DrugindexOnline^{2nd edition}

Generic Name: Alendronate/Cholecalciferol Tablets (a-LEN-droe-nate/KOE-le-kal-SIF-er-ol)
Brand Name: Fosamax Plus D

Alendronate/Cholecalciferol is used for:

Treating and preventing osteoporosis in certain patients. It may also be used for other conditions as determined by your doctor.

Alendronate/Cholecalciferol is a bisphosphonate and vitamin D combination. The biphosphonate works by slowing bone loss. Vitamin D helps the body to form bone normally.

Do NOT use Alendronate/Cholecalciferol if:

• you are allergic to any ingredient in Alendronate/Cholecalciferol
• you have certain esophagus problems (eg, narrowing, blockage)
• you are unable to stand or sit upright for at least 30 minutes
• you have low blood calcium levels or severe kidney problems

Contact your doctor or health care provider right away if any of these apply to you.

Before using Alendronate/Cholecalciferol :

Some medical conditions may interact with Alendronate/Cholecalciferol . Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding
• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
• if you have allergies to medicines, foods, or other substances
• if you have a history of stomach or bowel problems (eg, inflammation, ulcer, nutrient absorption problems), esophagus problems (eg, heartburn, reflux disease, severe irritation), or kidney problems, or if you have difficult or painful swallowing
• if you have high or low blood vitamin D levels, mental problems, poor health, cancer (eg, leukemia, lymphoma), anemia, blood clotting problems, an infection, sarcoidosis, or calcium metabolism problems
• if you have poor dental hygiene, other dental problems, or you will be having a dental procedure
• if you smoke or drink alcohol
• if you take a corticosteroid (eg, prednisone), or you have had or will be having chemotherapy or radiation treatment
• if you are a woman who has not yet reached menopause

Some MEDICINES MAY INTERACT with Alendronate/Cholecalciferol . Tell your health care provider if you are taking any other medicines, especially any of the following:

• Aspirin or nonsteroidal anti-inflammatory drugs (NSAIDs) (eg, ibuprofen) because the risk of side effects, such as esophagus or stomach irritation, may be increased
• Anticonvulsants (eg, phenytoin), bile acid sequestrants (eg, cholestyramine, colestipol), cimetidine, mineral oil, olestra, orlistat, or thiazide diuretics (eg, hydrochlorothiazide) because they may decrease Alendronate/Cholecalciferol 's effectiveness

This may not be a complete list of all interactions that may occur. Ask your health care provider if Alendronate/Cholecalciferol may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Alendronate/Cholecalciferol :

Use Alendronate/Cholecalciferol as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• An extra patient leaflet is available with Alendronate/Cholecalciferol . Talk to your pharmacist if you have questions about this information.
• Swallow Alendronate/Cholecalciferol whole. Do not break, crush, chew, or suck on the tablet before swallowing.
• Take Alendronate/Cholecalciferol by mouth on an empty stomach in the morning at least 30 minutes before your first food, drink, or other medicine of the day. Do NOT take Alendronate/Cholecalciferol at bedtime or before you get out of bed in the morning.
• Take Alendronate/Cholecalciferol with a full glass of plain water (8 oz/240 mL). Do not take Alendronate/Cholecalciferol with mineral water, coffee, tea, or juice. Do not lie down for 30 minutes after taking Alendronate/Cholecalciferol and until you eat your first food of the day.
• Alendronate/Cholecalciferol is usually taken 1 time each week. Be sure you understand how to take Alendronate/Cholecalciferol . Contact your doctor or pharmacist if you have any questions.
• Continue to use Alendronate/Cholecalciferol even if you feel well. Do not miss any doses.
• If you miss a dose of Alendronate/Cholecalciferol , do not take it later in the day. Take it on the morning after you remember and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Alendronate/Cholecalciferol .

