Actonel

Actonel

     * Generic Name: risedronate sodium
     * Brand Name: Actonel


     * What is risedronate (Actonel, Atelvia)?
     * What are the possible side effects of risedronate (Actonel,
       Atelvia)?
     * What is the most important information I should know about
       risedronate (Actonel, Atelvia)?
     * What should I discuss with my healthcare provider before taking
       risedronate (Actonel, Atelvia)?
     * How should I take risedronate (Actonel, Atelvia)?
     * What happens if I miss a dose (Actonel, Atelvia)?
     * What happens if I overdose (Actonel, Atelvia)?
     * What should I avoid while taking risedronate (Actonel,
       Atelvia)?
     * What other drugs will affect risedronate (Actonel, Atelvia)?
     * Where can I get more information (Actonel, Atelvia)?

What is risedronate (Actonel, Atelvia)?

   Risedronate is a bisphosphonate (bis FOS fo nayt) medicine that
   alters bone formation and breakdown in the body. This can slow bone
   loss and may help prevent bone fractures.

   Risedronate is used to treat osteoporosis caused by menopause,
   steroid use, or gonadal failure. This medicine is for use when you
   have a high risk of bone fracture due to osteoporosis.

   Risedronate is also used to treat Paget's disease of bone.

   Risedronate may also be used for purposes not listed in this medication
   guide.

What are the possible side effects of risedronate (Actonel, Atelvia)?

   Get emergency medical help if you have signs of an allergic reaction
   (hives, difficult breathing, swelling in your face or throat) or a
   severe skin reaction (fever, sore throat, burning in your eyes,
   skin pain, red or purple skin rash that spreads and causes blistering
   and peeling).

   Stop using risedronate and call your doctor at once if you have:
     * chest pain, new or worsening heartburn;
     * difficulty or pain when swallowing;
     * pain or burning under the ribs or in the back;
     * severe heartburn, burning pain in your upper stomach, or
       coughing up blood;
     * new or unusual pain in your thigh or hip;
     * jaw pain, numbness, or swelling;
     * severe joint, bone, or muscle pain; or
     * low calcium levels--muscle spasms or contractions, numbness or
       tingly feeling (around your mouth, or in your fingers and toes).

   Common side effects may include:
     * heartburn, indigestion;
     * stomach pain, diarrhea;
     * back pain, joint pain, muscle pain; or
     * flu-like symptoms.

   This is not a complete list of side effects and others may occur. Call
   your doctor for medical advice about side effects. You may report side
   effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about risedronate
(Actonel, Atelvia)?

   You should not take risedronate if you have problems with your
   esophagus, or low levels of calcium in your blood.

   Do not take risedronate if you cannot sit upright or stand for at least
   30 minutes after taking the medicine.

   Risedronate can cause serious problems in the stomach or esophagus.
   Stop using risedronate and call your doctor at once if you have chest
   pain, new or worsening heartburn, or pain when swallowing.

   Also call your doctor if you have muscle spasms, numbness or tingling
   (in hands and feet or around the mouth), new or unusual hip pain,
   or severe pain in your joints, bones, or muscles.

   Actonel Patient Information including How Should I Take
   Osteoporosis:Are Your Bones at Risk?

   Osteoporosis Slideshow Pictures
   Osteoporosis: Super Foods for Your Bones

   Super Foods for Your Bones Slideshow Pictures
   RxList

   Take the Osteoporosis Quiz

What should I discuss with my healthcare provider before taking risedronate
(Actonel, Atelvia)?

   You should not take risedronate if you are allergic to it, or if you
   have:
     * low levels of calcium in your blood (hypocalcemia); or
     * problems with the muscles in your esophagus (the tube that connects
       your mouth and stomach).

   Do not take risedronate if you cannot sit upright or stand for at least
   30 minutes. Risedronate can cause serious problems in the stomach or
   esophagus. You must stay upright for at least 30 minutes after taking
   this medicine.

   To make sure risedronate is safe for you, tell your doctor if you have
   ever had:
     * trouble swallowing;
     * problems with your stomach or digestion;
     * hypocalcemia;
     * a dental problem (you may need a dental exam before you begin
       taking risedronate);
     * kidney disease; or
     * any condition that makes it hard for your body to absorb
       nutrients from food (malabsorption).

   In rare cases, this medicine may cause bone loss (osteonecrosis) in the
   jaw. Symptoms include jaw pain or numbness, red or swollen gums, loose
   teeth, or slow healing after dental work. The longer you use
   risedronate, the more likely you are to develop this condition.

