Calcifediol extended-release capsules

What is this medicine?

Calcifediol (kal si fe DI ol) is a man-made form of vitamin D. It helps the body have the right amounts of parathyroid hormone, calcium, phosphorus, and vitamin D. It is used in patients with chronic renal failure.

How should I use this medicine?

Take this medicine by mouth with a glass of water. Follow the directions on the prescription label. You can take it with or without food. If it upsets your stomach, take it with food. Take your medicine at regular intervals. Do not take it more often than directed. Do not stop taking except on your doctor's advice.

Talk to your pediatrician regarding the use of this medicine in children. Special care may be needed.

What side effects may I notice from receiving this medicine?

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

• allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue

• bone pain

• breathing problems

• confusion

• increased thirst

• increased urination

• muscle pain

• weight loss

• unusually weak or tired

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

• constipation

• dry mouth

• headache

• loss of appetite

• metallic taste

What may interact with this medicine?

This medicine may interact with the following medications:

• calcium supplements

• certain antibiotics like clarithromycin, telithromycin

• certain medicines for cholesterol like cholestyramine

• certain medicines for seizures like phenobarbital

• digoxin

• diuretics like hydrochlorothiazide

• medicines for fungal infections like ketoconazole, itraconazole, and voriconazole

• medicines for HIV called protease inhibitors

• nefazodone

• phosphate-binding agents

• vitamin D

What if I miss a dose?

If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses

Where should I keep my medicine?

Keep out of the reach of children.

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

What should I tell my health care provider before I take this medicine?

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

• high levels of calcium, phosphorus, or vitamin D in the blood

• on hemodialysis

• an unusual or allergic reaction to calcifediol, vitamin D, other medicines, foods, dyes, or preservatives

• pregnant or trying to get pregnant

• breast-feeding

What should I watch for while using this medicine?

Visit your doctor or health care professional for regular checkups. It may be some time before you see the benefit from this medicine. Do not stop taking your medicine unless your doctor tells you to. Your doctor may order blood tests or other tests to see how you are doing.

You may need to follow a special diet. Talk to your doctor. Do not take any non-prescription medicines that have vitamin D, phosphorus, magnesium, or calcium including antacids, unless directed by your doctor.