Brand Names: Stalevo 100, Stalevo 125, Stalevo 150, Stalevo 200, Stalevo 50, Stalevo 75

Generic Name: carbidopa, entacapone, and levodopa (Pronunciation: KAR bi DOE pa, en TAK a pone, LEE voe DOE pa)

• What is carbidopa, entacapone, and levodopa (Sinemet CR)?
• What are the possible side effects of carbidopa, entacapone, and levodopa?
• What is the most important information I should know about carbidopa, entacapone, and levodopa?
• What should I discuss with my healthcare provider before taking carbidopa, entacapone, and levodopa?
• How should I take carbidopa, entacapone, and levodopa?
• What happens if I miss a dose?
• What happens if I overdose?
• What should I avoid while taking carbidopa, entacapone, and levodopa?
• What other drugs will affect carbidopa, entacapone, and levodopa?
• Where can I get more information?

What is carbidopa, entacapone, and levodopa (Sinemet CR)?

Levodopa is converted to a chemical called dopamine (DOE pa meen) in the brain. Symptoms of Parkinson's disease may be caused by low levels dopamine in the brain.

Carbidopa helps prevent the breakdown of levodopa before it can reach the brain and take effect.

When used with carbidopa, entacapone, and levodopa (Atamet, Parcopa, Sinemet), entacapone increases levels of levodopa in the body.

The combination of carbidopa, entacapone, and levodopa is used to treat Parkinson symptoms such as muscle stiffness, tremors, spasms, and poor muscle control.

Carbidopa, entacapone, and levodopa may also be used for other purposes not listed in this medication guide.

Stalevo 100

oblong, brown, imprinted with LCE 100

Stalevo 150

oval, brown, imprinted with LCE 150

Stalevo 50

round, brown, imprinted with LCE 50

What are the possible side effects of carbidopa, entacapone, and levodopa?

You may notice that your sweat, urine, or saliva appears dark in color, such as red, brown, or black. This is not a harmful side effect, but it may cause staining of your clothes or bed sheets.

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any of these serious side effects:

• nausea, sweating, feeling like you might pass out (especially when you first start taking this medication);
• depression, confusion, hallucinations, unusual thoughts or behavior, thoughts about hurting yourself;
• twitching or uncontrollable movements of your eyes, lips, tongue, face, neck, arms, or legs;
• tremor (uncontrolled shaking);
• muscle pain, tenderness, or weakness with fever or flu symptoms;
• fast, pounding, or uneven heartbeats;
• tight feeling in your chest, trouble breathing;
• easy bruising or bleeding;
• bloody or tarry stools, coughing up blood;
• pain or burning when you urinate; or
• chest pain or heavy feeling, pain spreading to the arm or shoulder, general ill feeling.

Less serious side effects may include:

• stomach pain or upset, loss of appetite, constipation;
• dry mouth, changes in your sense of taste;
• unusual skin changes;
• dizziness or drowsiness;
• headache, blurred vision;
• sleep problems (insomnia), strange dreams;
• agitation or anxiety;
• muscle cramps, back pain; or
• mild skin rash or itching.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about carbidopa, entacapone, and levodopa?

Do not take this medication if you have used an MAO inhibitor such as isocarboxazid (Marplan), phenelzine (Nardil), or tranylcypromine (Parnate) within the past 14 days.

You should not take this medication if you are allergic to carbidopa (Lodosyn), entacapone (Comtan), or levodopa (Larodopa), or if you have narrow-angle glaucoma, unusual skin lesions, or a history of skin cancer.

Tell your doctor about all of your medical conditions, especially heart disease, high blood pressure, asthma or other breathing problems, liver or kidney disease, a hormonal disease, an ulcer, glaucoma, or mental illness. Also tell your doctor about all the medications you use.

It may take up to several weeks of using carbidopa, entacapone, and levodopa before your symptoms improve. For best results, keep using the medication as directed. Talk with your doctor if your symptoms do not improve after a few weeks of treatment. Also tell your doctor if the effects of this medication seem to wear off quickly in between doses.

You may have increased sexual urges, unusual urges to gamble, or other intense urges while taking this medication. Talk with your doctor if you believe you have any intense or unusual urges while taking carbidopa, entacapone, and levodopa.

Do not stop using carbidopa, entacapone, and levodopa without first talking to your doctor.