FOSAMAX PLUS D- alendronate sodium and cholecalciferol tablet 
Merck Sharp & Dohme Corp.

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MEDICATION GUIDE
FOSAMAX® PLUS D (FOSS-ah-max PLUS D)
(alendronate sodium/cholecalciferol)
Tablets

Read the Medication Guide that comes with FOSAMAX® PLUS D before you start taking it and each time you get a refill. There may be new information. This Medication Guide does not take the place of talking with your doctor about your medical condition or treatment. Talk to your doctor if you have any questions about FOSAMAX PLUS D.

What is the most important information I should know about FOSAMAX PLUS D?

FOSAMAX PLUS D can cause serious side effects including:

  1. Esophagus problems
  2. Low calcium levels in your blood (hypocalcemia)
  3. Bone, joint, or muscle pain
  4. Severe jaw bone problems (osteonecrosis)
  5. Unusual thigh bone fractures
  1. Esophagus problems.
    Some people who take FOSAMAX PLUS D may develop problems in the esophagus (the tube that connects the mouth and the stomach). These problems include irritation, inflammation, or ulcers of the esophagus which may sometimes bleed.
    • It is important that you take FOSAMAX PLUS D exactly as prescribed to help lower your chance of getting esophagus problems. (See the section "How should I take FOSAMAX PLUS D tablet?")
    • Stop taking FOSAMAX PLUS D and call your doctor right away if you get chest pain, new or worsening heartburn, or have trouble or pain when you swallow.

  2. Low calcium levels in your blood (hypocalcemia).
    FOSAMAX PLUS D may lower the calcium levels in your blood. If you have low blood calcium before you start taking FOSAMAX PLUS D, it may get worse during treatment. Your low blood calcium must be treated before you take FOSAMAX PLUS D. Most people with low blood calcium levels do not have symptoms, but some people may have symptoms. Call your doctor right away if you have symptoms of low blood calcium such as:
    • Spasms, twitches, or cramps in your muscles
    • Numbness or tingling in your fingers, toes, or around your mouth

    Your doctor may prescribe calcium and vitamin D to help prevent low calcium levels in your blood, while you take FOSAMAX PLUS D. Take calcium and vitamin D as your doctor tells you to.

  3. Bone, joint, or muscle pain.
    Some people who take FOSAMAX PLUS D develop severe bone, joint, or muscle pain.

  4. Severe jaw bone problems (osteonecrosis).
    Severe jaw bone problems may happen when you take FOSAMAX PLUS D. Your doctor should examine your mouth before you start FOSAMAX PLUS D. Your doctor may tell you to see your dentist before you start FOSAMAX PLUS D. It is important for you to practice good mouth care during treatment with FOSAMAX PLUS D.

  5. Unusual thigh bone fractures.
    Some people have developed unusual fractures in their thigh bone. Symptoms of a fracture may include new or unusual pain in your hip, groin, or thigh.

Call your doctor right away if you have any of these side effects.

What is FOSAMAX PLUS D?

FOSAMAX PLUS D is a prescription medicine used to:

FOSAMAX PLUS D should not be used to treat vitamin D deficiency.

It is not known how long FOSAMAX PLUS D works for the treatment of osteoporosis. You should see your doctor regularly to determine if FOSAMAX PLUS D is still right for you.

FOSAMAX PLUS D is not for use in children.

Who should not take FOSAMAX PLUS D?

Do not take FOSAMAX PLUS D if you:

What should I tell my doctor before taking FOSAMAX PLUS D?

Before you start FOSAMAX PLUS D, be sure to talk to your doctor if you:

Especially tell your doctor if you take:

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Certain medicines may affect how FOSAMAX PLUS D works.

Know the medicines you take. Keep a list of them and show it to your doctor and pharmacist each time you get a new medicine.

How should I take FOSAMAX PLUS D tablet?

After swallowing FOSAMAX PLUS D, wait at least 30 minutes:

Do not lie down for at least 30 minutes after you take FOSAMAX PLUS D and after you eat your first food of the day.

If you miss a dose of FOSAMAX PLUS D, do not take it later in the day. Take your missed dose on the next morning after you remember and then return to your normal schedule. Do not take 2 doses on the same day.

If you take too much FOSAMAX PLUS D, call your doctor. Do not try to vomit. Do not lie down.

What are the possible side effects of FOSAMAX PLUS D?

FOSAMAX PLUS D may cause serious side effects.

The most common side effects of FOSAMAX PLUS D are:

You may get allergic reactions, such as hives or swelling of your face, lips, tongue, or throat.

Worsening of asthma has been reported.

Tell your doctor if you have any side effect that bothers you or that does not go away.

These are not all the possible side effects of FOSAMAX PLUS D. For more information, ask your doctor or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

How do I store FOSAMAX PLUS D?

Keep FOSAMAX PLUS D and all medicines out of the reach of children.

General information about the safe and effective use of FOSAMAX PLUS D.

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use FOSAMAX PLUS D for a condition for which it was not prescribed. Do not give FOSAMAX PLUS D to other people, even if they have the same symptoms you have. It may harm them.

This Medication Guide summarizes the most important information about FOSAMAX PLUS D. If you would like more information, talk with your doctor. You can ask your doctor or pharmacist for information about FOSAMAX PLUS D that is written for health professionals. For more information, go to: www.fosamaxplusd.com or call 1-800-622-4477 (toll-free).

What are the ingredients in FOSAMAX PLUS D?

Active ingredients: alendronate sodium and cholecalciferol (vitamin D3).

Inactive ingredients: cellulose, lactose, medium chain triglycerides, gelatin, croscarmellose sodium, sucrose, colloidal silicon dioxide, magnesium stearate, butylated hydroxytoluene, modified food starch, and sodium aluminum silicate.

Revised: 8/2019
Merck Sharp & Dohme Corp.