Cholecalciferol

What it is used for

• Treat osteoporosis in women after menopause. FOSAMAX PLUS D 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 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.

The most important thing to know

FOSAMAX PLUS D can cause serious side effects including:

• Esophagus problems
• Low calcium levels in your blood (hypocalcemia)
• Bone, joint, or muscle pain
• Severe jaw bone problems (osteonecrosis)
• Unusual breaks in thigh and other bones

• 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.
• 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: 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.
  • Spasms, twitches, or cramps in your muscles
  • Numbness or tingling in your fingers, toes, or around your mouth
• Bone, joint, or muscle pain. Some people who take FOSAMAX PLUS D develop severe bone, joint, or muscle pain.
• 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.
• Unusual breaks in thigh and other bones. Some people have had unusual bone breaks, including thigh bone when taking FOSAMAX PLUS D. A break in the thigh bone can feel like a new pain in your hip, groin, or thigh. People taking FOSAMAX PLUS D can also have breaks in other bones.

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

How to take it

• Take FOSAMAX PLUS D exactly as your doctor tells you.
• FOSAMAX PLUS D works only if taken on an empty stomach.
• Take 1 dose of FOSAMAX PLUS D 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 while you are sitting or standing.
• Take your FOSAMAX PLUS D tablet 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 FOSAMAX PLUS D with mineral water, coffee, tea, soda, or juice.
• Do not take FOSAMAX PLUS D at bedtime.

After swallowing FOSAMAX PLUS D, 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 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.

Side effects, and when to stop

FOSAMAX PLUS D may cause serious side effects.

The most common side effects of FOSAMAX PLUS D 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 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.

Who should not take it

Do not take FOSAMAX PLUS D 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 or any of its ingredients. A list of ingredients is at the end of this leaflet.

What to say before you start

Before you start FOSAMAX PLUS D, 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, trying to become pregnant or suspect that you are pregnant. If you become pregnant while taking FOSAMAX PLUS D, stop taking it and contact your doctor. 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 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.

Storing it

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

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.