Madopar 0.250 mg. 100 capsules

Madopar HBS WHAT IS AND WHAT IT IS USED?
Madopar HBS 100 mg / 25 mg hard capsules with sustained-release is used in the treatment of Parkinson's disease.
Madopar HBS 100 mg / 25 mg hard capsules with sustained-release composition comprises a drug substance of 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 patients with this disease is contained in an amount insufficient substance called dopamine. Signs of the disease are slow movements, rigid muscles, shaking, they may be expressed very differently in different patients. In the brain, levodopa is converted to dopamine, thereby increasing the amount in the brain to-thermal levels. Benserazide itself does not penetrate into the brain, but it serves to prevent the conversion of levodopa to dopamine outside the brain. This helps to reduce side effects in other parts of the body.
Madopar HBS 100 mg / 25 mg are hard prolonged-release capsules. This means that they remain in the stomach for several hours, and the active ingredients are released into the blood.
By taking this medicine, the symptoms of patients suffering from Parkinson's disease can be reduced. Madopar HBS 100 mg / 25 mg hard capsules extended release 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) to levodopa or benserazide, or any of the other ingredients of Madopar;
- If you suffer from hormonal disorder eg. Increased activity of the thyroid gland
- If you have kidney, liver or heart disease;
- If you suffer from any neurological or psychiatric disorders;
- If you have narrow-angle glaucoma (high pressure in the eye);
- If you have or have had skin cancer (malignant melanoma);
- Or if you take the last 14 days you are taking medicines known as monoamine oxidase inhibitors (antidepressants);
- If you are pregnant or breast-feeding;
- If you are under 25 years of age (as treatment can affect bone growth). Take special care with Madopar

Be sure to tell your doctor:
- If you have a surgery because general anesthesia with halothane administration of Madopar should be discontinued 12-48 hours before surgery, as can surges 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 asthma, since drugs that you 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 sulfate (used to treat iron deficiency); metoclopramide (used to treat nausea and vomiting); phenothiazines, thioxanthenes, butyrophenones (all used to treat certain mental disorders, including severe anxiety (agitation), nausea, vomiting and hiccups, amphetamines (drugs that stimulate the nervous system), opioids (eg. morphine) - used to relieve pain; all other drugs to treat Parkinson's disease (e., anticholinergic drugs, amantadine, a dopamine agonist, an inhibitor of COMT), or any medications that affect the nervous system, including those which are not prescribed by your doctor. It is very important as the use of more than one drug at the same time can strengthen or weaken the effect of the medicine. Patients who are treated with this medicine, you should not use antacids (medicines that neutralize stomach acid). Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

Tell your doctor if you or someone in your family / person who takes care of you notice impulse or urge to do unusual things for you or you can not resist the impulse, urge or temptation to do something that would harm you or others around you. These behaviors are called violation of impulse control and may include gambling addiction, binge acceptance of excessive amounts of food or indiscriminate spending an unusually strong sex drive or enhance sexual thoughts or feelings. May be necessary for your doctor to review your treatment. No association was found between administration of Madopar, which is not a dopamine agonist, and these events, but it is recommended to monitor for signs of symptoms such as Madopar is a dopaminergic drug.
Your doctor may want to do some research periodically, such as blood and urine, checking heart rate and blood pressure.
Madopar may affect the results of testing the level of sugar and other substances in the blood. If you are diabetic, you may need to be monitored more frequently blood sugar.
If your condition has improved during treatment, you can restore your normal activities gradually. If you exert too much too fast, you risk injury

Pregnancy and lactation
Do not take Madopar during pregnancy. You must tell your doctor if you are pregnant, if you are pregnant or plan to become pregnant. Mothers who breastfeed their children should not take Madopar, because it can not exclude the possibility of the occurrence of musculoskeletal disorders (defects) in children.
Ask your doctor or pharmacist before taking any medicine.

Driving and using machines
IMPORTANT
Treatment with levodopa is associated with somnolence, very rarely observed excessive daytime somnolence and episodes of sudden sleep onset. If you get these symptoms, you should tell your doctor and until such recurrent episodes and somnolence must refrain from driving or engaging in activities where impaired alertness may put you or others at risk of serious injury (eg. operating machinery).

3. HOW TO TAKE Madopar HBS?
Always take Madopar exactly as prescribed by your doctor. If you are not sure, ask your doctor or pharmacist. The doctor will prescribe the right dose for you. The dose you are 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 increased 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 received prior treatment with levodopa therapy usually starts by replacing every 100 mg of levodopa with a sustained-release capsule, Madopar HBS 100 mg / 25 mg. Then your doctor will adjust the dose in 2 to 3 days to find the right dose.
Madopar HBS 100 mg / 25 mg hard prolonged-release capsules are taken orally (by mouth). Madopar should be taken, if possible, 30 minutes or one hour before a meal. Adverse effects from the gastrointestinal tract, which may occur mainly in the initial stages of treatment, can be controlled to a great extent when administered with Madopar 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, do not have to make up the missed dose by doubling the next. You just have to continue with the next dose at the time, although the process may again get some of the symptoms of Parkinson's disease.
is change the prescribed dose yourself. If you feel that the effect of the drug is too weak or too strong, talk to your doctor.

