Gelatinous solid capsules (125): the size No. 2, opaque structure with the case pinkish-corporal, a lid of light blue color and black marking of "ROCHE"; in capsules – the granulated powder of light-beige color, sometimes скомковавшийся (on 30 or 100 pieces in glass bottles of dark color, in a cardboard pack 1 bottle);
Gelatinous solid capsules with the modified release (GSS 125): the size No. 1, opaque structure with the case light blue, a lid of dark green color and a rubiginous text of "ROCHE"; in capsules – the granulated powder of yellowish or white color, sometimes скомковавшийся (30 or 100 pieces in glass bottles of dark color, in a cardboard pack 1 bottle);
The tablets dispersed (high-speed) (125): a flat cylindrical form, with slanted edge, have almost white or white color with an easy mramornost of a surface, on one party dividing risk, on another – an engraving of "ROCHE 125", with a slight smell or without it, diameter of a tablet about 11 mm, thickness about 4,2 mm (30 or 100 pieces in glass bottles of dark color, in a cardboard pack 1 bottle);
Tablets 250: a flat cylindrical form, with slanted edge, pale red color with insignificant impregnations, on one party the engraving of "ROCHE", crosswise risk and a hexagon, is applied on another – crosswise dividing risk; diameter of a tablet is 12,6-13,4 mm, thickness is 3-4 mm (30 or 100 pieces in glass bottles of dark color, in a cardboard pack 1 bottle).

Active ingredients of Madoparum – a levodopa and a benserazida a hydrochloride, their content in drug (respectively):

1 capsule (size No. 2 and No. 1) – 100 mg and 28,5 mg that is equivalent to 25 mg of a benserazid;
1 tablet dispersed (125) – 100 mg and 28,5 mg that is equivalent to 25 mg of a benserazid;
1 tablet (250) – 200 mg and 57 mg that is equivalent to 50 mg of a benserazid.

Auxiliary components:

Capsules 125: magnesium stearate, cellulose microcrystallic, povidone, talc;
The GSS 125 capsules (with the modified release): Mannitolum, the vegetable oil hydrogenated, povidone, a gipromelloz, calcium hydrophosphate, magnesium stearate, talc;
Tablets 125: starch corn prezhelatinizirovanny, citric acid anhydrous, magnesium stearate, cellulose microcrystallic;
Tablets 250: calcium hydrophosphate, Mannitolum, cellulose microcrystallic, кросповидон, starch corn prezhelatinizirovanny, ethyl cellulose, silicon dioxide colloid anhydrous, dye ferrous oxide red, magnesium stearate, sodium docusate.

Structure of capsules: titanium dioxide (E171), gelatin.

In addition as a part of capsules:

Capsules 125: a lid – dye indigo carmine (E132), the case – dye ferrous oxide red (E172);
GSS 125 capsules: a lid – dye indigo carmine (E132), dye ferrous oxide yellow (E172), the case – dye indigo carmine (E132).

Indications to use

Use of Madoparum is shown to patients with Parkinson's disease:

Idiopathic syndrome of "uneasy legs";
Syndrome of "uneasy legs" at the patients with a chronic renal failure who are on dialysis.

Besides, at a dysphagy and an akineziya in morning and evening of days, to patients with a phenomenon of "exhaustion of effect of a single dose" or a phenomenon of "increase in stage of latency before clinical effect of drug" appoint the dispersed high-speed tablets 125.

At any types of fluctuations of action of a levodopa ("dose peak dyskinesia" or "a phenomenon of the end of a dose", including an immovability at night) use of the GSS 125 Madoparum capsules is shown.

Contraindications

Mental pathologies with a psychotic component;
Dekompensirovanny disturbance of functions of bodies of endocrine system;
Cardiovascular diseases in a decompensation stage;
Dekompensirovanny disturbance of functions of a liver;
Dekompensirovanny disturbance of functions of kidneys (except patients with a syndrome of the "uneasy legs" which are on dialysis);
Simultaneous use of non-selective monoamine oxidase inhibitors (MAO), combinations of A and MAO MAO inhibitors of type B;
Closed-angle glaucoma;
Age up to 25 years;
Period of pregnancy and breastfeeding;
Hypersensitivity to drug components.

