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|Sandimmune Soft Gelatin Capsules

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Sandimmune Soft Gelatin Capsules

Generic Name: Cyclosporine Soft Gelatin Capsules (SYE-kloe-spor-een)
Brand Name: Sandimmune

Sandimmune Soft Gelatin Capsules should always be used along with adrenal corticosteroids (eg, hydrocortisone), but not with other medicines that suppress the immune system. The risk of developing an infection or a certain type of cancer (lymphoma) may be increased by suppressing the immune system.

Sandimmune Soft Gelatin Capsules cannot be interchanged with other forms of cyclosporine (eg, Neoral) without your doctor"s approval.

If you are taking Sandimmune Soft Gelatin Capsules for a long period of time, especially for a liver transplant, lab tests should be performed to monitor your progress or to check for side effects such as toxicity or decreased effectiveness.

Sandimmune Soft Gelatin Capsules is used for:

Preventing the rejection of organ transplants (kidney, liver, and heart). It is used in combination with adrenal corticosteroids. It may also be used to treat chronic rejection in patients previously treated with other immunosuppressive agents. It may also be used for other conditions as determined by your doctor.

Sandimmune Soft Gelatin Capsules is an immunosuppressant. How Sandimmune Soft Gelatin Capsules works is not fully understood, but it may block certain white blood cells (lymphocytes).

Do NOT use Sandimmune Soft Gelatin Capsules if:

you are allergic to any ingredient in Sandimmune Soft Gelatin Capsules
you are taking bosentan, disulfiram, fluorouracil, an immunosuppressant (eg, azathioprine, tacrolimus), metronidazole, orlistat, or a potassium-sparing diuretic (eg, spironolactone)
you are having radiation therapy for psoriasis
you are going to be vaccinated with a live vaccine

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

Before using Sandimmune Soft Gelatin Capsules:

Some medical conditions may interact with Sandimmune Soft Gelatin 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 liver, kidney, brain, or nerve problems; high blood potassium or uric acid levels; low blood magnesium or cholesterol levels; high blood pressure; cancer; gout; an infection; or problems absorbing food or medicine; or have had a recent vaccination
if your diet contains high amounts of potassium
if you have a history of seizures

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

Many prescription and nonprescription medicines (eg, used for infections, inflammation, aches and pains, high blood pressure, cancer, gout, diabetes, heartburn, high cholesterol, irregular heartbeat or other heart problems, birth control, Parkinson disease, stomach and intestinal problems, endometriosis, HIV, seizures, blood clotting, weight loss, arthritis, psoriasis, depression, sleep, other conditions), multivitamin products, and herbal or dietary supplements (eg, St. John"s wort) may interact with Sandimmune Soft Gelatin Capsules. They may increase the risk of side effects or decrease the effectiveness of this or other medicines
Immunosuppressants (eg, azathioprine, tacrolimus) because risk of developing an infection or cancer may be increased
Potassium-sparing diuretics (eg, spironolactone ) because the risk of high blood potassium levels may be increased
Bosentan because the risk of its side effects and toxic effects may be increased by Sandimmune Soft Gelatin Capsules
Orlistat because it may decrease Sandimmune Soft Gelatin Capsules"s effectiveness
Disulfiram, fluorouracil, or metronidazole because flushing, headache, fast or irregular heartbeat, shortness of breath, nausea, or vomiting may occur

This may not be a complete list of all interactions that may occur. Ask your health care provider if Sandimmune Soft Gelatin 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 Sandimmune Soft Gelatin Capsules:

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

Take Sandimmune Soft Gelatin Capsules on a regular schedule with regard to food and time of day.
Do not eat grapefruit or drink grapefruit juice while you use Sandimmune Soft Gelatin Capsules.
If you also take sirolimus, do not take it within 4 hours after taking Sandimmune Soft Gelatin Capsules. Check with your doctor if you have questions.
If you miss a dose of Sandimmune Soft Gelatin Capsules, 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.

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

Important safety information:

Sandimmune Soft Gelatin Capsules may cause dizziness. These effects may be worse if you take it with alcohol or certain medicines. Use Sandimmune Soft Gelatin Capsules with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
Do not switch to another doseform or change brands of Sandimmune Soft Gelatin Capsules without talking to your doctor. Products made by other companies may not work as well for you.
Sandimmune Soft Gelatin Capsules may increase your risk of skin cancer. Avoid the sun, sunlamps, or tanning booths until you know how you react to Sandimmune Soft Gelatin Capsules. Use a sunscreen or wear protective clothing if you must be outside for more than a short time.
Sandimmune Soft Gelatin Capsules may increase risk of developing certain forms of cancer. Discuss any questions or concerns with your doctor.
Do not receive a live vaccine (eg, measles, mumps) while you are taking Sandimmune Soft Gelatin Capsules. Talk with your doctor before you receive any vaccine.
Check with your doctor before you use a salt substitute or a product that has potassium in it.
Sandimmune Soft Gelatin Capsules may lower the ability of your body to fight infection. Avoid contact with people who have colds or infections. Tell your doctor if you notice signs of infection like fever, sore throat, rash, or chills.
Tell your doctor or dentist that you take Sandimmune Soft Gelatin Capsules before you receive any medical or dental care, emergency care, or surgery.
Diabetes patients - Sandimmune Soft Gelatin Capsules may affect your blood sugar. Check blood sugar levels closely. Ask your doctor before you change the dose of your diabetes medicine.
Lab tests, including kidney and liver function tests; cyclosporine levels; and blood pressure, lipids, and electrolytes, may be performed while you use Sandimmune Soft Gelatin Capsules. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
Use Sandimmune Soft Gelatin Capsules with caution in the ELDERLY; they may be more sensitive to its effects.
PREGNANCY and BREAST-FEEDING: Sandimmune Soft Gelatin Capsules may cause harm to the fetus. If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Sandimmune Soft Gelatin Capsules while you are pregnant. Sandimmune Soft Gelatin Capsules is found in breast milk. Do not breast-feed while taking Sandimmune Soft Gelatin Capsules.

Possible side effects of Sandimmune Soft Gelatin 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:

Acne; dizziness; flushing; headache; increased hair growth; nausea; runny nose; sleeplessness; stomach discomfort; vomiting.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); black, tarry stool; blood in the urine; chest pain; chills; confusion; dark urine; diarrhea; fast or irregular heartbeat; fever; gum disease or overgrowth; increased or decreased urination; infection; loss of coordination; mental or mood changes; muscle cramps; numbness or tingling of the skin; seizures; severe or persistent headache or dizziness; shortness of breath; sore throat; tremors; unusual bleeding or bruising; unusual lumps; unusual thickening or lesion of the skin; unusual tiredness or weakness; vision changes; wheezing; yellowing of the skin or eyes.

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. 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.

Proper storage of Sandimmune Soft Gelatin Capsules:

Store this medicine 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 Sandimmune Soft Gelatin Capsules out of the reach of children and away from pets.

General information:

If you have any questions about Sandimmune Soft Gelatin Capsules, please talk with your doctor, pharmacist, or other health care provider.
Sandimmune Soft Gelatin 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 Sandimmune Soft Gelatin 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.

Issue Date: November 1, 2006

Database Edition 06.4.1.002

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