100 mg / 25 mg tablets
levodopa and benserazide
What Levodopa / Benserazide ratiopharm is and what it is used for
Levodopa / Benserazide Ratiopharm is used for treating 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.
Levodopa / Benserazide Ratiopharm includes levodopa together with benserazide, a substance that prevents levodopa from being converted to dopamine out in the body but allows the transformation to take place in the brain. This largely avoids the unwanted effects of dopamine on the body’s other organs.
Levodopa / Benserazide Ratiopharm 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.
Levodopa and benserazide contained in Levodopa / Benserazide Ratiopharm may also be approved for the treatment of other conditions not mentioned in this product information. Ask your doctor, pharmacist, or other healthcare professional if you have any further questions, and always follow their instructions.
What you need to know before you use Levodopa / Benserazide ratiopharm
Do not use Levodopa / Benserazide ratiopharm
- if you are allergic to levodopa or benserazide or any of the other ingredients of this medicine (see section 6).
- if you have hormonal disorders such as adrenal marrow 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 severe liver or kidney disease.
- if you have glaucoma ( glaucoma ) with narrow chamber angle .
- if you suffer from severe psychiatric illness (which includes psychotic conditions).
- together with certain MAOIs (see “Other medicines and Levodopa / Benserazide ratiopharm” below).
- if you are younger than 25 years.
- if you have heart disease, e.g. severe cardiac arrhythmia (heart rhythm disorders) and heart failure .
- if you are pregnant.
- if you are a fertile woman and do not use a reliable method of contraception.
Warnings and cautions
Talk to your doctor before using Levodopa / Benserazide Ratiopharm
- you have increased pressure in the eye ( glaucoma )
- you need to undergo anesthesia
- you have severe cardiovascular disease
- you have previously had a drop in blood pressure (dizziness) when you get up quickly
- you suffer from dementia or confusion
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.
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 Levodopa / Benserazide Ratiopharm. Contact your doctor if you become depressed or experience psychological changes during treatment with Levodopa / Benserazide Ratiopharm (see also section 4 “Possible side effects”).
Contact your doctor if you notice skin changes such as pigment changes.
During treatment, your blood levels, your heart function, and your kidney and liver function should be checked.
If you have diabetes, frequent blood sugar measurements should be made to adjust the dose of one of your antidiabetic medicines to your blood sugar levels.
Use of Levodopa / Benserazide Ratiopharm 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.
Other medicines and Levodopa / Benserazide ratiopharm
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
The effect of the treatment can be affected if Levodopa / Benserazide Ratiopharm and certain other medicines are taken at the same time.
The doctor needs to know if you are already being treated with:
- Certain sedatives and medicines for psychiatric illness ( haloperidol , melperon, dixyrazine, chlorpromazine, levomepromazine, flufenazine, perfenazine, proclorperazine, thioridazine).
- Iron preparations
- Opioids (for severe pain)
- Adrenaline , noradrenaline (for asthma attacks, cardiac arrest, shock )
- Isoprenaline (to stimulate heart rate)
- Amphetamine (in ADHD )
- Methyldopa (for high blood pressure )
- Amitriptyline or imipramine (for depression)
- Blood pressure lowering agents
- Some over-the-counter medicines for acid stomach and heartburn (antacids)
Levodopa / Benserazide Ratiopharm should not be taken with a combination of MAO-A inhibitors (moclobemide) and MAO-B inhibitors ( selegiline, rasagiline).
If Levodopa / Benserazide Ratiopharm is taken with other medicines for Parkinson’s disease (anticholinergics, amantadine, COMT inhibitors, or dopamine agonists), one dose of Levodopa / Benserazide Ratiopharm or the other medicine may need to be reduced.
Levodopa / Benserazide ratiopharm with food and drink
Levodopa / Benserazide Ratiopharm should preferably be taken 30 minutes before or 1 hour after a meal. Nausea and other stomach discomforts can be relieved if you take the medicine with a light snack (such as a biscuit). Protein-rich foods may reduce the effect of the drug slightly.
