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What Madopar is and what it is used for
Madopar dispersible tablets are used to treat Parkinson's disease.
Madopar dispersible tablets contain the active substance levodopa, an antiparkinsonian drug, and benserazide (in the form of a hydrochloride) that is a decarboxylase inhibitor and aids the action of levodopa.
It is known that in certain parts of the brain people with this disease are in insufficient quantity of the substance called dopamine. Signs of the disease are slow movements, stiff muscles and trembling, and they may be expressed in a very different way in individual patients. In the brain, levodopa converts to dopamine, thus increasing its amount to normal levels. Benzazepam does not enter the brain itself, but serves to prevent levodopa from converting to the dopamine outside the brain. This helps to reduce side effects in other parts of the body.
Taking this drug, the symptoms of patients suffering from Parkinson's disease may decrease. Madopar, however, does not cure the disease because the cause of dopamine deficiency in the brain is not removed.
2. What you need to know before taking Madopar
Do not take Madopar:
if you are allergic (hypersensitive) to levodopa or benserazide or any of the other ingredients of this medicine (listed in section 6);
if you suffer from a hormonal disorder, such as increased thyroid activity;
if you have kidney, liver or heart disease;
if you suffer from some nervous or mental illness;
if you have angle-closure glaucoma (increased intraocular pressure);
if you have or have had skin cancer (malignant melanoma);
if you take or during the last 14 days you have taken medicines known as monoamine oxidase inhibitors (antidepressants, ie used to treat depression);
if you are pregnant or breast-feeding;
if you are under 25 years of age (because treatment may affect bone growth).
Warnings and precautions
Talk to your doctor or pharmacist before taking Madopar:
if you are going to have surgery due to the fact that in general halothane anesthesia, Madopar should be discontinued 12-48 hours before surgery, as blood pressure fluctuations and / or arrhythmias may occur. Madopar treatment may resume after surgery, following the advice of your doctor;
if you have pulmonary disease;
if you have endocrine disease;
if you have kidney disease;
if you have heart disease;
if you have stomach ulcer;
if you have soft bones;
if you suffer from bronchial asthma because the medicines you can take for this disease (sympathomimetic medicines) can interact with your medicine;
if you are taking medicines for high blood pressure;
if you are taking any of the following medicines: monoamine oxidase inhibitors (used to treat depressed moods); reserpine (used to treat hypertension); iron sulphate (used to treat iron deficiency); metoclopramide and domperidone (used to treat nausea and vomiting); phenothiazines, thioxanthenes, butyrophenones and pimozide (all of which are used to treat some mental illnesses, including severe anxiety, nausea, vomiting and hiccups, amphetamines (nervous system stimulants), opiates (eg morphine) all other medicines to treat Parkinson's disease (eg anticholinergic medicines, amantadine, dopamine agonists, COMT inhibitor, bromocriptine) or all medicines that affect the nervous system, including those that are not have been prescribed by your doctor This is extremely important as the use of more than one drug at the same time can potentiate or weaken the effect of your medication Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, , available without prescription.
Tell your doctor if you or someone in your family / caregiver notice an urge or an irresistible desire to do things unusual to you, or you can not resist the impulse, the urge, or the temptation to do something that would harm to you or others around you. This behavior is called a "impulse control disorder" and may include addiction to gambling, a tendency to excessive food intake or indiscriminate spending, unusually strong sexual attraction, or an increase in sexual thoughts or feelings. Your doctor may need to review your treatment. A relationship between Madopar's non-dopamine agonist administration and these events has not been established, but it is advised to monitor for such symptoms because Madopar is a dopaminergic medicine.
Sometimes when you take high amounts of medicine for a long time when they
If you are over 65 years of age, if you are also taking medicines for high blood pressure or other medicines that lower your blood pressure when standing up, which may cause dizziness, fainting or fainting (orthostatic hypotension), the doctor will closely monitor your condition, especially at the beginning of treatment or when increasing the dose.
