Rythmodan

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Disopyramide 100mg (as base)

Available from:

Pharmacy Retailing (NZ) Ltd t/a Healthcare Logistics

INN (International Name):

Disopyramide 100 mg (as base)

Dosage:

100 mg

Pharmaceutical form:

Capsule

Composition:

Active: Disopyramide 100mg (as base) Excipient: Gelatin Indigo carmine Iron oxide red Magnesium stearate Maize starch Purified talc Starch Titanium dioxide

Units in package:

Blister pack, 1x100, 100 capsules

Class:

Prescription

Prescription type:

Prescription

Manufactured by:

Sanofi Chimie

Product summary:

Package - Contents - Shelf Life: Blister pack, 1x100 - 100 capsules - 24 months from date of manufacture stored at or below 30°C

Authorization date:

1973-04-27

Patient Information leaflet

RYTHMODAN
®
1
Rythmodan
®
disopyramide
Consumer Medicine Information
What is in this leaflet
This leaflet answers some common
questions about Rythmodan. 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 or pharmacist
has weighed the risks of you taking
Rythmodan 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 Rythmodan is
used for
Rythmodan belongs to a group of
medications called antiarrhythmics.
This means it acts to correct irregular
heartbeats to a normal rhythm and to
slow an overactive heart. This allows
the heart to work more efficiently.
Rythmodan is used to treat and
prevent ventricular arrhythmias
(irregular heartbeat).
Ask your doctor if you have any
questions about why Rythmodan
has been prescribed for you.
Your doctor may have prescribed
Rythmodan for another reason. This
medicine is available only with a
doctor's prescription.
Before you take
Rythmodan
When you must not take it
Do not take Rythmodan if you
have an allergy to Rythmodan or
any of the ingredients listed at the
end of this leaflet.
Some symptoms of an allergic
reaction may include skin rash,
itching, shortness of breath or
swelling of the face, lips or tongue,
which may cause difficulty in
swallowing or breathing.
Do not give Rythmodan to a child or
adolescent. Rythmodan is not
recommended for use during
pregnancy, unless you and your
doctor or pharmacist have discussed
the risks and benefits involved.
Do not take Rythmodan if you are
taking other antiarrhythmics or other
heart medications without first
discussing with your doctor.
Do not take Rythmodan without first
discussing all previous and pre-
existing heart problems with your
doctor.
Do not take Rythmodan if you are
breast-feeding or plan to breast-
feed.
Rythmodan passes into breast milk
and theref

Summary of Product characteristics

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Page 1
NEW ZEALAND DATA SHEET
1
PRODUCT NAME
Rythmodan 100mg capsules
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Rythmodan 100mg capsules contain 100mg of disopyramide
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
100 mg capsules: green & beige, marked RY RL
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Disopyramide is indicated for the treatment of symptomatic and/or
life-threatening arrhythmias.
Specific indications are as follows:
Disopyramide is indicated in the following symptomatic arrhythmias:

atrial or ventricular extrasystoles

treatment of atrial arrhythmias

atrial fibrillation or flutter: preparation for cardioversion;
substitution for cardioversion, when
the latter is contraindicated or unfeasible; prevention of relapses
following restoration of sinus
rhythm

prevention of attacks of paroxysmal tachycardia, Bouveret type,
including Wolff-Parkinson-
White syndrome

prevention of relapses of paroxysmal ventricular tachycardia
4.2
DOSE AND METHOD OF ADMINISTRATION
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The daily dose of RYTHMODAN capsules must be administered as no less
than 3 equal divided
doses.
Adults with Normal Hepatic and Renal Function:
Prevention or Curative Treatment of Symptomatic Arrhythmias
Initial treatment: 400 to 600 mg per day
Maintenance treatment: reached by progressively reducing the daily
dose by 100 mg per day to
reach a final dose of 300 to 400 mg per day on average.
Substitution Treatment for Cardioversion
When cardioversion is contraindicated or otherwise not feasible, the
initial capsule dosage can be
increased to 800 mg on the first day in 4 divided doses.
Preparation for cardioversion, after stopping digitalis
100 mg capsule on the previous evening
3 x 100 mg just before cardioversion in three doses at hourly
intervals
100 mg capsule on the evening of cardioversion followed by the usual
maintenance treatment
from the next day onwards.
Adults with Renal Insufficiency:
The initial capsule dose should never be more th