Madopark – Levodopa / Benserazide Uses, Dose And Side Effects


Madopark 100 mg / 25 mg tablet, 100 mg / 25 mg tablet, 50 mg / 12.5 mg tablet, 100 mg / 25 mg prolonged-release Levodopa / Benserazide Capsule

What Madopark Is And What Madopark Used For?

Madopark is used in the treatment of Parkinson’s disease. The cause of the symptoms of Parkinson’s disease is a lack of dopamine in certain parts of the brain. Dopamine is a substance that transmits nerve signals.

Parkinson’s disease is lifelong, and treatment must last a lifetime. Dopamine must be added to alleviate the prevalent deficiency. Dopamine can not reach the brain from other parts of the body, but it can levodopa which in the brain cells is converted to dopamine.

Madopark includes levodopa and benserazide, a substance that prevents levodopa from being converted to dopamine in the body but allows the conversion to take place in the brain. This largely avoids the unwanted effects of dopamine on the body’s other organs.

It relieves many of the symptoms that are characteristic of Parkinson’s disease:

  • Tremors
  • Muscle stiffness
  • Slow movements
  • Difficulty starting movements
  • Difficulty swallowing
  • Difficulty maintaining balance
  • Abnormally large salivary secretion

Madopark Quick mite and Madopark Quick are quickly absorbed into the body after dissolving in water and may also be suitable for those who have difficulty swallowing.

Madopark Depot releases levodopa for a longer period when passing through the stomach and intestines, which gives a more even effect.

What You Need To Know Before Taking Madopark

Do Not Take:

  • If you are allergic to levodopa, benserazide, or any of the other ingredients of this medicine (listed in section 6).
  • If you have hormonal disorders, such as adrenal tumors, increased thyroid function and so-called Cushing’s syndrome (causes, among other things, increased fat in the face and torso caused by overproduction of adrenal cortex hormones).
  • If you have liver or kidney disease.
  • If you have heart diseases, such as severe heart arrhythmias (heart rhythm disorders) and heart failure
  • If you have a severe psychiatric illness.
  • If you have narrow-angle glaucoma.
  • If you are being treated with a combination of MAO-A and MAO-B inhibitors (see “Other medicines and Madopark”).
  • If you are younger than 25 years.
  • If you are pregnant.
  • If you are a fertile woman and do not use a reliable method of contraception.
  • Madopark Depot contains vegetable oil, which includes soybean oil. If you are allergic to peanuts or soy, do not use it.

Warnings And Cautions

Talk to your doctor or pharmacist before taking this medicine. If you have severe cardiovascular disease, increased pressure in the eye ( glaucoma ), or suffer from dementia or confusion, you should consult a doctor before starting treatment with this medicine.

During treatment, your blood counts, your heart function, and your kidney and liver function should be checked. Eye pressure should be measured regularly if you have glaucoma with an open ventricular angle. If you have diabetes, your blood sugar levels should be checked regularly.

Skin check-ups should also be done regularly during treatment with it. Tell your doctor if you have previously had a drop in blood pressure and dizziness when you get up quickly.

Contact your doctor if you experience increased sleepiness or have temporary sudden sleep attacks (see section “Driving and using machines”). Patients with Parkinson’s disease may be depressed, and depression may also occur in patients treated with this medicine.

Contact your doctor if you become depressed or experience mental changes during treatment with Madopark. Tell your doctor if you or your family/carer notice that you develop a strong desire or desire to behave in ways that are unusual for you or if you can not resist the impulse, drive, or temptation to perform certain activities. which may harm you or others.

These behaviors are called impaired impulse control and may include gambling addiction, compulsive eating, compulsive buying, an abnormally high sex drive, or increased sexual thoughts and feelings. Your doctor may need to re-evaluate your treatment.

This medicine can cause a syndrome called dopaminergic dysregulation syndrome, which leads to excessive drug use and doses much higher than prescribed by your doctor. This, in turn, can result in behavioral disorders. Contact your doctor if you experience this.

The treatment with Madopark should not be stopped abruptly, as you may suffer from changes in blood pressure, fever, disturbances of consciousness, and muscle stiffness, which can be life-threatening. Seek medical attention if a combination of these symptoms occurs. Tell your doctor if you are going to have anesthesia surgery.

