Stalevo 125

This combination medication is used to treat symptoms of Parkinson's disease. Parkinson's disease is believed to be due to a lack of an important chemical (dopamine) in the brain. Levodopa is converted into dopamine in the brain, leading to the relief of Parkinson's disease symptoms. Both carbidopa and entacapone are given with levodopa to increase the amount of levodopa that is converted into dopamine.

If you miss a dose, use it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.

Take this medication by mouth exactly as prescribed. Do not increase the dose or take more frequently without consulting your doctor. The manufacturer directs not to split the tablet before taking it. However, many similar drugs (immediate-release tablets) can be split. Follow your doctor's directions on how to take this medication. It is best to avoid a high protein diet (decreases the amount of levodopa that your body takes in) during treatment, unless directed otherwise by your doctor. Consult your doctor or pharmacist for more details. The dosage is based on your medical condition, previous drug therapy, response to therapy, and side effects if they occur. Some patients may experience a "wearing-off" (worsening of symptoms) before the next dose is due. An "on-off" effect might also occur, in which sudden short periods of stiffness occur. If these effects occur, contact your doctor for possible dose adjustments that may help to lessen this effect. Do not stop taking this medication without consulting your doctor. Some conditions may become worse when the drug is suddenly stopped. Your dose may need to be gradually decreased. Use this medication regularly in order to get the most benefit from it. To help you remember, use it at the same time(s) each day. If symptoms worsen while using this medication, contact your doctor immediately.

Your healthcare professional (e.g., doctor or pharmacist) may already be aware of any possible drug interactions and may be monitoring you for it. Do not stop or change the dosage of any medicine without checking with them first. This drug should not be used with the following medication because very serious interactions may occur: tetrabenazine. Avoid taking MAO inhibitors (e.g., furazolidone, isocarboxazid, linezolid, moclobemide, phenelzine, procarbazine, tranylcypromine) within 2 weeks before, during, and after treatment with this medication. In some cases a serious (possibly fatal) drug interaction may occur. Certain MAO inhibitors (rasagiline, selegiline) may be used cautiously with close monitoring by your doctor. If you are currently using any of these medications listed above, tell your doctor or pharmacist before starting this medication. If you are taking rasagiline or selegiline for Parkinson's disease, ask your doctor if you should continue taking it. Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription products you may use, especially of: medications to treat high blood pressure (hypertension), other drugs to treat Parkinson's disease (including other drugs that contain levodopa, carbidopa, or entacapone), iron vitamins, tricyclic antidepressants (e.g., amitriptyline), phenytoin, papaverine, isoproterenol, adrenaline (epinephrine), norepinephrine, dopamine, dobutamine, alpha-methyldopa, apomorphine, isoetharine, bitolterol, probenecid, cholestyramine, metoclopramide, selegiline, certain antibiotics (e.g., erythromycin, ampicillin, rifampin, chloramphenicol). Also, report use of any medicine that can make you drowsy, such as: sedatives, tranquilizers, anti-anxiety medicine, anti-seizure drugs, narcotic pain relievers (e.g., codeine), psychiatric medicines, certain drowsiness-causing antihistamines (e.g., diphenhydramine). This medication can cause false results with urine glucose testing in diabetics. Blood glucose testing should be performed instead. This document does not contain all possible interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist.

Do not share this medication with others. Laboratory and/or medical tests (e.g., liver function tests, eye exams) should be performed periodically to monitor your progress or check for side effects. Consult your doctor for more details. People with Parkinson's disease may have an increased risk for developing skin cancer (melanoma). Tell your doctor promptly if you notice a change in the appearance or size of moles or other unusual skin changes. Ask your doctor if you should have regular skin exams.

If overdose is suspected, contact your local poison control center or emergency room immediately. US residents can call the US national poison hotline at 1-800-222-1222. Canadian residents should call their local poison control center directly. Symptoms of overdose may include: severe dizziness, irregular or fast heartbeat, increased blinking/eyelid spasms (blepharospasms).

Before taking this medication, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details. This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: glaucoma (narrow-angle). Before using this medication, tell your doctor or pharmacist your medical history, especially of: liver disease, glaucoma (wide-angle), breathing problems, heart disease (especially history of heart attack), kidney disease, ulcers, mental/mood disorders (e.g., depression, schizophrenia), blood disorders. To minimize dizziness and lightheadedness, get up slowly when rising from a seated or lying position. This drug may make you dizzy or drowsy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Limit alcoholic beverages. Before you have surgery with a general anesthetic, including dental surgery, tell the doctor or dentist you are taking this medication. This medication should be used only when clearly needed during pregnancy. Discuss the risks and benefits with your doctor. Levodopa passes into breast milk. It is unknown if carbidopa or entacapone pass into breast milk. Consult your doctor before breast-feeding.

Store at room temperature at 77 degrees F (25 degrees C) away from light and moisture. Brief storage from 59 to 86 degrees F (15-30 degrees C) is permitted. Do not store in the bathroom. Keep all medicines away from children and pets. Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.

Diarrhea, nausea, vomiting, headache, dizziness, drowsiness, stomach upset, loss of appetite, dry mouth, or difficulty sleeping may occur. If any of these effects persist or worsen, notify your doctor or pharmacist promptly. Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects. Tell your doctor immediately if any of these serious side effects occur: involuntary movements (especially twitching of the eyelid), fainting or falling, difficulty swallowing, stomach/abdominal pain, vision changes (including blurred vision). Tell your doctor immediately if any of these unlikely but serious side effects occur: black/tarry stools, muscle pain, change in the amount of urine, mental/mood changes (such as confusion, hallucinations, thoughts of suicide, compulsive behavior including urge to gamble), signs of infection (e.g., persistent sore throat). Seek immediate medical attention if any of these highly unlikely but very serious side effects occur: chest pain, high fever, severe muscle stiffness, fast heartbeat, fast breathing, increased sweating. This medication may cause the saliva, urine, or sweat to turn a dark color. This is harmless; however, it may discolor clothing. A serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction include: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing. This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist. In the US - Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.