ARYTHMOL SR 325 Milligram Prolonged Release Capsules
Țară: Irlanda
Limbă: engleză
Sursă: HPRA (Health Products Regulatory Authority)
Caracteristicilor produsului
(SPC)
16-04-2024
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Ingredient activ:
PROPAFENONE HYDROCHLORIDE
Disponibil de la:
Abbott Laboratories Ireland Ltd
INN (nume internaţional):
PROPAFENONE HYDROCHLORIDE
Dozare:
325 Milligram
Forma farmaceutică:
Prolonged Release Capsules
Tip de prescriptie medicala:
Product subject to prescription which may be renewed (B)
Statutul autorizaţiei:
Withdrawn
Data de autorizare:
2013-05-08
Caracteristicilor produsului
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Arythmol SR 325 mg prolonged release capsules
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each prolonged release capsule contains 325 mg, propafenone hydrochloride
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Prolonged release capsule, hard
White to almost white opaque capsule stamped with red Abbott logo and “325” on the cap and a red stripe on the body.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Arythmol SR (sustained/prolonged release) is indicated to prolong the time to recurrence of symptomatic atrial
arrhythmias in patients without significant structural heart disease and with a history of symptomatic atrial fibrillation.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
The dose of Arythmol SR must be individually titrated on the basis of response and tolerance. Titration to the
individual maintenance dose should be supervised by a cardiologist (repeated ECG recordings and blood pressure
measurements). It is recommended that therapy be initiated with 225 mg propafenone hydrochloride (as prolonged-
release capsules) given every twelve hours. The dosage may be increased at a minimum interval of 5 days to 325 mg
propafenone hydrochloride (as prolonged-release capsules) given every twelve hours. If additional therapeutic effect is
needed, the dose of propafenone hydrochloride (as prolonged-release capsules) may be increased to 425 mg given
every twelve hours after a minimum of another 5 day interval. To facilitate dose titration, additional strengths of
propafenone SR are available. Direct comparison of propafenone SR capsules with propafenone IR (immediate/instant
release) tablets has not been studied in clinical trials.
In those patients in whom significant widening of the QRS c
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