Cinacalcet Hydrochloride Oral tablet

What is this medicine?

CINACALCET (sin a CAL set) is used to treat patients with chronic kidney disease who are on dialysis. It is also used to treat high levels of calcium in the blood of patients with certain parathyroid gland problems.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

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

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

• heart failure

• liver disease

• low blood calcium

• seizure disorder

• an unusual or allergic reaction to cinacalcet, other medicines, foods, dyes, or preservatives

• pregnant or trying to get pregnant

• breast-feeding

How should I use this medicine?

Take this medicine by mouth with a glass of water. Follow the directions on the prescription label. Do not break, chew, or crush tablets. Take this medicine with food or right after a meal. Take your medicine at regular intervals. Do not take your medicine 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.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

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.

What may interact with this medicine?

Do not take this medicine with any of the following medications:

• thioridazine

This medicine may also interact with the following medications:

• erythromycin

• flecainide

• grapefruit juice

• medicines for depression, anxiety, or psychotic disturbances

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

• medicines for pain

• medicines for sleep

• St. John's wort

• vinblastine

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medicine?

Visit your doctor for regular checks on your progress. Your doctor will order important blood tests while you are taking this medicine. This medicine may cause an increase or decrease in your blood pressure. Check your blood pressure as directed. Ask your doctor or health care professional what your blood pressure should be and when you should contact him or her.

This medicine alters the calcium level in your blood. You may need to be on a special diet. Talk to your health care provider about the foods you eat and the vitamins you take.

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

• breathing problems

• bone, joint pain

• changes in blood pressure

• confusion, irritable

• depression

• hallucinations

• muscle cramps, pains, spasms

• seizures

• unusual tingling, pain

• 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):

• diarrhea

• dizziness

• loss of appetite

• nausea

• vomiting

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

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.