PC - Merz tablets p / o 100mg, No. 30

Parkinson's disease (muscle rigidity, tremor, hypo- or akinesia).
Extrapyramidal disorders caused by taking antipsychotics or other drugs (dyskinesia, akathisia and parkinsonism).
Herpes zoster neuralgia.

Inside, after meals with a small amount of liquid, preferably in the first half of the day. The first 3 days - 1 tablet per day, then increase the dose to 2 tablets per day, and it is possible to further increase the dose by 1 tablet per week. The usual effective dose is 1 to 3 tablets twice a day. The maximum daily dose is 600 mg. In the case of combined treatment, it is necessary to determine the dose individually. The last dose is recommended to be taken in the afternoon no later than 16-00.
In elderly patients, in particular in patients with agitation and confusion, preddeliriya and delirium, a lower dosage is required.

Active substance: amantadine sulfate 100 mg
Excipients:
lactose monohydrate 108.4 mg
microcrystalline cellulose 70 mg
potato starch 19 mg
gelatin 10 mg
povidone 9 mg
croscarmellose sodium 6.6 mg
talc 6 mg
silicon colloidal dioxide 0.5 mg
magnesium stearate 0, 5 mg
Sheath:
talc 3.115 mg
butyl methacrylate copolymer 2.121 mg
titanium dioxide 1.192 mg
magnesium stearate 1.055 mg
sunset yellow dye (E 110) 0.917 mg

Hypersensitivity to any component of the drug; severe congestive heart failure (class IV according to the New York Heart Association), cardiomyopathy, myocarditis, atrioventricular block II and III degree, bradycardia with a heart rate of less than 55 beats / min, prolongation of the QT interval of more than 420 ms, ventricular arrhythmia (including number of ventricular flutter), pregnancy and the period of breastfeeding, low blood levels of potassium and magnesium, simultaneous administration with drugs that prolong the QT interval, severe renal failure (creatinine clearance less than 10 ml / min), childhood (up to 18 years), hereditary galactose deficiency, lactase deficiency, glucose-galactose malabsorption, phenylketonuria, sucrose-isomaltose deficiency, hereditary fructose deficiency,psychosis (in history).

With caution
Prostatic hyperplasia, narrow-angle glaucoma, renal failure of varying severity (there is a risk of drug accumulation), agitation, delirium, depression of the central nervous system, exogenous psychosis (including a history), coadministration with memantin, triamterene / hydrochlorothiazide ...

Tradename:

PC-Merz

International non-proprietary name:

amantadine

Dosage form:

film-coated tablets

Composition

Active substance: amantadine sulfate 100 mg
Excipients:
lactose monohydrate 108.4 mg
microcrystalline cellulose 70 mg
potato starch 19 mg
gelatin 10 mg
povidone 9 mg
croscarmellose sodium 6.6 mg
talc 6 mg
silicon colloidal dioxide 0.5 mg
magnesium stearate 0, 5 mg
Sheath:
talc 3.115 mg
butyl methacrylate copolymer 2.121 mg
titanium dioxide 1.192 mg
magnesium stearate 1.055 mg
sunset yellow dye (E 110) 0.917 mg

Description : round biconvex tablets, odorless, orange film-coated, with a notch on one side.

Pharmacotherapeutic group:

antiparkinsonian drug

ATX code : N04BB01

Pharmacological properties

Pharmacodynamics:
Amantadine has an indirect agonistic effect on striatal dopamine receptors. Increases the extracellular concentration of dopamine by both intensifying its production and blocking the reuptake of dopamine by presynaptic neurons. At therapeutic concentrations, amantadine slows down the production of acetylcholine and thus has an anticholinergic effect.

Pharmacokinetics:
After oral administration, the peak plasma concentration is reached after 2-8 hours. When taking 200 mg per day, a stable plasma concentration of 400-900 ng / ml is achieved for 4-7 days. The total clearance is 17.7 ± 10 l / h in healthy volunteers; the half-life is from 10 to 30 hours, with an average of about 15 hours. Amantadine is about 67% bound to blood plasma proteins. Penetrates the blood-brain barrier. Excreted by the kidneys practically unchanged (90% of a single dose); a small amount is excreted in feces. Dialysis is ineffective (about 5% per procedure).

