This combination product contains 2 ingredients: levodopa and benserazide. Together, they are used to treat Parkinson's disease.

Parkinson's disease is an illness that develops when the brain is not receiving enough of the chemical dopamine to allow the body to move normally. Levodopa helps to control the symptoms of Parkinson's disease by correcting the chemical imbalance in the brain that produces symptoms. Levodopa can be used alone, but adding benserazide lowers the amount of levodopa that is required, and may reduce some of the side effects such as nausea and vomiting that are associated with levodopa. Although levodopa helps relieve symptoms of Parkinson's disease, it does not slow down the progression of the disease.

Your doctor may have suggested this medication for conditions other than those listed in these drug information articles. If you have not discussed this with your doctor or are not sure why you are taking this medication, speak to your doctor. Do not stop taking this medication without consulting your doctor.

Do not give this medication to anyone else, even if they have the same symptoms as you do. It can be harmful for people to take this medication if their doctor has not prescribed it.

Treatment with levodopa - benserazide should be started at low doses and increased gradually to reduce the risk of side effects while gaining maximum benefit from the medication.

For someone who has never taken levodopa, the recommended starting dose is one capsule of levodopa 100 mg - benserazide 25 mg once or twice a day. Your doctor will usually increase the dose by one capsule every third or fourth day until the best effect occurs without side effects.

When the dose gets higher, your doctor may increase the dose at 2 to 4 week intervals. This dose should be divided so that the medication is taken at least 4 times a day with, or immediately after, meals.

If you have been taking another form of levodopa, your doctor will determine your starting dose, based on the amount of levodopa you have been taking most recently. The dose of levodopa in levodopa - benserazide is usually quite a bit lower than your original dose. The benserazide helps the levodopa to get to where it is needed, so less levodopa is needed.

Most people find the best dose is 4 to 8 capsules of levodopa 100 mg - benserazide 25 mg daily (divided into 4 to 6 doses).

Many things can affect the dose of 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 one above, do not change the way that you are taking the medication without consulting your doctor.

When first starting the medication, it may be taken with meals or a snack to reduce stomach upset. Protein prevents levodopa - benserazide from being absorbed. Take this medication with a small snack, such as crackers or biscuits to help prevent upset stomach.

Swallow the capsules whole and do not open them. Do not dissolve them in liquid.

It is important to take this medication 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 almost time for your next dose, skip the missed dose and 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 this medication at room temperature, protect it from light and moisture, and keep it out of the reach of children.

50 mg/12.5 mg

Each light grey and blue capsule, marked with "ROCHE" in black ink on both body and cap, contains 50 mg of levodopa and 12.5 mg of benserazide base in the form of benserazide hydrochloride. Nonmedicinal ingredients: gelatin, indigotine, iron oxide, magnesium stearate, mannitol, microcrystalline cellulose, povidone, talc, and titanium dioxide.

100 mg/25 mg

Each blue and pale pink capsule, marked with "ROCHE" in black ink on both body and cap, contains 100 mg of levodopa and 25 mg of benserazide base in the form of benserazide hydrochloride. Nonmedicinal ingredients: gelatin, indigotine, iron oxide, magnesium stearate, microcrystalline cellulose, povidone, talc, and titanium dioxide.

200 mg/50 mg

Each blue and caramel-coloured capsule, marked with "ROCHE" in black ink on both body and cap contains 200 mg of levodopa and 50 mg of benserazide base in the form of benserazide hydrochloride. Nonmedicinal ingredients: gelatin, indigotine, iron oxide, magnesium stearate, microcrystalline cellulose, povidone, talc, and titanium dioxide.

Do not take this medication if you:

• are allergic to levodopa, benserazide, or any ingredients of the medication
• are under 25 years of age
• are pregnant or may become pregnant
• cannot take sympathomimetic amines (e.g., epinephrine)
• are being treated for severe mental health problems
• have active heart disease, blood-related conditions, endocrine disease, liver disease, lung disease, or kidney disease
• have narrow-angle glaucoma
• have taken MAO inhibitors (e.g., moclobemide, phenelzine, tranylcypromine) within 2 weeks of taking levodopa - benserazide

Many medications can cause side effects. A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent.

