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Ingredient Name: CARBIDOPA (KAR-bi-DOE-pa) and LEVODOPA (LEE-voe-DOE-pa)

Drug Manufacturer: APOTEX USA

Common Uses: This medicine is an antidyskinetic combination used for treating symptoms associated with Parkinson disease and parkinsonism-like symptoms caused by other conditions. It may also be used to treat other conditions as determined by your doctor.

Before Using This Medicine: Some medicines or medical conditions may interact with this medicine. INFORM YOUR DOCTOR OR PHARMACIST of all prescription and over-the-counter medicine that you are taking. DO NOT TAKE THIS MEDICINE IF you have taken a monoamine oxidase inhibitor (MAOI) (eg, phenelzine) within the last 14 days. ADDITIONAL MONITORING OF YOUR DOSE OR CONDITION may be needed if you are taking tricyclic antidepressants (eg, amitriptyline); metoclopramide; blood pressure medicines or selegiline; or butyrophenones, (eg, haloperidol), isoniazid, papaverine, phenothiazines (eg, chlorpromazine), phenytoin, or risperidone. DO NOT START OR STOP any medicine without doctor or pharmacist approval. Inform your doctor of any other medical conditions, including an irregular heartbeat, heart disease, ulcer, mental or mood disorders, seizures, blood pressure problems, asthma, lung problems, liver or kidney problems, blood or hormone problems, stomach or intestinal bleeding, glaucoma, a history of heart attack, allergies, pregnancy, or breast-feeding. USE OF THIS MEDICINE IS NOT RECOMMENDED if you have narrow-angle glaucoma, undiagnosed skin growths, skin cancer, or a history of skin cancer. THIS MEDICINE SHOULD NOT BE USED IN CHILDREN; safety and effectiveness in children have not been confirmed. Contact your doctor or pharmacist if you have any questions or concerns about using this medicine.

