Alendronate is used to treat osteoporosis caused by menopause, steroid use, or gonadal failure. alendronate 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.

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.

Alendronate comes as a tablet, an effervescent tablet, and a solution (liquid) to take by mouth. The solution is usually taken on an empty stomach once a week in the morning. The 5-mg and 10-mg tablets are usually taken on an empty stomach once a day in the morning, and the 35-mg and 70-mg tablets are usually taken on an empty stomach once a week in the morning. The 40-mg tablets are usually taken once a day in the morning for six months to treat Paget's disease of bone. The effervescent tablets are usually taken on an empty stomach once weekly in the morning. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take alendronate exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

Alendronate may not work properly and may damage the esophagus (tube between the mouth and stomach) or cause sores in the mouth if it is not taken according to the following instructions. Tell your doctor if you do not understand, you do not think you will remember, or you are unable to follow these instructions:

• You must take alendronate just after you get out of bed in the morning, before you eat or drink anything. Never take alendronate at bedtime or before you wake up and get out of bed for the day.
• After you take alendronate, do not eat, drink, or take any other medications (including vitamins or antacids) for at least 30 minutes. Do not lie down for at least 30 minutes after you take alendronate. Sit upright or stand upright until at least 30 minutes have passed and you have eaten your first food of the day.
• If you are taking the alendronate tablets, swallow the tablet with a full glass (6 to 8 ounces [180 to 240 mL]) of plain water. Never take alendronate tablets with tea, coffee, juice, milk, mineral water, sparkling water, or any liquid other than plain water. Swallow the tablets whole; do not split, chew or crush them. Do not suck on the tablets.
• If you are taking the alendronate oral solution, drink at least 2 ounces (60 milliliters [1/4 cup]) of water after taking alendronate oral solution. Never take alendronate solution with tea, coffee, juice, milk, mineral water, sparkling water, or any liquid other than plain water.
• If you are taking the alendronate effervescent tablets, dissolve one effervescent tablet in a full glass (4 ounces [120 milliliters]) of plain, non-carbonated drinking water before drinking. Never dissolve alendronate effervescent tablets with tea, coffee, juice, milk, mineral water, sparkling water, or any liquid other than plain water. Wait at least 5 minutes after the effervescence stops, stir the solution for 10 seconds and drink it. Do not swallow, suck, or chew on the effervescent tablets.

Alendronate controls osteoporosis and Paget's disease of bone but does not cure these conditions. It may take 3 months or longer before your bone density begins to increase. Alendronate helps to treat and prevent osteoporosis only as long as it is taken regularly. Continue to take alendronate even if you feel well. Do not stop taking alendronate without talking to your doctor, but talk to your doctor from time to time about whether you still need to take alendronate.

Ask your pharmacist or doctor for a copy of the manufacturer's information for the patient.

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.

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 alendronate.

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.

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.

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.

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom). Do not freeze alendronate solution.

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

You should eat and drink plenty of foods and drinks that are rich in calcium and vitamin D while you are taking alendronate. Your doctor will tell you which foods and drinks are good sources of these nutrients and how many servings you need each day. If you find it difficult to eat enough of these foods, tell your doctor. In that case, your doctor can prescribe or recommend a supplement.

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.

Get emergency medical help if you have signs of an allergic reaction: hives; wheezing, difficulty breathing; swelling of your face, lips, tongue, or throat.

Alendronate may cause serious side effects. 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 of alendronate 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.

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.

Keep all appointments with your doctor and the laboratory. Your doctor may order certain lab tests to check your body's response to alendronate.

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

• Fosamax® Plus D (containing Alendronate, Cholecalciferol)