Alendronate Generic (Fosamax) US$ 1.75 ea

What is the most important information I should know about alendronate?

You should not take alendronate if you have low levels of calcium in your blood (hypocalcemia), or a problem with the movement of muscles in your esophagus.

Do not take an alendronate tablet if you cannot sit upright or stand for at least 30 minutes. Alendronate can cause serious problems in the stomach or esophagus (the tube that connects your mouth and stomach). You will need to stay upright for at least 30 minutes after taking this medication.

What is alendronate?

Alendronate is in the group of medicines called bisphosphonates (bis FOS fo nayts). It alters the cycle of bone formation and breakdown in the body. Alendronate slows bone loss while increasing bone mass, which may prevent bone fractures.

Alendronate is used in men and women to treat or prevent osteoporosis that is caused by menopause or by taking steroids. Alendronate is also used to increase bone mass in men who have osteoporosis, and to treat Paget's disease of bone in men and women.

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

What should I discuss with my healthcare provider before taking alendronate?

You should not take alendronate if you are allergic to it, or if you have low levels of calcium in your blood (hypocalcemia), or a problem with the movement of muscles in your esophagus.

Do not take an alendronate tablet if you cannot sit upright or stand for at least 30 minutes. Alendronate can cause serious problems in the stomach or esophagus (the tube that connects your mouth and stomach). You will need to stay upright for at least 30 minutes after taking this medication.

To make sure alendronate is safe for you, tell your doctor if you have:

• trouble swallowing;
• a vitamin D deficiency;
• a dental problem;
• kidney disease; or
• an ulcer or other problem in your stomach or esophagus.

In rare cases, this medicine may cause bone loss (osteonecrosis) in the jaw. Symptoms include jaw pain or numbness, red or swollen gums, loose teeth, or slow healing after dental work. The longer you use alendronate, the more likely you are to develop this condition.

Osteonecrosis of the jaw may be more likely if you have cancer or received chemotherapy, radiation, or steroids. Other risk factors include blood clotting disorders, anemia (low red blood cells), and a pre existing dental problem.

Talk with your doctor about the risks and benefits of using this medication.

FDA pregnancy category C. It is not known whether alendronate will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication.

It is not known whether alendronate passes into breast milk or if it could harm a nursing baby. Tell your doctor if you are breast-feeding a baby.

How should I take alendronate?

Follow all directions on your prescription label. Do not take this medicine in larger or smaller amounts or for longer than recommended.

Alendronate tablets are taken either once each day or once each week.

To use the Binosto effervescent tablet, dissolve the tablet in at least 4 ounces of water. Stir this mixture and drink all of it right away. To make sure you get the entire dose, add a little more water to the same glass, swirl gently and drink right away.

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

Take Fosamax with a full glass (6 to 8 ounces) of water. Use only plain water (not mineral water) when taking the tablet.

Do not crush, chew, or suck the Fosamax tablet. Swallow the pill whole.

After taking alendronate, carefully follow these instructions:

• Do not lie down or recline for at least 30 minutes after taking alendronate.
• Do not eat or drink anything other than plain water.
• Do not take any other medicines including vitamins, calcium, or antacids for at least 30 minutes after taking alendronate. It may be best to take your other medicines at a different time of the day. Talk with your doctor about the best dosing schedule for your other medicines.

To be sure this medication is helping your condition, your bone mineral density will need to be tested on a regular basis. You may not need to take alendronate for longer than 3 to 5 years if you take it for osteoporosis. Visit your doctor regularly.

If you need to have any dental work (especially surgery), tell the dentist ahead of time that you are using alendronate. You may need to stop using the medicine for a short time.

Alendronate is only part of a complete program of treatment that may also include diet changes, exercise, and taking calcium and vitamin supplements. Follow your diet, medication, and exercise routines very closely.

Store at room temperature away from moisture and heat.

What happens if I miss a dose?

If you take alendronate once daily: If you forget to take this medicine first thing in the morning, do not take it later in the day. Wait until the following morning to take the medicine and skip the missed dose. Do not take two (2) tablets in one day.

If you take alendronate once a week: 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 two (2) tablets in one day.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. Drink a full glass of milk and call your local poison control center or emergency room right away. Do not make yourself vomit and do not lie down.

Overdose symptoms may include nausea, heartburn, stomach pain, diarrhea, muscle cramps, numbness or tingling, tight muscles in your face, seizure (convulsions), irritability, and unusual thoughts or behavior.

What should I avoid while taking alendronate?

Avoid taking any other medicines including vitamins, calcium, or antacids for at least 30 minutes after taking alendronate. Some medicines can make it harder for your body to absorb alendronate.

What are the possible side effects of alendronate?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; 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 worsening heartburn;
• severe joint, bone, or muscle pain, new or unusual pain in your thigh or hip;
• fever, body aches, flu symptoms; or
• jaw pain, numbness, or swelling.
• new or unusual pain in your thigh or hip;

Common side effects may include:

• mild heartburn, bloating;
• mild nausea, vomiting, or stomach pain;
• diarrhea, gas, or constipation;
• mild joint pain or swelling;
• swelling in your hands or feet; or
• dizziness, eye pain, headache.

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 other drugs will affect alendronate?

Tell your doctor about all medicines you use, and those you start or stop using during your treatment with alendronate, especially:

• NSAIDs (non-steroidal anti-inflammatory drugs)--ibuprofen (Advil, Motrin), naproxen (Aleve), celecoxib, diclofenac, indomethacin, meloxicam, and others.

This list is not complete. Other drugs may interact with alendronate, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.

Where can I get more information?

Your pharmacist can provide more information about alendronate.