Madopar

Uses

What is Madopar® (levodopa, benserazide) used for?

Madopar® is commonly used for the treatment of Parkinson’s disease. It belongs to a group of medicines called antiparkinsonian agents. Antiparkinsonian agents work on the central nervous system. The symptoms of Parkinson’s disease are caused by a deficiency of a natural substance in the brain called dopamine. Madopar® helps to replace this substance. By improving muscle control, Madopar® allows more normal movements of the body.

How should I take Madopar® (levodopa, benserazide)?

• Madopar® capsules or tablets should be swallowed whole with a glass of water or non-alcoholic drink.
• Madopar ® HBS capsules should be swallowed whole and not chewed, opened or dissolved in liquid.
• MADOPAR® Rapid tablets are for people who have difficulty swallowing whole tablets or who require the medicine to work quickly. They may be dissolved in at least 25-50ml of water. The tablets will dissolve completely within a few minutes giving a milky-looking liquid which you should drink within 30 minutes. Remember to stir the liquid immediately before taking.
• MADOPAR® tablets can be broken across the score line. Any tablets which do not break cleanly along the line should not be taken.
• Do not chew capsules or tablets.

How do I store Madopar® (levodopa, benserazide)?

Madopar® is best stored at room temperature away from direct light and moisture. To prevent drug damage, you should not store Madopar® in the bathroom or the freezer. There may be different brands of Madopar® that may have different storage needs. It is important to always check the product package for instructions on storage, or ask your pharmacist. For safety, you should keep all medicines away from children and pets.

You should not flush Madopar® down the toilet or pour them into a drain unless instructed to do so. It is important to properly discard this product when it is expired or no longer needed. Consult your pharmacist for more details about how to safely discard your product.

Precautions & warnings

What should I know before using Madopar® (levodopa, benserazide)?

Do not take Madopar® if:

• You have an allergy to any medicine containing levodopa or benserazide.
• You have taken a non-selective monoamine oxidase inhibitor (MAO-I) medicine such as tranylcypromine or phenelzine within the last 2 weeks.
• You have taken a combination of a selective MAO-A inhibitor such as moclobemide with a selective MAO-B inhibitor such as selegiline or rasagiline.
• You have untreated heart, liver, kidney, lung, blood or endocrine (hormonal) disease.
• You have narrow (closed) angle glaucoma (high pressure in the eye).
• You are being treated for severe mental illness (active psychosis or serious psychoneurosis).
• You have melanoma or suspected melanoma.
• You are under the age of 30.
• You are being treated for Huntington’s chorea or intention tremor.

Is it safe during pregnancy or breastfeeding?

Madopar® is contra-indicated in pregnancy and in women of childbearing potential in the absence of adequate contraception.

Since it is not known whether benserazide passes into breast milk, mothers requiring Madopar® treatment should not nurse their infants, since the occurrence of skeletal malformations in the infants cannot be excluded.

Side effects

What side effects can occur from Madopar® (levodopa, benserazide)?

The common side effects are:

• Abnormal involuntary jerking movements of the body
• Mental changes (including paranoia, depression, mania, agitation and hallucinations)
• Nausea
• Vomiting
• Loss of appetite
• Weight gain
• Constipation
• Skin rash
• Itching
• Confusion
• Tiredness
• Sleeplessness
• Poor muscle tone
• Hiccups
• Restlessness
• Water retention
• Cramps
• Changes in sex drive
• Signs of compulsive behavior
• Dark urine, mouth, saliva, tongue and teeth with a red tinge
• Bleeding or bruising
• Frequent infections (fever, severe chills)
• Sore throat or mouth ulcers

Tell your doctor as soon as possible if you notice any of the following:

• Palpitations
• Changes in the rhythm
• Rate of the heartbeat
• Chest pain
• Dizziness
• Diarrhea
• Confusion

Not everyone experiences these side effects. There may be some side effects not listed above. If you have any concerns about a side-effect, please consult your doctor or pharmacist.

Interactions

What drugs may interact with Madopar® (levodopa, benserazide)?

Madopar® may interact with other drugs that you are currently taking, which can change how your drug works or increase your risk for serious side effects. To avoid any potential drug interactions, you should keep a list of all the drugs you are using (including prescription drugs, nonprescription drugs, and herbal products) and share it with your doctor and pharmacist. For your safety, do not start, stop, or change the dosage of any drugs without your doctor’s approval.

These medicines include:

• Sympathomimetics
• Blood pressure lowering medications
• Antiparkinsonian medications
• Medicines containing iron
• Medicines for relief nausea
• Medications for mental illness
• General anesthetics
• Opioids
• Antacids

Does food or alcohol interact with Madopar® (levodopa, benserazide)?

