Multak of the tab. of p/o of 400 mg No. 60

Tablets "Multak ^® " are shown for maintenance of a sinoatrial rate after successful cardioversion at adult clinically stable patients with the paroxysmal or persistent fibrillation of auricles (FA). Due to its profile safety "Multak ^® " should appoint only after consideration of alternative approaches to treatment.

Structure

Active ingredient - dronedaron (one tablet supports a dronedaron of a hydrochloride in terms of dronedaron 400 mg).

Excipients: gipromelloza, starch corn, krospovidon (type A), half-oxameasures, lactose monohydrate, silicon dioxide colloidal anhydrous, magnesium stearate; cover: gipromelloza, titan dioxide (E 171), polyethyleneglycol, wax of karnaubskiya.

Contraindication

• hypersensitivity to active ingredient or to any of excipients;
• blockade of II or III degree, a total block of a leg of a ventriculonector, distal blockade, dysfunction of sinus node, disturbance of conductivity in auricles or a sick sinus syndrome (except for use cases along with the functioning pacemaker);
• bradycardia <50 beats per minute;
• continuous fibrillation of auricles (FA) with FP duration ≥ 6 months (or unknown duration) if the doctor made the decision to stop trying restoration of a sinoatrial rate;
• unstable hemodynamics;
• heart failure or left ventricular systolic dysfunction in the anamnesis or now;
• toxic damage of a liver or lungs connected with the previous use of Amiodaronum;
• simultaneous use with powerful inhibitors of P450 cytochrome (CYP) 3A4, such, as ketokonazol, itrakonazol, vorikonazol, pozakonazol, telitromitsin, klaritromitsin, nefazodon and ritonavir;
• medicines which cause tachycardia of torsades de pointes for example of a fenotiazina, tsizaprid, bepridit, tricyclic antidepressants, terfenadin and certain oral macroleads (for example erythromycin), antiarrhytmic means of class I and III;
• QTc interval defined by a formula Bazetta: ≥ 500 ms;
• heavy liver failure;
• heavy renal failure (clearance of creatinine <30 ml/minute);
• simultaneous use with dabigatrany.

Route of administration

only under observation of the expert.

in out-patient conditions.

before medicament use "Multak ^® " should stop treatment by antiarrhytmic means of class I or III (flekainid, propafenon, quinidine, Disopyramidum, a dofetilida, sotalol, Amiodaronum).

. It must be kept in mind that effect of Amiodaronum after the termination of its use can continue a long time in connection with its long elimination half-life. If transition on "Multak ^® " is supposed, then it needs to be carried out under observation of the expert.

Adult the recommended dose makes 400 mg 2 times a day. To apply on one tablet in the morning and in the evening at meal time.

Is recommended to swallow of a tablet entirely, washing down with water. The tablet can be divided into two equal parts.

should not wash down tablets "Multak ^® " grapefruit juice.

in case of the admission of a dose the patients have to accept the following dose according to a certain scheme, it is not necessary to double a dose.

Pregnant

Still appropriate evidential data on use of a dronedaron to pregnant women is not present

Feature of use

whether it is removed dronedaron and its metabolites in breast milk. Available pharmakodinamicheskiye / toxicological data of researches on animals showed existence of a dronedaron and its metabolites in breast milk. The risk for newborns/babies cannot be excluded. The decision on that to stop feeding by a breast or to stop/abstain from medicament treatment "Multak ^® ", it is necessary to accept taking into account advantages of feeding by a breast for the child and need of treatment for the woman.

Dronedaron did not affect fertility in researches on animals.

Children

Experience of use. The relevant data are absent.

Drivers

medicament Influence "Multak ^® " on ability to run vehicles or to work with other mechanisms is absent or is insignificant. However undesirable reactions, such as increased fatigue can affect ability to run vehicles or to work with other mechanisms.

Overdose

whether can dronedaron and/or its metabolites to be removed by dialysis (hemodialysis, peritoneal dialysis or haemo filtration).

Specific antidote is absent. In case of overdose the treatment has to be supporting and directed to relief of symptoms.

Side effects

Most frequent reason of the termination of therapy medicament "Multak ^® " were gastrointestinal disorders (3.2% of patients against 1.8% in group of placebo). In all researches when receiving a dronedaron on 400 mg twice a day such side effects as diarrhea, nausea and vomiting, increased fatigue and an asthenia were most often observed.

to Store

in original packing at a temperature below 30 °C, out of children's reach.

Expiration date - 3 years.