Entacapone Oral tablet

What is this medicine?

ENTACAPONE (en TA ka pone) is used in combination with levodopa; carbidopa therapy to treat Parkinson's disease.

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:

• liver disease

• an unusual or allergic reaction to entacapone, other medicines, foods, dyes, or preservatives

• pregnant or trying to get pregnant

• breast-feeding

How should I use this medicine?

Take this medicine by mouth with a glass of water at the same time you take your levodopa-carbidopa. Follow the directions on the prescription label. You can take this medicine with or without food. 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:

• isoniazid

• medicines called MAO Inhibitors like Nardil, Parnate, Marplan, Eldepryl

• procarbazine

This medicine may also interact with the following medications:

• ampicillin

• apomorphine

• bitolterol

• cholestyramine

• chloramphenicol

• dopamine, dobutamine

• epinephrine, norepinephrine

• erythromycin

• isoetharine

• isoproterenol

• methyldopa

• probenecid

• rifampicin

• 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?

This medicine may also increase the side effects caused by levodopa-carbidopa like nausea or restless movements. If you notice an increase in or the appearance of certain side effects, 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 may interfere with the effect of this medicine. Avoid alcoholic drinks. Dizziness and sleepiness are more common at the beginning of treatment with this medicine.

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.

This medicine may cause urine to look dark yellow to orange or brown in color. This is normal and is not cause for concern.

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

• decrease in urination

• diarrhea

• feeling faint or lightheaded, falls

• fever

• hallucinations

• involuntary muscle movements

• sore muscles

• stomach pain

• vomiting

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

• constipation

• drowsiness or fatigue

• nausea

• upset stomach

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.