CYCLOSPORINE 25MG (MOD) CAPS
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NEORAL 25 MG CAPSULES
Ingredient Name: CYCLOSPORINE (SYE-kloe-spor-een)
Drug Manufacturer: NOVARTIS
Common Uses: This medicine is an immunosuppressant used to prevent rejection of organ transplants (kidney, liver, and heart). This medicine is also used to treat psoriasis and rheumatoid arthritis in certain patients. It may also be used to treat other conditions as determined by your doctor.
Before Using This Medicine: WARNING: This medicine suppresses the immune system, which may increase your risk of developing an infection or cancer. In kidney, liver, or heart transplant patients, this medicine may be used along with other medicines that suppress the immune system. Using these medicines together may further increase your risk of developing an infection or cancer (eg, lymphoma). THIS MEDICINE CANNOT BE SWITCHED WITH OTHER FORMS OF CYCLOSPORINE (eg, Sandimmune) without your doctor's approval. If you are taking this medicine for a transplant or for rheumatoid arthritis, lab tests may be performed to monitor your progress or to check for side effects. IF YOU ARE USING THIS MEDICINE FOR PSORIASIS and you have previously used certain other forms of treatment (eg, psoralen ultraviolet A / PUVA therapy, ultraviolet B / UVB therapy, medicines that suppress the immune system, coal tar, radiation therapy), you may have an increased risk for developing skin cancer. THIS MEDICINE MAY CAUSE HIGH BLOOD PRESSURE OR KIDNEY PROBLEMS. This risk may be increased with high doses or long-term use of this medicine. Kidney function tests must be performed while you are taking this medicine to check for side effects. INFORM YOUR DOCTOR OR PHARMACIST of all prescription and over-the-counter medicine that you are taking. DO NOT TAKE THIS MEDICINE if you are taking aliskiren, bosentan, disulfiram, dronedarone, enzalutamide, lovastatin, metronidazole, mifepristone, orlistat, pitavastatin, a potassium-sparing diuretic (eg, spironolactone), or simvastatin. DO NOT TAKE THIS MEDICINE if you have taken or will be taking tacrolimus within 24 hours before or after using this medicine. DO NOT TAKE THIS MEDICINE if you have had a liver transplant and are taking sirolimus. ADDITIONAL MONITORING OF YOUR DOSE OR CONDITION may be needed if you are taking other prescription or nonprescription medicines (eg, used for infections, inflammation, allergic reactions, asthma, aches and pains, high blood pressure, cancer, gout, diabetes, heartburn or reflux, high cholesterol, irregular heartbeat or other heart problems, birth control, Parkinson disease, stomach or bowel problems, endometriosis, HIV, seizures, blood thinning, weight loss, arthritis, psoriasis, mental or mood problems, sleep, fibrocystic breast disease, hepatitis C, high blood prolactin levels, immune system suppression, pulmonary arterial hypertension), multivitamin products, or herbal or dietary supplements (eg, St. John's wort). Tell your doctor if you are taking medicines that may harm the kidney (eg, aminoglycoside antibiotics, nonsteroidal anti-inflammatory drugs / NSAIDs, such as ibuprofen) or the liver (eg, acetaminophen). Ask your doctor if you are unsure if any of your medicines might harm the kidney or liver, or might interact with this medicine. DO NOT START OR STOPany medicine without doctor or pharmacist approval. Inform your doctor of any other medical conditions, including liver, kidney, brain, or nerve problems; gout or high blood uric acid levels; low blood magnesium or cholesterol levels; high blood pressure; cancer; an infection; a weakened immune system; problems absorbing food or medicine; high blood potassium levels; allergies; pregnancy; or breast-feeding. Tell your doctor if you have recently had or will be having a vaccine, if your diet contains a lot of potassium, if you drink alcohol, or if you have a history of alcohol abuse or seizures. Tell your doctor if you are having phototherapy for psoriasis, or are having radiation treatment. USE OF THIS MEDICINE IS NOT RECOMMENDED if you have psoriasis or rheumatoid arthritis and also have kidney problems, uncontrolled high blood pressure, or cancer. USE OF THIS MEDICINE IS NOT RECOMMENDED if you are using other therapies for psoriasis (eg, PUVA or UVB therapy, methotrexate or other medicines that suppress the immune system, coal tar, radiation therapy). Contact your doctor or pharmacist if you have any questions about taking this medicine.
