Stalevo 75, Stalevo 100, Stalevo 50, Stalevo 200, Stalevo 125, Stalevo 150

Levodopa, Carbidopa, and Entacapone

(lee voe DOE pa, kar bi DOE pa, & en TA ka pone)

Stalevo

It is used to treat Parkinson's disease.

If you are allergic to this drug; any part of this drug; or any other drugs, foods, or substances. Tell your doctor about the allergy and what signs you had. If you have any of these health problems: Glaucoma, a skin lump or growth, or a history of skin cancer. If you have taken certain drugs for depression or Parkinson's disease in the last 14 days. This includes isocarboxazid, phenelzine, tranylcypromine, selegiline, or rasagiline. Very high blood pressure may happen. This is not a list of all drugs or health problems that interact with this drug. Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take this drug with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

Tell all of your health care providers that you take this drug. This includes your doctors, nurses, pharmacists, and dentists. Avoid driving and doing other tasks or actions that call for you to be alert until you see how this drug affects you. To lower the chance of feeling dizzy or passing out, rise slowly if you have been sitting or lying down. Be careful going up and down stairs. Have blood work checked as you have been told by the doctor. Talk with the doctor. This drug may affect certain lab tests. Tell all of your health care providers and lab workers that you take this drug. This drug may "wear off" as the time for your next dose gets closer. Tell your doctor if this happens and it bothers you. It may take a few months to see the full effect. Talk with your doctor before you drink alcohol or use other drugs and natural products that slow your actions. A dark color (red, brown, or black) may show up in your saliva, urine, or sweat. This is not harmful but may discolor your clothes. If diarrhea or throwing up happens, talk with the doctor. You will need to make sure to avoid dehydration and electrolyte problems. Neuroleptic malignant syndrome (NMS) is a very bad and sometimes deadly health problem that has happened when this drug was stopped all of a sudden. NMS has also happened when the dose of this drug was lowered. Call your doctor right away if you have any fever, muscle cramps or stiffness, dizziness, very bad headache, confusion, change in thinking, fast heartbeat, heartbeat that does not feel normal, or are sweating a lot. Tell your doctor if you are pregnant, plan on getting pregnant, or are breast-feeding. You will need to talk about the benefits and risks to you and the baby.

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect: Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat. New or worse behavior or mood changes like depression or thoughts of suicide. Hallucinations (seeing or hearing things that are not there). Very bad dizziness or passing out. Feeling confused. Throwing up blood or throw up that looks like coffee grounds. Black, tarry, or bloody stools. Muscle pain or weakness, dark urine, or trouble passing urine. A skin lump or growth. Change in color or size of a mole. Strong urges that are hard to control (such as eating, gambling, sex, or spending money). Trouble controlling body movements that is new or worse. Chest pain or pressure. Shortness of breath. Fever, chills, or sore throat; any unexplained bruising or bleeding; or feeling very tired or weak. Some people have fallen asleep during activities like driving, eating, or talking. Some people did not feel sleepy and felt alert right before falling asleep. This has happened up to 1 year after this drug was started. If you fall asleep during activities, do not drive or do other tasks or actions that call for you to be alert while you take this drug. Call your doctor right away if this happens or you feel very sleepy.

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away: Feeling dizzy, sleepy, tired, or weak. Constipation, diarrhea, stomach pain, upset stomach, or throwing up. Dry mouth. Headache. Trouble sleeping. Back pain. These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-332-1088. You may also report side effects at https://www.fda.gov/medwatch.

Use this drug as ordered by your doctor. Read all information given to you. Follow all instructions closely. Take with or without food. Swallow whole. Do not chew, break, or crush. If you take an iron product or a multivitamin that has iron, ask your doctor or pharmacist how to take it with this drug. Iron may lower how well your body is able to absorb this drug. Diets high in protein, fat, or calories may lower how well your body absorbs this drug; tell your doctor if you have a diet like this or if you will be changing your diet. Talk with your doctor. Do not stop taking this drug all of a sudden without calling your doctor. You may have a greater risk of side effects. If you need to stop this drug, you will want to slowly stop it as ordered by your doctor. Keep taking this drug even when you are not having symptoms. Keep a diary of your signs. Keep taking this drug as you have been told by your doctor or other health care provider, even if you feel well. Take this drug at the same time of day.

Take a missed dose as soon as you think about it. If it is close to the time for your next dose, skip the missed dose and go back to your normal time. Do not take 2 doses at the same time or extra doses.

Store at room temperature in a dry place. Do not store in a bathroom. Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets. Throw away unused or expired drugs. Do not flush down a toilet or pour down a drain unless you are told to do so. Check with your pharmacist if you have questions about the best way to throw out drugs. There may be drug take-back programs in your area.

If your symptoms or health problems do not get better or if they become worse, call your doctor. Do not share your drugs with others and do not take anyone else's drugs. Some drugs may have another patient information leaflet. Check with your pharmacist. If you have any questions about this drug, please talk with your doctor, nurse, pharmacist, or other health care provider. If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using this medicine.