Madopar Tabl 125 mg Ds 100 pcs

What is Madopar and when is it used?

Prescriptened by your doctor.

1. Parkinson's disease

Parkinson's disease manifests itself in slowed movements, stiffness of the muscles and tremors. These symptoms differ from patient to patient or from patient to patient. Therefore, the popular term ?paralysis? is not always applicable.Today we know that in Parkinson's disease there is an insufficient amount of a certain substance in certain centers of the brain. This substance is called dopamine. Its deficiency can lead to the disorders mentioned. The difficulty in treating Parkinson's disease is that insufficient amounts of dopamine can pass from the blood to the brain. In contrast, this can be the chemical precursor of dopamine (levodopa).Unfortunately, the body converts a large part of the levodopa administered into dopamine outside of the brain. As a result, the blood cannot carry enough levodopa to the brain. In addition, the dopamine produced outside the brain causes unpleasant side effects.Madopar is a medicine used to treat the symptoms of Parkinson's disease. It contains two components: levodopa and benserazide (as the hydrochloride).Outside the brain, benserazide prevents levodopa from being converted into dopamine. Since benserazide itself does not penetrate into the brain, the following happens in your body: The levodopa (1st component of Madopar) can hardly be converted into dopamine outside the brain because of benserazide (2nd component of Madopar). Because levodopa enters the brain from the blood - and benserazide does not - levodopa is now mainly converted to dopamine in the brain. This is the goal of treatment, which is to replenish the missing dopamine in the brain. In this way, Madopar can have a beneficial effect on the symptoms of Parkinson's disease. However, it does not cure the disease as it does not address the cause of the dopamine deficiency in the brain. A causal control of the disease is still not possible.

2. Restless legs syndrome

Madopar is used to treat idiopathic (with no known cause) and symptomatic (in kidney failure) restless legs syndrome.

When should Madopar not be taken?

In case of hypersensitivity to one of the ingredients.If you are under 25 years of age, you must not take Madopar.If you have a special type of glaucoma (narrow-angle glaucoma), you must not take Madopar. Your doctor will look into this question.In the case of very severe hormonal disorders, severe kidney, liver and heart diseases, the use of Madopar is prohibited. The same applies to certain nervous diseases.If you are taking certain medicines to treat depression or Parkinson's disease (called non-selective MAOIs or a combination of two selective MAOIs, type A and type B), you must not use Madopar.Madopar must not be used during pregnancy or by women of childbearing potential who are not using reliable contraception.In certain cases, your doctor may have other reasons for not allowing you to take Madopar. He / she will explain this to you on a case-by-case basis.

When should you take caution when taking / using Madopar?

