Special Warning : אזהרת שימוש

4.4. Special warnings and precautions for use

Cases of severe skin reactions including Stevens-Johnson syndrome, toxic epidermal necrolysis, and acute generalised exanthematous pustulosis (AGEP) have been reported with Rovamycine. Patients must be informed of the signs and symptoms of these conditions and the skin should be closely monitored.
If any signs or symptoms of Stevens-Johnson syndrome, toxic epidermal necrolysis (e.g.
progressive skin eruption often with blisters or mucosal lesions) or AGEP (generalised febrile erythema associated with pustules) (see section 4.8) occur, treatment must be discontinued and any further administration of spiramycin alone or in combination with other agents is contraindicated.
As the active substance is not eliminated via the renal route, there is no need to adjust the dose in patients with kidney failure.
Very rare cases of haemolytic anaemia have been reported in patients with glucose-6- phosphate-dehydrogenase deficiency. Use of spiramycin in these patients is therefore not recommended.

Prolongation of the QT interval
Cases of prolonged QT interval have been reported in patients taking macrolides, including spiramycin.
Caution should be exercised when using spiramycin, in patients with known risk factors for prolongation of the QT interval such as:
-     uncorrected electrolyte imbalance (e.g. hypokalaemia, hypomagnesaemia), -     congenital long QT syndrome,
-     cardiac disease (e.g. heart failure, myocardial infarction, bradycardia).
- concomitant use of medicinal products that are known to prolong the QT interval (e.g. class IA and III antiarrhythmics, tricyclic antidepressants, some antibiotics, some antipsychotics, hydroxychloroquine and chloroquine),
- elderly subjects, neonates and women may be more susceptible to QT prolongation. (See sections 4.2, 4.5, 4.8 and 4.9)

This medicinal product contains less than 1 mmol (23 mg) sodium per tablet, that is to say essentially ‘sodium-free’.

Effects on Driving