ARYTHMOL 300 Milligram Film Coated Tablet

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

PROPAFENONE HYDROCHLORIDE

Available from:

Teva B.V.

ATC code:

C01BC03

INN (International Name):

PROPAFENONE HYDROCHLORIDE

Dosage:

300 Milligram

Pharmaceutical form:

Film Coated Tablet

Prescription type:

Product subject to prescription which may be renewed (B)

Therapeutic area:

Antiarrhythmics, class Ic

Authorization status:

Authorised

Authorization date:

2017-06-23

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Arythmol 300 mg Film-coated Tablets.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 300 mg propafenone hydrochloride.
For a full list of excipients see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablets.
White to off-white film-coated tablet, biconvex, embossed “300” on
one face.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Symptomatic supraventricular tachyarrhythmias requiring treatment,
such as AV junctional tachycardias,
supraventricular tachycardias in patients with Wolff-Parkinson-White
(WPW) syndrome or paroxysmal atrial
fibrillation.
Severe symptomatic ventricular tachyarrhythmias, if the physician
considers these to be life-threatening.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
The dosage is to be adjusted to the individual patient’s
requirements.
In those patients in whom significant widening of the QRS complex or
second or third degree AV block occurs, a dose
reduction should be considered.
_Adults_:
A daily dose of 450 to 600 mg of propafenone hydrochloride, divided in
two or three doses per day, is recommended in
the titration period and for maintenance therapy in patients weighing
around 70 kilograms. Occasionally, it may be
necessary to increase the daily dose to 900 mg of propafenone
hydrochloride. The daily dose should be reduced
accordingly for patients with a lower body weight. Dose increases
should not be attempted until the patient is receiving
treatment for three to four days.
The individual maintenance dose should be determined under
cardiological surveillance including ECG monitoring and
repeated blood pressure control (titration phase).
_Elderly population:_
No overall differences in safety or effectiveness were observed in
this patient population, but greater sensitivity of
some older individuals cannot be ruled out, these patients should be
carefully monitored. Treatment should be initiated
gradually and with particular caution in small incremental doses. The
same applies to maintenance t