This is a combination medication that contains alendronate and cholecalciferol. It is used to treat osteoporosis for postmenopausal women and for men. Alendronate belongs to a family of medications known as bisphosphonates.

Alendronate increases the thickness of bone (bone mineral density) by slowing down the cells that usually break down bone (osteoclasts). This allows the cells that build bone (osteoblasts) to work more efficiently. By making bones stronger, alendronate can help to reduce the incidence of osteoporosis-related fractures.

Cholecalciferol, also called vitamin D3, is a vitamin that is needed for calcium absorption and healthy bones.

This medication may be available under multiple brand names and/or in several different forms. Any specific brand name of this medication may not be available in all of the forms or approved for all of the conditions discussed here. As well, some forms of this medication may not be used for all of the conditions discussed here.

Your doctor may have suggested this medication for conditions other than those listed in these drug information articles. If you have not discussed this with your doctor or are not sure why you are taking this medication, speak to your doctor. Do not stop taking this medication without consulting your doctor.

Do not give this medication to anyone else, even if they have the same symptoms as you do. It can be harmful for people to take this medication if their doctor has not prescribed it.

The recommended dose of alendronate - cholecalciferol is one tablet once weekly. The overall appropriate dosage of alendronate - cholecalciferol for you is determined by your doctor and is based on how much vitamin D you require.

The tablet should be taken first thing in the morning when you get up, and at least half an hour before you take your first meal, beverage, or other medication of the day. To reduce the risk of irritating the throat or esophagus, take the tablet with a full glass (250 mL) of plain water only. If your normal drinking water is classified as "hard water," it may decrease the absorption of this medication and you should consider taking it with distilled water.

After swallowing, do not lie down until 30 minutes have passed and you have eaten your first meal of the day. Do not take this medication at bedtime or before getting up in the morning. Swallow the tablets whole. Do not chew or suck on the tablets.

Many things can affect the dose of medication that a person needs, such as the severity of the condition, other medical conditions and other medications. If your doctor has recommended a dose different from the ones listed here, do not change the way that you are taking the medication without consulting your doctor.

It is important to take this medication exactly as prescribed by your doctor. If you miss a dose, take the missed dose the morning after you remember. Then, return to your weekly dose on the original day of the week. Do not take 2 doses on the same day or take a double dose to make up for a missed one. If you are not sure what to do after missing a dose, contact your doctor or pharmacist for advice.

Store this medication at room temperature, protect it from light and moisture, and keep it out of the reach of children. Store the tablets in the original blister package until use.

70 mg/2800 IU
Each white-to-off-white, oval, biconvex tablet, engraved "APO" on one side, "A-D28" on the other side, contains 91.37 mg of alendronate sodium, equivalent to 70 mg of alendronate and 28 mg of cholecalciferol concentrate, equivalent to 70 µg (2800 IU) of cholecalciferol. Nonmedicinal ingredients: butylated hydroxytoluene, hydroxypropyl methylcellulose, colloidal silicon dioxide, magnesium stearate, mannitol, and microcrystalline cellulose.

70 mg/5600 IU
Each white-to-off-white, oval, biconvex tablet, engraved "APO" on one side, "A-D56" on the other side, contains 91.37 mg of alendronate sodium, equivalent to 70 mg of alendronate and 56 mg of cholecalciferol concentrate, equivalent to 140 µg (5600 IU) of cholecalciferol. Nonmedicinal ingredients: butylated hydroxytoluene, hydroxypropyl methylcellulose, colloidal silicon dioxide, magnesium stearate, mannitol, and microcrystalline cellulose.

Do not take alendronate - cholecalciferol if you:

• are allergic to alendronate, cholecalciferol, or any ingredients of the medication
• cannot stand or sit upright for at least 30 minutes
• have an abnormality of the esophagus (passage leading from throat to stomach) that delays the emptying of the esophagus into the stomach
• have low blood calcium
• have reduced kidney function (creatinine clearance less than 35 mL per minute)

Many medications can cause side effects. A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent. The side effects listed below are not experienced by everyone who takes this medication. If you are concerned about side effects, discuss the risks and benefits of this medication with your doctor.

The following side effects have been reported by at least 1% of people taking this medication. Many of these side effects can be managed, and some may go away on their own over time.

Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.

• changed sense of taste
• constipation
• dizziness
• diarrhea
• heartburn
• indigestion
• mild flu-like symptoms (e.g., sore throat, lack of energy, cough, fever)
• mild skin rash or redness
• nausea
• pain in bones, muscles, or joints (mild to moderate)
• rash
• spinning sensation
• swollen joints in hands and legs
• vomiting

Although most of these side effects listed below don't happen very often, they could lead to serious problems if you do not seek medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

• delayed healing and infection of mouth and jaw (usually after tooth extraction)
• difficulty swallowing
• mouth sores
• persistent ear pain
• severe joint, bone, or muscle pain
• symptoms of low calcium levels such as muscle spasms, and prickling or tingling sensations around the mouth or in the hands or feet
• vision changes or eye pain, redness or light sensitivity

Stop taking the medication and seek immediate medical attention if any of the following occur:

• new or unusual pain in the hip or thigh
• signs of a serious allergic reaction (e.g., swelling of face or throat, hives, or difficulty breathing)
• signs of a severe skin reaction (e.g., high fever; rash; sores; painful blisters on the skin, mouth, or eyes; or skin peeling off)
• signs of damage to the esophagus (e.g., pain in the esophagus or behind the breastbone, chest pain, difficulty swallowing, pain when swallowing, or new or worsening heartburn)
• symptoms of a stomach or intestinal ulcer (e.g., nausea, vomiting, abdominal pain, loss of weight or appetite, black or bloody stools, or vomiting blood)

Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are taking this medication.