Madopar may affect the results of testing the level of sugar and other substances in the blood. If you are a diabetic, you may need to monitor your blood sugar more often.
If you have urine tests, tell your doctor or nurse that you are being treated with Madopar. This is because your medicine can affect the results of some studies (false-positive results for the presence of the ketone).
If your condition improves during treatment, you should restore your normal activity gradually. If you strain too much too quickly, you risk hurting yourself.
When Madopar is taken with food rich in protein, it can reduce the effect it usually has on you.
Pregnancy, breastfeeding and fertility
If you are pregnant or are breast-feeding, think you may be pregnant or plan to become pregnant, ask your doctor or pharmacist for advice before taking this medicine.
Do not take Madopar during pregnancy.
Mothers who breastfeed their children should not take Madopar because the possibility of childhood skeletal malformations can not be ruled out.
Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
Levodopa treatment is associated with somnolence, with excessive daytime sleepiness and episodes of sudden sleep onset. If you experience such symptoms, you should tell your doctor. Until such recurrent episodes and drowsiness resolve, you must refrain from driving or engaging in activities where impaired alertness may expose you or others to the risk of serious injury (eg when working with machines).
3. How to take Madopar
Always take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist. Your doctor will prescribe the appropriate dose for you. The dose prescribed by your doctor will depend on your individual symptoms and your response to the medicine.
The usual starting dose is half a dispersible tablet three or four times a day. If the disease is at an advanced stage, the starting dose is a Madopar Dispersible Tablet three times a day.
This initial dose may be increased by one dispersible Madopar tablet once or twice a week.
The maintenance dose is usually between four to eight dispersible Madopar tablets daily, with the required maximum dose usually not exceeding six Madopar Dispersible Tablets per day.
Treatment usually starts with a low dose. It slowly rises to a dose that will adequately control your symptoms. During this initial period your condition may get worse until you find the right dose for you.
Madopar dispersible tablets are taken orally (orally). Madopar should be taken 30 minutes before or one hour after a meal. The tablets should be dispersed in a glass of cold water or squeezed orange (for details, see below). Tablets should not be dispersed in pure fruit juice or hot beverages as this will reduce the effectiveness of your medicine. Once dispersed in water, the Madopar tablet should be drunk as soon as possible.
Guidelines for dispersible tablets
Put the Madopar tablet in at least 25 ml of cold water or squeezed orange.
The tablet will be completely dispersed for a few minutes, forming a white, milk-like liquid.
Some sludge may appear at the bottom of the glass. Do not worry. This is normal and will not reduce the effectiveness of your medicine.
Stir or shake the liquid just before you drink it.
If you forget to take Madopar
If you forget to take a single dose, do not take a double dose to make up for the missed dose. You should simply continue with the next dose at the scheduled time, although in the meantime you may get some of the symptoms of Parkinson's again.
Do not modify the prescribed dose yourself. If you think the effect of the medicine is too weak or too strong, tell your doctor.
If you take more Madopar than you should
With too much dispersible tablets, the symptoms and signs are similar to those seen with Madopar's usual intake but may be stronger. Cardiac arrhythmias, confusion and insomnia, nausea and vomiting, and unusual uncontrolled movements have been observed.
If you take too many tablets or if someone else
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everyone gets them.
Blood and lymphatic system disorders: Haemolytic anemia, transient leucopenia (decreased white blood cell count) and thrombocytopenia (platelet count reduction) have been reported rarely. Therefore, as with any long-term treatment with medicines containing levodopa, your doctor will periodically monitor the number of blood cells and your liver and kidney function.
Metabolism and nutrition disorders: A loss of appetite (anorexia) has been reported.
