Stalevo 200

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.

Store at room temperature away from moisture and heat.

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.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. Overdose symptoms may include weakness, loss of coordination, trouble breathing, fainting, or seizure (convulsions).

Carbidopa, entacapone, and levodopa combination is used to treat Parkinson's disease, sometimes called 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 treatments is that this medicine contains entacapone. 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.

It is very important that your doctor check your progress at regular visits to allow changes in your dose and to check for any unwanted effects.

Do not take this medicine if you have taken a monoamine oxidase (MAO) inhibitor (eg, isocarboxazid [Marplan®], phenelzine [Nardil®] or tranylcypromine [Parnate®]) in the past 2 weeks.

Do not stop taking this medicine without first checking with your doctor. Your doctor may want you to gradually reduce the amount you are taking before stopping completely.

Check with your doctor right away if you are having convulsions (seizures), difficulty with breathing, a fast heartbeat, a high fever, high or low blood pressure, increased sweating, loss of bladder control, severe muscle stiffness, unusually pale skin, or tiredness. These could be symptoms of a serious condition called neuroleptic malignant syndrome (NMS).

This medicine may cause dizziness, drowsiness, trouble in controlling movements, or trouble in concentrating or seeing clearly. It may even cause you to fall asleep without warning while you drive, talk, or eat. Make sure you know how you react to this medicine before you drive, use machines, or do other jobs that require you to be alert, well-coordinated, or able to think or see well.

Dizziness, lightheadedness, or fainting may occur with this medicine, especially when you get up from a lying or sitting position suddenly. These symptoms are more likely to occur when you begin taking this medicine, or when the dose is increased. Getting up slowly may also help. If this problem continues or gets worse, check with your doctor.

This medicine will add to the effects of other CNS depressants (medicines that make you drowsy or less alert). Some examples of CNS depressants are antihistamines or medicine for hay fever, other allergies, or colds, sedatives, tranquilizers, or sleeping medications, prescription pain medicine or narcotics, medicine for seizures or barbiturates, muscle relaxants, or anesthetics, including some dental anesthetics. Check with your medical doctor or dentist before taking any of the above while you are taking this medicine.

This medicine may cause diarrhea, and in some cases it can be severe. It can occur months after starting this medicine. Do not take any medicine to treat diarrhea without first checking with your doctor. Diarrhea medicines may make the diarrhea worse or make it last longer. If you have any questions about this or if mild diarrhea continues or gets worse, check with your doctor.

If you develop any unusual or strange thoughts and behavior while receiving this medicine, be sure to discuss it with your doctor. Other changes might be confusion, worsening of depression, visual hallucinations (seeing things that are not there), suicidal thoughts, and unusual excitement, nervousness, or irritability.

Check with your doctor right away if you have dark-colored urine, fever, muscle cramps or spasms, muscle pain or stiffness, or unusual tiredness or weakness. These may be symptoms of a condition called rhabdomyolysis.

Check with your doctor right away if you are having shortness of breath, chest tightness, or any type of breathing problem while being treated with this medicine.

It is important that your doctor check your skin regularly for signs of a skin cancer called melanoma. If you notice any unusual red, brown, or black spots on your skin, talk to your doctor right away.

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. This is normal and nothing to worry about.

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

Some people who have used this medicine had unusual changes in their behavior. Talk with your doctor right away if you start having problems with gambling or an increased interest in sex while using this medicine.

Before you have any medical tests, tell the medical doctor in charge that you are taking this medicine. The results of some tests may be affected by this medicine.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Common side effects of Stalevo 200 include: diarrhea, dyskinesia, hyperkinesia, nausea, dark urine, and urine discoloration. Other side effects include: abdominal pain, and vomiting. See below for a comprehensive list of adverse effects.

Applies to carbidopa / entacapone / levodopa: oral tablet

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

Check with your doctor immediately if any of the following side effects occur while taking carbidopa / entacapone / levodopa:

• Twitching, twisting, or uncontrolled repetitive movements of the tongue, lips, face, arms, or legs

• Bleeding gums
• bloody or black, tarry stools
• bloody or cloudy urine
• change in size, shape, or color of an existing mole
• changes in skin color
• chest pain, discomfort, or tightness
• constipation
• constricted pupil
• convulsions
• cough
• difficult or labored breathing
• difficulty with speaking
• drooling
• drooping eyelid (ptosis)
• facial dryness
• fast, irregular, or pounding heartbeat
• fever with or without chills
• general feeling of illness
• hallucinations (seeing, hearing, or feeling things that are not there)
• hoarseness
• large, flat, blue, or purplish patches in the skin
• large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
• loss of appetite
• loss of bladder control
• lower abdominal or stomach 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
• pain
• painful or difficult urination
• pinpoint red spots on the skin
• raised red swellings on the skin, the buttocks, legs, or ankles
• restlessness
• severe mental changes
• shakiness and unsteady walk
• shuffling walk
• sore throat
• sores, ulcers, or white spots on the lips or in the mouth
• sweating
• swollen glands
• trembling, or other problems with muscle control or coordination
• unusual bleeding or bruising
• unusual tiredness or weakness
• vomiting

