ARYTHMOL Film Coated Tablet 150 Milligram
Țară: Irlanda
Limbă: engleză
Sursă: HPRA (Health Products Regulatory Authority)
Caracteristicilor produsului
(SPC)
28-04-2024
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Ingredient activ:
PROPAFENONE HYDROCHLORIDE
Disponibil de la:
PCO Manufacturing
Dozare:
150 Milligram
Forma farmaceutică:
Film Coated Tablet
Data de autorizare:
2011-04-01
Caracteristicilor produsului
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Arythmol 150 mg Film-coated Tablets.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 150 mg propafenone hydrochloride.
For a full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Film-coated tablets.
_Product imported from the UK:_
White, biconvex, film-coated tablets and embossed “150” on one face.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Symptomatic supraventricular tachyarrhythmias warranting treatment, such as AV junctional tachycardias,
supraventricular tachycardias in patients with WPW syndrome or paroxysmal atrial fibrillation.
Serious symptomatic ventricular tachyarrhythmias if life-threatening or necessitating treatment in the judgement of the
physician.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
The tablets should be swallowed whole and taken with a drink after food.
The dosage should be adjusted to the individual patient’s requirements.
In those patients in whom significant widening of the QRS complex or second or third AV block occurs, a dose
reduction should be considered.
Adults: A daily doses of 450 to 600 mg of propafenone hydrochloride, divided in two or three doses per day, is
recommended in the titrated 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: In elderly patients or patien
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