Drug: Actonel with Calcium

Actonel with Calcium Generic Name: calcium carbonate and risedronate (KAL see um KAR bo nate and rye SED roe nate)
Brand Name: Actonel with Calcium What is calcium carbonate and risedronate? Calcium carbonate is a mineral that is needed for many functions of the body, especially bone formation and maintenance. 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 fractures. Calcium carbonate and risedronate is a combination medicine used to treat or prevent postmenopausal and steroid-induced osteoporosis. Calcium carbonate and risedronate may also be used for purposes not listed in this medication guide. What is the most important information I should know about calcium carbonate and risedronate? You should not use this medicine if you have low levels of calcium in your blood (hypocalcemia), or a problem with the movement of muscles in your esophagus. Do not take a calcium carbonate and risedronate tablet if you cannot sit upright or stand for at least 30 minutes. Risedronate can cause serious problems in the stomach or esophagus (the tube that connects your mouth and stomach). What should I discuss with my healthcare provider before taking calcium carbonate and risedronate? You should not use calcium carbonate and risedronate if you are allergic to it, or if you have: low levels of calcium in your blood (hypocalcemia); or a problem with the movement of muscles in your esophagus. Do not take a calcium carbonate and risedronate tablet if you cannot sit upright or stand for at least 30 minutes. Risedronate 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. To make sure this medicine is safe for you, tell your doctor if you have: low or high levels of calcium in your blood; kidney disease; trouble swallowing; or an ulcer in your stomach or esophagus. 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 calcium carbonate and 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 calcium carbonate and risedronate will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant. It is not known whether calcium carbonate and 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 calcium carbonate and risedronate? Follow all directions on your prescription label. Do not take this medicine in larger or smaller amounts or for longer than recommended. Actonel with Calcium is packaged as two separate medicines: 4 risedronate tablets and 24 calcium tablets. Take a risedronate tablet one day per week, first thing in the morning, at least 30 minutes before you eat or drink anything or take any other medicine. Take a calcium tablet with food every day for the 6 days in between your risedronate doses. Only the calcium tablet should be taken with food. Risedronate must be taken on an empty stomach. Take the risedronate tablet first thing in the morning, at least 30 minutes before you eat or drink anything or take any other medicine. Take the risedronate tablet on the same day each week and always first thing in the morning. Take the risedronate tablet with a full glass (6 to 8 ounces) of water. Use only plain water (not mineral water) when taking a risedronate tablet. Do not crush, chew, or suck the risedronate tablet. Swallow the pill whole. After taking a risedronate tablet, carefully follow these instructions: Do not lie down or recline for at least 30 minutes. Do not eat or drink anything other than plain water. Do not take any other medicines including vitamins, calcium, or antacids for at least 30 minutes. It may be best to take your other medicines at a different time of the day. Talk with your doctor about the best dosing schedule for your other medicines. Calcium carbonate and risedronate is only part of a complete program of treatment that may also include diet changes, exercise, and taking vitamin supplements. Follow your diet, medication, and exercise routines very closely. Take only the amount of calcium that your doctor recommends. Do not use other calcium supplements unless your doctor has told you to. Your bone mineral density will need to be checked often. You may not need to take this medication for longer than 3 to 5 years if you take it for osteoporosis. Store at room temperature away from moisture and heat. What happens if I miss a dose? If you forget to take a risedronate tablet: If you forget to take this medicine first thing in the morning, do not take it later in the day. Wait until the following morning to take the medicine and skip the missed dose. Do not take two (2) tablets in one day. If you forget to take a calcium carbonate tablet: Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose. What happens if I overdose? Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. Drink a full glass of milk and call your local poison control center or emergency room right away. Do not make yourself vomit and do not lie down. Overdose symptoms may include nausea, heartburn, stomach pain, diarrhea, muscle cramps, numbness or tingling, tight muscles in your face, seizure (convulsions), irritability, and unusual thoughts or behavior. What should I avoid while taking calcium carbonate and risedronate? Do not take any other medicines including vitamins, calcium, or antacids for at least 30 minutes after taking a risedronate tablet. Do not take an iron supplement at the same time you take a calcium tablet. Take these minerals at separate times of the day. Calcium carbonate and risedronate side effects Get emergency medical help if you have signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Stop using this medication 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 joint, bone, or muscle pain; new or unusual pain in your thigh or hip; jaw pain, numbness, or swelling; or severe skin reaction--fever, sore throat, swelling in your face or tongue, burning in your eyes, skin pain followed by a red or purple skin rash that spreads (especially in the face or upper body) and causes blistering and peeling. Common side effects may include: mild heartburn, nausea, or stomach upset; diarrhea, gas, or constipation; muscle, joint, or back pain; pain or burning with urination; mild skin rash; or headache or depressed mood. 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. See also: Side effects (in more detail) What other drugs will affect calcium carbonate and risedronate? 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 calcium carbonate and risedronate, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.

