CARBIDOPA-LEVODOPA-ENTACAPONE (Generic for STALEVO 100)

Take this medicine by mouth with a glass of water. Follow the directions on the prescription label. Do not cut, crush, or chew this medicine. Take only one tablet of this medicine at each dose. You can take this medicine with or without food. However, avoid foods that are high in fat, calories, and protein near the time of taking this medicine. Take your doses at regular intervals. Do not take your medicine more often than directed. Do not stop taking except on the advice of your doctor or health care professional.
 
Talk to your pediatrician regarding the use of this medicine in children. Special care may be needed.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.
NOTE: This medicine is only for you. Do not share this medicine with others.

Visit your health care professional for regular checks on your progress. Tell your health care professional if your symptoms do not start to get better or if they get worse. Do not stop taking except on your health care professional's advice. You may develop a severe reaction. Your health care professional will tell you how much medicine to take.
 
You may get drowsy or dizzy. Do not drive, use machinery, or do anything that needs mental alertness until you know how this medicine affects you. Do not stand or sit up quickly, especially if you are an older patient. This reduces the risk of dizzy or fainting spells. Alcohol may interfere with the effect of this medicine. Avoid alcoholic drinks.
 
When taking this medicine, you may fall asleep without notice. You may be doing activities like driving a car, talking, or eating. You may not feel drowsy before it happens. Contact your health care provider right away if this happens to you.
 
There have been reports of increased sexual urges or other strong urges such as gambling while taking this medicine. If you experience any of these while taking this medicine, you should report this to your health care provider as soon as possible.
 
Your mouth may get dry. Chewing sugarless gum or sucking hard candy, and drinking plenty of water may help. Contact your doctor if the problem does not go away or is severe.
 
You may experience a 'wearing off' effect prior to the time for your next dose of this medicine. You may also experience an 'on-off' effect where the medicine apparently stops working for anything from a minute to several hours, then suddenly starts working again. Tell your doctor or health care professional if any of these symptoms happen to you. Your dosage may need adjustment.
 
A high protein diet can slow or prevent absorption of levodopa. Avoid high protein foods near the time of taking this medicine to help prevent this problem. You may want to eat higher protein foods later in the day or in small amounts. Discuss your diet with your doctor or nutritionist.
 
Do not take iron supplements within 2 hours of taking this medicine. The iron may decrease the amount of levodopa in your system and decrease the effectiveness of the drug
 
If you have diabetes, you may get a false-positive result for sugar in your urine. Check with your doctor or health care professional.
 
This medicine may discolor your urine, saliva or sweat, making it look darker or red in color. This is of no cause for concern. However, this may stain clothing or fabrics.
 
This medicine may cause a decrease in vitamin B6. You should make sure that you get enough vitamin B6 while you are taking this medicine. Discuss the foods you eat and the vitamins you take with your health care professional.
 
You should check your skin often for changes to moles and new growths while taking this medicine. Call your doctor if you notice any of these changes.

If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses.

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Keep out of the reach of children.

Store at room temperature between 15 and 30 degrees C (59 and 86 degrees F). Throw away any unused medicine after the expiration date.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.