"The US Food and Drug Administration (FDA) has approved an extended-release capsule formulation of carbidopa-levodopa (Rytary, IPX066, Impax Pharmaceuticals) for the treatment of Parkinson's disease (PD), postencephalitic parkinsonism, an"...
Stalevo Consumer (continued)
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.
Some people using this medication have reported falling asleep suddenly during their usual daily activities (such as talking on the phone, driving). In some cases, sleep occurred without any feelings of drowsiness beforehand. Therefore, you should not drive or take part in other possibly dangerous activities until you are certain that this medication will not cause drowsiness or sudden sleep. If you experience increased sleepiness or fall asleep during the day, do not drive or take part in other possibly dangerous activities until you have discussed this effect with your doctor. Your risk is increased with use of alcohol or other medications that can make you drowsy.
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, persistent diarrhea, 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.
Read the Stalevo (carbidopa, levodopa and entacapone) Side Effects Center for a complete guide to possible side effects
PRECAUTIONS: 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.
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Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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