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WHAT Madopar NVS AND WHAT IT IS USED
Madopar NVS 100 mg / 25 mg hard capsules with sustained-release is used to treat Parkinson's disease.
Madopar NVS 100 mg / 25 mg hard capsules udalzhZheno release the drug substance contains levodopa, which is anti-Parkinsonian drug, and benserazide (as hydrochloride), which is a decarboxylase inhibitor and assists the action of levodopa. The two active ingredients act together to treat Parkinson's disease. It is known that in certain parts of the brain in humans with this disease is contained in an insufficient amount of a substance called dopamine.
Signs of the disease are slow motion, rigid muscles and tremors, as they may be expressed very differently in individual patients. In the brain, levodopa is converted to dopamine, thereby increasing quantities in the brain to normal levels.
Benserazide not itself enters into the brain, but it serves to prevents the conversion of levodopa into dopamine outside the brain. This helps to reduce side effects in other parts of the body.
Madopar HBS 100 mg / 25 mg are hard capsules prolonged release. This means that they remain in the stomach for several hours, and the active ingredients are released into the blood.
Taking this drug, the symptoms of patients suffering from Parkinson's disease can be reduced. Madopar NVS 100 mg / 25 mg hard capsules to extended release, however, does not cure the disease as the cause of the shortage of dopamine in the brain is not removed.
2. BEFORE YOU TAKE Madopar HBS
Do not take Madopar:
• If you are allergic (hypersensitive) (I levodopa or benserazide, or any of the other ingredients of Madopar;
• If you suffer from hormonal disorder for example. increased activity of the thyroid gland;
• if you have kidney, liver or heart disease;
• If you suffer from some nervous or mental illness;
• if you have narrow-angle glaucoma (high pressure in the eye);
• if you have or have had skin cancer (malignant melanoma);
• if you are taking or the last 14 days you are taking medicines known as inhibitors monoaminooksidzata; (Antidepressants)
• If you are pregnant or breast-feeding;
• If you are under 25 years of age (as treatment may affect bone growth).
Take special care with Madopar HBS
Be sure to tell your doctor:
• If you are having surgery because under general anesthesia with halothane administration of Madopar should be discontinued 12-48 hours before surgery because they may experience fluctuations in blood pressure and / or arrhythmias. Madopar therapy may be resumed after surgery by following your doctor's recommendations;
• if you have lung disease;
• if you have a stomach ulcer;
• if you have soft bones;
• if you suffer from bronchial asthma as drugs that can take for this disease (sympathomimetic drugs) may interact with your medicine;
• if you are taking medicines for high blood pressure;
• if you are taking any of the following medications: monoamine oxidase inhibitors (used to treat depressive moods); reserpine (used to treat hypertension); ferrous sulphate (used to treat iron deficiency); metoclopramide (used to treat nausea and vomiting); phenothiazines, thioxanthenes, butyrophenones (all are used for the treatment of some mental disorders, including severe anxiety (agitation), nausea, vomiting and hiccups, amphetamines (drugs which stimulate the nervous system) drugs (eg. morphine) - used to relieve pain; all other drugs to treat Parkinson's disease (eg., anticholinergic drugs, amantadine, dopamine agonists, COMT inhibitor) or any medications that affect the nervous system, including ones that are not prescribed by your doctor. This is extremely important as the use of more than one drug at the same time can strengthen or weaken the effect of making drugs. Patients being treated with this medicine should not use antacids (medicines that neutralize acids in the stomach). Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription;
• In patients with Parkinson's disease treated with dopamine agonists have been reported pathological gambling, increased libido. No association was found between the use of Madopar, which is not a dopamine agonist, and these events, but it is recommended to monitor events such symptoms as Madopar is a dopaminergic drug.
Your doctor may want to do some research periodically, such as blood and urine, checking heart rate and your blood pressure.
Madopar may affect the results of testing the level of sugar and other substances in the blood.
3. HOW TO TAKE Madopar HBS
Always take Madopar exactly as you have been told by your doctor. If you're not sure, ask your doctor or pharmacist. The doctor will prescribe the correct dose for you. Dose prescribed by your doctor will depend on your individual symptoms and your response to the drug.
Treatment usually starts with a low dose. It gradually increases to find a dose that adequately control your symptoms. During this initial period, your condition may get worse as you find the right dose for you.
The usual starting dose is one capsule three times daily for patients who have not previously received levodopa. Patients who have previously been treated with levodopa, usually begin treatment and replace every 100 mg of levodopa with a sustained release capsule with HBS Madopar 100 mg / 25 mg. Then your doctor will adjust the dosage to 2 to 3 days to find the right dose.
HBS Madopar 100 mg / 25 mg hard prolonged-release capsules are taken orally (by mouth). Madopar should be taken, if possible, 30 minutes before or one hour after a meal.