How to Use This Medicine: Follow the directions for using this medicine provided by your doctor. TAKE THIS MEDICINE ON A REGULAR SCHEDULE with regard to food and time(s) of day. If you take it with food, try to always take it with food. If you prefer to take it on an empty stomach, then always try to take it on an empty stomach. DO not eat grapefruit or drink grapefruit juice while you use this medicine. IF YOU ALSO TAKE SIROLIMUS, do not take it within 4 hours after taking this medicine. Check with your doctor if you have questions. STORE THIS MEDICINE at room temperature, between 68 and 77 degrees F (20 and 25 degrees C), away from heat, moisture, and light. Store in the original container. Do not store in the bathroom. KEEP THIS MEDICINE out of the reach of children and away from pets. CONTINUE TO TAKE THIS MEDICINE even if you feel well. Do NOT miss any doses. IF YOU MISS A DOSE OF THIS MEDICINE, 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.
Cautions: DO NOT TAKE THIS MEDICINE if you have had an allergic reaction to it or if you are allergic to any ingredient in this product. DO NOT SWITCH to another doseform or change brands of this medicine without talking to your doctor. Products made by other companies may not work as well for you. LABORATORY AND/OR MEDICAL TESTS, including kidney and liver function; cyclosporine levels; and blood pressure, lipids, and electrolytes, may be performed to monitor your progress or to check for side effects. PATIENTS WHO ARE BEING TREATED FOR PSORIASIS will need to have careful skin and physical examinations, including blood pressure measurements, before starting this medicine. Keep all doctor and laboratory appointments while you are taking this medicine. BEFORE YOU HAVE ANY MEDICAL OR DENTAL TREATMENTS, emergency care, or surgery, tell the doctor or dentist that you are taking this medicine. THIS MEDICINE MAY CAUSE DIZZINESS. Do not drive, operate machinery, or do anything else that could be dangerous until you know how you react to this medicine. Using this medicine alone, along with other medicines, or with alcohol may lessen your ability to drive or to perform other potentially dangerous tasks. THIS MEDICINE MAY INCREASE YOUR RISK OF SKIN CANCER. Avoid the sun, sunlamps, or tanning booths until you know how you react to this medicine. Use a sunscreen or wear protective clothing if you must be outside for more than a short time. It may also increase your risk of developing other forms of cancer (eg, lymphoma). Discuss any questions or concerns with your doctor. THIS MEDICINE MAY REDUCE THE NUMBER OF BLOOD CELLS THAT ARE NEEDED FOR CLOTTING. To prevent bleeding, avoid situations where bruising or injury may occur. THIS MEDICINE MAY LOWER YOUR RESISTANCE TO INFECTION. This may increase the risk of serious and sometimes fatal infections. Prevent infection by avoiding contact with people with colds or other infections. Do not touch your eyes or the inside of your nose unless you have thoroughly washed your hands first. DO NOT USE A SALT SUBSTITUTE or potassium supplement without checking with your doctor. BEFORE YOU BEGIN TAKING ANY NEW MEDICINE, either prescription or over-the-counter, check with your doctor or pharmacist. DO NOT RECEIVE A LIVE VACCINE (eg, measles, mumps) while you are taking this medicine. Talk with your doctor before you receive any vaccine. CAUTION IS ADVISED WHEN USING THIS MEDICINE IN THE ELDERLY because they may be more sensitive to the effects of this medicine. FOR WOMEN: THIS MEDICINE HAS BEEN SHOWN TO CAUSE HARM to the human fetus. IF YOU BECOME PREGNANT, discuss with your doctor the benefits and risks of using this medicine during pregnancy. THIS MEDICINE HAS ALCOHOL in it. Discuss any questions or concerns with your doctor. THIS MEDICINE IS EXCRETED in breast milk. DO NOT BREAST-FEED while taking this medicine. DIABETES PATIENTS: Thismedicine may affect your blood sugar. Check blood sugar levels closely and ask your doctor before adjusting the dose of your diabetes medicine.