Liver, kidney and blood count examinations are necessary at regular intervals.Your doctor will measure your eye pressure regularly if you have glaucoma (open-angle glaucoma).If you have a stomach ulcer, osteomalacia (a disease that causes loss of bone strength), depression, or have ever had certain serious heart diseases (myocardial infarction, coronary artery disease, cardiac arrhythmias), your doctor will be particularly careful about your treatment monitor.In diabetics, the blood sugar values ??should be checked more often and the dosage of the antidiabetic therapy adjusted.This medicine can impair your ability to react, drive and use tools or machines!In rare cases, drowsiness and sudden sleep may occur during treatment. The latter can sometimes occur without warning or drowsiness. You must therefore not drive a vehicle or engage in other activities (e.g. use tools or machines) while taking Madopar, in which reduced alertness puts you or others at risk, if you suffer from sudden sleep or severe sleepiness during the day and until you have had sufficient experience with the There are impairments.Some patients have shown unusual behavior for them while taking medicines from the same and related class of substances as Madopar. Examples of such behavior are an unusually strong urge to gamble (gambling with increased spending), increased sex drive and / or other impulse control disorders (inability to withstand sudden impulses) or addictive behavior or compulsive behaviors such as compulsive shopping, binge eating and compulsive eating.If you or your family members are developing behavior that is atypical or unusual for you, please discuss this with your doctor.In a small number of patients taking Madopar, an obsessive increase in the daily dose of Madopar has occurred without this being necessary to control motor skills. This compulsive increase in the daily dose of Madopar resulted in mental and behavioral disorders.Tell your doctor or health care professional if you or your family / caregiver notice that you develop addiction-like symptoms that lead to craving for high doses of Madopar and other medicines used to treat Parkinson's disease (known to It has been observed that patients with Parkinson's disease have a higher risk of developing black skin cancer compared to the general population. It is not known whether the increased risk was due to Parkinson's disease itself or to other factors such as levodopa treatment. Therefore, during a Madopar treatment, you should regularly check your skin for suspicious changes and have your skin checked regularly by suitable specialists (e.g.If you are taking medicines for the treatment of depression, for Parkinson's disease or medicines that stimulate the sympathetic nervous system (so-called sympathomimetics such as certain medicines for the treatment of asthma and poor circulation), it is imperative that you inform your doctor.The way Madopar works can be influenced by certain medicines. These are, for example, certain antihypertensive drugs, certain drugs for the treatment of mental illnesses, certain drugs for the treatment of mental illnesses (so-called antipsychotics), certain iron supplements, highly effective painkillers of the opioid type and some drugs for stomach complaints (e.g. nausea, irritable stomach, heartburn) .If Madopar is taken at the same time as other medicaments for the treatment of symptoms in Parkinson's disease (e.g. amantadine, selegiline, bromocriptine, dopamine agonists, COMT inhibitors, anticholinergics), the side effects can be increased. It may therefore be necessary for your doctor to prescribe a lower dose of Madopar or the other medicine.Please note that taking a protein-rich meal at the same time reduces the effectiveness of Madopar.Madopar must not be stopped suddenly, as withdrawal symptoms may occur with symptoms such as high fever, muscle stiffness or psychological changes. As this can be life-threatening, you must contact your doctor immediately in this case. You should therefore only discontinue Madopar gradually in consultation with your doctor.Madopar DR tablets and Madopar tablets contain less than 1 mmol sodium (23 mg) per tablet, ie they are almost ?sodium-free?.Tell your doctor or pharmacist if you

• suffer from other diseases,have allergies ortake other medicines (including ones you have bought yourself!) or apply them externally!

Can Madopar be taken during pregnancy or while breastfeeding?

You must not take Madopar if you are pregnant. If you are of childbearing age, you may only use Madopar if you take reliable measures to prevent pregnancy. If you become pregnant during treatment, your doctor will need to decide how to stop it.Do not breast-feed during treatment with Madopar.

How do you use Madopar?

Taking the right amount at the right time is important for the success of the treatment. Your doctor will therefore determine the correct amount and frequency of intake for your case and work closely with you to find the most suitable treatment regimen for you. Therefore, follow his / her instructions with the utmost care. Your doctor will generally prescribe small doses of Madopar for you at the start of treatment and gradually increase the dose. He / she does this to give your body time to adapt to the medicine. In doing so, he avoids undesirable effects as much as possible.Since Madopar helps to replace a substance insufficiently provided by the body itself, it is almost always a medicinal product for long-term use. However, there are cases in which the dose has to be reduced or the drug has to be discontinued entirely. In addition to the pregnancy already mentioned, this can be the case, for example, when switching to another necessary drug or with certain additional illnesses. Your doctor will know about this and will advise you. As a patient with Parkinson's disease, you must remain under regular medical check-ups and must not undertake any other disease treatments without consulting your doctor. If you are forced to change doctors or to see another doctor,The insufficient presence of dopamine is also involved in the cause of restless legs syndrome. In the case of restless legs syndrome, the dosage depends on the severity of the disease, whereby the optimal effectiveness must be determined individually by carefully adjusting the dose. Madopar is usually taken for a long time. Your doctor will decide on the dosage and the duration of the treatment. It is taken one hour before going to bed, preferably with a little liquid and a low-protein snack (e.g. biscuits). If you take the capsules or tablets with a meal that is high in protein, the absorption of Madopar in the gastrointestinal tract will be reduced and its effectiveness may be reduced.

