Stalevo 50

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.

Carbidopa, entacapone, and levodopa may also be used for purposes not listed in this medication guide.

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.

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 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.

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 might 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.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

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.

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.

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

• 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 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

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

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Common side effects of Stalevo 50 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

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