In the U.S.—

• Antidyskinetic

Carbidopa, entacapone and levodopa (kar-bi-DOE-pa, en-TA-ka-pone and lee-voe-DOE-pa ) is used to treat Parkinson's disease, sometimes referred to as shaking palsy. Parkinson's disease is a disorder of the central nervous system (brain and spinal cord).

Dopamine is a naturally occurring substance in the brain that helps provide control of movement and activities such as walking and talking. In patients with Parkinson's disease there is not enough dopamine in some parts of the brain. Levodopa (a component of this medicine) enters the brain and helps replace the missing dopamine, which allows people to function better. By increasing the amount of dopamine in the brain levodopa helps control symptoms and helps you to perform daily activities such as dressing, walking and handling utensils.

This medicine is a combination of three different medicines. This medicine is known as a levodopa therapy. The difference between this medicine and other levodopa therapies is that this medicine also has entacapone in it. Entacapone helps levodopa last longer by blocking a substance called COMT enzyme. This enzyme breaks down levodopa before it reaches the brain. When less levodopa is broken down, more is available to the brain. Increased availability of levodopa may lead to smoother and steadier levels of dopamine in the brain, which may provide better symptom control for longer periods each day. This may lead to improvement in daily activities.

This medicine is available only with your doctor's prescription, in the following dosage forms:

Oral
• Tablets (U.S.)

In deciding to use a medicine, the risks of using the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For carbidopa, entacapone and levodopa combination, the following should be considered:

Allergies—Tell your doctor if you have ever had any unusual or allergic reaction to carbidopa, entacapone or levodopa. Also tell your doctor and pharmacist if you are allergic to any other substances, such as foods, preservatives, or dyes.

Diet—Since protein may interfere with the body's response to levodopa, high protein diets should be avoided. Intake of normal amounts of protein should be spaced equally throughout the day, or taken as directed by your doctor.

Pregnancy—Carbidopa, entacapone and levodopa has not been studied in pregnant women. However, studies in animals have shown that entacapone causes problems with the development of offspring. Before taking this medicine, make sure your doctor knows if you are pregnant or if you may become pregnant.

Breast-feeding—It is not known whether carbidopa, entacapone and levodopa passes into breast milk. Breast feeding is not recommended during treatment.

Children—Studies on this medicine have been done only in adult patients, and there is no specific information comparing use of carbidopa, entacapone or levodopa in children with use in other age groups.

Older adults—Many medicines have not been studied specifically in older people. Therefore, it may not be known whether they work the same way in older people as they do in younger adults or if they cause different side effects or problems in older people. There is no specific information comparing the use of carbidopa, entacapone and levodopa combination in the elderly with use in other age groups.

Other medicines—Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking carbidopa, entacapone and levodopa combination, it is especially important that your doctor and pharmacist know if you are taking any of the following:

• Alpha-methyldopa (e.g., Aldomet, Aldoril)
• Apomorphine (e.g., Apokyn)
• Bitolterol (e.g., Tornalate)
• Dobutamine (e.g., Dobutrex)
• Dopamine (e.g., Intropin)
• Epinephrine (e.g., Adrenalin)
• Isoetharine (e.g., Beta-2, Bronkometer)
• Isoproterenol (e.g., Isuprel)
• Norepinephrine (e.g., Levophed)—These medicines can cause certain side effects when given at the same time as carbidopa, entacapone and levodopa combination.

• Phenelzine (e.g., Nardil) or
• Tranylcypromine (e.g., Parnate)—Taking carbidopa, entacapone and levodopa combination while you are taking or within 2 weeks of taking these medicines may cause sudden extremely high blood pressure; at least 14 days should be allowed between stopping treatment with one medicine and starting treatment with the other medicine)

Tell your health care professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

• Narrow–angle glaucoma (eye pressure problem)—Carbidopa, entacapone and levodopa combination should not be used in patients with this medical problem.

• Melanoma, history of (skin cancer) or
• Skin lesions, undiagnosed (rashes that involve changes in color or texture of the skin)—This medicine may make these medical problems worse.

