Alendronate Sodium, Cholecalciferol Oral tablet, weekly

What is this medicine?

ALENDRONATE; CHOLECALCIFEROL (a LEN droe nate; KOL e cal SIF er ol) has two medicines to help reduce calcium loss from bones and to increase the production of normal, healthy bone in patients with osteoporosis.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

What should I tell my health care provider before I take this medicine?

They need to know if you have any of these conditions:

• dental disease

• kidney disease

• low level or high level of blood calcium

• problems sitting or standing for 30 minutes

• problems swallowing

• stomach, intestine, or esophagus problems like acid reflux or GERD

• vitamin D toxicity

• an unusual or allergic reaction to alendronate, cholecalciferol, medicines, foods, lactose, dyes, or preservatives

• pregnant or trying to get pregnant

• breast-feeding

How should I use this medicine?

You must take this medicine exactly as directed or you will lower the amount of medicine you absorb into your body or you may cause yourself harm. Take your dose by mouth first thing in the morning, after you are up for the day. Do not eat or drink anything before you take this medicine. Swallow your medicine with a full glass (6 to 8 fluid ounces) of plain water. Do not take this tablet with any with any other drink. Follow the directions on the prescription label. After taking this medicine, do not eat breakfast, drink, or take any medicines or vitamins for at least 30 minutes. Stand or sit up for at least 30 minutes after you take this medicine; do not lie down. Take the medicine on the same day every week. Do not take your medicine more often than directed. Do not stop taking except on your doctor's advice.

Talk to your pediatrician regarding the use of this medicine in children. Special care may be needed.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

If you miss a dose, take the dose on the morning after you remember. Take your next dose on your regular chosen day of the week, but do not take 2 tablets on the same day. Do not take double or extra doses.

What may interact with this medicine?

• antacids

• aspirin and aspirin like drugs

• calcium supplements, especially calcium with vitamin D

• cholestyramine or colestipol

• cimetidine, ranitidine, or other medicines used to decrease stomach acid

• corticosteroids

• iron supplements

• magnesium supplements

• mineral oil

• NSAIDs, medicines for pain and inflammation, like ibuprofen or naproxen

• orlistat

• phenobarbital

• phenytoin

• phosphorous supplements

• primidone

• steroid medicines like prednisone or cortisone

• thiazide diuretics

• vitamins with minerals, especially with vitamin D

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medicine?

Visit your doctor or health care professional for regular checkups. It may be some time before you see the benefit from this medicine. Do not stop taking your medicine unless your doctor tells you to. Your doctor may order blood tests or other tests to see how you are doing.

You should make sure that you get enough calcium and vitamin D while you are taking this medicine. Discuss the foods you eat and the vitamins you take with your health care professional.

If you have pain when swallowing, difficulty swallowing, heartburn, or stomach pain, immediately call your doctor or health care professional.

If you are taking an antacid, a mineral supplement like calcium or iron, or a vitamin with minerals, wait to take them at least 30 minutes after you take this medicine. Do not take them at same time.

This medicine can make you more sensitive to the sun. If you get a rash while taking this medicine, sunlight may cause the rash to get worse. Keep out of the sun. If you cannot avoid being in the sun, wear protective clothing and use sunscreen. Do not use sun lamps or tanning beds/booths.

Some people who take this medicine have severe bone, joint, and/or muscle pain. This medicine may also increase your risk for a broken thigh bone. Tell your doctor right away if you have pain in your upper leg or groin. Tell your doctor if you have any pain that does not go away or that gets worse.

What side effects may I notice from receiving this medicine?

Side effects that you should report to your doctor or health care professional as soon as possible:

• allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue

• bone, muscle, or joint pain

• changes in vision

• heartburn or chest pain

• pain or difficulty swallowing

• redness, blistering, peeling or loosening of the skin, including inside the mouth

• stomach pain

• unusual bleeding or bruising

• unusually weak or tired

• vomiting

Side effects that usually do not require medical attention (report to your doctor or health care professional if they continue or are bothersome):

• diarrhea or constipation

• headache

• nausea

• stomach gas or fullness

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medicine?

Keep out of the reach of children.

Store at room temperature between 20 and 25 degrees C (68 and 77 degrees F). Protect the medicine from moisture and light. Throw away any unused medicine after the expiration date.