Reception of Madoparum is contraindicated to the women of childbearing age who are not using reliable methods of contraception.

Route of administration and dosage

Madoparum is taken inside for half an hour to or in 1 hour after food.

Capsules are swallowed entirely, it is not recommended to open the GSS 125 Madoparum capsules as it will cause loss of effect of the modified release of active ingredient.

Tablets 250 can be split up for simplification of swallowing, a tablet dispersed before reception dissolve in 25-50 ml of water. The tablet is dissolved within several minutes, the formed milky-white solution it is necessary to accept in the next half an hour, having carefully mixed it.

Use of drug is begun with gradual selection of the individual dose providing optimum therapeutic effect.

The recommended dosing:

Initial stage of a disease: treatment should be begun with administration of drug in a dose 50 mg / 12,5 with mg (a levodopa / бенсеразид) 3-4 times a day. Considering portability of drug the patient, the dose is recommended to be increased gradually. The optimum clinical effect is reached within 4-6 weeks, usually, at a daily dose of 300-800 mg / 75-200 in mg in 3 and more receptions. If necessary, it is necessary to start further increase in a daily dose not earlier than in 1 month;
Maintenance dose: on 100 mg / 25 mg of 3-6 times a day, for optimization of effect it is necessary to use the tablets dispersed or the GSS 125 capsules;
Syndrome of "uneasy legs": drug accept in 1 hour prior to a dream during food no more than 400 mg / 100 mg (500 mg of Madoparum) a day;
Idiopathic syndrome of "uneasy legs" with disorders of backfilling: it is necessary to take capsules 125 or tablets 250, an initial dose – 50 mg / 12,5 mg mg-100 / 25 mg (a levodopa / бенсеразид). For achievement of clinical effect the dose should be raised to 200 mg / 50 mg;
Idiopathic syndrome of "uneasy legs" with disorders of backfilling and a dream: an initial dose – on 1 GSS 125 and 1 capsule to the capsule 125 in 1 hour prior to withdrawal to a dream. In case of need it is necessary to increase GSS 125 dose to 2 capsules;
Idiopathic syndrome of "uneasy legs" with disorders of backfilling, a dream and within a day: in addition – 1 tablet dispersed or 1 capsule 125, but no more than 400 mg / 100 mg (500 mg of Madoparum) a day;
Syndrome of "uneasy legs" against the background of a chronic renal failure at the patients receiving dialysis: 1 capsule 125 or 1 the tablet dispersed for half an hour prior to carrying out dialysis.

In case of purpose of Madoparum in a combination with other protivoparkinsonichesky means emergence of need for decrease in their dose or gradual cancellation is possible.

The tablets dispersed (high-speed) – a special form of drug for patients with an akineziya or a dysphagy in morning and evening of days, phenomena of "exhaustion of effect of a single dose" or "increases in stage of latency before clinical effect of drug". At emergence during the day of a phenomenon of "exhaustion of effect of a single dose" or a phenomenon of the "inclusion switching off" sick it is necessary to transfer to more frequent administration of drug in smaller single doses or (and it is more preferable) on use of the GSS 125 capsules.

It is desirable to begin transition to GSS 125 with reception of the morning dose corresponding to the tablets dispersed or tablets 250, at the same time it is recommended to keep also the mode of therapy.

Gradually begin to increase a dose (approximately by 50%) in 2-3 days. It is necessary to warn patients about a possible temporary aggravation of symptoms during this period as action of GSS 125 begins a bit later.

For achievement of more bystry clinical effect it is recommended to combine reception of GSS 125 with capsules 125 or tablets dispersed (high-speed). This combination is optimum for the first morning dose.

It is necessary to select a dose of GSS 125 carefully and slowly, with a break in 2-3 days and more between changes.

For achievement of positive effect at patients with the shown symptoms at night, gradual increase in an evening dose (before going to bed) of GSS 125 to 2 capsules is recommended.

At emergence of dyskinesia against the background of reception of GSS 125 it is necessary to increase intervals between receptions (it gives bigger effect, than reduction of a single dose).

At insufficient efficiency of Madoparum of GSS 125 it is necessary to return to earlier applied drug forms.