Other Drugs And Madopark

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. The effect of this medicine can be affected if Madopark and certain other medicines are taken simultaneously. Therefore, consult a physician before using other medications.

Certain sedatives and neuroleptics (eg medicines containing haloperidol, mailperson, dixyrazine, chlorpromazine, levomepromazine, fluphenazine, perphenazine, prochlorperazine, thioridazine), opioids (used for severe pain), antihypertensive drugs, antipsychotics, and antipsychotics of Madopark.

This medicine should not be taken with adrenaline, noradrenaline, amphetamine, isoprenaline, methyldopa, amitriptyline, or imipramine.

Madopark should not be taken with MAO-A (moclobemide) and MAO-B ( selegiline, rasagiline) inhibitors. If this medicine is taken with other medicines for Parkinson’s disease (anticholinergics, amantadine, COMT inhibitors, or dopamine agonists), one dose of this medicine or the other medicine may need to be reduced.

Domperidone, a medicine for nausea, vomiting, and acid regurgitation, may affect the effect of Madopark. Some over-the-counter remedies for acid stomach and heartburn (antacids) may reduce the effect of Madopark Depot.

Some laboratory analyses may be affected by Madopark. The effect of Madopark can be reduced if taken with a high-protein meal.

Pregnancy And Breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

There is a possibility that the fetus is affected. You should, therefore, not use this medicine if you become pregnant or if you are a fertile woman and do not use a reliable method of contraception. If you can get pregnant, then use reliable contraceptive methods.

Therefore, always consult your doctor. To rule out pregnancy, it is recommended that a pregnancy test be performed before starting treatment.

Treatments must be stopped if you become pregnant while being treated with this medicine. The active substances in this medicine pass into breast milk, and women should not breastfeed their children. Therefore consult a doctor before use during breastfeeding.

Driving And Using Machines

Madopark can significantly impact the ability to drive and use machines. This medicine can cause increased sleepiness and temporary sudden sleep attacks.

If you suffer from these symptoms, you should refrain from driving or participating in activities as impaired attention may expose yourself or others to danger or the risk of serious injury (eg when using machines).

You are responsible for assessing whether you can drive a motor vehicle or perform work that requires sharpened vigilance. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.

Madopark Tablets Contain Sodium

This medicine contains less than 1 mmol (23 mg) sodium per tablet, ie essentially ‘sodium-free.’

How To Take Madopark?

Always take this medicine exactly as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure.

Dose one is determined by the doctor, who adjusts it individually for you. Never change the prescribed dose yourself without consulting your doctor. Do not stop treatment without consulting your doctor.

Good to know is that:

1 tablet Madopark =

= 1 tablet Madopark Quick =

= 2 tablets Madopark Quick mite.

Madopark, Madopark Quick, Madopark Quick mite, and Madopark Depot should preferably be taken 30 minutes before or 1 hour after a meal. Nausea and another stomach discomfort can be relieved if you take medicine with a low-protein snack (such as a biscuit). Protein-rich foods may reduce the effect of the drug slightly.

Dissolve Madopark Quick and Madopark Quick mite in 1/2 glass of water or swallow the tablets whole with water. When the tablets are dissolved in water, a milky white solution forms; the solution should be stirred before drinking.

Swallow Madopark Depot prolonged-release capsules whole along with water.

Take tablets whole or divide them with water.

Use For Children And Adolescents

The safety of Madopark in patients under 25 years of age has not been established. This medicine should, therefore, not be given to patients under 25 years of age.

If You Stop Taking Madopark

Treatment with this medicine should not be stopped abruptly (see section 2, warnings and precautions) If you have any further questions about the use of this product, ask your doctor or pharmacist.

Possible Madopark Side Effects

This medicine can cause side effects like all medicines, although not everybody gets them. The following side effects have been reported (occurring in an unknown number of users) during treatment with this medicine:

Blood side effects: Effects on blood count.

Side effects in metabolism: Loss of appetite.

Mental side effects:

  • Depression
  • Agitation * (restless movement)
  • Anxiety *
  • Difficulty sleeping *
  • Increased sleepiness and
  • In rare cases, temporary sudden sleep attacks during the day may occur
  • Hallucinations *
  • Delusions *
  • Confusion *
  • Dopaminergic dysregulation syndrome (excessive) use of medication.

