Alendronate/cholecalciferol (By mouth)
Alendronate Sodium (a-LEN-droe-nate SOE-dee-um), Cholecalciferol (koe-le-kal-SIF-er-ol)
Prevents or treats osteoporosis (thinning of the bones) in women after menopause. Treats osteoporosis in men.
Fosamax Plus DThere may be other brand names for this medicine.
When This Medicine Should Not Be Used:You should not use this medicine if you have had an allergic reaction to alendronate or a vitamin D supplement. Do not use this medicine if you have esophagus (the tube that runs from your throat to your stomach) problems, trouble swallowing, very low calcium in your blood (hypocalcemia), or severe kidney disease. You should not use this medicine if you cannot stand or sit upright for at least 30 minutes after taking the medicine. You should not give this medicine to children.
How to Use This Medicine:
- Your doctor will tell you how much of this medicine to use and how often. Do not use more medicine or use it more often than your doctor tells you to.
- If any of this medicine stays in your esophagus, it may cause serious damage. To lower the risk of this problem, use this medicine exactly as directed by your doctor.
- It is best to take this medicine on an empty stomach.
- Take this medicine as soon as you get out of bed in the morning, before you eat or have anything to drink. Swallow the tablet whole with a full glass (6 to 8 ounces) of plain water only (not mineral water, coffee, tea, soda, juice, or any other liquid). Do not chew or suck on the tablet. Take this medicine while you are sitting or standing. Do not take the medicine while you are still in bed, and do not take it at bedtime.
- Wait at least 30 minutes after you take the medicine before you eat or drink anything or take any other medicines. This will help your body absorb the medicine.
- Do not lie down for at least 30 minutes after taking this medicine, and do not lie down until after you have eaten some food.
- Carefully follow your doctor's instructions about diet and exercise. It is especially important that you get enough calcium and vitamin D in your diet.
- Follow your dosing instructions given to you by your doctor closely. It may affect the way this medicine works if you do not. Do not stop using this medicine suddenly without asking your doctor.
- This medicine should come with a Medication Guide. Read and follow these instructions carefully. Ask your doctor or pharmacist if you have any questions. Ask your pharmacist for the Medication Guide if you do not have one.
If a dose is missed:
- This medicine is usually taken one time per week. If you miss your regularly scheduled dose or you forget to take your medicine, wait until the next morning to take it. Do not use extra medicine to make up for a missed dose. You should never take two tablets in one day.
How to Store and Dispose of This Medicine:
- Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep your medicine in the original package until you are ready to use it. Keep the package and tablets dry.
- Ask your pharmacist, doctor, or health caregiver about the best way to dispose of any outdated medicine or medicine no longer needed.
- Keep all medicine away from children and never share your medicine with anyone.
Drugs and Foods to Avoid:
Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.
- Make sure your doctor knows if you are also using pain or arthritis medicine (sometimes called "NSAIDs"). This includes aspirin, ibuprofen, Advil, Aleve, Celebrex, Ecotrin, or Motrin.
- Tell your doctor if you also use mineral oils, olestra (Olean), orlistat (Xenical), or medicines to lower your cholesterol (such as cholestyramine, colestipol, Colestid, or Questran). Also tell your doctor if you use medicines to treat seizures (such as phenobarbital, Luminal), cimetidine (Tagamet), diuretic or "water pill" (such as hydrochlorothiazide [HCTZ]), or a phenothiazine medicine (such as prochlorperazine, Compazine, Mellaril, or Phenergan).
- Make sure your doctor knows if you are also using cancer treatment, radiation treatment, or steroids (such as prednisone, dexamethasone, methylprednisolone, Decadron, or Medrol).
- Wait at least 30 minutes after you take this medicine before taking any calcium supplements and antacids.
- Do not drink alcohol or smoke tobacco. Both alcohol and smoking can make your bone problems worse.
Warnings While Using This Medicine:
- Make sure your doctor knows if you are pregnant or breastfeeding, or if you have kidney disease, stomach ulcers, heartburn, trouble swallowing, or any other kind of stomach or bowel problems. Tell your doctor if you have trouble absorbing minerals in your stomach (malabsorption syndrome).
- Tell your doctor if you have anemia, blood clotting problems, blood or bone marrow problems (such as leukemia, lymphoma, sarcoidosis), cancer, an infection, a vitamin or mineral imbalance, poor oral hygiene, or dental problems.
- It is very important that you tell your dentist that you are taking this medicine. If you are having any dental procedures, you may have an increased chance of getting a severe problem with your jaw. Your dentist might want you to stop taking this medicine before the procedure. Tell your doctor or dentist right away if you have pain or soreness in your jaw.
- This medicine can irritate your esophagus. If you think this medicine has started to damage your esophagus, stop taking the medicine and call your doctor. Symptoms of damage to the esophagus are heartburn (either new or worse than usual), pain when swallowing, pain in the center of your chest, trouble swallowing, or feeling that food gets stuck on the way to your stomach.
- This medicine may cause severe bone, joint, or muscle pain while you are using it. Make sure you tell your doctor about any new pain or soreness in your bones or joints.
- This medicine may increase your risk of developing fractures of the thigh bone. This may be more common if you use it for a long time. Check with your doctor right away if you have a dull or aching pain in the thighs, groin, or hips.
- Your doctor will need to check your progress at regular visits while you are using this medicine. Be sure to keep all appointments.
Possible Side Effects While Using This Medicine:
Call your doctor right away if you notice any of these side effects:
- Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
- Bloody, black, or tarry stools.
- Blurred vision, eye problems.
- Chest pain, heartburn, or burning in your throat.
- Difficult or painful swallowing.
- Heavy jaw feeling.
- Loosening of a tooth.
- Pain, swelling, or numbness in the mouth or jaw.
- Severe bone, joint, or muscle pain.
- Severe stomach pain or enlarged abdomen (stomach).
- Swelling in your hands, ankles, or feet.
- Tooth problems.
If you notice these less serious side effects, talk with your doctor:
- Mild bone, muscle, or joint pain.
- Mild stomach pain, nausea, indigestion, diarrhea, constipation, or gas.
If you notice other side effects that you think are caused by this medicine, tell your doctor
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088
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