Section 4.4

The oral solution contains less than 1 mmol sodium (23 mg) per dose, that is to say, essentially ‘sodium free’.

Section 4.8 Undesirable effects

Frequency: Not known

Stevens-Johnson syndrome/toxic epidermal necrolysis

Section 2:

This medicine contains less than 1 mmol sodium (23 mg) per dose, that is to say, essentially ‘sodium free’.

Section 4:

Not known: frequency cannot be estimated from the available data

●      Severe or life‑threatening rash with blisters and peeling skin that may start in and around the mouth, nose, eyes, and genitals and spread to other areas of the body (Stevens‑Johnson syndrome or toxic epidermal necrolysis).