Side effects in the sense organs and nervous system: After prolonged treatment, involuntary movements and fluctuations in the effect of the medicine can occur, which means that your mobility can suddenly change.

A severe condition with altered blood pressure, altered consciousness, muscle stiffness, and fever (similar to a condition called malignant neuroleptic syndrome) can occur in rare cases if treatment with Madopark is stopped abruptly. Lost or changed taste experience.

Side effects on the heart and blood vessels:

  • Disturbed heart rhythm
  • Dizziness (when you get up quickly)

Side effects in the gastrointestinal tract:

  • Nausea
  • Vomiting
  • Diarrhea
  • Discolored saliva
  • Discolored tongue
  • Discolored teeth
  • Discolored oral mucosa
  • Nausea
  • Another discomfort from the stomach can be reduced if the medicine is taken with a snack with a low protein content (eg a biscuit).

Contact your doctor if troublesome side effects occur, as one may need to be adjusted.

Hepatic side effects:

  • Hepatic effects were detected during the sampling

Skin side effects:

  • Itching and rash

Musculoskeletal and connective tissue disorders:

  • Ant crawls

Side effects in the urinary tract: Discolored urine.

* These side effects may occur, especially in elderly patients and patients who have or have had these diseases.

You may also experience the following side effects:

  • Inability to resist an impulse to perform an action that can be harmful such as:
  • A strong impulse to excessive gambling despite serious consequences for you personally or for your family
  • Altered or increased sexual interest or behavior that makes you or others noticeably concerned, e.g. an increased sexual drive
  • Uncontrollable and excessive need to buy things and spend money
  • Binge eating (eating large amounts of food in a short time) or compulsive eating (eating more food than normal and more than is needed to satisfy your hunger)

Tell your doctor if you experience these behaviors to discuss ways to manage or reduce the symptoms.

How To Store Madopark?

  • Keep this medicine out of sight and reach of children.
  • Madopark tablets: Do not store them above 30 ° C. Close the jar tightly. Moisture sensitive.
  • Madopark Quick and Madopark Quick mite tablets: After Madopark Quick and Madopark Quick mite tablets are dissolved in water, the solution should be drunk within 30 minutes. Close the jar tightly. Moisture sensitive.
  • Madopark Depot hard depot capsules: Do not store above 30 ° C in the original package. Close the jar tightly. Moisture sensitive.
  • Do not use this medicine after the expiry date stated on the label and carton after EXP. Day. The expiration date is the last day of the specified month.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines that are no longer required. These measures will help to protect the environment.

Contents Of The Pack And Other Information

Content Declaration

One tablet contains:

  • The active substances are levodopa 100 mg and benserazide 25 mg.
  • The other ingredients are mannitol, magnesium stearate, sodium docusate, anhydrous colloidal silica, anhydrous calcium hydrogen phosphate, microcrystalline cellulose, ethylcellulose, corn starch, crospovidone, red iron oxide (dye E172).

Madopark Quick and Madopark Quick mite tablets, respectively :

One tablet contains:

  • The active substances are levodopa 100 mg and benserazide 25 mg and levodopa 50 mg and benserazide 12.5 mg respectively.
  • The other ingredients are anhydrous citric acid, magnesium stearate, microcrystalline cellulose, and corn starch.

Madopark Depot hard depot capsules:

One capsule contains:

  • The active substances are levodopa 100 mg and benserazide 25 mg.
  • The other ingredients are mannitol, magnesium stearate, calcium hydrogen phosphate, hypromellose, gelatin, talc, vegetable oil (containing soybean oil), povidone K90, indigo carmine (dye E132), titanium dioxide (dye E171), yellow iron oxide (dye E172).

What The Medicine Looks Like And Contents Of The Pack

  • Madopark tablets (pink, cylindrical, biconvex tablets with double-sided cross-cut): glass jars of 100 pcs.
  • Madopark Quick tablets (white, cylindrical, flat tablets with beveled edges and cut-outs, marked ROCHE 125): glass jars of 100 pcs.
  • Madopark Quick mite tablets (white, cylindrical, flat tablets with beveled edges and break notches, marked ROCHE 62.5): glass jars of 100 pcs.
  • Madopark Depot hard depot capsules (blue/green capsules, marked ROCHE): glass jars of 100 pcs.

Marketing Authorisation Holder

Roche AB

Box 1228
171 23 Solna

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