2. Country of Origin (why so many countries?)
Stalevo is a combination medication is used to treat symptoms of Parkinson's disease (such as shakiness, stiffness, difficulty moving). Parkinson's disease is thought to be caused by too little of a naturally occurring substance (dopamine) in the brain. Levodopa changes into dopamine in the brain, helping to control movement. Carbidopa and entacapone prevent the breakdown of levodopa in the bloodstream so more levodopa can enter the brain. Carbidopa can also reduce some of levodopa's side effects such as nausea and vomiting.
Take this medication by mouth with or without food as directed by your doctor, usually 3 to 4 times a day. Take only one tablet for each dose. Swallow the tablet whole. Do not crush, chew, or split the tablet. Doing so may cause you to get the wrong dose and may also cause staining of the mouth, dentures, and saliva.
Taking this medication with food may help to decrease nausea. It is best to avoid a high-protein diet (it decreases the amount of levodopa that your body takes in) during treatment, unless directed otherwise by your doctor. Also avoid taking this medication with a high-fat, high-calorie meal since this can slow down the time it begins to work by about 2 hours.
Separate your dose of this medication by as many hours as possible from any iron supplements or products containing iron (such as multivitamins with minerals) you may take. Iron can reduce the amount of this medication absorbed by the body. Consult your doctor or pharmacist for more details.
The dosage is based on your medical condition and response to treatment. Use this medication regularly to get the most benefit from it. To help you remember, take it at the same times each day.
Some patients may experience a "wearing-off" (worsening of symptoms) before the next dose is due. An "on-off" effect might also occur, in which sudden short periods of stiffness occur. If these effects occur, contact your doctor for possible dose adjustments that may help to lessen this effect.
Do not stop taking this medication without consulting your doctor. Some conditions may become worse when this drug is suddenly stopped. Your dose may need to be gradually decreased.
Tell your doctor if your condition does not improve or if it worsens.
Before taking this medication, tell your doctor or pharmacist if you are allergic to carbidopa, levodopa, or entacapone; 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 (such as asthma), heart disease (such as heart attack, irregular heartbeat), kidney disease, stomach/intestinal ulcer, mental/mood disorders (such as depression, schizophrenia), blood disorders, seizures, sleep disorders.
This drug may make you dizzy or drowsy. Alcohol or marijuana (cannabis) can make you more dizzy or drowsy. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Limit alcoholic beverages. Talk to your doctor if you are using marijuana (cannabis).
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.
Diarrhea, nausea, vomiting, dizziness, lightheadedness, drowsiness, stomach upset, loss of appetite, trouble sleeping, headache, or dry mouth may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.
This medication may cause saliva, urine, or sweat to turn a dark color. This effect is harmless, but your clothes may be stained.
To reduce the risk of dizziness and lightheadedness, get up slowly when rising from a sitting or lying position.
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 even if you have used this medication for a long time. If you experience increased sleepiness or fall asleep during the day, do not drive or do 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.
Tell your doctor right away if you have any serious side effects, including: new/worsening movements you can't control/spasms, greatly increased eye blinking/twitching, fainting, diarrhea that doesn't stop, vision changes (such as blurred vision), eye pain, severe stomach/abdominal pain, black/tarry stools, vomit that looks like coffee grounds, muscle pain/tenderness/weakness, signs of kidney problems (such as change in the amount of urine), mental/mood changes (such as confusion, hallucinations, thoughts of suicide), signs of infection (such as sore throat that doesn't go away), easy bleeding/bruising, unusual tiredness, tingling of the hands/feet, 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.
Suddenly stopping or reducing the dose of this medication may rarely cause a very 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.
Q: What happens if I miss a dose?
A: Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.
Q: What should I avoid while taking Stalevo?
A: Avoid driving or hazardous activity until you know how Stalevo 100 will affect you. Your reactions could be impaired. Avoid getting up too fast from a sitting or lying position, or you may feel dizzy.
Avoid taking iron supplements without your doctor's advice. Also avoid increasing the amount of protein in your diet (protein sources include meat, eggs, and cheese). Taking iron or eating too much protein can make it harder for your body to digest and absorb Stalevo.
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