Rythmodan 100mg capsules

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Disopyramide

Available from:

Neon Healthcare Ltd

ATC code:

C01BA03

INN (International Name):

Disopyramide

Dosage:

100mg

Pharmaceutical form:

Oral capsule

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 02030200; GTIN: 5013841101527

Patient Information leaflet

IS THIS LEAFLET HARD TO
SEE OR READ?
PHONE [phone]
FOR HELP
READ ALL OF THIS LEAFLET CAREFULLY BEFORE
YOU START TAKING THIS MEDICINE.
•
Keep this leaflet. You may need to read it
again.
•
If you have any further questions, ask your
doctor or pharmacist.
•
This medicine has been prescribed for you.
Do not pass it on to others. It may harm
them, even if their symptoms are the same
as yours.
•
If any of the side effects gets serious, or if
you notice any side effects not listed in this
leaflet, please tell your doctor or pharmacist.
IN THIS LEAFLET:
1.
What Rythmodan Capsules are and what
they are used for
2.
Before you take Rythmodan Capsules
3.
How to take Rythmodan Capsules
4.
Possible side effects
5.
How to store Rythmodan Capsules
6.
Further information
1. WHAT RYTHMODAN CAPSULES ARE
AND WHAT THEY ARE USED FOR
The name of your medicine is Rythmodan
100mg Capsules (called Rythmodan Capsules
in this leaflet). Rythmodan Capsules contain a
medicine called disopyramide.
This belongs to a group of medicines called
anti-arrhythmic agents.
It works by controlling the uneven beating of
your heart and returns it to the normal rhythm.
It is used for controlling your heartbeat in the
following situations:
•
Arrhythmias - where your heartbeats are
uneven, or unusually fast or slow
•
To keep your heart beating at a normal
rhythm
•
To stop unusual heartbeats (arrhythmias)
happening after a heart attack
•
To stop unusual heartbeats (arrhythmias)
during an operation
2. BEFORE YOU TAKE RYTHMODAN CAPSULES
DO NOT TAKE RYTHMODAN CAPSULES
AND TELL YOUR DOCTOR IF:
✕
You are allergic (hypersensitive) to
disopyramide or any of the other
ingredients of Rythmodan (see Section 6:
Further Information)
Signs of an allergic reaction include: a rash,
swallowing or breathing problems, swelling
of your lips, face, throat or tongue.
✕
You have any other heart problems - apart
from unusual heartbeats (arrhythmias)
✕
You are taking other medicines to control
your heart rhythm (see section below ‘Taking
other medicines

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Rythmodan 100mg Capsules.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Capsule containing Disopyramide 100mg.
For excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Capsules have a green cap and yellow body and are printed in black ink
with RY on
one part and RL on the other
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Rythmodan is used in the treatment of cardiac arrhythmias as follows
1.
The prevention and treatment of arrhythmias occurring after myocardial
infarction.
2.
Maintenance of normal rhythm following electroconversion e.g. atrial
fibrillation, atrial flutter.
3.
Persistent ventricular extrasystoles.
4.
Control of arrhythmias following the use of digitalis or similar
glycosides.
5.
Suppression
of
arrhythmias
during
surgical
procedures
e.g.
cardiac
catheterisation.
6.
The prevention of paraxysmal supraventricular tachycardia.
7.
Other types of arrhythmias e.g. atrial extrasystoles, Wolff-Parkinson-
White Syndrome.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology: Oral
300 mg to 800mg daily in divided doses.
_Elderly _
A dose reduction due to reduced renal and hepatic function in the
elderly (especially
elderly non-smokers) should be considered (see section 4.4)
_Paediatric population_
_ _
The safety and efficacy of disopyramide in children less than 18 years
has not been
established. Current available evidence is available in section 4.4,
5.1 and 5.2.
4.3
CONTRAINDICATIONS
Hypersensitivity to the active substance or to any of the excipients
listed in section
6.1.
Disopyramide is contra–indicated in un–paced second or third
degree atrioventricular
block; bundle–branch block associated with first degree
atrioventricular block; un-
paced bifasicular block; pre-existing long QT syndromes; severe sinus
node
dysfunction and severe heart failure, unless secondary to cardiac
arrhythmia. It is also
contra–indicated in concomitant administration with other
anti–arrhythmics or other
drugs liable to provoke ventricular arrhythmias, e