If you take more than the amount of Madopar
When taking too many capsules symptoms and signs are similar to the adverse reactions observed in the ordinary administration of Madopar, but may also be more pronounced. Were observed 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 if someone else accidentally takes your medicine, contact your doctor, pharmacist or nearest hospital.

If you stop taking Madopar
Your doctor will advise you when to stop taking the drug. Typically Madopar 100 mg / 25 mg hard capsules prolonged release is taken for a long period because it replaces dopamine, which is not produced in sufficient quantities in patients with Parkinson's disease.
You must tell your doctor if you want to stop the drug. Although this rarely occurs, sudden discontinuation can cause serious side effects, eg. reported for neuroleptic malignant-like syndrome (hyperpyrexia and muscle stiffness, likely changes in psychological state and an increase in serum creatinine phosphokinase), which can be life-threatening after abrupt discontinuation of 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 cases 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: anorexia reported.
Psychiatric Disorders: Depression is common in patients with Parkinson's disease, including those who are being treated with levodopa. May occur: agitation, anxiety, insomnia, hallucinations, seeing imaginary people or objects, temporary disorientation, especially in elderly patients and patients with a history of such disorders.
Nervous System: Some people may experience a loss or change in taste. In later stages of treatment may occur uncontrolled, abnormal movements of the arms, legs, face and tongue. These reactions can be overcome or become affordable by reducing the dose. Once the drug is administered over many years may experience changes in response to treatment. These include episodes when sudden movements are difficult (episodes of "freezing"), a return of symptoms of the disease before the next dose of the drug (worsening at the end of the dose) or sudden changes of periods of good symptom control ("op" periods) to periods with poor control of symptoms ("off 'periods). They can usually be overcome or become bearable by reducing the daily dosage or more frequently adopted in low doses. Administration of Madopar is associated with somnolence, very rarely been associated with excessive daytime somnolence and episodes of sudden sleep onset episodes.

Cardiac disorders may occur changes in heart rhythm.

Vascular disorders: There have been isolated reports of changes in blood pressure.

Gastrointestinal disorders during treatment with Madopar reported nausea, vomiting and diarrhea. Adverse gastrointestinal effects can occur mainly in the early stages of treatment may be controlled largely by Madopar be taken with food or liquid, or slowly increase the dose.
Skin and subcutaneous tissue disorders: In rare cases may occur allergic skin reactions such as itching and rash.
Research: may occur transient increase in liver transaminases and alkaline phosphatase. Have been reported cases of an increase of gamma-glutaminyl transferase. During treatment with Madopar is observed increase in blood urea nitrogen. The color of the urine may change, usually yield a red tint, which darkens when urine stays. These changes are the result of the action of the drug and are not cause for concern.
You may get the following side effects:
Unable to resist the impulse, urge or temptation to do something you or others around you, this could include:
- Strong desire to bet excessively gambling regardless of the consequences for yourself as an individual or for your family.
- Changed or increased sexual interest and behavior can greatly concerns you or others, this includes increased sexual desire.
- Uncontrolled and lavish shopping or spending money.
- Overeating (binge acceptance of excessive amounts of food in a short time) or compulsive eating (eating more food than normal and more than is necessary to satisfy hunger).
Tell your doctor if you develop any of these behaviors. He / she will discuss with you how to treat or how to reduce the symptoms.
If any of the side effects gets serious, or if 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 the bottle tightly closed.
- Do not use Madopar HBS after the expiry date (EXP) which is stated on the carton. The expiry date refers to the last day of that month.
- Return the remaining drug to the pharmacy. Only keep it if your doctor has told you.

6. FURTHER INFORMATION
What Madopar HBS?
The active substances are: levodopa and benserazide.
The other ingredients are calcium hydrogen phosphate anhydrous; methylhydroxypropylcellulose; hydrogenated vegetable oil; mannitol; talc; povidone; magnesium stearate.
Each capsule contains 100 mg of levodopa and 25 mg benserazide as hydrochloride.

Madopar HBS looks like and contents of the pack?
Madopar HBS 100 mg / 25 mg hard capsules extended release are a gray-blue opaque body and dark green opaque cap, imprinted with ROCHE,
The capsules are sold in bottles of dark glass with a plastic screw cap, including a desiccant. Bottles containing 100 capsules.