home > drugs a-z list > fosamax plus d (alendronate sodium & cholecalciferol) drug center > fosamax plus d (alendronate sodium & cholecalciferol) drug - medication guide and patient information

MEDICATION GUIDE

FOSAMAX PLUS D® (alendronate sodium & cholecalciferol)
(FOSS-ah-max PLUS D)
(alendronatesodium/cholecalciferol) Tablets

Read the Medication Guide that comes with FOSAMAX PLUS D® (alendronate sodium & cholecalciferol) 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 (alendronate sodium & cholecalciferol) .

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

FOSAMAX PLUS D (alendronate sodium & cholecalciferol) 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 (alendronate sodium & cholecalciferol) 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 (alendronate sodium & cholecalciferol) exactly as prescribed to help lower your chance of getting esophagus problems. (See the section "How should I take FOSAMAX PLUS D (alendronate sodium & cholecalciferol) ?")
• Stop taking FOSAMAX PLUS D (alendronate sodium & cholecalciferol) 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 (alendronate sodium & cholecalciferol) may lower the calcium levels in your blood. If you have low blood calcium before you start taking FOSAMAX PLUS D (alendronate sodium & cholecalciferol) , it may get worse during treatment. Your low blood calcium must be treated before you take FOSAMAX PLUS D (alendronate sodium & cholecalciferol) . 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 (alendronate sodium & cholecalciferol) . Take calcium and vitamin D as your doctor tells you to.

3. Bone, joint, or muscle pain.

Some people who take FOSAMAX PLUS D (alendronate sodium & cholecalciferol) 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 (alendronate sodium & cholecalciferol) . Your doctor should examine your mouth before you start FOSAMAX PLUS D (alendronate sodium & cholecalciferol) . Your doctor may tell you to see your dentist before you start FOSAMAX PLUS D (alendronate sodium & cholecalciferol) . It is important for you to practice good mouth care during treatment with FOSAMAX PLUS D (alendronate sodium & cholecalciferol) .

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 (alendronate sodium & cholecalciferol) ?

FOSAMAX PLUS D (alendronate sodium & cholecalciferol) is a prescription medicine used to:

• Treat osteoporosis in women after menopause. FOSAMAX PLUS D (alendronate sodium & cholecalciferol) helps increase bone mass and reduces the chance of having a hip or spinal fracture (break).
• Increase bone mass in men with osteoporosis.

FOSAMAX PLUS D (alendronate sodium & cholecalciferol) should not be used to treat vitamin D deficiency.

It is not known how long FOSAMAX PLUS D (alendronate sodium & cholecalciferol) works for the treatment and prevention of osteoporosis. You should see your doctor regularly to determine if FOSAMAX PLUS D (alendronate sodium & cholecalciferol) is still right for you.

FOSAMAX PLUS D (alendronate sodium & cholecalciferol) is not for use in children.

Who should not take FOSAMAX PLUS D (alendronate sodium & cholecalciferol) ?

Do not take FOSAMAX PLUS D (alendronate sodium & cholecalciferol) if you:

• Have certain problems with your esophagus, the tube that connects your mouth with your stomach
• Cannot stand or sit upright for at least 30 minutes
• Have low levels of calcium in your blood
• Are allergic to FOSAMAX PLUS D (alendronate sodium & cholecalciferol) or any of its ingredients. A list of ingredients is at the end of this leaflet.

What should I tell my doctor before taking FOSAMAX PLUS D (alendronate sodium & cholecalciferol) ?

Before you start FOSAMAX PLUS D (alendronate sodium & cholecalciferol) , be sure to talk to your doctor if you:

• Have problems with swallowing
• Have stomach or digestive problems
• Have low blood calcium
• Plan to have dental surgery or teeth removed
• Have kidney problems
• Have sarcoidosis, leukemia, lymphoma. These conditions may cause changes in vitamin D.
• Have been told you have trouble absorbing minerals in your stomach or intestines (malabsorption syndrome)
• Are pregnant or plan to become pregnant. It is not known if FOSAMAX PLUS D can harm your unborn baby.
• Are breast-feeding or plan to breast-feed. It is not known if FOSAMAX PLUS D passes into your milk and may harm your baby.

