Uses of Fosamax Plus D:

• It is used to treat soft, brittle bones (osteoporosis).

What do I need to tell my doctor BEFORE I take Fosamax Plus D?

• If you have an allergy to alendronate, vitamin D, cholecalciferol, or any other part of Fosamax Plus D (alendronate and cholecalciferol).
• If you are allergic to Fosamax Plus D (alendronate and cholecalciferol); any part of Fosamax Plus D (alendronate and cholecalciferol); or any other drugs, foods, or substances. Tell your doctor about the allergy and what signs you had.
• If you have any of these health problems: A swallowing tube (esophagus) that is not normal, high calcium levels, low calcium levels, very bad kidney disease, or trouble swallowing.
• If you are not able to stand or sit up for 30 minutes.

This is not a list of all drugs or health problems that interact with Fosamax Plus D (alendronate and cholecalciferol).

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take Fosamax Plus D (alendronate and cholecalciferol) with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

What are some things I need to know or do while I take Fosamax Plus D?

• Tell all of your health care providers that you take Fosamax Plus D (alendronate and cholecalciferol). This includes your doctors, nurses, pharmacists, and dentists.
• Very bad swallowing tube (esophagus) problems like irritation, swelling, ulcers, and bleeding have happened with Fosamax Plus D (alendronate and cholecalciferol). Talk with the doctor.
• Worsening of asthma has happened in people taking drugs like this one. Talk with the doctor.
• This medicine may raise the chance of a broken leg. Talk with the doctor.
• Have a bone density test as you have been told by your doctor. Talk with your doctor.
• Have blood work checked as you have been told by the doctor. Talk with the doctor.
• This medicine works best when used with calcium/vitamin D and weight-bearing workouts like walking or PT (physical therapy).
• Follow the diet and workout plan that your doctor told you about.
• If you are taking other sources of vitamin D, talk with your doctor.
• Have a dental exam before starting Fosamax Plus D (alendronate and cholecalciferol).
• Take good care of your teeth. See a dentist often.
• Talk with your doctor before you drink alcohol.
• If you smoke, talk with your doctor.
• If you are pregnant or you get pregnant while taking Fosamax Plus D (alendronate and cholecalciferol), call your doctor right away.
• Tell your doctor if you are breast-feeding. You will need to talk about any risks to your baby.

How is this medicine (Fosamax Plus D) best taken?

Use Fosamax Plus D (alendronate and cholecalciferol) as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• Take on an empty stomach before breakfast.
• Take at least 30 minutes before the first food, drink, or drugs of the day.
• Do not lie down for at least 30 minutes after taking Fosamax Plus D (alendronate and cholecalciferol).
• Take with a full glass of water.
• Take with plain water only. Avoid taking with mineral water, milk, or other drinks.
• Swallow whole. Do not chew, break, or crush.
• Keep taking Fosamax Plus D (alendronate and cholecalciferol) as you have been told by your doctor or other health care provider, even if you feel well.

What do I do if I miss a dose?

• Take the missed dose on the next morning after you think about it and then go back to your normal time.
• Do not take 2 doses on the same day.

What are some side effects that I need to call my doctor about right away?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Signs of low calcium levels like muscle cramps or spasms, numbness and tingling, or seizures.
• Black, tarry, or bloody stools.
• Chest pain.
• Coughing up blood.
• Heartburn.
• Trouble swallowing.
• Very bad pain when swallowing.
• Sore throat.
• Throwing up blood or throw up that looks like coffee grounds.
• Very bad bone, joint, or muscle pain.
• Any new or strange groin, hip, or thigh pain.
• Mouth sores.
• This medicine may cause jawbone problems. The risk may be higher with longer use, cancer, dental problems, ill-fitting dentures, anemia, blood clotting problems, or infection. It may also be higher if you have dental work, chemo, radiation, or take other drugs that may cause jawbone problems. Many drugs can do this. Talk with your doctor if any of these apply to you, or if you have questions. Call your doctor right away if you have jaw swelling or pain.

What are some other side effects of Fosamax Plus D?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Stomach pain.
• Upset stomach or throwing up.
• Diarrhea or constipation.
• Muscle or joint pain.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-332-1088. You may also report side effects at https://www.fda.gov/medwatch.

If OVERDOSE is suspected:

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

How do I store and/or throw out Fosamax Plus D?

• Store in the original container at room temperature.
• Protect from light.
• Store in a dry place. Do not store in a bathroom.
• Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
• Throw away unused or expired drugs. Do not flush down a toilet or pour down a drain unless you are told to do so. Check with your pharmacist if you have questions about the best way to throw out drugs. There may be drug take-back programs in your area.

Consumer Information Use and Disclaimer

• If your symptoms or health problems do not get better or if they become worse, call your doctor.
• Do not share your drugs with others and do not take anyone else's drugs.
• This medicine comes with an extra patient fact sheet called a Medication Guide. Read it with care. Read it again each time Fosamax Plus D (alendronate and cholecalciferol) is refilled. If you have any questions about Fosamax Plus D (alendronate and cholecalciferol), please talk with the doctor, pharmacist, or other health care provider.
• If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.