Adverse effects from the gastrointestinal tract, which may occur mainly in the initial stages of treatment, can be controlled to a large extent when Madopar taken with a snack (e. Biscuits) or liquids, or when the dose is gradually increased .
If you forget to take Madopar
If you forget to take a dose, you do not have to make up the missed dose as double next. You just have to continue with the next dose at the time, although in the meantime may again get some of the symptoms of Parkinson's disease.
Do not change your prescribed dose. If you think the effect of the drug is too weak or too strong, talk to your doctor.
If you take more than the amount Madopar
When taking too many capsules signs and symptoms are similar to side effects seen with usual intake of Madopar, but may also be more pronounced. There have cardiac arrhythmia, confusion and insomnia, nausea and vomiting, and abnormal involuntary movements. If overdose Madopar HBS, which is a controlled release, onset of the symptoms and signs may be delayed due to delayed absorption of the active ingredients in the stomach.
If you take too many capsules or someone else accidentally takes your medicine, immediately contact your doctor, pharmacist or nearest hospital.
If you stop taking Madopar
Your doctor will advise you when to stop taking the drug. Typically, NBS Madopar 100 mg / 25 mg hard capsules prolonged release is considered for a long period of time, since it replaces the substance dopamine, which is not produced in sufficient quantities in patients with Parkinson's disease.
You should tell your doctor if you want to stop the drug. Although this rarely occurs, abrupt discontinuation can cause serious side effects, for example. reported Neuroleptic malignant like syndrome (hyperpyrexia and muscular rigidity, the likelihood of change in psychological state and an increase in serum creatinine phosphokinase) which can be life-threatening after abrupt discontinuation of treatment with drugs containing levodopa. To avoid this, your doctor will advise you to discontinue treatment. If you have any further questions on the use of this product, ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Madopar can cause side effects, although not everybody gets them.
Blood and lymphatic system disorders:
In rare reports of hemolytic anemia, transient leukopenia and thrombocytopenia. Therefore, as with any long-term treatment with drugs containing levodopa Your doctor will monitor blood counts and liver and your kidney function.
Metabolism and nutrition disorders:
Depression is common in patients with Parkinson's disease, including those who are being treated with levodopa. Can be seen: agitation, anxiety, insomnia, hallucinations, seeing 6aobrazhaemi people or objects temporary disorientation, especially in elderly patients and patients with a history of such disorders.
Nervous system disorders:
Some people may experience a loss or change of taste. In later stages of treatment may arise uncontrolled, abnormal movements of the arms, legs, face and tongue. These reactions can be overcome or become manageable by dose reduction. Once the drug is taken for many years may experience changes in response to treatment. These include episodes when movements suddenly make it difficult (episodes of "freezing") return of symptoms of the disease before taking the next dose of the drug (worsening at the end of dose) or sudden changes by periods of good symptom control ( "Off" periods) to periods with lower symptom control ( "Off" periods). They can usually be overcome or become bearable by reducing daily doses or more often accept lower doses. The use of Madopar is associated with somnolence, and rarely has been associated with excessive daytime sleepiness and episodes of sudden sleep onset.
May occur changes in heart rhythm.
There are isolated reports of blood pressure changes.
During treatment with Madopar reported nausea, vomiting and diarrhea. Adverse gastrointestinal effects that can occur mainly in the early stages of treatment can be controlled largely by Madopar taken with food or liquid, or slowly increase.
Skin and subcutaneous tissue disorders:
In rare cases may occur allergic skin reactions such as itching and rash.
May occur transient increases in liver transaminases and alkaline phosphatase. Have been reported cases of increase in the gamma-glutaminyl transferase. During treatment with Madopar is observed increase in blood urea nitrogen. The color of urine may change, usually yields a red hue that darkens when urine stays. These changes are the result of the action of the drug and are not cause for concern.
If any of the side effects gets serious, or you notice other effects not listed in this leaflet, please tell your doctor or pharmacist.
5. HOW TO STORE Madopar HBS
• Keep out of reach of children.
• Do not store above 25 ° C
• Store in the original package to protect from moisture.
• Keep container tightly closed.
• Do not use Madopar HBS after the expiry date (EXP) stated on the carton. The expiry date refers to the last day of that month.
• Return the rest of medicine at the pharmacy. Only keep it if your doctor has advised.
6. FURTHER INFORMATION
What Madopar HBS
• The active substances are levodopa and benserazide.
• The other ingredients are: calcium phosphate dibasic anhydrous; methylhydroxypropylcellulose; hydrogenated vegetable oil; mannitol; talc; povidone; magnesium stearate.
Each capsule contains 100 mg of levodopa and 25 mg benserazide as the hydrochloride.
Madopar HBS looks like and contents of the pack
Madopar HBS 100 mg / 25 mg hard prolonged-release capsules are a gray-blue opaque body and dark green opaque cap with inscription ROSNE.
The capsules are sold in an amber glass bottle with a plastic screw cap, including a desiccant. The bottles containing 100 capsules.
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