   Osteonecrosis of the jaw may be more likely if you have cancer or
   received chemotherapy, radiation, or steroids. Other risk
   factors include blood clotting disorders, anemia (low red blood
   cells), and a pre existing dental problem.

   Talk with your doctor about the risks and benefits of using this
   medication.

   It is not known whether this medicine will harm an unborn baby. Tell
   your doctor if you are pregnant or plan to become pregnant.

   It is not known whether risedronate passes into breast milk or if it
   could harm a nursing baby. Tell your doctor if you are breast-feeding a
   baby.

How should I take risedronate (Actonel, Atelvia)?

   Risedronate tablets come in different strengths (number of milligrams
   per pill) that are taken on different schedules. You may need to take a
   tablet once per day, once per week, once per month, or for 2 days in a
   row once per month.

   Your dosing schedule will depend on why you are taking risedronate and
   in what tablet strength. If you change strengths, you may also need to
   change your schedule.

   Follow all directions on your prescription label. Do not take this
   medicine in larger or smaller amounts or for longer than recommended.

   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.

   Take the Atelvia tablet just after breakfast, with at least 4 ounces of
   water.

   Use only plain water when taking a risedronate tablet. Do not use
   coffee, tea, soda, juice, or mineral water.

   Do not crush, chew, or suck on a risedronate tablet. Swallow it whole.

   For at least 30 minutes after taking risedronate:
     * Do not lie down or recline.
     * Do not take any other medicine including vitamins, calcium, iron,
       antacids, or laxatives.

   Take this medicine at the same time each day or on the same day each
   week or each month (depending on your dosing schedule).

   Pay special attention to your dental hygiene while taking risedronate.
   Brush and floss your teeth regularly. If you need to have any dental
   work (especially surgery), tell the dentist ahead of time that you are
   using risedronate.

   Risedronate is only part of a complete program of treatment that may
   also include diet changes, exercise, bone mineral density
   testing, and taking calcium and vitamin supplements. Follow your
   doctor's instructions very closely.

   Store at room temperature away from moisture and heat. Keep unused
   effervescent tablets in the foil blister pack.

   Your doctor will determine how long to treat you with this medicine.
   Risedronate is often given for only 3 to 5 years.

   Actonel Patient Information including If I Miss a Dose
   Osteoporosis:Are Your Bones at Risk?

   Osteoporosis Slideshow Pictures
   Osteoporosis: Super Foods for Your Bones

   Super Foods for Your Bones Slideshow Pictures
   RxList

   Take the Osteoporosis Quiz

What happens if I miss a dose (Actonel, Atelvia)?

   Once-daily dosing: If you forget to take risedronate first thing in the
   morning, do not take it later in the day. Wait until the following
   morning and skip the missed dose. Do not take two (2) doses in one day.

   Once-per-week or once-per-month dosing: If you forget to take
   risedronate on your scheduled day, take it first thing in the morning
   on the day after you remember the missed dose. Then return to your
   regular weekly or monthly schedule on your chosen dose day. Do not take
   2 doses in one day.

What happens if I overdose (Actonel, Atelvia)?

   Drink a full glass of milk and seek emergency medical attention or call
   the Poison Help line at 1-800-222-1222. Do not make yourself vomit and
   do not lie down.

What should I avoid while taking risedronate (Actonel, Atelvia)?

   Do not take two different brands or strengths of risedronate at the
   same time.

   Avoid taking any other medicines for at least 30 minutes after taking
   risedronate. This includes vitamins, calcium, iron, antacids, or
   laxatives. Some medicines can make it harder for your body to absorb
   risedronate.

   Avoid smoking, or try to quit. Smoking can reduce your bone mineral
   density, making fractures more likely.

   Avoid drinking large amounts of alcohol. Heavy drinking can also cause
   bone loss.

What other drugs will affect risedronate (Actonel, Atelvia)?

   Tell your doctor about all your current medicines and any you start or
   stop using, especially:
     * aspirin;
     * iron supplements;
     * antacids, laxatives; or
     * NSAIDs (nonsteroidal anti-inflammatory drugs)--ibuprofen (Advil,
       Motrin), naproxen (Aleve), celecoxib, diclofenac,
       indomethacin, meloxicam, and others.

   This list is not complete. Other drugs may interact with risedronate,
   including prescription and over-the-counter medicines, vitamins, and
   herbal products. Not all possible interactions are listed in this
   medication guide. Talk with your doctor about the best dosing schedule
   for your other medicines.

Where can I get more information (Actonel, Atelvia)?

   Your pharmacist can provide more information about risedronate.
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