Possible Side Effects: SIDE EFFECTS that may occur while taking this medicine include acne; dizziness; flushing; headache; increased hair growth; mild cough; mild diarrhea; nausea; runny nose; sleeplessness; stomach discomfort; or vomiting. If they continue or are bothersome, check with your doctor. SOME PATIENTS TREATED WITH THIS MEDICINE have developed severe and sometimes fatal infections, such as progressive multifocal leukoencephalopathy (PML) or severe kidney problems associated with BK virus infection. In kidney transplant patients, BK virus infection may cause loss of the transplanted kidney. Tell your doctor right away if you notice symptoms of PML (eg, confusion or disorientation; you do not care about things that you usually care about; changes in thinking, strength, or vision; one-sided weakness; trouble walking or talking; loss of balance or coordination) or kidney problems (eg, change in the amount of urine produced, difficult or painful urination, blood in the urine). THIS MEDICINE MAY CAUSE certain brain or nervous system problems, such as posterior reversible encephalopathy syndrome (PRES). Most of the time, this has gone back to normal after this medicine was stopped. Call your doctor right away if you experience fainting, seizures, vision problems (eg, blindness), trouble walking or moving, or mental or mood changes. CONTACT YOUR DOCTOR IMMEDIATELY if you experience black, tarry stool; burning, numbness, or tingling; change in the appearance of a mole; chest, jaw, or arm pain; confusion; decreased coordination; fast or irregular heartbeat; gum disease or overgrowth; mental or mood changes (eg, depression); mouth sores or swelling; muscle aches, cramps, pain, or weakness; ringing in the ears or hearing loss; seizures; severe or persistent diarrhea; severe or persistent headache or dizziness; shortness of breath; stomach pain; sudden unusual sweating; symptoms of infection (eg, fever, chills, sore throat, severe or persistent cough, increased or painful urination, warm or painful skin); symptoms of liver problems (eg, dark urine; pale stools; severe or persistent nausea, vomiting, or loss of appetite); tremors; unusual bleeding or bruising; unusual lumps; unusual swelling; unusual thickening or growth on the skin; unusual tiredness or weakness; vision changes (eg, blindness); vomit that looks like coffee grounds; wheezing; or yellowing of the skin or eyes. AN ALLERGIC REACTION to this medicine is unlikely, but seek immediate medical attention if it occurs. Symptoms of an allergic reaction include rash; hives; itching; difficulty breathing; tightness in the chest; or swelling of the mouth, face, lips, or tongue. This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. You may report side effects toFDA at 1-800-FDA-1088.
Overdose: IF OVERDOSE IS SUSPECTED, contact your local poison control center or emergency room immediately. Symptoms of overdose may include drowsiness, fast or irregular heartbeat, headache, symptoms of kidney problems (eg, change in the amount of urine produced), or vomiting.
Additional Information: DO NOT SHARE THIS MEDICINE with others for whom it was not prescribed. DO NOT USE THIS MEDICINE for other health conditions. IF YOU WILL BE USING THIS MEDICINE FOR AN EXTENDED PERIOD OF TIME, be sure to obtain necessary refills before your supply runs out. CHECK WITH YOUR PHARMACIST about how to dispose of unused medicine.
Copyright 2012 Wolters Kluwer Health, Inc.
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