ARYTHMOL 150 Milligram Film Coated Tablet

Land: Irland

Sprog: engelsk

Kilde: HPRA (Health Products Regulatory Authority)

Aktiv bestanddel:

PROPAFENONE HYDROCHLORIDE

Tilgængelig fra:

BGP Products Ireland Limited

ATC-kode:

C01BC03

INN (International Name):

PROPAFENONE HYDROCHLORIDE

Dosering:

150 Milligram

Lægemiddelform:

Film Coated Tablet

Indgivelsesvej:

Oral use

Enheder i pakken:

Pack size: 90

Klasse:

IC

Recept type:

Product subject to prescription which may be renewed (B)

Fremstillet af:

AbbVie Deutschland GmbH & Co. KG

Terapeutisk gruppe:

Antiarrhythmics

Terapeutisk område:

Antiarrhythmics, class Ic

Terapeutiske indikationer:

Symptomatic supraventricular tachyarrhythmias requiring treatment, such as AV junctional tachycardia, supraventricular tachycardia in patients with Wolff-Parkinson-White (WPW) syndrome or paroxysmal atrial fibrillation. Severe symptomatic ventricular tachyarrhythmia, if the physician considers these to be life-threatening.

Autorisation status:

Authorised

Autorisation dato:

2015-03-27

Indlægsseddel

ARYTHMOL
®

150 MG FILM-COATED TABLETS
ARYTHMOL
®

300 MG FILM-COATED TABLETS
PROPAFENONE HYDROCHLORIDE
IN THIS LEAFLET:
1.  What Arythmol is & what it is used for
2.  Before you take Arythmol
3.  How to take Arythmol
4.  Possible side effects
5.  How to store Arythmol
6.  Further information
1.  WHAT ARYTHMOL IS & WHAT IT IS USED FOR
Arythmol belongs to a group of medicines called 
antiarrhythmic agents. Arythmol slows down the heart rate 
and helps to regulate the heartbeat. Arythmol tablets are 
used to treat arrhythmias (abnormal heart rhythms).
2.  BEFORE YOU TAKE ARYTHMOL
DO NOT TAKE THIS MEDICINE
If you: 
-  are allergic (hypersensitive) to propafenone 
    hydrochloride or any of the other ingredients 
    of this medicine (see section 6).
-  suffer from a heart rhythm disorder called Brugada 
syndrome.
-  have had a heart attack within the last 3 months.
-  suffer from heart failure or any other heart problems 
other than abnormal heart rate/heart rhythm.
-  have an unusually slow heart rate or low blood pressure 
(hypotension).
-  suffer from breathing problems, such as chronic 
bronchitis or emphysema (sometimes known as COPD).
-  have been told you that you have an imbalance of 
potassium or sodium in your blood.
-  suffer from myasthenia gravis which causes muscle 
weakness
-  are taking ritonavir.
TAKE SPECIAL CARE WITH ARYTHMOL
Tell your doctor BEFORE you take this medicine if you
-  are pregnant or thinking of becoming pregnant
-  are breast feeding
-  suffer from any breathing problems, such as asthma.  
-  suffer from liver or kidney disease
-  have a heart pacemaker, it may need to be altered.
If surgery is planned, tell your surgeon or dentist that you 
are taking this medicine. It may affect the anaesthetic 
used.
Arythmol is NOT suitable for children.
Your doctor may perform ECGs and blood pressure 
monitoring prior to and during treatment to monitor your 
individual dose.
TAKING OTHER MEDICINES
Please

Produktets egenskaber

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.
White to off-white film-coated tablet, biconvex and embossed “150” on one face.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Symptomatic supraventricular tachyarrhythmias requiring treatment, such as AV junctional tachycardia,
supraventricular tachycardia in patients with Wolff-Parkinson-White (WPW) syndrome or paroxysmal atrial
fibrillation.
Severe symptomatic ventricular tachyarrhythmia, 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 sensiti