Ritmodan Shortage: AIFA Monitors, AICARM Defends Patient

di Francesca Conti

The Italian Medicines Agency (AIFA) has communicated a temporary shortage of Disopyramide-based medicines, used in the treatment of various forms of cardiac arrhythmias. The affected products are Ritmodan 100 mg hard capsules (AIC 021894035) and Ritmodan Retard 250 mg prolonged-release tablets (AIC 027218015), both authorised for the prevention and treatment of arrhythmias such as atrial fibrillation, flutter, tachycardia and extrasystoles.

The reduction in availability is due to production problems reported by the marketing authorization holder, Cheplapharm Arzneimittel GmbH. In particular, Ritmodan Retard 250 mg risks being unavailable in the coming weeks, while the distribution of Ritmodan 100 mg is currently limited to ensure its therapeutic continuity.

According to AIFA, supplies are expected to resume starting from May 20, 2025 for Ritmodan Retard and from the beginning of June for Ritmodan 100 mg. In the meantime, the Agency is in constant contact with the owner company to monitor the situation and evaluate possible mitigation measures.

Among the actions taken:

Blocking of the export of Ritmodan 100 mg, in order to allocate available stocks to the domestic market;
Request for advance on supplies, currently under evaluation;
Sensitization of the Regions to encourage, where possible, the importation of equivalents from abroad by making them available at hospital pharmacies;
Involvement of private pharmacies to verify the possibility of resorting to galenic preparation, limited however by the difficulty of finding the raw material.

Therapeutic indications and substitution strategies. Both formulations of Ritmodan are used in cardiology for the treatment and prevention of arrhythmia relapses, particularly after acute episodes such as myocardial infarction.

To ensure therapeutic continuity during this period of shortage, AIFA, in agreement with the main scientific societies of cardiology (AICARM APS, SIC and ANMCO), proposes a temporary replacement scheme, based on the use of Ritmodan 100 mg capsules instead of Ritmodan Retard. The suggested dosage includes, based on the patient's needs:

Dosage regimen RITMODAN RETARD 250 mg prolonged-release tablets	Alternative dosage regimen with RITMODAN 100 mg hard capsules
250 mg x 2 (one tablet in the morning + one tablet in the evening)	100 mg x 4 (1 capsule every 6 hours)
250 mg + 125 mg (one tablet in the morning + half a tablet in the evening)	100 mg x 3 (1 capsule every 8 hours) (one capsule in the morning, one capsule at noon and one capsule in the evening)
125 mg x 2 (half a tablet in the morning + half a tablet in the evening)	100 mg x 2 (one capsule in the morning and one capsule in the evening)

The Agency recommends that prescribing physicians avoid, where possible, starting new treatments with Ritmodan in both formulations during the waiting period. Pharmacists are asked to dispense only the quantity strictly necessary, to avoid hoarding and to ensure therapeutic continuity for patients already in treatment.

IMPORTANT: AVAILABILITY ABROAD

AICARM has identified two foreign suppliers who, on the basis of an order and payment, can supply the drug. To obtain the details of the suppliers and the methods of purchase, we invite you to contact our service Hearts Listening.

INTERNATIONAL PHARMACY DR. MERLONI

Corso San Gottardo 25
CH – 6830 Chiasso
Switzerland

Email: chiasso@merlonipharma.ch

Phone no.: +41 91 690 10 50
Fax no.: + 41 91 682 89 35

INTERNATIONAL PHARMACY SERVICE

Via Scialoja 20, Borgo Maggiore
San Marino

Email: farmacia.internazionale@iss.sm

Tel: 0549 994930
Fax: +0549 994020

CONTACTS LISTENING HEARTS

For further information write or call the free Cuori in Ascolto help desk:

Hearts listening: https://www.aicarm.it/cuori-in-ascolto/
Phone+ 39 055 0620178

AIFA PRESS RELEASE

Download here: Ritmodan Information

SUBJECT: Shortage of medicines based on Disopyramide RITMODAN 100 mg hard capsules, 40 capsules (AIC 021894035) and RITMODAN RETARD 250 mg prolonged-release tablets, 20 tablets (AIC 027218015)