The side effects listed below are not experienced by everyone who takes this medication. If you are concerned about side effects, discuss the risks and benefits of this medication with your doctor.

The following side effects have been reported by at least 1% of people taking this medication. Many of these side effects can be managed, and some may go away on their own over time.

Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.

• dark sweat or urine
• diarrhea
• dizziness, faintness, or lightheadedness when rising from lying or sitting position
• increase in sexual ability or desire
• increased sweating
• nausea
• nightmares
• stained saliva or mouth, teeth, and gums
• vomiting

Although most of the side effects listed below don't happen very often, they could lead to serious problems if you do not seek medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

• compulsive behaviour (e.g., gambling, spending)
• false or unusual sense of well-being
• fast, slow, or irregular heartbeat
• fainting
• impaired ability to think
• mood or mental changes
• agitation
• anxiety
• confusion
• delusions
• fearfulness
• hallucinations (seeing or hearing things that are not there)
• nervousness
• restlessness
• suspiciousness
• signs of depression (e.g., poor concentration, changes in weight, changes in sleep, decreased interest in activities, thoughts of suicide)
• taking more medication than ordered
• unwanted movements or difficulty moving
• absence of or decrease in body movement
• clenching, gnashing, or grinding teeth
• inability to move the eyes
• increased blinking or spasms
• increased blinking or twitching of eyelids
• increased hand tremor
• muscle twitching
• shakiness and unsteady walk, clumsiness, trembling problems with muscle control or coordination
• sudden freezing, hypotonia (decreased muscle tone), and postural instability
• tightness of the mouth, lips, or tongue
• twitching, twisting, uncontrolled repetitive movements of tongue, lips, face, arms, or legs
• twisting of the neck to one side (torticollis)

Stop taking the medication and seek immediate medical attention if any of the following occur:

• signs of a serious allergic reaction (e.g., abdominal cramps, difficulty breathing, nausea and vomiting, or swelling of the face and throat)
• sudden onset of sleep

Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are taking this medication.

Before you begin using 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 use this medication.

Behaviour changes: Some people experience changes in behaviour associated with taking levodopa - benserazide. There have been reports of aggressive behaviour or hostility, anxiousness, disorientation or decreased memory. If you experience any of these effects or notice them in a family member who is taking this medication contact your doctor as soon as possible. You may notice compulsive behaviour, such as gambling, increased sexual activity or inappropriate spending. If you experience or notice compulsive behaviour in a family member, ensure that they see their doctor.

Depression: This medication is known to cause mood swings and symptoms of depression. If you have depression or a history of depression, discuss with your doctor how this medication 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.

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 this medication contact your doctor as soon as possible.

Diabetes: Levodopa - benserazide can cause changes in blood glucose. If you have diabetes discuss with your doctor how this medication 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.

Heart disease: This medication has been associated with changes in heart rhythm. If you have a history of heart attack or heart arrhythmias, discuss with your doctor how this medication 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.

Glaucoma: Levodopa - benserazide may increase pressure inside the eye for people with chronic wide-angle glaucoma. If you have glaucoma, discuss with your doctor how this medication 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.

People with closed-angle glaucoma should not use this medication.

Kidney function: If you have reduced kidney function or kidney disease, discuss with your doctor how this medication 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: If you have reduced liver function or liver disease, discuss with your doctor how this medication 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.

Medication withdrawal: Do not stop taking levodopa - benserazide suddenly as severe withdrawal effects such as high fever, muscle stiffness, confusion or loss of consciousness, sweating, racing or irregular heartbeat, or fainting may occur. If you feel it is necessary to stop taking this medication, discuss this with your doctor.

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 this medication. Talk to your doctor if you have any concerns.

Physical activity: People with severe Parkinsonism who improve on levodopa - benserazide therapy should resume normal activities gradually and with caution to reduce the risk of injury. Physiotherapy and appropriate safeguards may be useful during this stage.