Psychiatric disorders: Depression is frequently observed in patients with Parkinson's disease, including those treated with levodopa. You may experience: agitation, anxiety, insomnia, hallucinations, vision of imaginary people or objects, temporary disorientation especially in elderly patients and patients predisposed to such disorders. There is also evidence of "dopamine dysregulation syndrome". (see section 2 "Warnings and Precautions").
Nervous system disorders: Some people may experience loss or change in taste. In the later stages of treatment, uncontrolled, unusual movements of the hands, legs, face and tongue (dyskinesia) may occur. These reactions can be overcome or made tolerable by dose reduction. Once the drug has been ingested for many years, changes in response to treatment may also occur. These include: episodes when the movements suddenly become obstructed (episodes of "freezing"), the recovery of the symptoms of the disease before taking the next dose of the medicine (worsening at the end of the dose) or sudden changes from periods of good control of the symptoms "periods") to periods with lesser control of the symptoms ("off" periods). They can usually be overcome or become tolerable by reducing daily doses or taking lower doses more often. Madopar's administration is associated with drowsiness, with very rarely excessive daytime sleepiness and sudden sleep onset episodes.
Cardiac disorders: Cardiac rhythm changes may occur.
Vascular disorders: There are individual reports of changes in blood pressure.
Gastrointestinal disorders: Nausea, vomiting and diarrhea have been reported with Madopar. Changes in the color of saliva, tongue, teeth, and oral mucosa can also be observed. Unwanted gastrointestinal reactions, which may occur predominantly in the early stages of treatment, can be controlled to a significant extent by taking Madopar with food or liquid or by slowly increasing the dose.
Skin and subcutaneous tissue disorders: In rare cases, skin allergic reactions such as itching and rash may occur.
Musculoskeletal and connective tissue disorders: "Restless legs syndrome" (neurological disorder characterized by discomfort in the extremities leading to an insurmountable desire for movement during which complaints abate).
Investigations: Transient increases in liver function parameters (hepatic transaminases and alkaline phosphatase) may occur. There have also been reports of increases in gamma-glutaminyl transferase. Madopar treatment also has an increase in blood urea. The color of the urine may change, usually producing a red hue that darkens when the urine stays. These changes are the result of the drug's action and are not a cause for concern. Other body fluids or tissues of the human body may also change color or stain, including saliva, tongue, teeth, or oral mucosa.
You may also experience the following side effects:
Inability to resist the impulse, urge, or temptation to do something that would harm you or others around you, this could include:
Strong desire to over-rely on gambling regardless of the consequences for you as a person or for your family;
Changed or enhanced sexual interest and behavior that may significantly affect you or others, including increased sexual desire;
Uncontrolled and wasteful shopping or spending money;
Overeating (tendency to take too much food for a short time) or compulsive eating (eating more food than normal and more than needed to satisfy hunger).
Tell your doctor if you develop any of these behaviors. He or she will discuss with you how to treat or how to reduce the symptoms.
How to Store Madopar
Keep out of the reach and sight of children.
Store below 25 ° C.
Store in the original package.
Keep the bottle tightly closed in order to protect from moisture.
Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiry date refers to the last day of that month.
Return the rest of the medicine to the pharmacy. Keep it only if your doctor has told you.
Do not dispose of medicines in the sewage system or in the household waste container. Ask your pharmacist how to dispose of medicines you no longer use. These measures will help to protect the environment.
6. Package Contents and Additional Information
What Madopar contains
The active substances are: levodopa and benserazide. Each dispersible tablet contains 100 mg of levodopa and 25 mg of benserazide as hydrochloride.
The other ingredients are: citric acid anhydrous; cornstarch; microcrystalline cellulose; magnesium stearate.
What Madopar looks like and what the package contains
Madopar 100 mg / 25 mg dispersible tablets are cylindrical, whitish, flat tablets with bevelled edges, marked "ROCHE 125" on one side and a single divider on the other.
The tablets are sold in dark glass bottles with a HDPE cap, with a dryer included. Each bottle contains 100 dispersible tablets.
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