RYTMONORM TABLET 150MG

Country: Malaysia

Language: English

Source: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Active ingredient:

PROPAFENONE HYDROCHLORIDE

Available from:

ABBOTT LABORATORIES (M) SDN. BHD.

INN (International Name):

PROPAFENONE HYDROCHLORIDE

Units in package:

50Tablet Tablets

Manufactured by:

ABBOTT GMBH & CO. KG

Patient Information leaflet

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
_ _
RYTMONORM® TABLET
_ _
Propafenone hydrochloride (150mg)
1
WHAT IS IN THIS LEAFLET
1. What Rytmonorm® is used for
2. How Rytmonorm® works
3. Before you use Rytmonorm®
4. How to use Rytmonorm®
5. While you are using it
6. Side effects
7. Storage and disposal of
Rytmonorm®
8. Product description
9. Manufacturer and product
registration holder
10. Date of revision
WHAT RYTMONORM®
IS USED FOR
Rytmonorm® belongs to a group of
medicines called antiarrhythmic
agents. Rytmonorm® is used to treat
and prevent arrhythmias (abnormal
heart rhythms).
HOW RYTMONORM® WORKS
Rytmonorm® slows down the heart
rate and helps to regulate the
heartbeat.
BEFORE YOU USE RYTMONORM®
_- When you must not use it _
•
If you are allergic to propafenone
or any of the ingredients listed at
the end of this leaflet
•
If you suffer from a heart rhythm
disorder called Brugada
syndrome.
•
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 are suffering from any
breathing problems, such as
asthma or chronic bronchitis or
emphysema
•
If you are diagnosed with
myasthenia gravis (muscle
weakness)
•
If you have electrolyte imbalance
•
If you are taking ritonavir
_- Before you start to use it _
Discuss with your doctor or
pharmacist before taking this
medication if:
•
You are pregnant or planning to
become pregnant or breast
feeding.
•
You suffer from any breathing
problems, such as asthma
•
You have a heart pacemaker
•
You suffer from liver or kidney
disease
•
Tell your surgeon or dentist that
you are taking propafenone if
surgery is planned. It may affect
the anaesthetic used.
_- Taking other medicines _
It is particularly important to tell your
doctor or pharmacist if you are
taking, have recently taken or might
take any other medicines. This also
concerns medicines obta

Summary of Product characteristics

PRODUCT NAME
Propafenone hydrochloride
BRAND NAMES
Rytmonorm
®
150mg, coated tablets
PRODUCT DESCRIPTION
Propafenone hydrochloride is a class 1c antiarrhythmic drug with some
structural
similarities to beta-blocking agents.
It is a white or colorless crystalline powder with a very bitter
taste. It is slightly soluble in
water (20 °C), chloroform and ethanol. Its chemical name is
2'-[2-hydroxy-3-
(propylamino)-propoxy]-3-phenylpropiophenone hydrochloride and its
chemical formula
is C21H27NO3·HCl. Its molecular weight is 377.92.
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.
DOSAGE AND ADMINISTRATION
ORAL
Owing to the bitter taste and surface anesthetic action of
propafenone, the film-coated
tablets and sugar-coated tablets should be swallowed whole (without
chewing) with
liquid after a meal. 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 has been
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).
_ _
_PEDIATRIC POPULATION_
In children, an averag