Stomach problems: This medication may cause stomach problems such as ulcers or bleeding. If you have stomach problems, discuss with your doctor how this medication 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.

Call your doctor immediately if you notice signs such as stomach or abdominal pain, black tarry stools, or vomiting blood. Using ASA and other anti-inflammatory medications at the same time as levodopa - benserazide, increases the risk of stomach ulcers and bleeding.

Sudden onset of sleep: People taking levodopa - benserazide have reported episodes of suddenly falling asleep, with no warning, while engaged in normal daily activities. This can happen at any time while taking this medication. The reason for this effect is not known, however Parkinson's disease often causes changes in the quality and pattern of normal sleep.

If you have a history of sleep disorders or are taking other medications that cause sleepiness, discuss with your doctor how this medication 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.

Surgery: This medication can interact with some of the medications used during surgery. If you have a surgery planned, let your surgeon and anesthetist know that you are taking levodopa - benserazide.

Pregnancy: The effects of using this medication during pregnancy have not been studied, however levodopa - benserazide may cause severe birth defects in the developing baby of a woman who is taking this medication. If you become pregnant while taking this medication, contact your doctor immediately.

Breast-feeding: Levodopa passes into breast milk. It is not known if benserazide passes into breast milk. If you are breast-feeding and are taking this medication, it may affect your baby. Talk to your doctor about whether you should continue breast-feeding.

Children: The safety of levodopa - benserazide has not been established for use by people under the age of 25 years. Benserazide may cause deformities in the bone development of people less than 25 years of age.

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

• aldesleukin
• aliskiren
• aldosterone antagonists (e.g., eplerenone, spironolactone)
• alpha blockers (e.g., alfuzosin, doxazosin, tamsulosin)
• alpha agonists (e.g., clonidine, methyldopa)
• amiodarone
• anesthetics
• angiotensin converting enzyme inhibitors (ACEIs; captopril, enalapril, ramipril)
• angiotensin receptor blockers (ARBs; e.g., candesartan, irbesartan, losartan)
• apomorphine
• antipsychotic medications (e.g., cariprazine, chlorpromazine, clozapine, haloperidol, olanzapine, pimozide, prochlorperazine, quetiapine, risperidone)
• barbiturates (e.g., butalbital, phenobarbital)
• beta-adrenergic blockers (e.g., atenolol, propranolol, sotalol)
• bortezomib
• brimonidine
• bromocriptine
• bupropion
• calcium channel blockers (e.g., amlodipine, diltiazem, nifedipine, verapamil)
• conivaptan
• diazoxide
• diuretics (water pills; e.g., furosemide, hydrochlorothiazide, triamterene)
• duloxetine
• glycopyrrolate
• guanfacine
• hydralazine
• iron salts (e.g., ferrous fumarate, ferrous gluconate, ferrous sulfate)
• isoniazid
• kava kava
• linezolid
• methylene blue
• methylphenidate
• metoclopramide
• minoxidil
• monoamine oxidase inhibitors (MAOIs; e.g., moclobemide, phenelzine, rasagiline, selegiline, tranylcypromine)
• morphine
• multivitamin/mineral supplements
• nabilone
• nitrates (e.g., nitroglycerin, isosorbide dinitrate, isosorbide mononitrate)
• obinutuzumab
• papaverine
• pentoxifylline
• phenytoin
• phosphodiesterase 5 inhibitors (e.g., sildenafil, tadalafil, vardenafil)
• pramipexole
• primidone
• pyridoxine (Vitamin B6)
• riociguat
• ropinirole
• rotigotine
• sacubitril
• sapropterin
• solriamfetol
• sympathomimetic medications (e.g., amphetamines, epinephrine, norepinephrine)
• tizanidine
• tretinoin
• tricyclic antidepressants (e.g., amitriptyline, clomipramine, desipramine)

If you are taking any medications containing this drug, 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 that you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the nicotine from cigarettes, or illegal drugs can affect the action of many medications, you should let your prescriber know if you use them.