Fosamax Plus D

Fosamax Plus D is used to treat osteoporosis (thinning of the bone) in women after menopause. This medication may also be used to increase bone mass in men who have osteoporosis.

This medication is only available with your doctor’s prescription.

This medication is available in the following forms:

• Tablet

Before using Fosamax Plus D, you must know all about the risks and complications associated with it.

As with all medicines, the risks must be compared to how much a medication will help you. This is a decision that you and your doctor will make together. For this medication, there are many things that need to be considered:

• Allergies: Inform your doctor if you have ever had an allergic reaction to doxorubicin or to any other medications. It is also important to inform your doctor of any non-medicine allergies such as foods, dyes, preservatives or animals.
• Pediatric: The use of this medication in children is not indicated.
• Geriatric: Up-to-date studies have not shown any problems specific to the elderly that would limit the use of this medication in the elderly population.
• Pregnancy: This medication is listed as Pregnancy Category C. This means that animal studies have shown an adverse effect and no studies have been performed on pregnant women OR there are no adequate studies on pregnant animals and pregnant women.
• Breastfeeding: There are no up-to-date studies in women for determining infant risk when using this medication while breastfeeding. Weigh the potential risks with the benefits before taking this medication while breastfeeding.
• Drug Interactions: Certain medications should not be used together. However, in certain cases, two medications may be used together, even if an interaction might occur. In these cases, your doctor may want to change your dose or take other precautions. When taking this medication, it is important that you inform your doctor if you are taking any prescription or over the counter medications.
• Other Interactions: Certain medications should not be used while eating, or while eating certain foods in case of negative interactions. Using alcohol or tobacco with certain mediations may also cause negative interactions. Talk with your doctor about the use of your medication with food, alcohol or tobacco.

Using this medication with any of the following is not normally recommended, but may be unavoidable. If used together, your doctor may change the dose or how often you take your medication, or give you special instructions about the use of food, alcohol or tobacco:

• Dairy

Other Medical Problems

Pre-existing medical problems may affect the use of this medication. Be sure to tell your doctor if you have any other medical problems, especially:

• Anemia (low iron in the blood)
• Blood clotting problems
• Cancer
• Dental or tooth problems
• Dental procedures (i.e. dental implants, tooth extraction)
• Infection
• Poor oral hygiene
• Surgery (i.e. dental surgery) - May increase risk for severe jaw problems.
• Blood or bone marrow problems (i.e. leukemia, lymphoma, sarcoidosis) - Use with caution. May cause changes in vitamin D.
• Esophageal problems (i.e. achalasia, stricture)
• Hypocalcemia (low calcium in the blood)
• Inability to stand or sit upright for at least 30 minutes
• Kidney disease, severe
• Trouble swallowing - Should not be used in patients with these conditions.
• Stomach or bowel problems (i.e. Barrett's esophagus, duodenitis, gastritis, heartburn, inflammation of the esophagus, or ulcers) - Use with caution. May make these conditions worse.
• Vitamin D deficiency - Should be treated first before using this medicine.

Only use Fosamax Plus D as directed by your doctor. Do not take more, less or for a longer or shorter period of time than your doctor tells you.

This medication comes with a patient information brochure. It is very important that your read this information.

Ask your doctor if you have any questions.

Take this medication with 6-8 ounces of plain water on an empty tomach. It should be taken as soon as you get out of bed in the morning and at least 30 minutes before taking any food, beverage or other medications. Food and beverages will decrease the amount of medication absorbed by the body. Waiting longer than 30 minutes will allow more of the drug to be absorbed. Medications such as antacids, calcium or vitamin supplements will also decrease the absorption of this medication.

Swallow the tablet whole. Do not suck or chew on the tablet because it may cause throat irritation.

Do not lie down for at least 30 minutes after taking alendronate and before having your first food for the day. This will help the medication reach your stomach faster and prevent irritation to the esophagus.

It is important to eat a well-balanced diet with adequate amounts of calcium and vitamin D. However, do not take any foods, beverages or calcium supplements within 30 minutes or longer after taking this medication. To do so may keep the medication from working properly.

Carefully follow the dosing instructions given to you by your doctor. If you don’t, it may affect the way this medication works.

Do not stop using this medication without asking your doctor.

Inform your doctor if you do weight-bearing exercises, smoke or drink excessively. Your doctor will need to take these into consideration when deciding on your dose.

