Stalevo

The daily dose of levodopa - carbidopa - entacapone tablets is based on how well the medication reduces the symptoms of Parkinson's disease, and how the side effects are tolerated. The dose of levodopa - carbidopa that a person is taking before starting Stalevo is the starting dose for this combination product.

Stalevo can be taken with or without food. Swallow the tablets whole. Do not crush or chew the tablets.

Many things can affect the dose of a medication that a person needs, such as body weight, other medical conditions, and other medications. If your doctor has recommended a dose different from the ones listed here, do not change the way that you are taking the medication without consulting your doctor.

It is important to take Stalevo exactly as prescribed by your doctor. If you miss a dose, take it as soon as possible and continue with your regular schedule. If it is less than one hour until your next dose, take the missed dose, wait one hour and then take the next dose. Afterwards, continue with your regular dosing schedule. Do not take a double dose to make up for a missed one. If you are not sure what to do after missing a dose, contact your doctor or pharmacist for advice.

Store Stalevo at room temperature, protect it from light and moisture, and keep it out of the reach of children.

Do not dispose of medications in wastewater (e.g. down the sink or in the toilet) or in household garbage. Ask your pharmacist how to dispose of medications that are no longer needed or have expired.

In addition to its desired action, this medication may cause some adverse effects, notably: it may decrease your appetite; it may cause diarrhea or constipation, depending on the person; occasionally, it may cause trembling and involuntary movements (also known as dyskinesia); it may cause dizziness - use caution when getting up from a lying or sitting position and use caution if driving; it may cause nausea and vomiting; it may turn your urine orange-brown. Each person may react differently to a treatment. If you think this medication may be causing adverse effects (including those described here, or others), talk to your health care professional. He or she can help you to determine whether or not the medication is the source of the problem.

50 mg/12.5 mg/200 mg
Each brownish- or greyish-red, round, convex, unscored, film-coated tablet, marked with "LCE 50" on one side, contains levodopa 50 mg, carbidopa 12.5 mg, and entacapone 200 mg. Nonmedicinal ingredients: croscarmellose sodium, glycerol 85%, hypromellose, magnesium stearate, maize starch, mannitol, polysorbate 80, povidone, red iron oxide, sucrose, titanium dioxide, and yellow iron oxide.

75 mg/18.75 mg/200 mg
Each light brownish red, oval-shaped, unscored, film-coated tablet, marked with "LCE 75" on one side, contains levodopa 75 mg, carbidopa 18.75 mg, and entacapone 200 mg. Nonmedicinal ingredients: croscarmellose sodium, glycerol 85%, hypromellose, magnesium stearate, maize starch, mannitol, polysorbate 80, povidone, red iron oxide, sucrose, and titanium dioxide.

100 mg/25 mg/200 mg
Each brownish- or greyish-red, oval-shaped, unscored, film-coated tablet, marked with "LCE 100" on one side, contains levodopa 100 mg, carbidopa 25 mg, and entacapone 200 mg. Nonmedicinal ingredients: croscarmellose sodium, glycerol 85%, hypromellose, magnesium stearate, maize starch, mannitol, polysorbate 80, povidone, red iron oxide, sucrose, titanium dioxide, and yellow iron oxide.

125 mg/31.25 mg/200 mg
Each light brownish red, oval-shaped, unscored, film-coated tablet, marked with "LCE 125" on one side, contains levodopa 125 mg, carbidopa 31.25 mg, and entacapone 200 mg. Nonmedicinal ingredients: croscarmellose sodium, glycerol 85%, hypromellose, magnesium stearate, maize starch, mannitol, polysorbate 80, povidone, red iron oxide, sucrose, and titanium dioxide.

150 mg/37.5 mg/200 mg
Each brownish- or greyish-red, elongated-ellipse shaped, unscored, film-coated tablet, marked with "LCE 150" on one side, contains levodopa 150 mg, carbidopa 37.5 mg, and entacapone 200 mg. Nonmedicinal ingredients: croscarmellose sodium, glycerol 85%, hypromellose, magnesium stearate, maize starch, mannitol, polysorbate 80, povidone, red iron oxide, sucrose, titanium dioxide, and yellow iron oxide.

