Entacapone

Entacapone is to be taken together with either levodopa-carbidopa or levodopa-benserazide to treat people with Parkinson's disease who experience end-of-dose "wearing off" of levodopa. End-of-dose "wearing off" refers to a decrease in the amount of time that levodopa is effective, which results in fluctuations in Parkinson's disease symptoms.

The recommended dose of entacapone is 200 mg taken with each levodopa-carbidopa or levodopa-benserazide dose, up to 8 times daily.

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

Entacapone has no effect on symptoms of Parkinson's disease when taken alone.

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 Entacapone exactly as prescribed by your doctor. If you miss taking a dose of entacapone with your levodopa dose, skip that dose and take your next entacapone dose with your next levodopa dose. 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 Entacapone 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 cause diarrhea; it may cause stomach ache; occasionally, it may cause trembling and involuntary movements (also known as dyskinesia); it may cause unusual tiredness; 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.

Each light brown, biconvex, ellipse-shaped, film-coated tablet, embossed "E200" on one side, plain on the other side contains entacapone 200 mg. Nonmedicinal ingredients: magnesium stearate, microcrystalline cellulose, povidone, and pregelatinized starch. Coating: iron oxide red, lecithin, polyethylene glycol, polyvinyl alcohol, talc, titanium dioxide, and yellow iron oxide.

Do not take entacapone if you:

• are allergic to entacapone or any ingredients of the medication
• are taking or have taken a non-selective monoamine oxidase inhibitor (MAOI) within the last 2 weeks (e.g., Moclobemide, Phenelzine, Tranylcypromine)
• have a previous history of neuroleptic malignant syndrome or rhabdomyolysis
• have liver impairment
• have pheochromocytoma (a tumour in the adrenal glands)
• have active heart, lung, kidney, blood, or hormonal disease
• have narrow-angle Glaucoma
• have or have had skin lesions that may be Melanoma
• have any condition where Epinephrine, norepinephrine, isoprenaline or dopamine should not be given

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

• alcohol
• antihistamines (e.g., Chlorpheniramine, Diphenhydramine, Hydroxyzine)
• anti-seizure medications (e.g., Carbamazepine, Gabapentin, Lamotrigine, Phenytoin, Phenobarbital)
• antipsychotics (e.g., Fluphenazine, Perphenazine, Quetiapine, Risperidone)
• Apomorphine
• azelastine
• Baclofen
• barbiturates (e.g., butalbital, phenobarbital)
• benzodiazepines (e.g., Alprazolam, Diazepam, Lorazepam)
• brimonidine
• Buprenorphine
• Buspirone
• chloral hydrate
• dobutamine
• dopamine
• droperidol
• epinephrine
• iron supplements
• isoproterenol
• Linezolid

• magnesium sulfate
• MAO inhibitors (e.g., moclobemide, phenelzine, Rasagiline, Selegiline, tranylcypromine)
• Methotrimeprazine
• methyldopa
• Mirtazapine
• muscle relaxants (e.g., Cyclobenzaprine, methocarbamol, orphenadrine)
• narcotic medications (e.g., Codeine, Fentanyl, Morphine)
• norepinephrine
• paraldehyde
• Pimozide
• Pramipexole
• Procarbazine
• Ropinirole
• selective serotonin reuptake inhibitors (e.g., Citalopram, Fluoxetine, Paroxetine, Sertraline)
• Tapentadol
• Tramadol
• tricyclic antidepressants (e.g., Amitriptyline, Clomipramine, Desipramine, Trimipramine)
• 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 this medication. 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 this medication.

Behavioural and mood changes: Entacapone may cause mood and psychiatric changes, including hallucinations, hypersexuality, pathological gambling, and increased libido. Tell your doctor as soon as possible if you notice any unusual changes in your behaviour, have thoughts of harming yourself, or feel depressed.

If you have depression or a history of depression, discuss with your doctor how Entacapone may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Entacapone, and whether any special monitoring is needed. If you experience symptoms of depression such as poor concentration, changes in weight, changes in sleep, decreased interest in activities, or notice them in a family member who is taking Entacapone contact your doctor as soon as possible.

Diarrhea: Diarrhea is a common side effect of Entacapone. 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.

Dizziness/reduced alertness: Entacapone may cause low blood pressure or dizziness and lightheadedness when rising from a lying or sitting position. People taking medications that can cause dizziness should rise slowly from sitting or lying down to reduce the possibility of severe dizziness or fainting. Do not drive, operate machinery, or perform other hazardous tasks until you have determined how Entacapone affects you.

Fructose intolerance: Entacapone contains fructose. If you have fructose intolerance, glucose-galactose malabsorption, or sucrase-isomaltase insufficiency, you should not take Entacapone. Talk to your doctor.

Heart disease: Entacapone may cause an increase in the risk of heart attack or heart disease. If you have a history of heart disease, discuss with your doctor how Entacapone may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Liver function: Liver disease or reduced liver function may cause Entacapone to build up in the body, causing side effects. Entacapone is not recommended for people with liver problems.

Melanoma: People with Parkinson's disease may be at 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 Entacapone. Talk to your doctor if you have any concerns.

Neuroleptic malignant syndrome (NMS): Entacapone may cause a potentially fatal reaction called neuroleptic malignant syndrome (NMS). If you develop symptoms of NMS, such as muscle stiffness, fever, confusion, sweating, or irregular heartbeat, stop taking Entacapone and seek immediate medical attention.

Prostate Cancer: A recent study has shown an increase in the number of cases of prostate cancer among men who have taken levodopa/carbidopa with or without entacapone for approximately 3 years. Although it is not clear whether this increased risk of prostate cancer is due to the medication or something else, it is important to have regular prostate examinations while taking medications for Parkinson's Disease.

Rhabdomyolysis (muscle breakdown): Occasionally, Entacapone 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.

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

Sudden onset of sleep: There are reports of people who take this combination medication treatment (entacapone with levodopa - carbidopa) falling asleep without prior warning or drowsiness. If you have a sleep disorder, discuss this with your doctor. If you experience drowsiness while taking this medication, avoid driving or using machinery.

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

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

Children: The safety and effectiveness of using Entacapone have not been established for children less than 18 years of age.

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. This medication should be swallowed whole. It should not be split, crushed or chewed. It must be used regularly and continuously to maintain its beneficial effects. Be sure to keep an adequate supply on hand. 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.