Especially tell your doctor if you take:

• antacids
• aspirin
• Nonsteroidal Anti-Inflammatory (NSAID) medicines

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 (alendronate sodium & cholecalciferol) 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 (alendronate sodium & cholecalciferol) tablet?

• Take FOSAMAX PLUS D (alendronate sodium & cholecalciferol) exactly as your doctor tells you.
• FOSAMAX PLUS D (alendronate sodium & cholecalciferol) works only if taken on an empty stomach.
• Take 1 dose of FOSAMAX PLUS D (alendronate sodium & cholecalciferol) 1 time a week, after you get up for the day and before taking your first food, drink, or other medicine.
• Take FOSAMAX PLUS D (alendronate sodium & cholecalciferol) while you are sitting or standing.
• Take your FOSAMAX PLUS D (alendronate sodium & cholecalciferol) tablet with a full glass (6-8 oz) of plain water.
• Do not chew or suck on a tablet of FOSAMAX PLUS D (alendronate sodium & cholecalciferol) .
• Do not take FOSAMAX PLUS D (alendronate sodium & cholecalciferol) with mineral water, coffee, tea, soda, or juice.
• Do not take FOSAMAX PLUS D (alendronate sodium & cholecalciferol) at bedtime.

After swallowing FOSAMAX PLUS D (alendronate sodium & cholecalciferol) , wait at least 30 minutes:

• Before you lie down. You may sit, stand or walk, and do normal activities like reading.
• Before you take your first food or drink except for plain water.
• Before you take other medicines, including antacids, calcium, and other supplements and vitamins.

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

If you miss a dose of FOSAMAX PLUS D (alendronate sodium & cholecalciferol) , 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 (alendronate sodium & cholecalciferol) , call your doctor. Do not try to vomit. Do not lie down.

What are the possible side effects of FOSAMAX PLUS D (alendronate sodium & cholecalciferol) ?

FOSAMAX PLUS D (alendronate sodium & cholecalciferol) may cause serious side effects.

• See "What is the most important information I should know about FOSAMAX PLUS D (alendronate sodium & cholecalciferol) ?"

The most common side effects of FOSAMAX PLUS D (alendronate sodium & cholecalciferol) are:

• Stomach area (abdominal) pain
• Heartburn
• Constipation
• Diarrhea
• Upset stomach
• Pain in your bones, joints, or muscles
• Nausea

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

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 (alendronate sodium & cholecalciferol) . 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 (alendronate sodium & cholecalciferol) ?

• Store FOSAMAX PLUS D (alendronate sodium & cholecalciferol) at room temperature, 68°F to 77°F (20°C to 25°C).
• Keep FOSAMAX PLUS D (alendronate sodium & cholecalciferol) away from light.
• Keep FOSAMAX PLUS D (alendronate sodium & cholecalciferol) package and tablets dry.
• Store FOSAMAX PLUS D (alendronate sodium & cholecalciferol) in the original package.

Keep FOSAMAX PLUS D (alendronate sodium & cholecalciferol) and all medicines out of the reach of children.

General information about the safe and effective use of FOSAMAX PLUS D (alendronate sodium & cholecalciferol) .

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use FOSAMAX PLUS D (alendronate sodium & cholecalciferol) for a condition for which it was not prescribed. Do not give FOSAMAX PLUS D (alendronate sodium & cholecalciferol) 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 (alendronate sodium & cholecalciferol) . If you would like more information, talk with your doctor. You can ask your doctor or pharmacist for information about FOSAMAX PLUS D (alendronate sodium & cholecalciferol) that is written for health professionals.

For more information, go to: www.fosamaxplusd.com or call 1-877-408-4699.

What are the ingredients in FOSAMAX PLUS D (alendronate sodium & cholecalciferol) ?

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.

This Medication Guide has been approved by the U.S. Food and Drug Administration.

Last reviewed on RxList: 3/11/2011
This monograph has been modified to include the generic and brand name in many instances.