When a pharmaceutical company changes an SPC or PIL, a new version is published on medicines.ie. For each version, we show the dates it was published on medicines.ie and the reasons for change.
In Section 2, Qualitative and quantitative composition, the statements - ‘3.0 mg/ml ciprofloxacin equivalent to 3.5 mg/ml ciprofloxacin hydrochloride. For excipients, see 6.1.’ - are replaced with ‘Each ml contains 3mg ciprofloxacin as ciprofloxacin hydrochloride. Excipients: contains benzalkonium chloride 0.06mg/ml. For a full list of excipients, see section 6.1.’
In Section 4.3, Contraindications, ‘Hypersensitivity to the active substance or to any of the excipients. Hypersensitivity to quinolones.’ is replaced with ‘Hypersensitivity to ciprofloxacin, to other quinolones or any of the excipients.’
In section 4.4, Special warnings and precautions for use, the statement ‘Efficacy and safety in children less than one year old have not been assessed.’ is removed. A statement regarding ‘Serious anaphylactic reactions require immediate emergency treatment with epinephrine and other resuscitation measures-’ is added.
In Section 6.3, Shelf-life, ‘4 weeks after first opening.’ is replaced with ‘Discard 4 weeks after first opening.’
In Section 6.4, Special precautions for storage, ‘No special precautions for storage.’ is replaced with ‘This medicinal product does not require any special storage precautions.’
In Section 9, Date of first authorisation or renewal of the authorisation, ‘Date of last renewal: 03 February 2011’ is added.
In Section 10, Date of revision of the text, the date of revision is updated to February 2011.