Indications for use

Parkinson's disease (muscle rigidity, tremor, hypo- or akinesia).
Extrapyramidal disorders caused by taking antipsychotics or other drugs (dyskinesia, akathisia and parkinsonism).
Herpes zoster neuralgia.

Contraindications

Hypersensitivity to any component of the drug; severe congestive heart failure (class IV according to the New York Heart Association), cardiomyopathy, myocarditis, atrioventricular block II and III degree, bradycardia with a heart rate of less than 55 beats / min, prolongation of the QT interval of more than 420 ms, ventricular arrhythmia (including number of ventricular flutter), pregnancy and the period of breastfeeding, low blood levels of potassium and magnesium, simultaneous administration with drugs that prolong the QT interval, severe renal failure (creatinine clearance less than 10 ml / min), childhood (up to 18 years), hereditary galactose deficiency, lactase deficiency, glucose-galactose malabsorption, phenylketonuria, sucrose-isomaltose deficiency, hereditary fructose deficiency,psychosis (in history).

With caution
Prostatic hyperplasia, narrow-angle glaucoma, renal failure of varying severity (there is a risk of drug accumulation), agitation, delirium, depression of the central nervous system, exogenous psychosis (including a history), coadministration with memantin, triamterene / hydrochlorothiazide ...

Method of administration and dosage

Inside, after meals with a small amount of liquid, preferably in the first half of the day. The first 3 days - 1 tablet per day, then increase the dose to 2 tablets per day, and it is possible to further increase the dose by 1 tablet per week. The usual effective dose is 1 to 3 tablets twice a day. The maximum daily dose is 600 mg. In the case of combined treatment, it is necessary to determine the dose individually. The last dose is recommended to be taken in the afternoon no later than 16-00.
In elderly patients, in particular in patients with agitation and confusion, preddeliriya and delirium, a lower dosage is required.

Overdose

Symptoms: nausea, vomiting, irritability, tremor, ataxia, decreased visual acuity, lethargy, depression, dysarthria, epileptic seizures, arrhythmia.
Treatment: gastric lavage, intake of activated charcoal, symptomatic therapy.

Interaction with other medicinal products

The simultaneous administration of amantadine and drugs that cause an increase in the OT interval is contraindicated, in particular:
- some class I A antiarrhythmic drugs (for example, kinidine, disopyramide, procainamide), and class III (for example, amiodarone and sotalol);
- some antipsychotic drugs (for example, thioridazine, chlorpromazine, pimozide);
- some tricyclic and tetracyclic antidepressants (for example, amitriptyline);
- some antihistamines (for example, astemizole, terfenadine);
- some macrolide antibiotics (for example, erythromycin, clarithromycin);
- some gyrase inhibitors (for example, sparfloxasin);
- antifungal agents of the azole group, and other drugs, in particular, bidupine, halofantrine, co-trimoxazole, pentamidine, cisapride and bepridil.
Concomitant use of diuretics, which are a combination of triamterene / hydrochlorothiazide, can lead to an increase in the concentration of amantadine in plasma. When taken simultaneously with other antiparkinsonian drugs (such as levodopa, bromocriptine, memantine, trihexyphenidil), it may be necessary to reduce the dose of the simultaneously taken drug, or both drugs in order to avoid undesirable consequences, in particular, psychotic reactions.
Anticholinergics, sympathomimetics, and memantine: Increase side effects.
Drugs that stimulate the central nervous system (including psychostimulants), ethanol increase the risk of side effects.

special instructions

Treatment with PK-Merz should not be stopped suddenly, as this can lead to worsening of symptoms. Patients suffering from cardiovascular diseases should be under constant medical supervision when prescribing PK-Merz. Alcohol intake is contraindicated during treatment. Use with caution during work for drivers of vehicles and people whose profession is associated with increased concentration of attention.

Release form

Tablets 100 mg. 10 tablets in a blister made of PVC / aluminum foil; 3 blisters are placed in a cardboard box along with instructions for use.

Storage conditions

At a temperature not higher than 25 ? C. Keep out of the reach of children.

Shelf life

5 years.
Do not use after the expiration date.

Conditions of dispensing from pharmacies

On prescription.