| Section 4.2 – Revised the indication in children
Section 4.3 – Revised ‘children under 15 years of age’ to ‘Children before the onset of puberty.’
Deleted the following: Combination with the following medications which could induce torsades de pointes:
- Class Ia antiarrhythmic agents such as quinidine, disopyramide, procainamide.
- Class III antiarrhythmic agents such as amiodarone, sotalol.
- Other medications such as bepridil, cisapride, sultopride, thioridazine, methadone, IV erythromycin, IV vincamine, halofantrine, pentamidine, sparfloxacin.
This list is not exhaustive.
(see 4.5 Interactions with other medical products and other forms of interaction)
Section 4.4 – Deleted the section on QT interval prolongation and replaced with ‘Caution should be exercised when amisulpride is prescribed in patients with known cardiovascular disease or family history of QT prolongation.’
Section 4.5 – Deleted the following:
COMBINATIONS WHICH are contraindicated
Medications which could induce torsades de pointes :
- Class Ia antiarrhythmic agents such as quinidine, disopyramide, procainamide.
- Class III antiarrhythmic agents such as amiodarone, sotalol.
- Other medications such as bepridil, cisapride, sultopride, thioridazine, methadone, IV erythromycin, IV vincamine, halofantrine, pentamidine, sparfloxacin.
This list is not exhaustive.
COMBINATIONS WHICH REQUIRE PRECAUTIONS FOR USE
Medications which enhance the risk of torsades de pointes or could prolong the QT interval :
- Bradycardia-inducing medications such as beta-blockers, bradycardia-inducing calcium channel blockers such as diltiazem and verapamil, clonidine, guanfacine ; digitalis.
- Medications which induce hypokalaemia or electrolyte imbalance : hypokalemic diuretics, stimulant laxatives, IV amphotericin B , glucocorticoids, tetracosactides.
- Neuroleptics such as pimozide, haloperidol ; imipramine antidepressants ; lithium.
Dopamine agonists (eg : levodopa) since it may attenuate their action
Added the following: ‘Caution is advised when prescribing amisulpride with medicines known to prolong the QT interval, e.g., class IA antiarrythmics (e.g., quinidine, disopyramide) and class III antiarrhythmics (e.g. amiodarone, sotalol), some antihistaminics, some other antipsychotics and antimalarials (e.g., mefloquine) (see section 4.4).’
Section 4.8 – Minor changes to formatting. Added ‘• Skin and subcutaneous tissue disorders: Frequency not known: Angioedema, urticaria’
Section 4.9 – Added ‘Fatal outcomes have been reported mainly in combination with other psychotropic agents.’
Added ‘until the patient recovers’ to sentence about QT interval prolongation.
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