Prolopa (Levodopa/Benserazide)

Serious Warnings and Precautions:

Some people feel sleepy, drowsy, or, rarely, may suddenly fall asleep without warning (i.e. without feeling sleepy or drowsy) when taking PROLOPA. During treatment with PROLOPA take special care when you drive or operate a machine. If you experience excessive drowsiness or a sudden sleep onset episode, refrain from driving and operating machines, and contact your physician.

Studies of people with Parkinson's disease show that they may be at an increased risk of developing melanoma, a form of skin cancer, when compared to people without Parkinson's disease. It is not known if this problem is associated with Parkinson's disease or the drugs used to treat Parkinson's disease. Therefore, patients treated with PROLOPA should have periodic skin examinations.

BEFORE you use PROLOPA talk to your doctor or pharmacist if you:

• have or have had any other health problems including: convulsions, diabetes, stomach ulcers, lung, liver, kidney or hormonal problems, depression or other mental disturbances, osteoporosis, clots in your veins, irregular heart rhythm or history of heart attack, glaucoma, skin cancer or suspicious skin lesions
• drive or operate machinery
• are pregnant or plan to become pregnant
• are breastfeeding or wish to breastfeed
• are allergic to any other medicines, foods, dyes or preservatives
• are going to have an operation that requires general anesthesia
• Tell your doctor if you or your family member/caregiver notices you are developing urges to gamble, increased sexual urges, excessive eating or spending, and/or other intense urges that could harm yourself or others. These behaviors are called impulse control disorders. Your doctor may need to review your treatments.

Like all medications PROLOPA capsules can cause some side effects. You may not experience any of them. For most patients these side effects are likely to be minor and temporary. However, some may be serious. Consult your doctor if you experience these or other side effects.

• The most common serious side effects are abnormal involuntary movements such as twitching or spasms which may or may not resemble your Parkinson's symptoms. It may help if the daily dose is reduced or smaller doses are taken more frequently.
• At the beginning of treatment, nausea, vomiting or diarrhea can occur.
• Psychiatric problems are common in people with Parkinson's disease and may occur during treatment with PROLOPA. These may include depression, confusion, anxiety, agitation, hallucinations, nightmares, and other mental changes.
• Other possible side effects include: changes in heart rhythm, changes in blood pressure, faintness, sleepiness, sweating, rash, itching, dark color in your sweat or urine, staining of your body fluids or tissues (saliva, tongue, teeth, tissue in your mouth). Very rarely changes in behaviour, such as compulsive gambling or change in sexual desire, may occur.
• Against the advice of their doctor, patients sometimes increase the quantity of drug they take well beyond what they need as treatment for their symptoms.
• PROLOPA can cause abnormal blood test results. Your doctor will decide when to perform blood tests and will interpret the results.

Drugs that may interact with PROLOPA include:

• sympathomimetic drugs, such as cough and cold medications containing epinephrine, isoproterenol or amphetamine
• blood pressure lowering medications
• other antiparkinsonian medications (e.g. amantadine, bromocriptine, and selegiline)
• some medications used to treat mental problems
• general anesthetics with halothane. If you know you are going to have an operation, that requires this type of anesthesia, you should stop PROLOPA 12-48 hours beforehand
• iron tablets or multivitamin tablets containing iron
• metoclopramide
• papaverine
• isoniazid
• phenytoin
• domperidone

Protein-rich diets (for example, a lot of meat, poultry or fish) may reduce the beneficial effects of PROLOPA.