sanofi-aventis

Update the SPC sections 4.2, 4.4, 4.5 and 4.8. Modifications relate to the undesirable effect, QT interval prolongation.

Update section 4.5 of the SPC with the addition of a possible interaction with some urine drug screens for opiates
Update section 4.8 of the SPC with the addition of the undesirable effect “sensory or sensorimotor peripheral neuropathy”

Section 4.4 Special Warnings and Precautions for Use:

Addition of the following section:

“Psychotic reactions

Psychotic reactions have been reported in patients receiving quinolones, including levofloxacin. In very rare cases these have progressed to suicidal thoughts and self-endangering behaviour- sometimes after only a single dose of levofloxacin (see section 4.8). In the event that the patient develops these reactions, levofloxacin should be discontinued and appropriate measures instituted. Caution is recommended if levofloxacin is to be used in psychotic patients or in patients with history of psychiatric disease.”

Section 4.8 Undesirable Effects:

In section 4.8 there has been some rearrangement of the information, with the section detailing neurological effects being split up, with a new section detailing psychotic reactions being added. Please see below for more details, all new information appears in red.

“Neurological

Uncommon:                 headache, dizziness/vertigo, drowsiness, insomnia.

Rare:                           paraesthesia, tremor, confusion, convulsion.

Very rare:                    hypoaesthesia, visual and auditory disturbances, disturbances of taste and smell.

Psychiatric disorders

Rare:                           anxiety, depression, psychotic reactions, agitation,

Very rare:                    hallucinations, psychotic reactions with self-endangering behaviour including suicidal ideation or acts (see section 4.4).”

Section 4.5 Interaction with other medicinal products and other forms of Interaction

Change of name (BAN to INN): cyclosporin will now be found as ciclosporin