• Heart attack, history of, with arrhythmias (abnormal heart rhythms)—This medicine should be used with caution with these medical problems.

• Wide-angle glaucoma (eye pressure problem)—This medicine should be used with caution with this medical problem.

It is very important that you take your medicine exactly as directed, and every time that you are supposed to take it. It is important that you do not stop taking your medication unless ordered by your doctor. It is also important to not start taking other medicines for your Parkinson's disease without first talking with your doctor.

You may experience a “wearing-off” effect towards the end of the dosing interval. You should tell your doctor if you have problems with this that affect your every day life. Your doctor may want to adjust your dose.

This medicine begins to release its ingredients 30 minutes after you take it.

It is possible that a dark color (red, brown, or black) may appear in saliva, urine, or sweat after taking this medicine. The color may cause some of your garments to become discolored.

It is important to discuss with your doctor any change to your diet. High protein diets or too much acidity in your stomach may cause problems with the way this medicine is absorbed by your body.

If you are taking multi-vitamin tablets or plan to start taking them discuss this with your doctor. Iron salts (in vitamins) may cause this medicine not to work as well.

Dosing—

The dose of carbidopa, entacapone and levodopa combination will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of carbidopa, entacapone and levodopa combination. If your dose is different, do not change it unless your doctor tells you to do so. If you have any questions about the proper dose of carbidopa, entacapone and levodopa combination ask your doctor.

• For oral dosage form (capsules):
  • For Parkinson's disease:
    • Adults—The starting dose is usually the same as the current dose you are taking. If you are starting this medicine for the first time your doctor may want to start you on a carbidopa and levodopa combination with entacapone and gradually switch you over to this combination.
    • Children—Use and dose must be determined by your doctor.

Storage—

To store this medicine:

• Keep out of the reach of children.
• Do not store in the bathroom, near the kitchen sink, or in other damp places. Heat or moisture may cause the medicine to break down.
• Keep the medicine from freezing. Do not refrigerate.
• Do not keep outdated medicine or medicine no longer needed. Ask your health care professional how you should dispose of any medicine you do not use. Be sure that any discarded medicine is out of the reach of children.

It is important to understand that hypotension (decrease in blood pressure, especially when getting up from a sitting position) may develop. This may occur more frequently when you are beginning treatment with the medicine or when your dosage is increased.

You should get up carefully after sitting or lying down, especially if you have been doing so for long periods of time. You should use extra caution when getting up after sitting or lying down, especially during the beginning of treatment with carbidopa, entacapone and levodopa combination.

It is very important that you discuss new medications with your doctor before starting any new medications.

It is possible that you may experience hallucinations (seeing or hearing things that are not there) or an increase in dyskinesia (trouble in moving). Talk with your doctor if you have any questions about this.

It is possible that you may become nauseous, especially when you are first starting your medicine.

It is important to tell your doctor if you are pregnant or breast-feeding or are planning to become pregnant or planning to breast feed your baby.

This medicine may cause some people to become drowsy, dizzy, or less alert than they are normally. Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you are dizzy or are not alert.

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Also, because of the way these medicines act on the body, there is a chance that they might cause other unwanted effects that may not occur until months or years after the medicine is used. These may include certain types of cancer, such as leukemia or bladder cancer. Discuss these possible effects with your doctor.

Check with your doctor immediately if any of the following side effects occur:

• More common-Entacapone
  • Twitching, twisting, uncontrolled repetitive movements of tongue, lips, face, arms, or legs 
  
  

