Madopark – Levodopa / benserazide uses, dose and side effects

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100 mg / 25 mg tablet, 100 mg / 25 mg tablet, 50 mg / 12.5 mg tablet, 100 mg / 25 mg prolonged-release capsule, hard
levodopa / benserazide

What Madopark is and what it is 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 a lifelong disease 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 together with 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.

Madopark relieves many of the symptoms that are characteristic of Parkinson’s disease; tremors, muscle stiffness, slow movements, and 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 Madopark:

  • if you are allergic to levodopa or 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 disease, 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 Madopark Depot .

Warnings and cautions

Talk to your doctor or pharmacist before taking Madopark.

If you have severe cardiovascular disease, increased pressure in the eye ( glaucoma ), suffer from dementia or confusion, you should consult a doctor before starting treatment with Madopark. During treatment, your blood counts, your heart function, and your kidney and liver function should be checked. If you have glaucoma with an open ventricular angle, measurement of eye pressure should be done regularly. If you have diabetes, your blood sugar levels should be checked regularly. Skin check-ups should also be done regularly during treatment with Madopark.

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 also section “Driving and using machines”).

Patients with Parkinson’s disease may be depressed and depression may also occur in patients treated with Madopark. 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 an increase in sexual thoughts and feelings. Your doctor may need to re-evaluate your treatment.

The use of Madopark can cause a syndrome called dopaminergic dysregulation syndrome, which leads to excessive use of the drug and in doses that are 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 then 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 Madopark can be affected if Madopark and certain other medicines are taken at the same time. 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.

Madopark should not be taken with medicines containing adrenaline, noradrenaline, amphetamine, isoprenaline, methyldopa, amitriptyline, or imipramine.

Madopark should not be taken with a combination of MAO-A (moclobemide) and MAO-B ( selegiline, rasagiline) inhibitors. If Madopark is taken with other medicines for Parkinson’s disease (anticholinergics, amantadine, COMT inhibitors, or dopamine agonists), one dose of Madopark 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 analyzes 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 Madopark 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.

If you become pregnant while being treated with Madopark, treatment must be stopped.

The active substances in Madopark pass into breast milk, and women should therefore not breastfeed their children. Therefore consult a doctor before use during breastfeeding.

Driving and using machines

Madopark can have a major impact on the ability to drive and use machines. Madopark 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 are fit to 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/or 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 the 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 Madopark tablets whole or divided with water.

Use for children and adolescents

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

If you stop taking Madopark

Treatment with Madopark should not be stopped abruptly (see section 2, warnings and precautions)

If you have any further questions on the use of this product, ask your doctor or pharmacist.

Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

The following side effects have been reported (occurring in an unknown number of users) during treatment with Madopark:

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 * and 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 in the heart and blood vessels: Disturbed heart rhythm and dizziness (when you get up quickly).

Side effects in the gastrointestinal tract: Nausea, vomiting, diarrhea, discolored saliva, discolored tongue, discolored teeth, and discolored oral mucosa. Nausea and 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 does one may need to be adjusted.

Hepatic side effects: Hepatic effects detected during 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 in 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 any of these behaviors to discuss ways to manage or reduce the symptoms.

How to store Madopark

Keep this medicine out of the sight and reach of children.

Madopark tablets: Do not store 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 which is 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 no longer required. These measures will help to protect the environment.

Contents of the pack and other information

Content declaration

Madopark tablets:

One tablet contains:

  • The active substances are levodopa 100 mg and benserazide 25 mg.
  • The other ingredients are mannitol, magnesium stearate, sodium ducosate, 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, 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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