Actonel with Calcium

Name: Actonel with Calcium

Warnings

ACTONEL

Bisphosphonates may cause upper gastrointestinal disorders such as dysphagia, esophagitis, and esophageal or gastric ulcer (see PRECAUTIONS).

CALCIUM

See PRECAUTIONS

How supplied

Actonel with Calcium is supplied in blister packages containing a 28-day course of therapy.

Four Actonel Tablets:
35 mg film-coated, oval, orange tablets with RSN on 1 face and 35 mg on the other

Twenty-four Calcium Carbonate Tablets, USP:
1250 mg calcium carbonate (equivalent to 500 mg elemental calcium) film-coated, oval, light blue tablets with NE 2 engraved on both faces

NDC 0149-0475-01

Store at 20°-25°C (68°-77°F); excursions permitted between 15°-30°C (59°-86°F) [See USP Controlled Room Temperature].

Actonel sold under U.S. patent No. 5,583,122; 5,935,602; 5,994,329; 6,015,801; 6,047,829; 6,096,342; 6,165,513; 6,225,294; 6,410,520; 6,432,932; 6,465,443; and 6,562,974.

Actonel mfg. by: Procter & Gamble Pharmaceuticals, Inc.
Cincinnati, OH 45202, or
Norwich Pharmaceuticals, Inc.
North Norwich, NY 13814

Calcium mfg. by: Norwich Pharmaceuticals, Inc.
North Norwich, NY 13814

Dist. by: Procter & Gamble Pharmaceuticals, Inc., TM Owner
Cincinnati, OH 45202

Marketed with: sanofi-aventis U.S. LLC
Bridgewater, NJ 08807

JANUARY 2008

Patient Information ACTONEL® (AK-toh-nel) with CALCIUM

ACTONEL (risedronate sodium tablets) 35 mg with CALCIUM (calcium carbonate tablets, USP) 1250 mg (equals 500 mg elemental calcium) for Postmenopausal Osteoporosis

Read this information carefully before you start to use your medicine. Read the information you get every time you get more medicine. There may be new information. This information does not take the place of talking with your health care provider about your medical condition or your treatment. If you have any questions or are not sure about something, ask your health care provider or pharmacist.

What is the most important information I should know about Actonel with Calcium?

ACTONEL may cause problems in your stomach and esophagus (the tube that connects the mouth and the stomach), such as trouble swallowing (dysphagia), heartburn (esophagitis), and ulcers. You might feel pain in your bones, joints, or muscles (See "What are the Possible Side Effects of Actonel with Calcium?").

You must follow the instructions exactly for Actonel with Calcium to work and to lower the chance of serious side effects. (See "How should I take Actonel with Calcium").

What is Actonel with Calcium?

  • Actonel with Calcium is a prescription medicine used to prevent and treat osteoporosis in postmenopausal women (See "What is Osteoporosis?").

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 see or feel a difference. ACTONEL helps lower the risk of breaking bones (fractures). Your health care provider may measure the thickness (density) of your bones or do other tests to check your progress.

Calcium is the main mineral that makes up your bones and teeth. Your body cannot make calcium. Calcium must come from the food you eat or from a calcium tablet. If your bones do not get enough calcium over time, they can become weak and break (fracture) easier.

See the end of this leaflet for information about osteoporosis.

Who should not take Actonel with Calcium?

Do not take ACTONEL if you:

  • 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. (See the end of this leaflet for a list of all the ingredients in ACTONEL).

Do not take Calcium if you:

  • have high blood calcium (hypercalcemia)
  • have an allergy to any ingredient in this product. (See the end of this leaflet for a list of all the ingredients.)

Tell your doctor before using ACTONEL if:

  • you are pregnant or may become pregnant. We do not know if ACTONEL can harm your unborn child.
  • you are breast-feeding or plan to breast-feed. We do not know if ACTONEL can pass through your milk and if it can harm your baby.
  • you have kidney problems. ACTONEL may not be right for you.

