These are the important things you must do to help make sure you will benefit from FOSAMAX:

1.After getting up for the day, swallow your FOSAMAX tablet with a full glass (6-8 oz.) of plain water only.

Not mineral water
Not coffee or tea
Not juice

2. After swallowing your FOSAMAX tablet do not lie down — stay fully upright (sitting or standing) for at least 30 minutes and until after your first food of the day. Do not chew or suck on a tablet of FOSAMAX. This will help the FOSAMAX tablet reach your stomach quickly and help avoid irritation of your esophagus (the tube that connects your mouth with your stomach).

3. After swallowing your FOSAMAX tablet, wait at least 30 minutes before taking your first food, beverage, or other medication of the day, including antacids, calcium supplements and vitamins. FOSAMAX is effective only if taken when your stomach is empty.

4. Do not take FOSAMAX at bedtime or before getting up for the day.

5. If you have difficulty or pain upon swallowing, chest pain, or new or worsening heartburn, stop taking FOSAMAX and call your doctor.

6. Take FOSAMAX once a day, every day.

7. It is important that you continue taking FOSAMAX for as long as your doctor prescribes it. FOSAMAX can treat your osteoporosis or help you from getting osteoporosis only if you continue to take it.

8. If you miss a dose do not take it later in the day. Continue your usual schedule of 1 tablet once a day the next morning.

FOSAMAX is for the treatment or prevention of osteoporosis (thinning of bone) in women after menopause. It reduces the chance of having a hip, wrist or spinal fracture.

You will find more information about osteoporosis throughout this publication.

FOSAMAX works by:

• Reducing the activity of the cells that cause bone loss
• Decreasing the faster rate of bone loss that occurs after menopause
• Increasing the amount of bone in most patients

These effects are seen as soon as three months after therapy with FOSAMAX has begun. These effects continue as long as you keep taking FOSAMAX. The density of bone is maintained or increased and the bone is less likely to fracture. Thus, FOSAMAX prevents or reverses the progression of osteoporosis.

Patients with:

• Certain disorders of the esophagus (the tube that connects your mouth with your stomach)
• Inability to stand or sit upright for at least 30 minutes
• Low levels of calcium in their blood
• Severe kidney disease
• Allergy to FOSAMAX

Patients who are:

• Pregnant or Nursing

FOSAMAX is for use by women after menopause. If you are pregnant or nursing, you should not be taking FOSAMAX. Talk to your doctor.

Talk to your doctor about any:

• Problems with swallowing
• Stomach or digestive problems
• Other medical problems you have or have had in the past

Some patients may develop severe digestive reactions including irritation, inflammation or ulceration (occasionally with bleeding) of the esophagus (the tube that connects your mouth with your stomach). These reactions can cause chest pain, heartburn or difficulty or pain upon swallowing. This may occur especially if patients do not drink a full glass of water with FOSAMAX and/or if they lie down in less than 30 minutes and before their first food of the day. Esophageal reactions may worsen if patients continue to take FOSAMAX after developing symptoms suggesting irritation of the esophagus.

Like all prescription drugs, FOSAMAX may cause side effects. Side effects usually have been mild. The generally have not caused patients to stop taking FOSAMAX. Some patients treated with FOSAMAX experienced abdominal (stomach) pain. This is the most commonly reported side effect. Less frequently reported side effects are:

Nausea, heartburn, irritation or pain of the esophagus (the tube that connects your mouth with your stomach), vomiting, difficulty swallowing, a full or bloated feeling in the stomach, constipation, diarrhea and gas.

Rarely stomach or other peptic ulcers (some severe) have occurred.

Bone, muscle or joint pain, headache, or an altered sense of taste were also experienced by some patients. Rarely, a rash has occurred. Allergic reactions such as hives or rarely swelling of the face, lips, tongue and/or throat which may cause difficulty in breathing or swallowing have also been reported. Mouth ulcers have occurred when the tablet was chewed or dissolved in the mouth.

Anytime you have a medical problem you think may be related to FOSAMAX, talk to your doctor.

Normally your bones are being rebuilt all the time. First, old bone is removed (resorbed). Then a similar amount of new bone is formed. This balanced process keeps your skeleton healthy and strong.

Osteoporosis is a thinning and weakening of the bones. It is common in women after menopause. Menopause happens when the ovaries stop producing the female hormone, estrogen, or are removed (which may occur, for example, at the time of a hysterectomy). After menopause, bone is removed faster than it is formed, so bone loss occurs and bones become weaker. Therefore, maintaining bone mass is important to keep your bones healthy.

At the start osteoporosis usually has no symptoms, but it can result in fractures (broken bones). Fractures usually cause pain. Fractures of the bones of the spine may not be painful, but over time they cause height loss. Eventually the spine becomes curved and the body becomes bent over. Fractures may happen during normal, everyday activity, such as lifting, or from minor injury that would normally not cause bone to break. Fractures most often occur at the hip, spine, or wrist. This can lead to pain, severe disability, or loss of mobility.

• Medication.

  Your doctor has prescribed FOSAMAX. FOSAMAX acts specifically on your bones. FOSAMAX is not a hormone and does not have the benefits and risks of estrogen (hormone replacement therapy) elsewhere in your body. Either FOSAMAX or estrogen may be used to treat or prevent osteoporosis. You may want to talk to your doctor about these options.

• Lifestyle changes.

  In addition to FOSAMAX, your doctor may recommend one or more of the following lifestyle changes:

  • Stop smoking. Smoking appears to increase the risk of osteoporosis.

  • Reduce the use of alcohol. Too much alcohol appears to increase the risk of osteoporosis and injuries that may cause fractures.

  • Exercise regularly. Like muscles, bones need exercise to stay strong and healthy. Exercise must be safe to prevent injuries including fractures. You should consult your doctor before you begin any exercise program.

  • Eat a balanced diet. Adequate dietary calcium is important. Your doctor can advise you whether you need to change your diet or take any dietary supplements such as calcium or vitamin D.

This medication was prescribed for your particular condition. Do not use it for another condition or give the drug to others. Keep FOSAMAX and all medicines out of the reach of children. If you suspect that more than the prescribed dose of this medicine has been taken, drink a full glass of milk and contact your local poison control center or emergency room immediately. Do not induce vomiting. Do not lie down.