Before you begin taking a medication, be sure to inform your doctor of any medical conditions or Allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should take Stalevo.
Behavioural and mood changes: Stalevo has been known to cause mood swings, changes in behaviour, and symptoms of depression. If you have depression or a history of depression, discuss with your doctor how Stalevo may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Stalevo, and whether any special monitoring is needed. You may notice compulsive behaviour, such as gambling, increased sexual activity, or inappropriate spending. If you experience symptoms of depression such as poor concentration, changes in weight, changes in sleep, decreased interest in activities, contact your doctor as soon as possible. If you notice compulsive behaviour or signs of depression in a family member, ensure that they see their doctor.
Bleeding: Levodopa – carbidopa – entacapone may cause a reduced number of platelets in the blood, which can make it difficult to stop cuts from bleeding. If you notice any signs of bleeding, such as frequent nosebleeds, unexplained bruising, or black and tarry stools, notify your doctor as soon as possible. Your doctor will order routine blood tests to make sure potential problems are caught early.
Diarrhea: Diarrhea is a common side effect of Stalevo. It may appear as early as the first week of starting treatment or many months after starting treatment. For some people, the diarrhea causes weight loss. If you notice any weight loss or have excessive diarrhea, contact your doctor.
Drowsiness/reduced alertness: Stalevo may cause Low Blood Pressure or dizziness and lightheadedness when rising from a lying or sitting position. Avoid driving or operating machinery until you know how Stalevo affects you.
Glaucoma: Stalevo may cause symptoms of glaucoma to get worse by increasing the pressure in the eye. If you have chronic wide-angle glaucoma, discuss with your doctor how Stalevo may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Stalevo, and whether any special monitoring is needed.
Heart disease: If you have heart disease (e.g., history of heart attack, arrhythmia), discuss with your doctor how Stalevo may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Stalevo, and whether any special monitoring is needed.
Infection: Stalevo has been reported to reduce the number of cells that fight infection in the body (white blood cells). If possible, avoid contact with people with contagious infections. Tell your doctor immediately if you notice signs of an infection, such as fever or chills, severe diarrhea, shortness of breath, prolonged dizziness, headache, stiff neck, weight loss, or listlessness. Your doctor will do blood tests regularly to monitor the number of specific types of blood cells in your blood.
Kidney disease: If you have kidney disease or reduced kidney function, discuss with your doctor how Stalevo may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Stalevo, and whether any special monitoring is needed.
Liver function: Liver disease or reduced liver function may cause Stalevo to build up in the body, causing side effects. If you have liver problems, discuss with your doctor how Stalevo may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Stalevo, and whether any special monitoring is needed.
Low blood pressure: Symptoms of low blood pressure, such as weakness or dizziness, particularly when rising suddenly from a sitting or lying position, may occur. People who are prone to low blood pressure or are taking medication to reduce blood pressure should be cautious when using Stalevo.
Melanoma: People with Parkinson's disease have an increased risk of developing melanoma (a type of skin cancer). It is not known if this increased risk is due to Parkinson's disease or to the medications used to treat Parkinson's disease. Your doctor will monitor you for skin cancer while you are taking Stalevo. Talk to your doctor if you have any concerns.
Neuroleptic malignant syndrome (NMS): Very rarely, levodopa - carbidopa - entacapone can cause a potentially fatal syndrome known as neuroleptic malignant syndrome (NMS). If you notice the symptoms of NMS such as high fever, muscle stiffness, confusion or loss of consciousness, sweating, racing or irregular heartbeat, or fainting, get immediate medical attention.
Peptic (stomach) ulcer: There is a possibility of stomach bleeding for people with a history of peptic ulcer who take levodopa - carbidopa - entacapone. If you have peptic ulcers or a history of peptic ulcers, discuss with your doctor how Stalevo may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Stalevo, and whether any special monitoring is needed. If you notice bloody or black tarry stools, stomach pain, or vomiting blood or material that looks like coffee grounds, contact your doctor immediately.
Prostate Cancer: Men who take Stalevo may have a slightly higher risk of developing prostate cancer. It is not known if this increased risk is due to the medication or some other factor. While taking Stalevo, it is important for men to keep appointments for regular prostate cancer screening. Talk to your doctor if you have any concerns.
Rhabdomyolysis (muscle breakdown): Occasionally, Stalevo may cause rapid breakdown of muscle tissue. If you notice signs of muscle weakness or pain, high body temperature, unexpected bruising, confusion, or difficulty passing urine, contact your doctor immediately.
Seizures: If you have seizures or a history of seizures, discuss with your doctor how Stalevo may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Stalevo, and whether any special monitoring is needed.
Stopping Stalevo: Stopping Stalevo too quickly can cause potentially life-threatening side effects. Before stopping Stalevo, discuss the risks and benefits with your doctor. Do not stop taking Stalevo until you have spoken with your doctor first.
Sudden onset of sleep: There are reports of people who take levodopa - carbidopa - entacapone combinations falling asleep with no warning or drowsiness. If you have a sleep disorder, discuss this with your doctor. If you experience drowsiness while taking Stalevo, avoid driving or using machinery.
Pregnancy: Stalevo should not be used during pregnancy unless the benefits outweigh the risks. If you become pregnant while taking Stalevo, contact your doctor immediately.
Breast feeding: Levodopa passes into breast milk. It is not known if carbidopa or entacapone pass into breast milk. If you are a breast-feeding mother and are taking levodopa - carbidopa - entacapone, it may affect your baby. Talk to your doctor about whether you should continue breast-feeding.
Children: The safety and effectiveness of using Stalevo have not been established for children.
