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RYTHMODAN Capsules (2019)

Αναφορές

Βιβλιογραφική αναφορά

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Περιεχόμενα

Name of the medicinal product

Rythmodan 100mg Capsules.

Qualitative and quantitative composition

Capsule containing Disopyramide 100mg. For excipients, see section 6.1.

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.

Therapeutic indications

Rythmodan is used in the treatment of cardiac arrhythmias as follows: The prevention and treatment of arrhythmias occurring after myocardial infarction. Maintenance of normal rhythm following electroconversion ...

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 ...

Contraindications

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; bundle–branch block ...

Special warnings and precautions for use

Antiarrhythmic drugs belonging to the class 1c (Vaughan Williams Classification) were included in the Cardiac Arrhythmia Suppression Trial (CAST), a long term multicentre randomised, double blind study ...

Interaction with other medicinal products and other forms of interaction

Combination with other antiarrhythmic drugs Combinations of antiarrhythmic drugs are not well researched and their effect may be unpredictable. Thus, antiarrhythmic combination should be avoided except ...

Pregnancy and lactation

Pregnancy Although Rythmodan has undergone animal tests for teratogenicity without evidence of any effect on the developing foetus, its safety in human pregnancy has not been established. Rythmodan has ...

Effects on ability to drive and use machines

Some adverse reactions may impair the patients ability to concentrate and react, and hence the ability to drive or operate machinery (See section 4.8).

Undesirable effects

Cardiac: It is accepted that the arrhythmogenic potential of disopyramide is weak. However, as with all antiarrhythmic drugs, disopyramide may worsen or provoke arrhythmias. This proarrhythmic effect is ...

Overdose

Signs and symptoms Toxic plasma levels are reflected by ECG abnormalities such as: marked prolongation of QT interval as a premonitory sign of other arrhythmias, in particular torsades de pointes which ...

Pharmacodynamic properties

Pharmacotherapeutic group: Antiarrhythmias, Class Ia ATC code: C01BA03 It decreases membrane responsiveness, prolongs the effective refractory period (ERP) and slows automaticity in cells with augmented ...

Pharmacokinetic properties

Elimination phase of plasma t<sub>1/2</sub>: 5-8 hours. Increased in hepatic impairment, cardiac and hepatic disease. Protein binding: 50-60%. Saturable and concentration dependent. Volume of distribution: ...

Preclinical safety data

Not applicable.

List of excipients

Maize starch Magnesium stearate STA-RX 1500 (pregelatinised starch) Talc Capsule shell: Gelatin Indigo carmine Iron oxide and Titanium dioxide (E171)

Incompatibilities

Not known.

Shelf life

Glass Bottle: 36 months. PVC Blister: 36 months.

Special precautions for storage

Do not store above 25°C.

Nature and contents of container

Glass Bottle containing 100 capsules. PVC Blister containing 84 capsules. Amber glass bottle with jaycap closure containing 100 capsules. PVC/PVdC blister strips in cardboard cartons containing 84 capsules. ...

Special precautions for disposal and other handling

None.

Marketing authorization holder

Aventis Pharma Limited, 410 Thames Valley Park Drive, Reading, Berkshire, RG6 1PT, UK Trading as: Sanofi, 410 Thames Valley Park Drive, Reading, Berkshire, RG6 1PT, UK

Marketing authorization number(s)

PL 04425/0607

Date of first authorization / renewal of the authorization

12 February 2009

Date of revision of the text

13 August 2019

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