Carbidopa, Levodopa, Entacapone Oral tablet

What is this medicine?

CARBIDOPA; LEVODOPA; ENTACAPONE (kar bi DOE pa; lee voe DOE pa; en TA ka pone) is used to treat Parkinson's disease. Carbidopa and entacapone help levodopa to work better.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

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

They need to know if you have any of these conditions:

• depression or other mental illness

• diabetes

• glaucoma

• heart disease, including history of a heart attack

• irregular heart beat

• kidney disease

• liver disease

• lung or breathing disease, like asthma

• melanoma or suspicious skin lesions

• stomach or intestinal ulcers

• an unusual or allergic reaction to levodopa, carbidopa, entacapone, other medicines, foods, dyes, or preservative

• pregnant or trying to get pregnant

• breast-feeding

How should I use this medicine?

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.

What if I miss a dose?

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.

What may interact with this medicine?

Do not take this medicine with any of the following medications:

• MAOIs like Marplan, Nardil, and Parnate

• reserpine

This medicine may also interact with the following medications:

• ampicillin

• apomorphine

• chloramphenicol

• cholestyramine

• droperidol

• epinephrine

• erythromycin

• iron supplements

• isoproterenol

• isoniazid, INH

• linezolid or tedizolid

• medicines for depression, anxiety, or psychotic disturbances

• medicines for high blood pressure

• metoclopramide

• phenytoin

• probenecid

• rasagiline

• rifampin

• selegiline

• warfarin

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medicine?

Visit your doctor or health care professional for regular checks on your progress. Do not take any additional medicines for Parkinson's disease without first consulting with your health care provider.

Entacapone may increase the side effects caused by Levodopa; Carbidopa such as nausea or restless movements. If you notice an increase in or the appearance of certain side effects that occurred only while you are taking Levodopa; Carbidopa, contact your physician. The dose of Levodopa-Carbidopa may need to be lowered. Do not decrease your medicine dose without asking your doctor or health care professional.

You may get dizzy or have difficulty controlling your movements. 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 can increase possible dizziness. Avoid alcoholic drinks.

If you find that you have sudden feelings of wanting to sleep during normal activities, like cooking, watching television, or while driving or riding in a car, you should contact your health care professional.

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.

There have been reports of increased sexual urges or other strong urges such as gambling while taking some medicines for Parkinson's disease. If you experience any of these urges while taking this medicine, you should report it to your health care provider as soon as possible.

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.

What side effects may I notice from receiving this medicine?

Side effects that you should report to your doctor or health care professional as soon as possible:

• allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue

• confusion

• diarrhea

• falling asleep during normal activities like driving

• fast, irregular heartbeat

• feeling faint or lightheaded

• fever

• hallucination, loss of contact with reality

• involuntary muscle movements

• mood changes like aggressive behavior, depression

• sore muscles

• stomach pain

• trouble passing urine or change in the amount of urine

• uncontrolled movements of the mouth, head, hands, feet, shoulders, eyelids or other unusual muscle movements

• unusually weak or tired

Side effects that usually do not require medical attention (report to your doctor or health care professional if they continue or are bothersome):

• constipation

• headache

• muscle twitches

• nightmares, trouble sleeping

• upset stomach or loss of appetite

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.

Where should I keep my medicine?

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.