| Section 2
addition of the following wording 'For a full list of excipients, see section 6.1.'
Section 4.2
addition of' (See section 4.4 QT interval prolongation) to elderly section
Section 4.3
'Hypersensitivity to the active substance or to any of the excipients' replaces 'Ofloxacin should not be used in patients with known hypersensitivity to 4-quinolone antibacterials or any of the tablet excipients.'
Section 4.4
Following information added;
QT interval prolongation
Very rare cases of QT interval prolongation have been reported in patients taking fluoroquinolones. Caution should be taken when using fluoroquinolones, including ofloxacin, in patients with known risk factors for prolongation of the QT interval such as, for example:
elderly, uncorrected electrolyte imbalance (e.g. hypokalemia, hypomagnesemia), congenital long QT syndrome, acquired QT prolongation, cardiac disease (e.g. heart failure, myocardial infarction, bradycardia), concomitant use of drugs that are known to prolong the QT interval (e.g. Class IA and III antiarrrhythmics, tricyclic antidepressants, macrolides).See also section 4.2 Elderly and section 4.5.
Peripheral neuropathy
Sensory or sensorimotor peripheral neuropathy has been reported in patients receiving fluoroquinolones, including ofloxacin. Ofloxacin should be discontinued if the patient experiences symptoms of neuropathy in order to prevent the development of an irreversible condition.
Section 4.5
Following information added
Drugs known to prolong QT interval
Ofloxacin, like other fluoroquinolones, should be used with caution in patients receiving drugs known to prolong the QT interval (e.g. Class IA and III antiarrhythmics, tricyclic antidepressants, macrolides).(See Section 4.4 QT interval prolongation).
Antacids, Sucralfate, Metal Cations
It may be necessary to confirm positive opiate or porphyrin screens by more specific methods.
Section 4.8
sensory or sensorimotor peripheral neuropathy added, hypaesthesiae deleted
Section 5.1
Added;
Pharmacotherapeutic group: Quinolone antibacterials, Fluoroquinolones. ATC code J01M A01
Section 6.6
deleted: none
added: no special requirements.
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