Product Information

Carbidopa, entacapone, and levodopa tablets

What is this medicine?

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 of dopamine in the brain. CARBIDOPA helps prevent the breakdown of levodopa before it can reach the brain and take effect. 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.

What should I tell my health care provider before I take this medicine?

Do not take this medication if you have used an MAO inhibitor such as furazolidone (Furoxone), isocarboxazid (Marplan), phenelzine (Nardil), or tranylcypromine (Parnate) in the last 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 that have not been checked by a doctor; or
• a history of malignant melanoma (skin cancer).

To make sure you can safely take this medication, tell your doctor if you have any of these other conditions:

• heart disease, high blood pressure, coronary artery disease, a heart rhythm disorder, or a prior heart attack;
• asthma, chronic obstructive pulmonary disease (COPD), or other breathing disorder;
• kidney disease, liver disease, or bile duct obstruction;
• an endocrine (hormonal) disease;
• a stomach or intestinal ulcer;
• glaucoma; or
• depression or other mental illness.

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 this medicine.

Carbidopa, entacapone, and levodopa may cause hallucinations (the sensation of hearing or seeing something that is not there). Call your doctor if you experience hallucinations.

Some people taking Parkinson's disease medications have developed skin cancer (melanoma). However, people with Parkinson's disease may have a higher risk of melanoma. Talk to your doctor about this risk and what skin symptoms to watch for. You may need to have regular skin exams.

FDA pregnancy category C. It is not known whether carbidopa, entacapone, and levodopa will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication.

Carbidopa, entacapone, and levodopa may pass into breast milk and could harm a nursing baby. You should not breast-feed while you are taking carbidopa, entacapone, and levodopa.

How should I take this medicine?

Take exactly as prescribed by your doctor. Do not take in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label. Take your medicine at regular intervals to keep a steady amount of the drug in your body at all times.

Drink plenty of liquids while you are taking this medication.

It may take up to several weeks before your symptoms improve. Keep using the medication as directed and tell 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.

Call your doctor if you have ongoing vomiting or diarrhea, or if you are sweating more than usual. You can easily become dehydrated while taking this medication, which can lead to severely low blood pressure or a serious electrolyte imbalance.

Do not stop using carbidopa, entacapone, and levodopa without first talking to your doctor. You may need to use less and less before you stop the medication completely.

This medication can cause unusual results with certain medical tests. Tell any doctor who treats you that you are using carbidopa, entacapone, and levodopa.

What if I miss a dose?

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What should I watch for while taking this medicine?

Carbidopa, entacapone, and levodopa may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert. Avoid getting up too fast from a sitting or lying position, or you may feel dizzy. Get up slowly and steady yourself to prevent a fall.

Avoid taking iron supplements or eating a diet that is high in protein (protein sources include meat, eggs, and cheese). These things can make it harder for your body to digest and absorb carbidopa, entacapone, and levodopa.

What side effects may I notice from this medicine?

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 a serious side effect such as:

• nausea, sweating, feeling like you migthisht pass out (especially when you first start taking this medication);
• depression, confusion, hallucinations, unusual thoughts or behavior, thoughts about hurting yourself;
• worsening symptoms such as tremors, twitching or uncontrollable movements of your eyes, lips, tongue, face, arms, or legs;
• severe or ongoing diarrhea, extreme thirst, increased urination, weight loss, leg discomfort, muscle weakness or limp feeling, uneven heart rate;
• feeling very thirsty or hot, being unable to urinate, heavy sweating, or hot and dry skin;
• fast, pounding, or uneven heartbeats;
• chest pain or heavy feeling, pain spreading to the arm or shoulder, general ill feeling;
• tight feeling in your chest, new or worsening cough, fever, trouble breathing;
• easy bruising or bleeding, bloody or tarry stools, coughing up blood;
• pain or burning when you urinate; or
• unexplained muscle pain, tenderness, or weakness.

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. mild rash or itching;
• dizziness or drowsiness, headache, blurred vision;
• muscle cramps, back pain; or
• agitation or anxiety, sleep problems (insomnia), strange dreams.

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.

What may interact with this medicine?

Cold or allergy medicine, narcotic pain medicine, sleeping pills, muscle relaxers, and medicine for seizures, depression or anxiety can add to sleepiness caused by carbidopa, entacapone, and levodopa. Tell your doctor if you regularly use any of these other medicines, or any other Parkinson's medications.

Tell your doctor about all other medicines you use, especially:

• apomorphine (Apokyn);
• cholestyramine (Prevalite, Questran);
• dobutamine (Dobutrex);
• epinephrine (Epi-Pen, and others);
• isoniazid (for treating tuberculosis);
• isoproterenol (Isuprel, Medihaler-Iso);
• methyldopa (Aldomet);
• metoclopramide (Reglan);
• papaverine (Pavabid, Papacon, Pavagen, Pavacot);
• phenytoin (Dilantin);
• probenecid (Benemid);
• blood pressure medication;
• an antibiotic such as ampicillin, chloramphenicol, erythromycin (E.E.S., EryPed, Ery-Tab, Erythrocin, Pediazole, and others), or rifampin (Rifadin, Rifater, Rifamate);
• an antidepressant such as amitriptyline (Elavil, Vanatrip, Limbitrol), doxepin (Sinequan), imipramine (Janimine, Tofranil), nortriptyline (Pamelor), and others; or
• medicines to treat psychiatric disorders, such as chlorpromazine (Thorazine), haloperidol (Haldol), prochlorperazine (Compazine), risperidone (Risperdal), and others.

This list is not complete and other drugs may interact with carbidopa, entacapone, and levodopa. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

Where can I keep my medicine?

Store at room temperature away from moisture and heat.