RYTMONORM Film-coated tablet Ref.[50652] Active ingredients: Propafenone

Source: Medicines and Medical Devices Safety Authority (NZ)  Revision Year: 2022  Publisher: Viatris Ltd, PO Box 11-183, Ellerslie, AUCKLAND www.viatris.co.nz Telephone 0800 168 169

Product name and form

Rytmonorm, 150 mg, film coated tablets.

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.

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.

Active Ingredient Description
Propafenone

Propafenone is a class IC anti-arrhythmic agent. It has a stabilising action on myocardial membranes, reduces the fast inward current carried by sodium ions with a reduction in depolarisation rate and prolongs the impulse conduction time in the atrium, AV node and primarily, in the His-Purkinje system.

List of Excipients

Rytmonorm 150 mg tablets also contain:

Microcrystalline cellulose
Sodium croscarmellose
Starch – pregelantinised
Hypromellose
Magnesium stearate
Macrogol
Titanium dioxide

Pack sizes and marketing

Blister packs. Pack size of 50 tablets.

Marketing authorization holder

Viatris Ltd, PO Box 11-183, Ellerslie, AUCKLAND
www.viatris.co.nz
Telephone 0800 168 169

Marketing authorization dates and numbers

Date of fisrt approval: 1 October 1992

Drugs

Drug Countries
RYTMONORM Germany, Ecuador, Estonia, Spain, Hong Kong, Croatia, Israel, Italy, Lithuania, Malta, Netherlands, New Zealand, Poland, Romania, Turkey

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