Brand Name(s): Fosamax

Generic Name Alendronate

What are alendronate tablets?

ALENDRONATE (Fosamax®) reduces calcium loss from bones. It helps prevent bone loss and increases production of normal healthy bone in patients with Paget's disease, osteoporosis, and other conditions which place someone at risk for bone loss, including after menopause in females or from the long-term use of corticosteroids (like prednisone) in men or women. Generic alendronate tablets are not yet available.

What should my health care professional know before I take alendronate?

They need to know if you have any of these conditions:

• dental disease
• kidney disease
• low level of blood calcium
• stomach, intestinal, or esophageal problems, like acid-reflux or GERD
• problems swallowing
• vitamin D deficiency
• an unusual or allergic reaction to alendronate, other medicines, foods, dyes, or preservatives
• pregnant or trying to get pregnant
• breast-feeding

How should I take this medicine?

Follow the directions on the prescription label. Some patients take alendronate every day. Other patients may only take a dose of alendronate once a week. If you take alendronate only once a week, take the medicine on the same day every week.

Take alendronate tablets by mouth in the morning, after you have risen for the day. Swallow the tablets with a full glass (6—8 fluid ounces) of plain water first thing in the morning. Do not take the tablets with any other type of liquid except plain water. Do not take with orange juice, coffee or other fluids as these may decrease the absorption of alendronate. Do not chew or suck on the tablets; this may cause mouth ulcers (sores). Do not eat or drink anything before you take your tablets and do not eat breakfast, drink, or take any other medicines for at least 30 minutes after taking alendronate. If you can wait for 2 hours before eating, your body will absorb even more of the medicine. After taking this medicine, remain sitting or standing upright (do not lie down) for at least 30 minutes to avoid irritation of your throat and esophagus (tube connecting mouth to stomach). Do not take this medicine at the same time as antacids, calcium, magnesium or iron supplements, or vitamins with minerals; if you take these medications, take them later in the day. Do not take your medicine more often than directed.

Contact your pediatrician or health care professional regarding the use of this medicine in children. Special care may be needed.

What if I miss a dose?

If you take a daily dose of alendronate: If you miss a dose, do not take it later in the day. Continue your normal schedule starting the next morning, before you have eaten. Do not take double or extra doses.

If you take a once-weekly dose of alendronate: If you miss a dose of alendronate 35-mg or 70-mg once a week, take the dose on the morning after you remember. Then return to taking your dose just once a week, as originally scheduled on your regular chosen day of the week. Never take 2 tablets on the same day. Do not take double or extra doses.

What drug(s) may interact with alendronate?

• aluminum hydroxide
• antacids
• anti-inflammatory drugs like ibuprofen, naproxen, and others
• aspirin
• calcium supplements
• iron supplements
• magnesium supplements
• parathyroid hormone
• teriparatide
• vitamins with minerals

Tell your prescriber or health care professional about all other medicines you are taking including non-prescription medicines. Also tell your prescriber or health care professional if you are a frequent user of drinks with caffeine or alcohol, if you smoke, or if you use illegal drugs. These can affect the way your medicine works. Check with your health care professional before stopping or starting any of your medicines.

What side effects might I notice from taking alendronate?

Side effects that you should report to your prescriber or health care professional as soon as possible:

More common

• stomach pain
• heartburn
• pain or difficulty swallowing

Rare or uncommon:

• allergic reactions such as skin rash or itching, hives, swelling of the face, lips, throat or tongue
• black or tarry stools
• constant jaw pain, especially burning or cramping
• eye inflammation, pain or change in vision
• muscle twitching
• redness, blistering, peeling or loosening of the skin, including inside the mouth
• vomiting

Side effects that usually do not require medical attention (report to your prescriber or health care professional if they continue or are bothersome):

• diarrhea or constipation
• headache
• stomach gas or fullness
• nausea
• changes in taste
• bone, muscle or joint pain
• rash, which may be made worse by prolonged exposure to sunlight

What should I watch for while taking alendronate?

Visit your prescriber or health care professional for regular checks on your progress. If you have Paget's disease it may be some time before you see the benefit from alendronate. Do not stop taking alendronate except on your prescriber's advice. Low blood levels of phosphorus and calcium can occur but usually do not cause serious problems. Your prescriber or health care professional may order regular blood tests to check for these problems.

It is very important to take alendronate with a full glass of water (6—8 ounces). Do not take with orange juice, coffee or other fluids as these may decrease the absorption of alendronate. Do not take alendronate with food. Wait at least 30 minutes or longer after taking alendronate before you eat, drink or take other medicines.

Because alendronate may irritate your throat, remain sitting or standing upright for at least 30 minutes after taking alendronate; do not lie down.

If you begin to have pain when swallowing, difficulty swallowing, heartburn or stomach pain, call your prescriber or health care professional right away.

You should make sure you get enough calcium and vitamin D in your diet while you are taking alendronate, unless directed otherwise by your health care provider. Discuss your dietary needs with your health care professional or nutritionist.

If you get bone pain, or a worsening of bone pain, check with your doctor. However, many patients have improvement in their bone pain during and after treatment with alendronate.

If you are taking an antacid, a mineral supplement like calcium or iron, or a vitamin with minerals, make sure that you wait at least 30 minutes, and preferably 2 hours before or after taking alendronate. Do not take them at same time.

Limit your time in sunlight or other UV exposure, such as tanning beds, while taking alendronate. Alendronate may cause a rash that is worsened by exposure to the sun.

Where can I keep my medicine?

Keep out of the reach of children in a container that small children cannot open.

Store at room temperature between 15 and 30 °C (59 and 86 °F). Throw away any unused medicine after the expiration date.