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|Zemplar Capsules

Zemplar Capsules

Zemplar Capsules is used for:

Preventing and treating high levels of parathyroid hormone in the blood due to long-term kidney disease.

Zemplar Capsules is a vitamin D compound. It works by blocking the formation and release of parathyroid hormone (PTH).

Do NOT use Zemplar Capsules if:

• you are allergic to any ingredient in Zemplar Capsules
• you have high levels of vitamin D or calcium in the blood

Contact your doctor or health care provider right away if any of these apply to you.

Before using Zemplar Capsules:

Some medical conditions may interact with Zemplar Capsules. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding
• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
• if you have allergies to medicines, foods, or other substances
• if you have heart problems, hardening or narrowing of the arteries (arteriosclerosis), or high blood phosphate levels

Some MEDICINES MAY INTERACT with Zemplar Capsules. Tell your health care provider if you are taking any other medicines, especially any of the following:

• Digitalis medicines (eg, digoxin) because risk of toxicity may be increased by Zemplar Capsules
• Clarithromycin, HIV protease inhibitors (eg, ritonavir, saquinavir), imidazole antifungals (eg, ketoconazole, itraconazole), nefazodone, telithromycin, or voriconazole because side effects of Zemplar Capsules may be increased

This may not be a complete list of all interactions that may occur. Ask your health care provider if Zemplar Capsules may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Zemplar Capsules:

Use Zemplar Capsules as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Zemplar Capsules may be taken with or without food.
• If you take cholestyramine, do not take it at the same time you take Zemplar Capsules. Talk with your doctor about how you should take cholestyramine with Zemplar Capsules.
• If you miss a dose of Zemplar Capsules and you are taking it once daily, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.
• If you miss a dose of Zemplar Capsules and you are taking it three times weekly, contact your doctor for instructions.

Ask your health care provider any questions you may have about how to use Zemplar Capsules.

Important safety information:

• Zemplar Capsules may cause lightheadedness. Do not drive, operate machinery, or do anything else that could be dangerous until you know how you react to Zemplar Capsules. Using Zemplar Capsules alone, with certain other medicines, or with alcohol may lessen your ability to drive or perform other potentially dangerous tasks.
• Carefully follow the diet instructions given to you by your health care provider, including instructions on vitamin D and phosphorus restrictions and calcium supplementation.
• Before you begin taking any new prescription or nonprescription medicine, including vitamin or mineral products, read the ingredients to see if it contains vitamin D or phosphorus. If it does or if you are uncertain, contact your doctor or pharmacist.
• Avoid excessive use of aluminum-containing products (eg, antacids) while using Zemplar Capsules.
• LAB TESTS, including blood calcium, phosphorus, and PTH levels, may be performed to monitor your progress or to check for side effects. Be sure to keep all doctor and lab appointments.
• Use Zemplar Capsules with extreme caution in CHILDREN. Safety and effectiveness have not been confirmed.
• PREGNANCY and BREAST-FEEDING: If you become pregnant while taking Zemplar Capsules, discuss with your doctor the benefits and risks of using Zemplar Capsules during pregnancy. It is unknown if Zemplar Capsules is excreted in breast milk. Do not breast-feed while you are using Zemplar Capsules.

Possible side effects of Zemplar Capsules:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Back or joint pain; diarrhea; feeling unwell; lightheadedness; nausea; vomiting.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); black tarry or bloody stools; chest pain; depression; fever or chills; irregular heartbeat; muscle cramps or spasms; pounding in the chest; stomach pain; swelling of the hands or feet; trouble breathing.

This is not a complete list of all side effects that may occur. If you have questions or need medical advice about side effects, contact your doctor or health care provider. You may report side effects to the FDA at 1-800-FDA-1088 (1-800-332-1088) or at http://www.fda.gov/medwatch.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org/findyour.htm), or emergency room immediately. High vitamin D levels, which can be dangerous, may occur if Zemplar Capsules is used in higher doses than necessary. Symptoms may include bone or muscle pain; decreased sex drive; dizziness; fever; irregular heartbeat; loss of appetite; mental or mood changes; metallic taste in mouth; persistent or severe constipation, headache, nausea, or vomiting; seizures; sensitivity to sunlight (eyes); unexplained runny nose; unusual drowsiness; unusually dry mouth; vision changes; weakness; weight loss.

Store Zemplar Capsules at 77 degrees F (25 degrees C). Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Zemplar Capsules out of the reach of children and away from pets.

General information:

• If you have any questions about Zemplar Capsules, please talk with your doctor, pharmacist, or other health care provider.
• Zemplar Capsules is to be used only by the patient for whom it is prescribed. Do not share it with other people.
• If your symptoms do not improve or if they become worse, check with your doctor.

This information is a summary only. It does not contain all information about Zemplar Capsules. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.