Important safety information:

• Alendronate/Cholecalciferol may cause dizziness. This effect may be worse if you take it with alcohol or certain medicines. Use Alendronate/Cholecalciferol with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
• Talk with your doctor before you drink alcohol, smoke, or use other tobacco products while taking Alendronate/Cholecalciferol .
• Follow the diet and exercise program given to you by your health care provider. Talk to your doctor about whether you should take a calcium and vitamin D supplement while you use Alendronate/Cholecalciferol .
• Talk to your doctor about the use of weight-bearing exercises to help prevent weak bones.
• Products that contain olestra may decrease the absorption of vitamin D. Talk with your doctor or pharmacist if you have questions about eating foods that contain olestra while you take Alendronate/Cholecalciferol .
• Alendronate/Cholecalciferol may cause jaw bone problems in some patients. Your risk may be greater if you have cancer, poor dental hygiene, or certain other conditions (eg, anemia, blood clotting problems, infection, dental problems). You risk may also be greater if you use certain medicines or therapies (eg, chemotherapy, corticosteroids, radiation). Talk to your doctor about having a dental exam before you start to use Alendronate/Cholecalciferol . Ask your doctor any questions you may have about dental treatment while you use Alendronate/Cholecalciferol .
• Proper dental care is important while you are taking Alendronate/Cholecalciferol . Brush and floss your teeth and visit the dentist regularly.
• Alendronate/Cholecalciferol may cause you to become sunburned more easily. Avoid the sun, sunlamps, or tanning booths until you know how you react to Alendronate/Cholecalciferol . Use a sunscreen or wear protective clothing if you must be outside for more than a short time.
• Tell your doctor or dentist that you take Alendronate/Cholecalciferol before you receive any medical or dental care, emergency care, or surgery.
• Lab tests, including bone density, blood calcium levels, and blood vitamin D levels, may be performed while you use Alendronate/Cholecalciferol . These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
• Alendronate/Cholecalciferol should not be used in CHILDREN; safety and effectiveness in children have not been confirmed.
• PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Alendronate/Cholecalciferol while you are pregnant. Alendronate/Cholecalciferol is found in breast milk. If you are or will be breast-feeding while you use Alendronate/Cholecalciferol , check with your doctor. Discuss any possible risks to your baby.

Possible side effects of Alendronate/Cholecalciferol :

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Bone, muscle, or joint pain; constipation; diarrhea; dizziness; feeling bloated or full; flu-like symptoms at the start of treatment; gas; headache; mild stomach pain; nausea; taste changes; vomiting.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); black, tarry, or bloody stools; chest pain; coughing or vomiting blood; difficult or painful swallowing; mouth sores; new, worsening, or severe heartburn; red, swollen, blistered, or peeling skin; severe bone, muscle, or joint pain; severe or persistent sore throat or stomach pain; swelling of the hands, legs, or joints; swelling or pain in your jaw.

This is not a complete list of all side effects that may occur. If you have questions or need medical advice about side effects, contact your doctor or health care provider. You may report side effects to the FDA at 1-800-FDA-1088 (1-800-332-1088) or at http://www.fda.gov/medwatch.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org/findyour.htm), or emergency room immediately. Drink a full glass (8 oz/240 mL) of milk. Do not lie down for at least 30 minutes or as directed by your doctor. Do not try to vomit. Symptoms may include loss of appetite; painful swallowing; severe heartburn; sluggishness; stomach pain or upset; unusual weakness.

Proper storage of Alendronate/Cholecalciferol :

Store Alendronate/Cholecalciferol between 68 and 77 degrees F (20 and 25 degrees C) in the original blister package. Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Alendronate/Cholecalciferol out of the reach of children and away from pets.

General information:

• If you have any questions about Alendronate/Cholecalciferol , please talk with your doctor, pharmacist, or other health care provider.
• Alendronate/Cholecalciferol is to be used only by the patient for whom it is prescribed. Do not share it with other people.
• If your symptoms do not improve or if they become worse, check with your doctor.

This information is a summary only. It does not contain all information about Alendronate/Cholecalciferol . If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.