Information for all patients receiving Madopar

You must never take Madopar without medical advice. You should also never change the dosage without the consent of your doctor. Always swallow the capsules and the Madopar DR tablets whole with alcohol-free liquid and at the same time take some low-protein food (e.g. biscuits). If possible, Madopar should be taken 30 minutes before or 1 hour after meals.If your doctor has prescribed Madopar in tablet form, but not Madopar DR, you can crumble the prescribed amount as required to make it easier to swallow.Madopar DR tablets may only be halved for intake.

Taking the tablets for oral suspension (Madopar LIQ)

Dissolve these tablets in a quarter (25 ml) glass of water. The tablets must not be dissolved in fruit juices, milk and hot drinks, as this makes Madopar less effective.In a few minutes, without stirring, the tablet has completely turned into a milky, flaky solution with a sediment.Madopar is now ready to drink. Stir well before drinking and drink all of the solution immediately, possibly with a tube. The solution must be drunk within 30 minutes of dissolving.If you are about to have an operation under general anesthesia, it is recommended - apart from emergencies - to stop taking Madopar at least 12 to 48 hours beforehand. The resumption takes place according to the order of the doctor.If you are under 25 years of age, you must not take Madopar.Do not change the prescribed dosage on your own. If you think that the medicine is too weak or too strong, talk to your doctor or pharmacist.

What side effects can Madopar have?

The following side effects may occur when taking Madopar:Especially with older patients or Patients or in patients resp. Patients who have suffered from such disorders in the past have seen mental disorders (sleep disorders, agitation, anxiety, hallucinations, behavioral problems, aggressiveness, delusional ideas, confusion), nightmares and temporal disorientation, low blood pressure, and cardiac arrhythmias. Depression and suicidal ideation can occur, but they can also be caused by the underlying disease.Loss of appetite, nausea, nausea, diarrhea and dry mouth can occur. In individual cases, a temporary change in taste sensation occurs, especially at the beginning of treatment.Skin symptoms such as itching and rash (fleeting reddening of the skin) caused by hypersensitivity reactions may occur. Blood count disorders and changes in other blood values ??can also occur.Unusual behaviors such as an unusually strong urge to gamble (gambling with increased spending on money), increased sex drive and / or other impulse control disorders (inability to withstand sudden impulses) or addictive or compulsive behavior such as compulsive shopping, binge eating and compulsive eating were observed while taking Madopar observed. In this context, please also read the section ?When should you be careful when taking Madopar??.Craving for large doses of Madopar that significantly exceed the doses needed to adequately control movement symptoms is known as dopamine dysregulation syndrome. Some patients experience unusually violent involuntary movements (dyskinesia), mood swings, or other side effects after taking high doses of Madopar.Drowsiness and sudden sleep attacks may occur. In this context, please also read the section ?When should you be careful when taking Madopar??.In addition, headaches, febrile infections, runny nose, bronchitis and slight discoloration of the urine (red color) can occur. There may also be discoloration or coloration of other body fluids or tissues, including saliva, tongue, teeth or the oral mucosa. Transient increases in certain liver enzymes have been seen with Madopar.In later phases of treatment, often only after years of regular use, other side effects can occur. Most often it is involuntary, excessive movements of the limbs, facial muscles and tongue. In addition, the most common side effect of long-term dopaminergic therapy is a deterioration (in the sense of a delayed appearance of the symptoms from the evening / night into the early afternoon and into the evening) before taking the next dose for the night.After long-term treatment, fluctuations in the response to the drug can occur, resulting in, for example, sudden freezing, deterioration in the effect (end-of-dose) or an abrupt transition from excessive physical activity to physical inactivity ("on-off phenomenon") ) appear.Both early and late side effects are highly dependent on the amount of drug taken. The distribution of the individual doses throughout the day may play an even greater role. If the amount is better distributed over the day or if the daily dose is reduced, sometimes even spontaneously, the side effects can recede.If you get any side effects, talk to your doctor or pharmacist. This also applies in particular to side effects that are not listed in this leaflet.