Do not take Stalevo if you:

• are allergic to levodopa, carbidopa, entacapone, or any ingredients of the medication
• are taking or have taken a nonselective monoamine oxidase inhibitors (M.O.S. within the last 2 weeks (e.g., Phenelzine, Tranylcypromine)
• cannot take sympathomimetic amines (e.g., Epinephrine)
• have a previous history of neuroleptic malignant syndrome or rhabdomyolysis
• have active heart disease, blood related diseases, endocrine disease, liver disease, lung disease, or Kidney Disease
• have been diagnosed as having pheochromocytoma (tumour of the adrenal gland)
• have liver impairment
• have narrow angle Glaucoma
• have undiagnosed skin lesions or a history of Melanoma (Skin Cancer)

There may be an interaction between levodopa - carbidopa - entacapone and any of the following:

• alcohol
• alpha-agonists (e.g., Clonidine, methyldopa)
• alpha-blockers (e.g., Alfuzosin, Doxazosin, Tamsulosin)
• amifostine
• angiotensin converting enzyme inhibitors (ACEIs; Captopril, Enalapril, Ramipril)
• angiotensin receptor blockers (ARBs; e.g., cand esartan, Irbesartan, Losartan)
• antihistamines (e.g., cetirizine, Diphenhydramine, Hydroxyzine)
• antipsychotics (e.g., Haloperidol, Quetiapine, Risperidone)
• azelastine
• barbiturates (e.g., butalbital, Phenobarbital)
• benzodiazepines (sedatives; e.g., Clonazepam, Diazepam, Lorazepam)
• beta-adrenergic blockers (e.g., Atenolol, Propranolol, Sotalol)
• brimonidine
• Buprenorphine
• Buspirone
• calcium channel blockers (e.g., Amlodipine, Diltiazem, Nifedipine, Verapamil)
• cannabis
• chloral hydrate
• Dacarbazine
• diuretics (water pills; e.g., Furosemide, Hydrochlorothiazide, triamterene)
• Duloxetine
• general anesthetics (medications used to put people to sleep before surgery)
• glycopyrrolate
• Guanfacine
• iron (e.g., ferrous sulfate, multivitamins)
• isoniazid
• kava kava
• MAO inhibitors (e.g., phenelzine, tranylcypromine)
• methyldopa
• Methylphenidate
• Metoclopramide
• Minoxidil
• multiple vitamin/mineral supplements
• muscle relaxants (e.g., Baclofen, Cyclobenzaprine, methocarbamol, orphenadrine)
• Nabilone
• narcotic pain relievers (e.g., Codeine, Fentanyl, Hydromorphone, Morphine)
• nitrates (e.g., Nitroglycerin, isosorbide dinitrate, isosorbide mononitrate)
• Obinutuzumab
• Olopatadine
• papaverine
• Pentoxifylline
• phosphodiesterase 5 inhibitors (e.g., Sildenafil, Tadalafil, Vardenafil)
• Pramipexole
• Ropinirole
• Rotigotine
• scopolamine
• seizure medications (e.g., Carbamazepine, Gabapentin, Phenytoin)
• selective serotonin reuptake inhibitors (e.g., Citalopram, Fluoxetine, Sertraline)
• sodium oxybate
• suvorexant
• Tapentadol
• thalidomide
• Tramadol
• tricyclic antidepressants (e.g., Amitriptyline, Desipramine)
• Warfarin
• Zolpidem
• Zopiclone

If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:

• stop taking one of the medications,
• change one of the medications to another,
• change how you are taking one or both of the medications, or
• leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.

Medications other than those listed above may interact with Stalevo. Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the Nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.

Before you begin taking a medication, be sure to inform your doctor of any medical conditions or Allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should take Stalevo.

Behavioural and mood changes: Stalevo has been known to cause mood swings, changes in behaviour, and symptoms of depression. If you have depression or a history of depression, discuss with your doctor how Stalevo may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Stalevo, and whether any special monitoring is needed. You may notice compulsive behaviour, such as gambling, increased sexual activity, or inappropriate spending. If you experience symptoms of depression such as poor concentration, changes in weight, changes in sleep, decreased interest in activities, contact your doctor as soon as possible. If you notice compulsive behaviour or signs of depression in a family member, ensure that they see their doctor.

Bleeding: Levodopa – carbidopa – entacapone may cause a reduced number of platelets in the blood, which can make it difficult to stop cuts from bleeding. If you notice any signs of bleeding, such as frequent nosebleeds, unexplained bruising, or black and tarry stools, notify your doctor as soon as possible. Your doctor will order routine blood tests to make sure potential problems are caught early.

Diarrhea: Diarrhea is a common side effect of Stalevo. It may appear as early as the first week of starting treatment or many months after starting treatment. For some people, the diarrhea causes weight loss. If you notice any weight loss or have excessive diarrhea, contact your doctor.

Drowsiness/reduced alertness: Stalevo may cause Low Blood Pressure or dizziness and lightheadedness when rising from a lying or sitting position. Avoid driving or operating machinery until you know how Stalevo affects you.

Glaucoma: Stalevo may cause symptoms of glaucoma to get worse by increasing the pressure in the eye. If you have chronic wide-angle glaucoma, discuss with your doctor how Stalevo may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Stalevo, and whether any special monitoring is needed.

