sanofi-aventis

Section 4.4 - The following text has been added

Clostridium difficile-associated disease

Diarrhoea, particularly if severe, persistent and/or bloody, during or after treatment with ofloxacin, may be symptomatic of pseudo-membranous colitis. If pseudo-membranous colitis is suspected, ofloxacin must be stopped immediately.  Appropriate specific antibiotic therapy must be started without delay (e.g. oral vancomycin, oral teicoplanin or metronidazole). Products inhibiting the peristalsis are contraindicated in this clinical situation

Section 4.5

Added ‘antipsychotics’ to the list of Drugs known to prolong QT interval

The following text has been added

In case of convulsive seizures, treatment with ofloxacin should be discontinued.

Vitamin K antagonists

Coagulation tests should be monitored in patients treated with vitamin K antagonists because of a possible increase in the effect of coumarin derivatives.

Section 4.6 has been revised

Section 4.8 has been tabulated

Section 4.9 Added ‘ECG monitoring should be undertaken, because of the the possibility of QT interval prolongation.’

Section 2

addition of the following wording 'For a full list of excipients, see section 6.1.'

Section 4.2

addition of the word zinc in the following sentence - 'Tarivid tablets should be swallowed with liquid; they should not be taken within two hours of magnesium/aluminium containing antacids, sucralfate, zinc or iron preparations since reduction of absorption of ofloxacin can occur.'

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 6.2

Deleted; 'none known'
Added: 'Not applicable.'

Section 6.4

Deleted: Store in dry place
Added: Store in the original package.

Section 6.6      

deleted: none
added: no special requirements.