FOSAMAX Once Weekly 70 mg ( Alendronate ) 2 tablets

WHAT IS ALENDRONATE (BINOSTO, FOSAMAX)?
Alendronate is used to treat osteoporosis caused by menopause, steroid use, or gonadal failure. This medicine is for use when you have a high risk of bone fracture due to osteoporosis.

Alendronate is also used to treat Paget's disease of bone.

Alendronate may also be used for purposes not listed in this medication guide.

WHAT ARE THE POSSIBLE SIDE EFFECTS OF ALENDRONATE (BINOSTO, FOSAMAX)?
Get emergency medical help if you have signs of an allergic reaction: hives; wheezing, difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using alendronate and call your doctor at once if you have:

chest pain, new or worsening heartburn;
difficulty or pain when swallowing;
pain or burning under the ribs or in the back;
severe heartburn, burning pain in your upper stomach, or coughing up blood;
new or unusual pain in your thigh or hip;
jaw pain, numbness, or swelling;
severe joint, bone, or muscle pain; or
low calcium levels--muscle spasms or contractions, numbness or tingly feeling (around your mouth, or in your fingers and toes).
Common side effects may include:

heartburn, upset stomach;
stomach pain, nausea;
diarrhea, constipation; or
bone pain, muscle or joint pain.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

WHAT IS THE MOST IMPORTANT INFORMATION I SHOULD KNOW ABOUT ALENDRONATE (BINOSTO, FOSAMAX)?
You should not take alendronate if you have problems with your esophagus, or low levels of calcium in your blood.

Do not take alendronate if you cannot sit upright or stand for at least 30 minutes after taking the medicine.

Alendronate can cause serious problems in the stomach or esophagus. Stop using alendronate and call your doctor at once if you have chest pain, new or worsening heartburn, or pain when swallowing.

Also call your doctor if you have muscle spasms, numbness or tingling (in hands and feet or around the mouth), new or unusual hip pain, or severe pain in your joints, bones, or muscles.

WHAT SHOULD I DISCUSS WITH MY HEALTHCARE PROVIDER BEFORE TAKING ALENDRONATE (BINOSTO, FOSAMAX)?
You should not take alendronate if you are allergic to it, or if you have:

low levels of calcium in your blood (hypocalcemia); or
problems with the muscles in your esophagus (the tube that connects your mouth and stomach).
Do not take alendronate if you cannot sit upright or stand for at least 30 minutes. Alendronate can cause serious problems in the stomach or esophagus. You must stay upright for at least 30 minutes after taking this medicine.

Tell your doctor if you have ever had:

trouble swallowing;
problems with your stomach or digestion;
hypocalcemia;
a dental problem (you may need a dental exam before you begin taking alendronate);
kidney disease; or
any condition that makes it hard for your body to absorb nutrients from food (malabsorption).
The effervescent tablet contains a lot of sodium. Tell your doctor if you are on a low-salt diet before using this form of alendronate.

This medicine may cause jaw bone problems (osteonecrosis). The risk is highest in people with cancer, blood cell disorders, pre-existing dental problems, or people treated with steroids, chemotherapy, or radiation. Ask your doctor about your own risk.

It is not known whether this medicine will harm an unborn baby. Tell your doctor if you are pregnant or trying to become pregnant. Stop using the medicine and tell your doctor right away if you become pregnant.

It may not be safe to breastfeed while using this medicine. Ask your doctor about any risk.

HOW SHOULD I TAKE ALENDRONATE (BINOSTO, FOSAMAX)?
Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

Alendronate is taken either once daily or once per week. Follow your doctor's dosing instructions very carefully.

Take alendronate first thing in the morning, at least 30 minutes before you eat or drink anything or take any other medicine. If you take alendronate only once per week, take it on the same day each week and always first thing in the morning.

Take with a full glass (6 to 8 ounces) of plain water. Do not use coffee, tea, soda, juice, or mineral water. Do not eat or drink anything other than plain water.

Measure liquid medicine carefully. Use the dosing syringe provided, or use a medicine dose-measuring device (not a kitchen spoon).

Do not crush, chew, or suck on an alendronate regular tablet. Swallow it whole.

Dissolve the effervescent tablet in at least 4 ounces of water (at room temperature, not hot or cold). Let the tablet dissolve for 5 minutes. Stir this mixture for 10 seconds and drink all of it right away. Add a little more water to the glass, swirl gently and drink right away.

For at least 30 minutes after taking alendronate:

Do not lie down or recline.
Do not take any other medicine including vitamins, calcium, or antacids.
Pay special attention to your dental hygiene while taking alendronate. Brush and floss your teeth regularly. If you need to have any dental work (especially surgery), tell the dentist ahead of time that you are using alendronate.

Alendronate is only part of a complete program of treatment that may also include diet changes, exercise, bone mineral density testing, and taking calcium and vitamin supplements. Follow your doctor's instructions very closely.

Store at room temperature away from moisture and heat. Keep unused effervescent tablets in the foil blister pack.

Your doctor will determine how long to treat you with this medicine. Alendronate is often given for only 3 to 5 years.

WHAT HAPPENS IF I MISS A DOSE (BINOSTO, FOSAMAX)?
Once-daily dosing: If you forget to take alendronate first thing in the morning, do not take it later in the day. Wait until the following morning and skip the missed dose. Do not take two (2) doses in one day.

Once-per-week dosing: If you forget to take alendronate on your scheduled day, take it first thing in the morning on the day after you remember the missed dose. Then return to your regular weekly schedule on your chosen dose day. Do not take 2 doses in one day.

WHAT HAPPENS IF I OVERDOSE (BINOSTO, FOSAMAX)?
Drink a full glass of milk and seek emergency medical attention or call the Poison Help line at 1-800-222-1222. Do not make yourself vomit and do not lie down.

WHAT SHOULD I AVOID WHILE TAKING ALENDRONATE (BINOSTO, FOSAMAX)?
Avoid taking any other medicines for at least 30 minutes after taking alendronate. This includes vitamins, calcium, and antacids. Some medicines can make it harder for your body to absorb alendronate.

Avoid smoking, or try to quit. Smoking can reduce your bone mineral density, making fractures more likely.

Avoid drinking large amounts of alcohol. Heavy drinking can also cause bone loss.

WHAT OTHER DRUGS WILL AFFECT ALENDRONATE (BINOSTO, FOSAMAX)?
Tell your doctor about all your other medicines, especially:

aspirin; or
NSAIDs (nonsteroidal anti-inflammatory drugs)--ibuprofen (Advil, Motrin), naproxen (Aleve), celecoxib, diclofenac, indomethacin, meloxicam, and others.
This list is not complete. Other drugs may affect alendronate, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.

WHERE CAN I GET MORE INFORMATION (BINOSTO, FOSAMAX)?
Your pharmacist can provide more information about alendronate.

REMEMBER, KEEP THIS AND ALL OTHER MEDICINES OUT OF THE REACH OF CHILDREN, NEVER SHARE YOUR MEDICINES WITH OTHERS, AND USE THIS MEDICATION ONLY FOR THE INDICATION PRESCRIBED.

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