Before you begin using a medication, be sure to inform your doctor of any medical conditions or allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use this medication.

Atypical femur fracture: There is evidence that long-term use of this type of medication may contribute to a type of rare fracture of the long bone in the thigh (femur) without any form of trauma.

If you experience new or unusual pain in the groin, hip, or thigh area, contact your doctor as soon as possible.

Bone, joint, and muscle problems: Rarely, people taking this medication experience severe bone, joint, or muscle pain. This usually goes away when the medication is stopped.

Calcium and vitamin D: Calcium and vitamin D are important for bone growth and strength. You may need to take calcium or additional vitamin D supplements to get the best effect from alendronate if you are not getting enough from your diet. Your doctor may test you for low calcium levels or vitamin D deficiency before you start taking alendronate-cholecalciferol.

Effects on the esophagus: Alendronate may irritate the lining of the esophagus (the passage from the throat to the stomach). In some cases, these effects have been severe and have required hospitalization. Stop taking the medication and contact your doctor immediately if you suddenly experience problems swallowing, find it painful to swallow, develop pain behind the sternum (breastbone), or have new or worsening heartburn.

To reduce the risk of irritation of the esophagus, swallow this medication with a full glass of plain water first thing in the morning when you get up. Do not lie down until 30 minutes have passed and you have eaten your first meal of the day. Do not chew or suck on the tablet, as this may lead to ulcers in the mouth or throat. Do not take this medication at bedtime or before getting up for the day.

Effects on the stomach and intestines: Rarely, people taking this medication have developed ulcers of the stomach or intestines. If you have stomach problems, such as ulcers and severe indigestion, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Get immediate medical attention if you have symptoms of a stomach or intestinal ulcer, such as nausea, vomiting, abdominal pain, loss of weight or appetite, black or bloody stools, or vomiting blood.

Eye inflammation: Some people who take alendronate experience symptoms of eye inflammation. If you experience swelling, redness, warmth, or sensitivity to light, contact your doctor as soon as possible.

Jaw problems: Rarely, alendronate may cause severe jaw problems associated with delayed healing and infection, especially for people with cancer or after tooth extractions. If you experience any pain in the jaw, especially after having a tooth removed, contact your doctor immediately.

Kidney function: Alendronate is removed from the body by the kidneys. If you have reduced kidney function or kidney disease, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Pregnancy: This medication has not been studied for use by pregnant women and therefore should not be taken during pregnancy. If you become pregnant while taking this medication, contact your doctor immediately.

Breast-feeding: It is not known if alendronate passes into breast milk. If you are breast-feeding and are taking this medication, it may affect your baby. Talk to your doctor about whether you should continue breast-feeding.

Children and adolescents: The safety and effectiveness of this medication have not been established for children under 18 years of age.

There may be an interaction between alendronate - cholecalciferol and any of the following:

• acetylsalicylic acid (ASA)
• aminoglycoside antibiotics (e.g., amikacin, gentamicin, tobramycin)
• antacids (e.g., aluminum hydroxide, calcium carbonate, magnesium hydroxide) (wait at least 30 minutes after taking this medication to take antacids)
• axitinib
• bevacizumab
• calcium supplements (wait at least 30 minutes after taking this medication to take calcium supplements)
• cholestyramine
• colestipol
• danazol
• deferasirox
• digoxin
• erdafitinib
• iron supplements –(wait at least 30 minutes after taking this medication to take iron supplements)
• lenalidomide
• magnesium supplements –(wait at least 30 minutes after taking this medication to take magnesium supplements)
• mineral oil
• multivitamin/mineral supplements
• nonsteroidal anti-inflammatory drugs (NSAIDs; e.g., ibuprofen and naproxen) orlistat
• other medications given by mouth (wait at least 30 minutes after taking this medication to take any other medication by mouth)
• pazopanib
• pomalidomide
• proton pump inhibitors (e.g., lansoprazole, omeprazole)
• regorafenib
• selenium
• sodium phosphates
• sorafenib
• sunitinib
• sucralfate
• thalidomide
• thiazide diuretics (water pills; e.g., hydrochlorothiazide)
• vandetanib
• other vitamin D analogues (e.g., alfacalcidol, calcitriol)
• zinc supplements

If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:

• stop taking one of the medications,
• change one of the medications to another,
• change how you are taking one or both of the medications, or
• leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.

Medications other than those listed above may interact with this medication. Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.