supplements. Follow your diet, medication, and exercise routines very closely.

FDA pregnancy category C. It is not known whether Actonel will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication. It is not known whether risedronate passes into breast milk or if it could harm a nursing baby. You should not breast-feed while you are taking Actonel.

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Stop using Actonel and call your doctor at once if you have a serious side effect such as:

• chest pain;
• difficulty or pain when swallowing;
• pain or burning under the ribs or in the back;
• new or worsening heartburn;
• severe or ongoing indigestion;
• severe joint, bone, or muscle pain;
• new or unusual pain in your thigh or hip;
• jaw pain, numbness, or swelling.

Less serious Actonel side effects may include:

• flu symptoms, muscle pain;
• mild stomach pain or upset stomach;
• diarrhea, constipation;
• mild joint or back pain;
• headache.