Heart disease: If you have heart disease (e.g., history of heart attack, arrhythmia), discuss with your doctor how Stalevo may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Stalevo, and whether any special monitoring is needed.

Infection: Stalevo has been reported to reduce the number of cells that fight infection in the body (white blood cells). If possible, avoid contact with people with contagious infections. Tell your doctor immediately if you notice signs of an infection, such as fever or chills, severe diarrhea, shortness of breath, prolonged dizziness, headache, stiff neck, weight loss, or listlessness. Your doctor will do blood tests regularly to monitor the number of specific types of blood cells in your blood.

Kidney disease: If you have kidney disease or reduced kidney function, discuss with your doctor how Stalevo may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Stalevo, and whether any special monitoring is needed.

Liver function: Liver disease or reduced liver function may cause Stalevo to build up in the body, causing side effects. If you have liver problems, discuss with your doctor how Stalevo may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Stalevo, and whether any special monitoring is needed.

Low blood pressure: Symptoms of low blood pressure, such as weakness or dizziness, particularly when rising suddenly from a sitting or lying position, may occur. People who are prone to low blood pressure or are taking medication to reduce blood pressure should be cautious when using Stalevo.

Melanoma: People with Parkinson's disease have an increased risk of developing melanoma (a type of skin cancer). It is not known if this increased risk is due to Parkinson's disease or to the medications used to treat Parkinson's disease. Your doctor will monitor you for skin cancer while you are taking Stalevo. Talk to your doctor if you have any concerns.

Neuroleptic malignant syndrome (NMS): Very rarely, levodopa - carbidopa - entacapone can cause a potentially fatal syndrome known as neuroleptic malignant syndrome (NMS). If you notice the symptoms of NMS such as high fever, muscle stiffness, confusion or loss of consciousness, sweating, racing or irregular heartbeat, or fainting, get immediate medical attention.

Peptic (stomach) ulcer: There is a possibility of stomach bleeding for people with a history of peptic ulcer who take levodopa - carbidopa - entacapone. If you have peptic ulcers or a history of peptic ulcers, discuss with your doctor how Stalevo may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Stalevo, and whether any special monitoring is needed. If you notice bloody or black tarry stools, stomach pain, or vomiting blood or material that looks like coffee grounds, contact your doctor immediately.

Prostate Cancer: Men who take Stalevo may have a slightly higher risk of developing prostate cancer. It is not known if this increased risk is due to the medication or some other factor. While taking Stalevo, it is important for men to keep appointments for regular prostate cancer screening. Talk to your doctor if you have any concerns.

Rhabdomyolysis (muscle breakdown): Occasionally, Stalevo may cause rapid breakdown of muscle tissue. If you notice signs of muscle weakness or pain, high body temperature, unexpected bruising, confusion, or difficulty passing urine, contact your doctor immediately.

Seizures: If you have seizures or a history of seizures, discuss with your doctor how Stalevo may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Stalevo, and whether any special monitoring is needed.

Stopping Stalevo: Stopping Stalevo too quickly can cause potentially life-threatening side effects. Before stopping Stalevo, discuss the risks and benefits with your doctor. Do not stop taking Stalevo until you have spoken with your doctor first.

Sudden onset of sleep: There are reports of people who take levodopa - carbidopa - entacapone combinations falling asleep with no warning or drowsiness. If you have a sleep disorder, discuss this with your doctor. If you experience drowsiness while taking Stalevo, avoid driving or using machinery.

Pregnancy: Stalevo should not be used during pregnancy unless the benefits outweigh the risks. If you become pregnant while taking Stalevo, contact your doctor immediately.

Breast feeding: Levodopa passes into breast milk. It is not known if carbidopa or entacapone pass into breast milk. If you are a breast-feeding mother and are taking levodopa - carbidopa - entacapone, it may affect your baby. Talk to your doctor about whether you should continue breast-feeding.

Children: The safety and effectiveness of using Stalevo have not been established for children.

This medication is typically used 4 times a day. However, your pharmacist may have suggested a different schedule that is more appropriate for you. Important: Follow the instructions on the label. Do not use more of this product, or more often, than prescribed. It must be used regularly and continuously to maintain its beneficial effects. Be sure to keep an adequate supply on hand. This medication should be swallowed whole. It should not be split, crushed or chewed. If you forget a dose, take it as soon as you remember -- unless it is almost time for your next dose. In that case, skip the missed dose. Do not double the next dose to catch up. This medication may be taken with or without food. If it were, however, to cause nausea, taking the product with food could provide relief. The medication may not be well absorbed if it is taken with protein-rich food. Ask your healthcare professional for details. To ensure effectiveness, avoid taking iron supplements or multivitamins for at least 2 to 3 hours before and after taking this medication.