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Fosamax Plus D Medication Guide Information

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?

This medication 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. 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.
2. Low calcium levels in your blood (hypocalcemia).  This medication 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.
   
3. Bone, joint, or muscle pain.  Some people who take this medication 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 this medication. It is important for you to practice good mouth care during treatment with this medication.
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 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 this medication. Take calcium and vitamin D as your doctor tells you to.

Call your doctor right away if you have any of the above mentioned side effects.

What is FOSAMAX PLUS D?

FOSAMAX PLUS D is a prescription medicine used to:

• Treat osteoporosis in women after menopause. This medication helps increase bone mass and reduces the chance of having a hip or spinal fracture (break).
• Increase bone mass in men with osteoporosis.

This medication should not be used to treat vitamin D deficiency.  It is not known how long this medication works for the treatment of osteoporosis. You should see your doctor regularly to determine if this medication is still right for you.  This medication is not for use in children.

Who should not take this medication?

Do not take this medication 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 this medication 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?

Before you start this medication, 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 this medication 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 this medication 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?

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

After swallowing this medication, 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 this medication and after you eat your first food of the day.

If you miss a dose of this medication, 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 this medication, call your doctor. Do not try to vomit. Do not lie down.

What are the possible side effects of FOSAMAX PLUS D?

The most common side effects of this medication 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 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 this medication. 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 this medication?

• Store this medication at room temperature, 68°F to 77°F (20°C to 25°C).
• Keep this medication away from light.
• Keep this medication package and tablets dry.
• Store this medication in the original package.

Keep this medication and all medicines out of the reach of children.

General information about the safe and effective use of this medication.

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use this medication for a condition for which it was not prescribed. Do not give this medication 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 this medication.   If you would like more information, talk with your doctor. You can ask your doctor or pharmacist for information about this medication that is written for health professionals. For more information, call 1-800-622-4477 (toll-free).

What are the ingredients in this medication?

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.

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