Alendronate; Cholecalciferol tablets

What are Alendronate; Cholecalciferol tablets?

ALENDRONATE; CHOLECALCIFEROL (Fosamax Plus D™) reduces calcium loss from bones and increases the production of normal healthy bone in patients with osteoporosis. The tablets contain alendronate and cholecalciferol (vitamin D₃). Generic alendronate; cholecalciferol tablets are not yet available.

What should my health care professional know before I receive Alendronate; Cholecalciferol?

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

• dental disease

• kidney disease

• lactose intolerance

• leukemia or lymphoma

• low level of blood calcium

• malabsorption syndrome

• sarcoidosis

• stomach, intestinal, or esophageal problems like acid-reflux or GERD

• problems swallowing

• vitamin D toxicity (too much vitamin D in the blood)

• an unusual reaction to alendronate, cholecalciferol, medicines, foods, dyes, or preservatives

• pregnant or trying to get pregnant

• breast-feeding

How should this medicine be used?

Follow the directions on the prescription label. Take alendronate; cholecalciferol on the same day every week.

Take alendronate; cholecalciferol 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 mineral water, tea, 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; cholecalciferol. 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 or bend over) for at least 30 minutes. This will help 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, 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 miss a dose of alendronate; cholecalciferol, 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; Cholecalciferol?

• antacids

• anti-inflammatory drugs like ibuprofen, naproxen, and others

• aspirin

• calcium supplements, especially calcium with vitamin D

• cholestyramine or colestipol

• cimetidine, ranitidine, or other medicines used to decrease stomach acid

• corticosteroids

• iron supplements

• ketoconazole

• magnesium supplements

• mineral oil

• orlistat

• phenobarbital, phenytoin, or primidone

• phosphorous supplements

• teriparatide

• thiazide diuretics (water pills)

• vitamins with minerals, especially vitamin D or calcium with vitamin D

Tell your prescriber or health care professional about all other medicines you are taking, including non-prescription medicines, nutritional supplements, or herbal products. 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 may affect the way your medicine works. Check with your health care professional before stopping or starting any of your medicines.

What should I watch for while taking Alendronate; Cholecalciferol?

Visit your prescriber or health care professional for regular checks on your progress. Do not stop taking alendronate; cholecalciferol except on your prescriber's advice. Do not take additional vitamin D unless directed by your healthcare professional. Do not take calcium with vitamin D unless directed by your health care professional. Your prescriber or health care professional may order regular blood tests to check for the amount of vitamin D, calcium, or other minerals in your blood.

It is very important to take alendronate; cholecalciferol with a full glass of water (6—8 ounces). Do not take with orange juice, coffee, mineral water, or other fluids, as these may decrease the absorption of alendronate. Do not take alendronate; cholecalciferol 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. Do not bend over while you are sitting, standing, or walking.

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 in your diet while you are taking alendronate; cholecalciferol, 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; cholecalciferol.

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

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

What side effects may I notice from receiving Alendronate; Cholecalciferol?

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

More common

• stomach pain

• heartburn or chest pain

• pain or difficulty swallowing

Rare or uncommon:

• allergic reactions such as skin rash or itching, hives, difficulty breathing, swelling of the face, lips, throat, or tongue

• black or tarry stools

• eye inflammation, pain, or change in vision

• 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

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 20—25 degrees C (68—77 degrees F). Keep your medication in the original container. The medicine needs to be protected from moisture and light. Do not keep the medicine in your bathroom. Throw away any unused medicine after the expiration date.