"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"...
Sinemet 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.
This medication may cause your urine, sweat or saliva to turn red, brown, or black. This is harmless, but your clothes may become discolored.
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 carbidopa/levodopa, 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 immediately if any of these unlikely but serious side effects occur: greatly increased eye blinking/twitching, fainting, mental/mood changes (e.g., confusion, depression, hallucinations, thoughts of suicide), unusual strong urges (such as increased gambling, increased sexual urges), worsening of involuntary movements/spasms.
Tell your doctor immediately if any of these rare but very serious side effects occur: easy bleeding/bruising, signs of infection (e.g., fever, persistent sore throat), tingling of the hands/feet, vision changes (e.g., blurred/double vision).
Seek immediate medical attention if any of these rare but very serious side effects occur: chest pain, seizures, vomit that looks like coffee grounds, black/tarry stools.
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.
For males, in the very unlikely event you have a painful or prolonged erection (lasting more than 4 hours), stop using this drug and seek immediate medical attention or permanent problems could occur.
A very serious allergic reaction 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 Sinemet (carbidopa-levodopa) 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 carbidopa or levodopa; 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: bleeding disorders, breathing problems (e.g., asthma, emphysema), glaucoma, heart or blood vessel problems (e.g., arrhythmias, heart attack, angina), kidney disease, liver disease, mental/mood disorders (e.g., depression, schizophrenia), peptic ulcer, seizure, sleep disorder.
This drug may make you drowsy or dizzy or cause blurred vision. Do not drive, use machinery, or do any activity that requires alertness or clear vision until you are sure you can perform such activities safely. Limit alcoholic beverages. See also Side Effects section.
To minimize lightheadedness, get up slowly when rising from a sitting or lying position.
Before having surgery, tell your doctor or dentist that 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 may pass into breast milk and affect milk production. 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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