• Incidence unknown-Carbidopa and Levodopa and/or Levodopa alone
  • Bleeding gums;  bloody or black, tarry stools;  bloody or cloudy urine;  bluish color;  change in size, shape or color of existing mole;  changes in skin color;  chest pain, discomfort, or tightness;  constipation ;  constricted pupil;  convulsions ;  cough;  dark-colored urine ;  difficult or labored breathing;  difficulty in speaking;  drooling;  drooping eyelid (ptosis);  facial dryness;  fast, irregular, or pounding heart beat;  fever with or without chills;  fixed position of eye ;  general feeling of illness;  hallucinations [seeing, hearing, or feeling things that are not there];  hoarseness;  high or low blood pressure ;  large, flat, blue or purplish patches in the skin ;  large, hive-like swelling on face, eyelids, lips, tongue, throat, hands, legs, feet, sex organs;  loss of appetite;  loss of bladder control;  lower abdominal pain;  lower back or side pain;  mole that leaks fluid or bleeds;  muscle cramps or spasms;  muscle pain or stiffness;  muscle trembling, jerking, or stiffness ;  nausea;  new mole;  pain;  painful knees and ankles;  pain or discomfort in arms, jaw, back or neck;  painful or difficult urination;  pale skin;  pinpoint red spots on skin;  raised red swellings on the skin, the buttocks, legs or ankles;  restlessness;  seizures;  severe mental changes;  severe stomach pain;  shakiness and unsteady walk;  shortness of breath;  shuffling walk;  sore throat;  sores, ulcers, or white spots on lips or in mouth;  stomach pain;  sweating;  swollen glands;  tenderness and swelling of foot or leg;  trembling, or other problems with muscle control or coordination;  uncontrolled movements, especially of face, neck, and back;  unusual bleeding or bruising;  unusual tiredness or weakness;  vomiting;  vomiting of blood or material that looks like coffee grounds 
  
  

Other side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. However, check with your doctor if any of the following side effects continue or are bothersome.

• More common-Entacapone
  • Absence of or decrease in body movement;  diarrhea;  dizziness;  urine discoloration 
  
  

• Less common-Entacapone
  • Acid or sour stomach;  anxiety;  bacterial infection;  belching;  bitter, sour or unusual taste in mouth;  bloated;  burning feeling in chest or stomach;  discomfort;  dry mouth;  excess air or gas in stomach or intestines;  fear;  full feeling;  heartburn ;  hyperventilation;  increased sweating;  indigestion;  irritability;  lack or loss of strength;  nervousness;  passing gas;  restlessness;  sleepiness or unusual drowsiness;  stomach discomfort, or upset;  swollen mouth and tongue;  tenderness in stomach area;  trouble sleeping;  urge to have bowel movement;  wheezing 
  
  

• Incidence unknown-Carbidopa and Levodopa and/or Levodopa alone
  • Being forgetful;  bizarre breathing patterns ;  bladder pain;  blurred vision;  body aches or pain;  burning, crawling, itching, numbness, prickling, "pins and needles" , or tingling feelings;  burning and upper abdominal pain;  burning sensation of the tongue;  clenching, gnashing, or grinding teeth;  confusion about identity, place, and time;  dark saliva;  dark sweat;  decreased mental acuity;  difficulty opening the mouth;  difficulty swallowing;  discouragement;  double vision;  ear congestion;  enlarged pupils;  excessive watering of mouth;  fainting;  faintness, or lightheadedness when getting up from a lying or sitting position suddenly;  false or unusual sense of well-being;  feeling like you will pass out;  feeling of warmth;  feeling sad or empty;  flushing;  hives or welts;  hair loss;  increased blinking;  headache;  hiccups;  increased interest in sexual ability, desire, drive, or performance;  increased interest in sexual intercourse;  lack of appetite ;  large, hard skin blisters;  leg pain;  lockjaw;  loss of interest or pleasure;  loss of voice;  muscle spasm, especially of neck and back;  nasal congestion;  nightmares;  numbness;  pain in the chest below the breastbone ;  painful or prolonged erection of the penis;  pharyngeal pain;  poor insight and judgment ;  pounding in the ears;  problems with memory or speech;  redness of skin;  redness of the face, neck, arms and occasionally upper chest ;  runny nose;  sense of stimulation ;  shoulder pain;  skin rash ;  sleeplessness;  slow movement ;  slow or fast heartbeat;  slow reflexes;  sneezing;  swelling;  tremor, increased;  trouble concentrating;  trouble recognizing objects ;  trouble thinking and planning;  twitching of eyelids;  urinary frequency;  urinary retention;  weight gain;  weight loss 
  
  

Other side effects not listed above may also occur in some patients. If you notice any other effects, check with your doctor.