Rytmonorm

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Propafenone hydrochloride 150mg;  ;  ; Propafenone hydrochloride 150mg

Available from:

Viatris Limited

INN (International Name):

Propafenone hydrochloride 150 mg

Dosage:

150 mg

Pharmaceutical form:

Tablet

Composition:

Active: Propafenone hydrochloride 150mg     Excipient: Croscarmellose sodium Hypromellose   Macrogol 400 Macrogol 6000 Magnesium stearate Maize starch Microcrystalline cellulose Purified water Titanium dioxide Active: Propafenone hydrochloride 150mg Excipient: Croscarmellose sodium Hypromellose   Macrogol 400 Macrogol 6000 Magnesium stearate Microcrystalline cellulose Pregelatinised maize starch Purified water Titanium dioxide

Units in package:

Blister pack, 50 tablets

Class:

Prescription

Prescription type:

Prescription

Manufactured by:

PharmaZell GmbH

Therapeutic indications:

For the treatment of supraventricular extrasystoles and supraventricular tachycardias, and in Wolff-Parkinson-White (WPW) syndrome. Also for the treatment of life-threatening documented ventricular tachyarrhythmia. The use of Rytmonorm is not recommended in patients with less severe ventricular arrhythmias, even if the patients are symptomatic. Because of the proarrhythimic effects of Rytmonorm, its use should be reserved for patients in whom, in the opinion of the physician, the potential benefits of treatment outweigh the risks.

Product summary:

Package - Contents - Shelf Life: Blister pack, - 50 tablets - 36 months from date of manufacture stored at or below 25°C

Authorization date:

1991-02-28

Patient Information leaflet

Page 1 of 4
NEW ZEALAND CONSUMER MEDICINE INFORMATION
RYTMONORM
®
_PROPAFENONE FILM COATED TABLET 150 MG_
WHAT IS IN THIS LEAFLET
Please read this leaflet carefully
before you start taking
RYTMONORM.
This leaflet answers some common
questions about RYTMONORM.
It does not contain all the available
information. It does not take the
place of talking to your doctor or
pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you taking
RYTMONORM against the benefits
they expect it will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE
MEDICINE. You may need to read it
again.
WHAT RYTMONORM
IS USED FOR
RYTMONORM is used to treat
arrhythmias (abnormal heart
rhythms).
RYTMONORM contains the active
ingredient propafenone
hydrochloride. It belongs to a group
of medicines called anti-arrhythmic
agents.
It works by slowing down the heart
rate and helping to regulate the
heartbeat.
Your doctor may have prescribed it
for another reason.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY THIS
MEDICINE HAS BEEN PRESCRIBED FOR
YOU.
This medicine is available only with
a doctor’s prescription.
There is not enough information to
recommend the use of this medicine
for children.
BEFORE YOU TAKE
RYTMONORM
_WHEN YOU MUST NOT TAKE _
_IT_
DO NOT TAKE RYTMONORM IF YOU
HAVE AN ALLERGY TO:

any medicine containing
propafenone hydrochloride

any of the ingredients listed
at the end of this leaflet.
Some of the symptoms of an
allergic reaction may include:
shortness of breath; wheezing
or difficulty breathing; swelling
of the face, lips, tongue or other
parts of the body; rash, itching
or hives on the skin.
DO NOT TAKE RYTMONORM IF YOU:

have a heart condition
called Brugada Syndrome

have had a heart attack
within the previous 3
months

have or have had significant
heart disease such as heart
failure, severe symptomatic
slow heart beat, changes in
heart rate in the absence of
an artificial pacemaker,
severe low blood p

Summary of Product characteristics

Page 1 of 14
NEW ZEALAND DATA SHEET
RYTMONORM
®
1. PRODUCT NAME
Rytmonorm, 150 mg, film coated tablets.
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each Rytmonorm film coated tablet contains 150 mg of propafenone (as
propafenone hydrochloride).
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Rytmonorm 150 mg - white to off-white, round, biconvex film coated
tablets embossed on one face
with “150”. The other face is unmarked.
4. CLINICAL PARTICULARS
_4.1 _
_THERAPEUTIC INDICATIONS_
For the treatment of supraventricular extrasystoles and
supraventricular tachycardias, and in Wolff-
Parkinson-White (WPW) syndrome. Also for the treatment of
life-threatening documented ventricular
tachyarrhythmia.
The use of Rytmonorm is not recommended in patients with less severe
ventricular arrhythmias,
even if the patients are symptomatic. Because of the proarrhythmic
effects of Rytmonorm, its use
should be reserved for patients in whom, in the opinion of the
physician, the potential benefits of
treatment outweigh the risks.
_4.2_
_DOSE AND METHOD OF ADMINISTRATION_
DOSE
The use of Rytmonorm should be initiated by a specialist physician.
The individual maintenance
dose should be determined under cardiological surveillance including
repeated ECG monitoring and
repeated blood pressure control (titration phase). If the QRS interval
is widened by more than 20%,
the corrected QT interval is lengthened or second or third degree AV
block occurs, the dose should
be reduced or discontinued until the ECG returns to normal.
The dosage is to be adjusted to the individual patient’s
requirements.
It is essential that each patient given Rytmonorm be evaluated
electrocardiographically and clinically
prior to and during therapy to determine whether the response to
Rytmonorm supports continued
treatment.
_ADULTS_
For initial and maintenance treatment a daily dose of 450 to 600 mg (1
film-coated tablet of
Rytmonorm 150 mg 3 times daily or up to 2 film coated tablets of
Rytmonorm 150 mg twice daily) is
recommended.
Pag