Rytmonorm

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Propafenone hydrochloride 300mg

Available from:

Viatris Limited

INN (International Name):

Propafenone hydrochloride 300 mg

Dosage:

300 mg

Pharmaceutical form:

Tablet

Composition:

Active: Propafenone hydrochloride 300mg Excipient: Croscarmellose sodium Hypromellose   Macrogol 400 Macrogol 6000 Magnesium stearate Maize starch Microcrystalline cellulose Purified water Titanium dioxide

Units in package:

Blister pack, 50 tablets

Class:

Prescription

Prescription type:

Prescription

Manufactured by:

PharmaZell GmbH

Therapeutic indications:

For the prophylaxis and treatment of supraventricular extrasystoles and supraventricular tachycardias, and in WPW syndrome. Also for the prophylaxis and treatment of life-threatening documented ventricular arrhythmias, such as sustained ventricular tachycardia. 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 - 60 months from date of manufacture stored at or below 25°C

Authorization date:

1992-10-01

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.
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