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins and herbal supplements. ACTONEL and Calcium can interact with other medicines. Keep a list of all the medicines you take. Show it to all your healthcare providers, including your dentist and pharmacist, each time you get a new medicine.

Tell your doctor before using Calcium if:

  • you have a history of kidney stones.
  • you are already taking calcium supplements.

How should I take Actonel with Calcium?

Actonel Tablets:

  • Choose 1 day of the week that you will remember and that best fits your schedule to take your ACTONEL 35- mg. Every week, take 1 ACTONEL 35- mg (orange) tablet in the morning on your chosen day.
  • 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. Do not take it with any other drink besides plain water. Do not take it with coffee, tea, juice, milk or other dairy drinks.
  • Swallow ACTONEL whole. Do not chew the tablet or keep it in your mouth to melt or dissolve.
  • After taking ACTONEL you must wait at least 30 minutes BEFORE:
    • 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.

Calcium Tablets:

  • Take one Calcium (blue) tablet daily with food for the following 6 days of the week.
  • When you have completed the week's regimen (one ACTONEL tablet on the first day followed by one Calcium tablet on each of the remaining 6 days), begin taking the next week's supply (refer back to the beginning of this section entitled "How Should I Take Actonel with Calcium").

Keep taking Actonel with Calcium for as long as your health care provider tells you.

For ACTONEL to treat your postmenopausal osteoporosis or keep you from getting postmenopausal osteoporosis, you have to take it exactly as prescribed.

Your health care provider may tell you to take more calcium as well as vitamin D and to exercise. If you take more calcium tablets, take each calcium tablet at separate times of the day with food. All calcium tablets should be taken at a different time of day than your ACTONEL tablet.

What should I do if I miss a dose of my ACTONEL?

  • If you miss a dose of your ACTONEL 35- mg (orange) tablet in the morning, do not take it later in the day. Take only 1 ACTONEL 35- mg tablet the next morning and return to your usual schedule. Take your Calcium (blue) tablet with food later in the same day that the missed ACTONEL tablet is taken. Do not take your ACTONEL and Calcium tablet at the same time.

What should I do if I miss a dose of Calcium?

  • If you miss a dose of a Calcium (blue) tablet and remember later in the day, you may take it with food.
  • If you miss a dose of a Calcium tablet the entire day, and you remember the next day, you may take two tablets on that day at separate times with food.
  • Do not take more than two Calcium tablets on the same day, unless recommended by your health care provider.

What should I avoid while taking Actonel with Calcium?

  • Do not eat or drink anything except water before you take ACTONEL and for at least 30 minutes after you take it.
  • Do not lie down for at least 30 minutes after you take ACTONEL.
  • Foods and some vitamin supplements and medicines can stop your body from absorbing (using) ACTONEL. Therefore, do not take anything other than plain water at or near the time you take ACTONEL. (See "How should I take ACTONEL?").

What are the possible side effects of Actonel with Calcium?

Stop taking ACTONEL and tell your health care provider right away if:

  • swallowing is difficult or painful
  • you have chest pain
  • you have very bad heartburn or it doesn't get better

ACTONEL may cause:

  • pain or trouble swallowing (dysphagia)
  • heartburn (esophagitis)
  • ulcers in your stomach and esophagus (the tube that connects the mouth and the stomach)
  • pain in bones, joints, or muscles, sometimes severe. Pain may start as soon as one day or up to several months after starting ACTONEL.

The most common side effects with ACTONEL include back pain, joint pain, upset stomach, abdominal (stomach area) pain, constipation, diarrhea, gas, and headache. Tell your health care provider if you have pain or discomfort in your stomach or esophagus. Rarely, severe skin reactions may occur. Patients may get allergic reactions such as rash, hives, or in rare cases, swelling that can be of the face, lips, tongue, or throat, which may cause trouble breathing or swallowing.

In rare cases, patients taking Actonel may get eye inflammation, usually with pain, redness and sensitivity to light.

Rarely, patients had had jaw problems associated with delayed healing and infection, often following tooth extraction.

