Propafenone Hydrochloride 300mg Film-coated tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Propafenone hydrochloride

Available from:

Accord Healthcare Ireland Ltd.

ATC code:

C01BC; C01BC03

INN (International Name):

Propafenone hydrochloride

Dosage:

300 milligram(s)

Pharmaceutical form:

Film-coated tablet

Therapeutic area:

Antiarrhythmics, class Ic; propafenone

Authorization status:

Marketed

Authorization date:

2012-03-30

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
PROPAFENONE HYDROCHLORIDE 150MG FILM-COATED TABLETS
PROPAFENONE HYDROCHLORIDE 300MG FILM-COATED TABLETS
Propafenone Hydrochloride
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.
▪
Keep this leaflet. You may need to read it again
▪
If you have any further questions, ask your doctor or pharmacist.
▪
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them, even
if their signs of illness are the same as yours.
▪
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side effects
not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Propafenone Hydrochloride tablets are and what are they used for.
2.
What you need to know before you take Propafenone Hydrochloride
tablets
3.
How to take Propafenone Hydrochloride tablets
4.
Possible side effects
5.
How to store Propafenone Hydrochloride tablets
6.
Contents of the pack and other information
1.
WHAT PROPAFENONE HYDROCHLORIDE TABLETS ARE AND WHAT ARE THEY USED FOR
Propafenone belongs to a group of medicines called anti-arrhythmic
agents.
Propafenone is used for the following:
▪
to slow down the heart rate and help to regulate the heartbeat
▪
to treat and prevent arrhythmias (abnormal heart rhythms).
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE PROPAFENONE HYDROCHLORIDE
TABLETS
_ _
DO NOT TAKE PROPAFENONE HYDROCHLORIDE TABLETS:
▪
if you are allergic (hypersensitive) to propafenone hydrochloride or
any of the other ingredients of this
medicine (see section 6).
▪
if you suffer from a heart rhythm disorder called Brugada syndrome
which causes you to have a
potentially life-threatening heart rhythm.
▪
if you have had a heart attack within the last 3 months.
▪
if you suffer from heart failure or any heart problems other than
abnormal heart rate/heart rhythm.
▪
if you have an unusually slow heart rate or low blood pressure
(hypotension).
▪
if you suffe

Summary of Product characteristics

Health Products Regulatory Authority
01 February 2023
CRN00CZKM
Page 1 of 8
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Propafenone Hydrochloride 300mg Film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 300mg propafenone hydrochloride
For the full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Film-coated Tablet
White to off-white, round, biconvex, film-coated tablets, with score
line on one side and plain on the other side.
The tablet can be divided in to equal halves.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Propafenone is indicated for the prophylaxis and treatment of
ventricular arrhythmias.
Propafenone is also indicated for the prophylaxis and treatment of
paroxysmal supraventricular tachyarrhythmias which include
paroxysmal atrial flutter/fibrillation and paroxysmal re-entrant
tachycardia’s involving the AV node or accessory bypass tracts,
when standard therapy has failed or is contraindicated.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
It is recommended that propafenone therapy should be initiated under
hospital conditions, by a physician experienced in the
treatment of arrhythmias. The individual maintenance dose should be
determined under cardiological surveillance including
ECG monitoring and blood pressure control. If the QRS interval is
prolonged by more than 160msec or the PQ interval is
prolonged by more than 20%, the dose should be reduced or discontinued
until the ECG returns to normal limits.
_ADULTS_
Initially, 150 mg three times daily increasing at a minimum of
three-day intervals to 300 mg twice daily and if necessary, to a
maximum of 300 mg three times daily.
The tablets should be swallowed whole and taken with a drink after
food. A reduction in the total daily dose is recommended
for patients below 70 kg bodyweight.
_ELDERLY_
No overall differences in safety or effectiveness were observed in
this patient population, but greater sensitivity of some older
individuals cannot be ruled out, therefore, these