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.
Ask your doctor or pharmacist for advice before taking any medicine.
Levodopa / Benserazide Ratiopharm should not be used during pregnancy as there is a risk of harm to the fetus. If you are a woman of childbearing potential, you should use a reliable method of contraception during treatment with Levodopa / Benserazide Ratiopharm.
The active substances in Levodopa / Benserazide Ratiopharm pass into breast milk, and women using Levodopa / Benserazide Ratiopharm should therefore avoid breastfeeding.
Driving and using machines
Levodopa / Benserazide Ratiopharm may cause increased sleepiness and temporary sudden sleep attacks. If you suffer from these symptoms, you should refrain from driving or engaging 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 attention. 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.
Levodopa / Benserazide ratiopharm contains sodium
This medicine contains less than 1 mmol (23 mg) sodium per tablet, ie it is essentially ‘sodium-free’.
How to use Levodopa / Benserazide ratiopharm
Always use Levodopa / Benserazide Ratiopharm exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure.
Take Levodopa / Benserazide Ratiopharm tablets whole or divided with water.
If you have the impression that the effect of Levodopa / Benserazide Ratiopharm is too strong or too weak, talk to your doctor or pharmacist.
Possible side effects
Like all medicines, Levodopa / Benserazide Ratiopharm can cause side effects, although not everybody gets them.
Common (may affect up to 1 in 10 people):
- Loss of appetite.
- Stomach upset such as nausea, vomiting, diarrhea.
- Disturbed heart rhythm.
- Dizziness (when you get up quickly).
- Insomnia.
- Involuntary movements.
- Quick-onset variations in mobility (a condition called on-off effect).
- Mental disorders such as depression, confusion and hallucinations *.
Rare (may affect up to 1 in 100 people):
- Effect on the number of blood cells .
- Itching .
- Rash.
- A severe condition with altered blood pressure , altered consciousness, muscle stiffness and fever (similar to a condition called neuroleptic malignant syndrome) can occur in rare cases if treatment with Levodopa / Benserazide ratiopharm is stopped abruptly.
Has been reported (occurs in an unknown number of users):
- Restless movements *.
- Anxiety*.
- Increased sleepiness and in rare cases, temporary sudden sleep attacks during the day may occur.
- Delusions*.
- Discoloration of the saliva, tongue, teeth or oral mucosa.
- Decreased appetite.
- Lost or changed taste experience.
- Ant crawls.
- After a long period of treatment, involuntary movements and fluctuations in the effect of the medicine can occur, which means that your mobility suddenly changes such as difficulty moving (the legs “freeze” at the start of walking or during walking).
- Dopaminergic dysregulation syndrome (excessive use of the drug).
- Liver effects detected during sampling.
* 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 Levodopa / Benserazide ratiopharm
Keep this medicine out of the sight and reach of children.
Do not store above 25 ° C.
Close the package tightly. Moisture sensitive.
Do not use this medicine after the expiry date which is stated on the carton after EXP. 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 package and other information
Content declaration
Levodopa / Benserazide ratiopharm 100 mg / 25 mg tablets
- The active substances are levodopa and benserazide hydrochloride. Each tablet contains 100 mg levodopa and 28.5 mg benserazide hydrochloride equivalent to 25 mg benserazide.
- The other ingredients are mannitol, calcium hydrogen phosphate dihydrate, microcrystalline cellulose, povidone, maize starch, sodium starch glycolate, ethylcellulose, red iron oxide (E172), colloidal anhydrous silica, sodium docosate and magnesium stearate.
What the medicine looks like and contents of the pack
Levodopa / Benserazide ratiopharm 100 mg / 25 mg tablets
Red, round, biconvex tablets with a notch on one side.
Packages: 10, 20, 50 and 100 tablets.
Marketing Authorization Holder and Manufacturer
ratiopharm GmbH, Graf-Arco-Strasse 3, D-89079 Ulm, Germany.
Merckle GmbH, Ludwig-Merckle-Strasse 3, D-89143 Blaubeuren, Germany.