Rythmodan Retard 250mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Disopyramide phosphate

Available from:

Dowelhurst Ltd

ATC code:

C01BA03

INN (International Name):

Disopyramide phosphate

Dosage:

250mg

Pharmaceutical form:

Modified-release tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 02030200

Patient Information leaflet

RYTHMODAN
® RETARD 250MG TABLETS
(disopyramide phosphate)
PATIENT INFORMATION LEAFLET
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.
This medicine is available using above name but will be referred to as
Rythmodan Retard throughout the leaflet.
IN THIS LEAFLET:
1. What Rythmodan Retard are and what they are used for
2. Before you take Rythmodan Retard
3. How to take Rythmodan Retard
4. Possible side effects
5. How to store Rythmodan Retard
6. Further information
1. WHAT RYTHMODAN RETARD ARE AND WHAT THEY ARE USED
FOR
The name of your medicine is Rythmodan Retard 250mg Tablets (called
Rythmodan Retard in this leaflet). Rythmodan Retard contains 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 RETARD
DO NOT TAKE RYTHMODAN RETARD IF:
- You are allergic (hypersensitive) to disopyramide or any of the
other
ingredients of Rythmodan Retard (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 takin

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Rythmodan Retard 250mg Modified Release Tablets
2.
QUALITATVE AND QUANTITATIVE COMPOSITION
Each tablet contains 322.5mg of the active substance Disopyramide
Phosphate
(equivalent to 250mg base).
Also contains 30mg of sucrose and 3.529mg of glucose, anhydrous.
For full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Modified release tablet.
Biconvex tablets and off-white in colour. One side has a break-line
and is
embossed 013 and E; the other side is embossed with the Roussel logo.
The tablet can be divided into equal doses.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Properties:
Prevention and control of a wide variety of cardiac arrhythmias,
probably by slowing
conduction in the his-Purkinje system and by increasing the effective
refractory
period of the atria and ventricles.
Indications:
1.
Maintenance of normal rhythm following conversion by parenteral drugs
or
electroconversion.
2.
Prevention of arrhythmias after myocardial infarction.
3.
Treatment of persistent ventricular and atrial extrasystoles,
paroxysmal supra
ventricular tachycardia, Wolff-Parkinson-White syndrome.
4.
Suppression of arrhythmias during surgical procedures.
5.
Control of arrhythmias following the use of digitalis or similar
glycosides.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Oral
Recommended dose for stabilised patients or those receiving Rythmodan
for the
first time is one to one and a half tablets (250-375mg) twice daily.
Tablets
should be swallowed and not crushed or chewed.
_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
There are insufficient data to recommend the use of Rythmodan in
children.
4.3
CONTRA–INDICATIONS
Hypersensitivity to Disopyramide Phosphate or to any of the excipients
listed
in section 6.1.
Disopyramide is contra–indicated in un–paced second or third
degree
atrioventricular block; bu