ARYTHMOL 300 Milligram Film Coated Tablet

Pays: Irlande

Langue: anglais

Source: HPRA (Health Products Regulatory Authority)

Ingrédients actifs:

PROPAFENONE HYDROCHLORIDE

Disponible depuis:

Abbott Laboratories Ireland Ltd

DCI (Dénomination commune internationale):

PROPAFENONE HYDROCHLORIDE

Dosage:

300 Milligram

forme pharmaceutique:

Film Coated Tablet

Type d'ordonnance:

Product subject to prescription which may be renewed (B)

Statut de autorisation:

Authorised

Date de l'autorisation:

0000-00-00

Notice patient

ARYTHMOL® 150 MG FILM-COATED TABLETS
ARYTHMOL® 300 MG FILM-COATED TABLETS
PROPAFENONE HYDROCHLORIDE
IMPORTANT INFORMATION
Read all of this leaflet carefully before you start taking this
medicine.
• Keep this leaflet as you may need to read it again
• This leaflet provides a summary of the information currently
available for Arythmol
• For further information or advice ask your doctor or pharmacist
• This medicine is for you only and should never be given to anyone
else, even if they appear to 
have the same symptoms as you
• Tell your doctor or pharmacist if you experience any side effects
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 as

Résumé des caractéristiques du produit

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.
_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 cautio