Rythmodan Retard 250 mg Prolonged-release Tablets

Држава: Ирска

Језик: Енглески

Извор: HPRA (Health Products Regulatory Authority)

Активни састојак:

Disopyramide

Доступно од:

Sanofi-Aventis Ireland Limited T/A SANOFI

АТЦ код:

C01BA; C01BA03

INN (Међународно име):

Disopyramide

Дозирање:

250 milligram(s)

Фармацеутски облик:

Prolonged-release tablet

Тип рецептора:

Product subject to prescription which may be renewed (B)

Терапеутска област:

Antiarrhythmics, class Ia; disopyramide

Статус ауторизације:

Marketed

Датум одобрења:

1981-07-02

Информативни летак

_créé le_
_par_
_modifié le_
_par_
25/08/2016
E WASCZCZYK
28/10/2016
THILL G
SANOFI
IRLANDE
_Laboratoires_
_Pays_
_Couleur_
_Nbre/Réf._
_Version N°_
_Type Article_
_Nom du produit_
_Référence article_
_Dosage_
_Quantité_
_N° version Logo/Name_
_N° version Country Ex._
_N° plan Dimensionnel_
_N° plan positionnement_
_Dimensions_
_Taille mini caractères_
_Code sécurité_
778530
_Numéro de pages_
1/4
NA
CRIE - V1 - 09/2012
1-606062
606062-1D
150 X 210 MM
10 PTS
5
NOTICE DOUBLE
RYTHMODAN
R778530
250 MG
CPS
1
BLEU REFLEX BLUE U
COMPIÈGNE
COMPIÈGNE
IS THIS LEAFLET HARD TO SEE
OR READ?
PHONE [phone] FOR HELP
READ ALL OF THIS LEAFLET CAREFULLY BEFORE
YOU START TAKING THIS MEDICINE BECAUSE IT
CONTAINS IMPORTANT INFORMATION FOR YOU.
•
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.
WHAT IS IN THIS LEAFLET:
• 1. What Rythmodan Retard is and what
it is 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 IS
AND WHAT IT IS USED FOR
The name of your medicine is
Rythmodan Retard 250mg Prolonged
Release 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

Карактеристике производа

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Rythmodan Retard 250 mg Prolonged-release Tablets.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 250mg disopyramide (as phosphate)
Excipients: Contains 30mg Sucrose and 3.5mg anhydrous glucose
For full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Prolonged-release tablet.
Whitish, circular, biconvex film-coated tablets having a single
scoreline on one face. On one surface is “O13” and “E”
and on the other side the Russel Uclaf logo.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
For the maintenance treatment of patients with various atrial and
ventricular arrhythmias, singly or in combination with
other appropriate agents.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Route of administration: The usual daily dose is one tablet in the
morning and evening.
Tablets should be swallowed whole, not crushed, bitten or chewed.
Children: Not recommended (see section 4.3).
4.3 CONTRAINDICATIONS
Disopyramide is contra–indicated
o
In second or third degree heart block and sinus node disease if no
pacemaker is present.
o
Bundle branch block associated with first degree atrioventricular
block.
o
Double block (left posterior or anterior hemiblock and RBBB)
o
Pre-existing long QT
o
Severe sinus node dysfunction
o
Severe heart failure, unless secondary to cardiac arrhythmia (see
section 4.4)
o
Concomitant administration with other antiarrhythmics or other drugs
liable to provoke ventricular arrhythmias
and especially torsades de pointes (see Section 4.5)
o
Cardiogenic shock
o
Hypersensitivity to disopyramide
The sustained release formulation is contraindicated in children and
in patients with renal or hepatic impairment.
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Antiarrhythmic drugs belonging to the class IC (Vaughan Williams
Classification) were included in the Cardiac
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