Madopar® may interact with food or alcohol by altering the way the drug works or increase the risk for serious side effects. Please discuss with your doctor or pharmacist any potential food or alcohol interactions before using this drug.

What health conditions may interact with Madopar® (levodopa, benserazide)?

Madopar® may interact with your health condition. This interaction may worsen your health condition or alter the way the drug works. It is important to always let your doctor and pharmacist know all the health conditions you currently have.

Dosage

The information provided is not a substitute for any medical advice. You should ALWAYS consult with your doctor or pharmacist before using this medication.

What is the dose of Madopar® (levodopa, benserazide) for an adult?

Patients not previously treated with levodopa

The recommended initial dose is one capsule or dispersible tablet of Madopar 50 mg/12.5 mg three or four times daily. If the disease is at an advanced stage, the starting dose should be one capsule or dispersible tablet of Madopar 100 mg/25 mg three times daily.

The daily dosage should then be increased by one capsule or dispersible tablet of Madopar 100 mg/25 mg, or their equivalent, once or twice weekly until a full therapeutic effect is obtained, or side-effects supervene.

In some elderly patients, it may suffice to initiate treatment with one capsule or dispersible tablet of Madopar 50 mg/12.5 mg once or twice daily, increasing by one capsule or dispersible tablet every third or fourth day.

The effective dose usually lies within the range of four to eight capsules or dispersible tablets of Madopar 100 mg/25 mg (two to four capsules of Madopar 200 mg/50 mg) daily in divided doses, most patients requiring no more than six capsules or dispersible tablets of Madopar 100 mg/25 mg daily.

Treatment should be continued for at least six months before failure is concluded from the absence of a clinical response.

Patients previously treated with levodopa

Levodopa alone should be discontinued and Madopar started on the following day. The patient should be initiated on a total of one less Madopar 100 mg/25 mg capsule or dispersible tablet daily than the total number of 500 mg levodopa tablets or capsules previously taken (for example, if the patient had previously taken 2g levodopa daily, then he should start on three capsules or dispersible tablets Madopar 100 mg/25 mg daily on the following day). Observe the patient for one week and then, if necessary, increase the dosage in the manner described for new patients.

Patients previously treated with other levodopa/decarboxylase inhibitor combinations

Previous therapy should be withdrawn for 12 hours. In order to minimize the potential for any effects of levodopa withdrawal, it may be beneficial to discontinue previous therapy at night and institute Madopar therapy the following morning. The initial Madopar dose should be one capsule or dispersible tablet of Madopar 50 mg/12.5 mg three or four times daily. This dose may then be increased in the manner described for patients not previously treated with levodopa.

Other anti-Parkinsonian drugs may be given with Madopar. Existing treatment with other anti-Parkinsonian drugs, e.g. anticholinergics or amantadine, should be continued during initiation of Madopar therapy. However, as treatment with Madopar proceeds and the therapeutic effect becomes apparent, the dosage of the other drugs may need to be reduced or the drugs gradually withdrawn.

Elderly

Although there may be an age-related decrease in tolerance to levodopa in the elderly, Madopar appears to be well-tolerated and side effects are generally not troublesome.

What is the dose of Madopar® (levodopa, benserazide) for a child?

The dosage has not been established in pediatric patients. It may be unsafe for your child. It is always important to fully understand the safety of the drug before using. Please consult with your doctor or pharmacist for more information.

How is Madopar® (levodopa, benserazide) available?

Madopar® is available in the following dosage forms and strengths:

Madopar® Capsules:

• Madopar® 62.5 capsules contain levodopa 50 mg and benserazide 12.5 mg.
• Madopar® 125 capsules contain levodopa 100 mg and benserazide 25 mg.
• Madopar® 250 capsules contain levodopa 200 mg and benserazide 50 mg.
• Madopar® HBS 125 (slow-release) capsules contain levodopa 100 mg and benserazide 25 mg.

Madopar® Tablets

• Madopar®125 tablets contain levodopa 100 mg and benserazide 25 mg.
• Madopar® 250 tablets contain levodopa 200 mg and benserazide 50 mg.

Madopar® Rapid (dispersible) Tablets:

• Madopar® Rapid 62.5 tablets contain levodopa 50 mg and benserazide 12.5 mg.
• Madopar® Rapid 125 tablets contain levodopa 100 mg and benserazide 25 mg.

What should I do in case of an emergency or overdose?

In case of an emergency or an overdose, call your local emergency services or go to your nearest emergency room.

What should I do if I miss a dose?

If you miss a dose of Madopar®, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and take your regular dose as scheduled. Do not take a double dose.