How to Use This Medicine: Follow the directions for taking this medicine provided by your doctor. TAKE THIS MEDICINE BY MOUTH ON AN EMPTY STOMACH at least 1 hour before or 2 hours after eating. Carefully follow the dosing schedule given to you by your health care provider. It may take several weeks to a few months to notice benefit from use because the dose is carefully adjusted over time. SWALLOW THIS MEDICINE WHOLE. Do not break, crush, or chew before swallowing. Some strengths of this medicine may be broken in half. If you have difficulty swallowing the tablet whole or if your doctor tells you to break the tablet in half, ask your pharmacist if your strength of medicine may be broken in half. DO NOT TAKE IRON SALTS (eg, ferrous sulfate) or vitamins that contain iron salts within 2 hours before or 2 hours after taking this medicine. Check with your doctor if you have questions. IF YOU HAVE BEEN TAKING LEVODOPA, do not start taking this medicine until at least 12 hours after your final dose of levodopa. DO NOT SUDDENLY STOP TAKING THIS MEDICINE. Some conditions may become worse when this medicine is suddenly stopped. Your dose may need to be slowly lowered by your doctor to avoid side effects. The effects of this medicine might start to wear off between doses. TALK WITH YOUR DOCTOR IF THIS MEDICINE STOPS WORKING WELL or if your condition worsens. STORE THIS MEDICINE at room temperature, between 59 and 86 degrees F (15 and 30 degrees C), in a tightly closed container. Store away from heat, moisture, and light. Do not store in the bathroom. TAKE THIS MEDICINE on a regular schedule to get the most benefit from it. Taking this medicine at the same times each day will help you to remember to take it. CONTINUE TO TAKE THIS MEDICINE even if you feel better. 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 USE THIS MEDICINE IF you are allergic to any ingredient in this medicine. Lab tests may be performed while you use this medicine. These tests may be used to monitor your condition or check for side effects. KEEP ALL DOCTOR AND LAB APPOINTMENTS. THIS MEDICINE MAY INTERFERE WITH CERTAIN LAB TESTS. Be sure your doctor and lab personnel know you are taking this medicine. BEFORE YOU RECEIVE ANY MEDICAL OR DENTAL CARE, EMERGENCY CARE, OR SURGERY, tell your doctor or dentist that you take this medicine. THIS MEDICINE MAY CAUSE DROWSINESS, DIZZINESS, OR LIGHTHEADEDNESS. These effects may be worse if you take it with alcohol or certain medicines. Use this medicine with caution. DO NOT DRIVE OR PERFORM OTHER POSSIBLY UNSAFE TASKS until you know how you react to it. THIS MEDICINE MAY CAUSE DIZZINESS, LIGHTHEADEDNESS, OR FAINTING; alcohol, hot weather, exercise, or fever may increase these effects. To prevent them, sit up or stand slowly, especially in the morning. Sit or lie down at the first sign of any of these effects. DO NOT DRINK ALCOHOL OR USE MEDICINES that may cause drowsiness while you are using this medicine; it may add to their effects. NEUROLEPTIC MALIGNANT SYNDROME (NMS) is a possibly fatal syndrome that can be caused by this medicine. Symptoms may include fever; stiff muscles; confusion; abnormal thinking; fast or irregular heartbeat; and sweating. Contact your doctor at once if you have any of these symptoms. Patients with Parkinson disease may have an increased risk of developing a certain type of skin cancer (melanoma). It is not known if this medicine also increases the risk of melanoma. You may need to have skin exams while you are using this medicine. TELL YOUR DOCTOR IF YOU NOTICE ANY UNUSUAL SKIN GROWTHS or a change in the appearance of a mole. SOME PEOPLE HAVE EXPERIENCED NEW, UNUSUAL, OR INCREASED URGES (eg, gambling, sexual urges) while using this medicine. Tell your doctor right away if you notice such effects. GRADUALLY INCREASE PHYSICAL ACTIVITY AS YOUR SYMPTOMS IMPROVE. A DARK COLOR (red, brown, or black) may appear in your saliva, urine, or sweat after taking this medicine. This is not harmful. BEFORE YOU BEGIN TAKING ANY NEW MEDICINES, either prescription or over-the-counter, check with your doctor or pharmacist. USE THIS MEDICINE WITH CAUTION IN THE ELDERLY; they may be more sensitive to its effects. FOR WOMEN: IF YOU BECOME PREGNANT, contact your doctor. You will need to discuss the benefits and risks of using this medicine while you are pregnant. IT IS NOT KNOWN IF THIS MEDICINE IS FOUND in breast milk. IF YOU ARE OR WILL BE BREAST-FEEDING while you are using this medicine, check with your doctor. Discuss any possible risks to your baby. DIABETES PATIENTS: This medicine may affect your blood sugar or cause the results of some tests for urine ketones to be wrong. CHECK BLOOD SUGAR LEVELS CLOSELY. Ask your doctor before you change your diet or the dose of your diabetes medicine.

Possible Side Effects: SIDE EFFECTS that may occur while taking this medicine include confusion, constipation, diarrhea, drowsiness, dizziness, dry mouth, headache, increased sweating, loss of appetite, nausea, taste changes, trouble sleeping, upset stomach, urinary tract infection, or vomiting . If they continue or are bothersome, check with your doctor. CONTACT YOUR DOCTOR IMMEDIATELY if you experience black, tarry stools; blood in vomit; chest pain; confusion; depression; fast or irregular heartbeat; fever; hallucinations; mental or mood changes; muscle pain or unusual stiffness; severe abdominal pain; severe lightheadedness or fainting; sore throat; thoughts of suicide; unexplained fever or sweating; unusual bruising or bleeding; unusual or painful movements or spasms of the face, eyelids, mouth, tongue, arms, hands, or legs; vision changes (blurred/double vision); 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; swelling of the mouth, face, lips, or tongue. This not a complete list of all side effects that may occur. If you have questions about side effects, contact your healthcare provider. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Overdose: If overdose is suspected, contact your local poison control center or emergency room immediately.

Additional Information: DO NOT SHARE THIS MEDICINE with others for whom it was not prescribed. DO NOT USE THIS MEDICINE for other health conditions. KEEP THIS MEDICINE out of the reach of children and pets. IF USING THIS MEDICINE FOR AN EXTENDED PERIOD OF TIME, obtain refills before your supply runs out.

Copyright 2009 Wolters Kluwer Health, Inc.

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