Long therapy can cause emergence of a phenomenon of "exhaustion", episodes of "hardening", a phenomenon of "inclusion switching off". Special cases of the mode of dosing consist in crushing of a daily dose of drug, that is in reduction of a single dose or reduction of an interval between administrations of drug at a phenomenon of "exhaustion" and episodes of "hardening", and at a phenomenon of "inclusion switching off" – in reduction of number of receptions at increase in a single dose. Then it is possible again to try to increase a dose for efficiency of treatment.

Dose adjustment is not required to patients with the renal failure proceeding in easy and moderate severity. Drug is well transferred by the patients who are on a hemodialysis.

For an exception of aggravation of symptoms of a syndrome of "uneasy legs" the daily dose of Madoparum should not exceed 400 mg / 100 mg (a levodopa / бенсеразид).

In case of increase of clinical symptoms the patient should lower a dose of a levodopa or to pass gradually to use of other means.

Side effects

Alimentary system: diarrhea, nausea, vomiting; in some cases – a xerostomia, change or loss of flavoring feelings;
Nervous system: sleeplessness, agitation, alarm, hallucinations, a temporary disorientation (especially at patients of advanced age and at the instruction in the anamnesis on these symptoms), nonsense, a depression, dizziness, a headache; (at late stages of therapy) sometimes – the expressed drowsiness, the spontaneous movements (like an athetosis or a chorea), episodes of "hardening", a phenomenon of "exhaustion" (easing of effect by the end of the period of action of a dose), episodes of sudden drowsiness, a phenomenon of "inclusion switching off", aggravation of a syndrome of "uneasy legs";
Cardiovascular system: orthostatic hypotension (at a dose decline of Madoparum weakens), arrhythmias, arterial hypertension;
System of a hemopoiesis: seldom – a tranzitorny leukopenia, hemolitic anemia, thrombocytopenia;
Respiratory system: rhinitis, bronchitis;
From an organism in general: anorexia;
Dermatological reactions: seldom – a skin itch, rash;
Laboratory indicators: sometimes – increase gamma глутамилтранспептидазы, a blood urea nitrogen, tranzitorny increase in activity of liver enzymes and an alkaline phosphatase, urine discoloration to red (when standing – darkening);
Others: febrile infection.

Special instructions

Substantially to reduce risk of emergence of undesirable reactions from the alimentary system, it is always necessary to accept drug with a small amount of liquid or food and to slowly increase a dose.

At patients with an open angle glaucoma it is necessary to control intraocular pressure regularly.

The maintenance of a levodopa as a part of drug demands periodic control of function of a liver and kidneys, a blood count.

Correction of the accepted dose of hypoglycemic means and carrying out frequent control of level of glucose in blood is necessary for patients with a diabetes mellitus.

Before the general anesthesia administration of drug should be continued as long as possible except a case of purpose of a galotanovy anesthesia which against the background of Madoparum can cause fluctuations of the arterial pressure (AP) and arrhythmia. Therefore at a galotanovy anesthesia administration of drug is recommended to be cancelled in 12-48 hours prior to the general anesthesia. After surgical intervention treatment is resumed from low doses and gradually raised to the previous level.

It is impossible to make sharp drug withdrawal, it can cause development of a malignant antipsychotic syndrome which characteristic signs are muscle tension, fervescence and kreatinfosfokinaza level in blood serum, mental changes. As the syndrome can take the form posing a threat for the patient's life to it careful observation of the doctor and purpose of the corresponding symptomatic therapy is required.

Use of drug needs to be accompanied with regular observation of the patient regarding possible emergence of side mental reactions. The depression can arise as against the background of therapy, and to be clinical display of parkinsonism.

Uncontrollable use of the increasing doses of drug can cause behavioural and cognitive frustration.

In case of drowsiness or sudden episodes of drowsiness it is necessary to lower a dose or to cancel Madoparum, the patient during this period needs to refuse control of vehicles and mechanisms.

Medicinal interaction

Simultaneous use of other medicines is shown only to destination the attending physician who, considering a clinical state and the possible accompanying pathologies of the patient, will make the recommendations allowing to avoid development of heavy side reactions.