Dosing

Different patients will be given a different dose of this medication based on the strength of the medication. The number of doses you take each day, the time between doses and the length of time you take this medication depends on the reason you are taking this medication. The following information only includes the average dose of this medication. If your dose is different, do not change it without first speaking to your doctor.

For postmenopausal osteoporosis

• Adults - 1 tablet once a week at least 30 minutes before the first food or drink of the day other than water. Each tablet contains 70mg of alendronate and 2800 international units of vitamin D3 or 70mg of alendronate and 5600 international units of vitamin D3

• Children - Use is not recommended.

For osteoporosis in men:

• Adults - 1 tablet once a week at least 30 minutes before the first food or drink of the day other than water. Each tablet contains 70mg of alendronate and 2800 international units of vitamin D3 or 70mg of alendronate and 5600 international units of vitamin D3

• Children - Use is not recommended.

Missed dose

If you miss your dose or forget to take it, take it the next morning after you remember and resume your normal dose the following.

Storage

Store this medication in a closed container at room temperature. Keep it away form heat, moisture and direct light. Do not freeze.

Keep our of the reach of children

Do not keep expired medication or medication you no longer need. Ask your doctor how to dispose of any medication you do not use.

In using Fosamax Plus D, you must be careful and take some precautions as advised by your doctor.

It is very important that your doctor checks in with the you often while you are receiving this medication to make sure that it is working properly.

Do not take other prescription or over-the-counter medications without asking your doctor.

This medication can irritate your esophagus. If you think this medication is beginning to damage your esophagus, stop taking it and call your doctor.

Some symptoms of damage to the esophagus are

• heartburn,
• pain when swallowing,
• pain in the center of your chest,
• trouble swallowing
• feeling that food gets stuck on the way to your stomach.

It is very important that you tell all of your doctors that you are taking this medication.

If you are having a dental procedure while taking this medication, you may have an increased chance of having a severe problem with your jaw.

Inform your doctor about any new medical problems, especially with your teeth or jaws. Inform your doctor if you have severe bone, join or muscle pain while taking this medication.

This medication could lower the amount of calcium in your blood.

Call your doctor immediately if you develop any signs of low calcium levels, such as muscle spasms or twitching or numbness or tingling in your fingers, toes or lips.

This medication may increase your risk of developing fractures of the thigh bone (femur). This may be more common if you use it for an extended period of time. Inform your doctor immediately if you have a dull or aching pain in the thighs, groin or hips.

Fosamax Plus D may produce unwanted side effects. Although not all of these side-effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if you experience any of the following side-effects:

Less common:

• Chest pain, discomfort or burning
• Difficulty swallowing
• Heartburn
• Muscle or bone pain
• Pain when swallowing
• Vomiting

Rare:

• Abdominal or stomach cramps
• Blistering, peeling, or loosening of the skin
• Bloating or swelling of the face, arms, hands, lower legs, or feet
• Chills
• Confusion
• Convulsions
• Cough
• Diarrhea
• Difficulty breathing
• Fever
• Irregular heartbeats (arrhythmias)
• Itching
• Joint pain
• Large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
• Mood or mental changes
• Muscle cramps in the hands, arms, feet, legs, or face
• Numbness and tingling around the mouth, fingertips, or feet
• Red skin lesions, often with a purple center
• Red, irritated eyes
• Shortness of breath
• Sore throat
• Sores, ulcers, or white spots in the mouth or on the lips
• Swelling of the neck
• Tremor
• Unusual tiredness or weakness
• Unusual weight gain or loss
• Vomiting

Some side effects that may occur do not normally need medical attention. These may leave as your body becomes accustomed to treatment. Ask your doctor about ways to prevent or reduce some of these side effects.

Talk to your doctor if any of the following side effects continue or are bothersome, or if you have questions:

Less common:

• Acid or sour stomach
• Belching
• Constipation
• Excess air or gas in the stomach or intestines
• Full feeling
• Headache
• Indigestion
• Passing gas
• Pressure in the stomach
• Stomach discomfort, upset, or pain
• Swelling of the abdominal or stomach area

Rare:

• Blurred vision or other change in vision
• Decreased vision
• Eye pain
• Eye redness
• Eye tenderness
• Flushing or redness of the skin
• Increased tearing
• Rash
• Redness of the eye
• Sensitivity of the eye to light
• Severe eye pain
• Tearing
• Unusually warm skin

Some patients may experience other side effects that are not listed. Check with your doctor if you notice any other side effects.

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