The PRAC recommendations include using the medicine at the lowest effective dose for as short a time as possible. Use is not recommended in the elderly, and the maximum daily dose should be no more than 100 mg in adults (50 mg in the elderly if use cannot be avoided), and 2 mg per kg body weight where used in children up to 40 kg in weight. Use must be avoided in patients who already have risk factors for heart rhythm disturbances or are taking other medicines that increase the risk of QT prolongation. Care is also needed in patients taking medicines that slow the heart rate or decrease the level of potassium in the blood, as these also increase the risk of problems with heart rhythm.
The product prescribing information will be updated accordingly.