What should also be noted?

The drug may only be used up to the date marked ?EXP? on the container.

Storage advice

Do not store above 25 ° C.Keep the container tightly closed in the outer carton in order to protect from moisture.Keep out of reach of CHILDREN.

More information

The test for ketone bodies in the urine can be false positive.Your doctor or pharmacist can provide you with further information. These people have the detailed information for specialists.

What's in Madopar?

Madopar capsules ?62.5? (blue-light gray) and ?125? (blue-pink), tablets ?125? (pink) and ?250? (pink), Madopar LIQ ?62.5? (beige) and ?125 »(Beige) (tablets for the preparation of an oral suspension: 50 + 12.5 and 100 + 25) and Madopar DR« 250 »(pink) (with biphasic active ingredient release: 200 + 50).

Active ingredients

1 Madopar capsule 62.5 contains: Levodopa 50 mg and benserazide 12.5 mg as benserazide hydrochloride1 Madopar capsule 125 contains: levodopa 100 mg and benserazide 25 mg as benserazide hydrochloride1 Madopar tablet 125 contains: levodopa 100 mg and benserazide 25 mg as benserazide hydrochloride1 Madopar tablet 250 contains: levodopa 200 mg and benserazide 50 mg as benserazide hydrochloride1 Madopar LIQ tablet 62.5 contains: levodopa 50 mg and benserazide 12.5 mg as benserazide hydrochloride1 Madopar LIQ tablet 125 contains: levodopa 100 mg and benserazide 25 mg as benserazide hydrochloride1 Madopar DR tablet 125 contains: levodopa 100 mg and benserazide 25 mg as benserazide hydrochloride

Auxiliary materialsMadopar, capsulesCapsule content:

Mannitol, microcrystalline cellulose, talc, povidone K90, magnesium stearate.

Capsule shell:

black iron oxide for 62.5 mg, red iron oxide for 125 mg, titanium dioxide, gelatin, indigotine.

Ink:

Shellac, propylene glycol (E1520), ammonia solution 28%, potassium hydroxide, black iron oxide.

Madopar DR tabletsTablet core:

Red iron oxide, microcrystalline cellulose, povidone K30, sodium starch glycolate type A, magnesium stearate, silicon dioxide hydrate.

Slow release layer:

Hypromellose, Mannitol, Red Iron Oxide, Povidone K30, Magnesium Stearate, Silica Hydrate.

Support layer:

Hypromellose, hydrogenated castor oil, red iron oxide, povidone K30, magnesium stearate, silicon dioxide hydrate.

Madopar tabletsTablet core:

Mannitol, calcium hydrogen phosphate, microcrystalline cellulose, pre-gelatinized starch, crospovidone, ethyl cellulose (made from genetically modified cotton), red iron oxide, highly dispersed silicon dioxide, docusate sodium, magnesium stearate.

Madopar LIQ tabletsTablet core:

Citric acid, pre-gelatinized starch, microcrystalline cellulose, magnesium stearate.

Approval number

38096, 43593, 52377, 53493 (Swissmedic).

Where can you get Madopar? Which packs are available?

In pharmacies, only with a prescription.

• Madopar 62.5 mg 100 capsulesMadopar 125 mg 100 capsulesMadopar 125 mg 100 tabletsMadopar 125 mg 30 tabletsMadopar DR 250 mg 30 tabletsMadopar DR 250 mg 100 tabletsMadopar Liquid 62.5 mg 100 tablets Madopar Liquid 125 mg 100 tablets Madopar Liquid 125 mg 30 tablets

Marketing authorization holder

Roche Pharma (Switzerland) AG, Basel.??????