"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)
This medication may cause the saliva, urine, or sweat to turn a dark color. This is harmless; however, it may discolor clothing.
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 taking this medication have fallen 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. This sleep effect may occur anytime during treatment with this medication, including up to 1 year after starting the medication. 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 of this sleep effect is increased by using alcohol or other medications that can make you drowsy. See also Precautions section.
Tell your doctor right away if you have any serious side effects, including: involuntary movements (especially twitching of the eyelid), fainting or falling, difficulty swallowing, stomach/abdominal pain, persistent diarrhea, vision changes (including blurred vision), black/tarry stools, muscle pain, change in the amount of urine, mental/mood changes (such as confusion, hallucinations, thoughts of suicide), signs of infection (e.g., persistent sore throat), unusual strong urges (such as increased gambling, increased sexual urges).
Get medical help right away if you have any very serious side effects, including: chest pain.
Abruptly stopping or reducing the dose of this medication may rarely cause a serious condition called neuroleptic malignant syndrome (NMS). Get medical help right away if you have any of the following symptoms: fever, unusual muscle stiffness, severe confusion, sweating, fast/irregular heartbeat, rapid breathing.
A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: 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.
Before using this medication, tell your doctor or pharmacist your medical history, especially of: liver disease, glaucoma, breathing problems, heart disease (especially history of heart attack), kidney disease, ulcers, mental/mood disorders (e.g., depression, schizophrenia), blood disorders, sleep 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. See also Side Effects section.
Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).
During pregnancy, this medication should be used only when clearly needed. 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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