These are not all the possible side effects of ACTONEL. You can ask your health care provider or pharmacist about other side effects. Any time you have a medical problem you think may be from ACTONEL, talk to your doctor.

Calcium may cause:

  • constipation
  • gas
  • nausea
  • abdominal pain
  • bloating
  • an increased chance of kidney stones

What is osteoporosis?

Osteoporosis is a disease that causes bones to become thinner. Thin bones can break easily. Most people think of their bones as being solid like a rock. Actually, bone is living tissue, just like other parts of the bodyyour heart, brain, or skin, for example. Bone just happens to be a harder type of tissue. Bone is always changing. Your body keeps your bones strong and healthy by replacing old bone with new bone.

Osteoporosis causes the body to remove more bone than it replaces. This means that bones get weaker. Weak bones are more likely to break. Osteoporosis is a bone disease that is quite common, especially in older women. However, young people and men can develop osteoporosis, too. Osteoporosis can be prevented, and with proper therapy it can be treated.

How can osteoporosis affect me?

  • You may not have any pain or other symptoms when osteoporosis begins.
  • You are more likely to break (fracture) a bone especially if you fall because osteoporosis makes your bones weaker. You are most likely to break a bone in your back (spine), wrist, or hip.
  • You may "shrink" (get shorter).
  • You may get a "hump" (curve) in your back.
  • You may have bad back pain that makes you stop some activities.

Who is at risk for osteoporosis?

Many things put women at risk for osteoporosis. The following women have a higher chance of getting Osteoporosis:

Women who

  • are going through or who are past menopause ("the change")
  • are white (Caucasian) or Asian
  • are thin
  • have a family member with osteoporosis
  • do not get enough calcium or vitamin D
  • do not exercise
  • smoke
  • drink alcohol often
  • take bone thinning medicines (like prednisone or other corticosteroids) for a long time

General information about Actonel with Calcium:

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

What if I have other questions about Actonel with Calcium?

This leaflet summarizes the most important information about Actonel with Calcium for osteoporosis. If you have more questions about Actonel with Calcium, ask your health care provider or pharmacist. They can give you information written for health care 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): crospovidone, ferric oxide red, ferric oxide yellow, hydroxypropyl cellulose, hydroxypropyl methylcellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, silicon dioxide, and titanium dioxide.

What are the ingredients of Calcium?

Calcium carbonate (1250 mg, equals 500 mg elemental calcium), pregelatinized starch, sodium starch glycolate, polyethylene glycol 3350, hypromellose, magnesium stearate, opaspray light blue, FD&C blue #2, polysorbate 80.

ACTONEL® with CALCIUM is marketed by:
Procter & Gamble Pharmaceuticals, Inc.
Cincinnati, OH 45202
and
sanofi-aventis U.S. LLC

Bridgewater, NJ 08807

August 2006

© 2006 Procter & Gamble Pharmaceuticals, Inc.

What is Actonel with Calcium?

Actonel with Calcium (risedronate and calcium) is packaged as two separate medicines: 4 Actonel tablets and 24 calcium tablets. Risedronate is in the group of medicines called bisphosphonates (bis FOS fo nayts). It alters the cycle of bone formation and breakdown in the body. Risedronate slows bone loss while increasing bone mass, which may prevent bone fractise.

Calcium is a mineral that is needed for many functions of the body, especially bone formation and maintenance.

Actonel is used to treat or prevent postmenopausal and steroid-induced osteoporosis. Actonel is also used to treat Paget's disease of bone.

Calcium carbonate is used to prevent and to treat calcium deficiencies.

Actonel with Calcium may also be used for purposes not listed in this medication guide.

What other drugs will affect Actonel with Calcium?

Tell your doctor about all your current medicines and any you start or stop using, especially:

  • levothyroxine or other thyroid medicine;

  • a diuretic or "water pill";

  • an iron supplement;

  • steroids (prednisone and others);

  • an antibiotic--ciprofloxacin, doxycycline, levofloxacin, minocycline, moxifloxacin, ofloxacin, tetracycline, and others; or

  • aspirin or other 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 Actonel with Calcium, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.

(web3)