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Note: This page contains information about the side effects of calcium carbonate / risedronate. Some of the dosage forms included on this document may not apply to the brand name Actonel with Calcium.Not all side effects for Actonel with Calcium may be reported. You should always consult a doctor or healthcare professional for medical advice. Side effects can be reported to the FDA here. For the ConsumerApplies to calcium carbonate / risedronate: tablets Check with your doctor if any of these most COMMON side effects persist or become bothersome: Constipation; diarrhea; dizziness; gas; mild back, joint, or muscle pain; mild flu-like symptoms (eg, fever, headache, muscle aches, tiredness); mild stomach pain or upset; nausea. Seek medical attention right away if any of these SEVERE side effects occur while taking calcium carbonate / risedronate: Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, throat, or tongue; unusual hoarseness); black, tarry, or bloody stools; chest pain; coughing or vomiting blood; difficult or painful swallowing; mouth sores; new, worsening, or persistent heartburn; painful or difficult urination; severe back pain; severe bone, muscle, or joint pain (especially in the hip, groin, or thigh); severe headache, dizziness, or blurred vision; severe or persistent sore throat or stomach pain; swelling or pain in your jaw; symptoms of low blood calcium (eg, spasms, twitches, or cramps in your muscles; numbness or tingling in your fingers or toes, or around your mouth); unusual eye pain, swelling, redness, or sensitivity to light. For Healthcare ProfessionalsApplies to calcium carbonate / risedronate: oral kitCardiovascularCardiovascular side effects of risedronate have included hypertension, cardiovascular disorders, and angina pectoris.[Ref]DermatologicDermatologic side effects of risedronate have included rash, pruritus, and skin cancer.[Ref]GastrointestinalGastrointestinal side effects of risedronate have included diarrhea, nausea, flatulence, gastrointestinal disorder, constipation, rectal disorder and tooth disorder.

Gastrointestinal side effects of calcium carbonate have included rebound hyperacidity, constipation (6% to 37%) and gallstones (rarely).[Ref]During phase 3 clinical studies of risedronate, patients with a history of upper gastrointestinal (GI) disease or abnormalities were not excluded. Severe upper GI side effects were not noted. Patients using NSAIDs or aspirin were also included in phase 3 clinical studies. GI side effects in patient using concomitant NSAIDs or aspirin were higher than in non users.

Rebound hyperacidity has been associated with calcium salt antacids. This side effect does not appear to be due to the acid buffering capacity of calcium carbonate, but is a consequence of a specific action of calcium on the parietal cell. Rare cases of calcium carbonate gallstones have been reported in the pediatric literature.[Ref]GeneralGeneral body side effects of risedronate have included infection, back pain, pain, abdominal pain, chest pain, hernia, otitis media, and asthenia.[Ref]HypersensitivityHypersensitivity side effects of risedronate have included angioedema, generalized rash, and bullous skin reactions.[Ref]MusculoskeletalThere were no deaths in a 1 year, double-blind, placebo-controlled study of risedronate 35 mg once a week for prevention of bone loss in 278 postmenopausal women without osteoporosis. More treated subjects on risedronate experienced arthralgia (risedronate 13.9%; placebo 7.8%), myalgia (risedronate 5.1%; placebo 2.1%), and nausea (risedronate 7.3%; placebo 4.3%) than subjects on placebo.[Ref]Musculoskeletal side effects of risedronate have included arthralgias, bone pain, joint disorder, myalgia, bone pain, bone disorder, bursitis, hypertonia, tendon disorder, and leg cramps.[Ref]Nervous systemNervous system side effects of risedronate have included headache, dizziness, depression, insomnia, anxiety, neuralgia, vertigo, hypertonia, paresthesia and tinnitus.[Ref]OcularOcular side effects have of risedronate included cataracts and conjunctivitis.[Ref]Iritis occurred in 3 patients in one supportive study. Treatment with topical steroids was effective in all cases. Iritis has not been observed in other clinical studies.[Ref]OncologicOncologic side effects of risedronate have included neoplasms which have occurred in 3% of patients receiving risedronate therapy.[Ref]RespiratoryRespiratory side effects of risedronate have included bronchitis and sinusitis. Postmarketing side effects have included exacerbations of asthma.[Ref]MetabolicProlonged ingestion of large amounts of calcium carbonate and other sources of exogenous calcium can rarely result in the "milk alkali syndrome" and calcinosis. The milk alkali syndrome is characterized by the triad of hypercalcemia, metabolic alkalosis, and renal insufficiency.[Ref]Metabolic side effects of calcium carbonate have rarely included hypercalcemia and hypophosphatemia. Other metabolic side effects have rarely included "mild alkali syndrome", calcinosis, and irreversible renal damage.[Ref]GenitourinaryGenitourinary side effects of risedronate have included urinary tract infection and cystitis.[Ref]HematologicHematologic side effects of risedronate have included ecchymosis and anemia.[Ref]RenalRenal side effects of calcium carbonate have included renal failure, formation of renal calcium, and a single case report of a calcium carbonate and calcium phosphate-filled renal cyst.[Ref]The renal failure that accompanies hypercalcemia and alkalosis in the milk alkali syndrome is usually transient.[Ref]

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Calcium carbonate / risedronate Pregnancy Warnings Calcium carbonate-risedronate has been assigned to pregnancy category C by the FDA. Animal studies have revealed fetal harm. There are no controlled data in human pregnancy. Calcium carbonate-risedronate is only recommended for use during pregnancy when there are no alternatives and benefit outweighs risk. Calcium carbonate / risedronate Breastfeeding Warnings There are no data on the excretion of calcium carbonate-risedronate into human milk. The manufacturer recommends that due to the potential for serious adverse reactions in nursing infants, a decision should be made to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.

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