Some side effects of carbidopa / entacapone / levodopa may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

• Absence of or decrease in body movement
• diarrhea
• dizziness
• urine discoloration

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

• Being forgetful
• bladder pain
• blurred vision
• body aches or pain
• burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
• burning and upper abdominal or stomach 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 swallowing
• discouragement
• double vision
• ear congestion
• enlarged pupils
• excessive watering of the mouth
• fainting
• false or unusual sense of well-being
• feeling like you will pass out
• feeling of warmth
• feeling sad or empty
• flushing
• hair loss
• headache
• hiccups
• hives or welts
• increased blinking
• increased interest in sexual ability, desire, drive, or performance
• increased interest in sexual intercourse
• lack of appetite
• large, hard skin blisters
• leg pain
• loss of voice
• muscle spasm, especially of the neck and back
• nasal congestion
• nightmares
• numbness
• pain in the chest below the breastbone
• painful or prolonged erection of the penis
• pharyngeal pain
• pounding in the ears
• problems with memory or speech
• redness of the face, neck, arms, and occasionally upper chest
• runny nose
• sense of stimulation
• skin rash
• sleeplessness
• slow movement
• slow or fast heartbeat
• slow reflexes
• sneezing
• swelling
• tremor, increased
• trouble concentrating
• trouble recognizing objects
• trouble thinking and planning
• urinary frequency
• urinary retention
• weight gain
• weight loss

Applies to carbidopa / entacapone / levodopa: oral tablet

Nervous system

Nervous system side effects most commonly reported with carbidopa-levodopa-entacapone have included dyskinesias (choreiform, dystonic, and involuntary movements) and headache. Hyperkinesia, hypokinesia, and dizziness have been reported with entacapone.

Convulsions have also been reported; however, a causal relationship with carbidopa-levodopa has not been established.[Ref]

Ocular

Ocular side effects reported with various carbidopa-levodopa products have included blurred vision, dilated pupils, diplopia, and oculogyric crisis.[Ref]

Psychiatric

Psychiatric side effects have included reports of psychotic episodes (including delusions, hallucinations, and paranoid ideation), agitation, anxiety, confusion, dream abnormalities including nightmares, depression (with or without development of suicidal tendencies), somnolence, and dementia.[Ref]

Respiratory

Respiratory side effects have included dyspnea, upper respiratory infection, pharyngeal pain, cough, pharyngitis, and rhinitis.[Ref]

Cardiovascular

Cardiovascular side effects have included reports of cardiac irregularities, myocardial infarction, and orthostatic effects (hypotension, hypertension, and syncope), and palpitations.[Ref]

Dermatologic

Dermatologic side effects have included rash, increased sweating, alopecia, dark sweat, and malignant melanoma.[Ref]

Gastrointestinal

Gastrointestinal (GI) side effects have included dark saliva, GI bleeding, development of duodenal ulcer, abdominal pain, anorexia, nausea, vomiting, diarrhea, constipation, dyspepsia, dry mouth, dysphagia, sialorrhea, flatulence, gastritis, taste alterations, heartburn, and hiccups.[Ref]

Hematologic

Hematologic side effects have included hemolytic and nonhemolytic anemia, agranulocytosis, thrombocytopenia, leukopenia, and purpura. Laboratory abnormalities reported have included decreased hemoglobin and hematocrit, serum potassium, Coombs' test, lactic dehydrogenase, bilirubin, and blood urea nitrogen (BUN); and elevated serum glucose.[Ref]

Hypersensitivity

Hypersensitivity side effects have included angioedema, urticaria, pruritus, and Henoch-Schonlein purpura, bullous lesions (with pemphigus- like reactions).[Ref]

Musculoskeletal

Musculoskeletal side effects have included asthenia, fatigue, back pain, shoulder pain, leg pain, and muscle cramps.[Ref]

Genitourinary

Genitourinary side effects have included dark urine, blood in the urine, urinary incontinence, urinary retention, urinary tract infection, and priapism,[Ref]

Hepatic

Hepatic side effects have included abnormalities in alkaline phosphatase, SGOT (AST), SGPT (ALT), and lactic dehydrogenase.[Ref]

Renal

Renal side effects have included increases in serum creatinine and uric acid.[Ref]

Metabolic

Metabolic side effects have included edema, weight gain, and weight loss.[Ref]

Some side effects of Stalevo 200 may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.