BINOSTO^® (alendronate sodium) Effervescent Tablets for oral solution

BINOSTO is a prescription medicine used to:

• Treat thinning of your bones (osteoporosis) in women after menopause. BINOSTO helps reduce the chance of having a hip or spinal fracture (break).
• Increase bone mass in men who have osteoporosis.

It is not known how long BINOSTO works for the treatment of osteoporosis. You should see your doctor regularly to determine if BINOSTO is still right for you.

BINOSTO is not for use in children.

Do not take BINOSTO 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 trouble swallowing liquids
• Have low levels of calcium in your blood
• Are allergic to BINOSTO or any of its ingredients.

BINOSTO Effervescent Tablet 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 BINOSTO 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 BINOSTO exactly as prescribed to help lower your chance of getting esophagus problems. (See the section “How should I take BINOSTO?” in the Medication Guide)
   • Stop taking BINOSTO 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).

   BINOSTO may lower the calcium levels in your blood. If you have low blood calcium, it must be treated before you take BINOSTO. 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
3. Bone, joint, or muscle pain.
   Some people who take BINOSTO develop severe bone, joint, or muscle pain.
4. Severe jaw bone problems (osteonecrosis).
   Severe jaw bone problems may happen when you take BINOSTO. Your doctor should examine your mouth or tell you to see your dentist before you start BINOSTO. It is important for you to practice good mouth care during treatment with BINOSTO.
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.

Tell your doctor about all medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements.

Especially tell your doctor if you take:

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

The most common side effects of BINOSTO 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, swelling of your face, lips, tongue, or throat.

Tell your doctor about any side effect that bothers you or that does not go away.

These are not all the side effects with BINOSTO. Ask your doctor or pharmacist for more information.

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

For more information, go to BINOSTO.com, or call 1-855-778-0177.