Prescribing Information

Fucithalmic 10mg/g Eye Drops (fusidic acid)

The prescribing information below is applicable to Finland as a reference market. However, the product indication for Fucithalmic in your own country of medical practice may vary.We highly recommend that you check your country specific Summary of Product Characteristics (SPC) and Patient Information Leaflet (PIL) for Fucithalmic for further information, if applicable.

Indication:

Eye infections, including keratitis, conjunctivitis, meibomitis, blepharitis, caused by bacteria susceptible to fusidic acid.

Dosage and Administration:

1 drop twice a day. Initially, more frequent dosage may be used. The eye should be cleaned frequently. For prevention of recurrence, treatment should be continued for at least 2 days after the symptoms have subsided.

Contraindications:

Hypersensitivity to the active substance or to any of the excipients.

Precautions and warnings:

Bacterial resistance has been reported to occur with the use of fusidic acid. As with all antibiotics, extended or recurrent use may increase the risk of developing antibiotic resistance. Contact lenses should not be worn/used when Fucithalmic is used. Microcrystalline fusidic acid may cause scratches in the contact lens or cornea. Contact lenses may be worn 15 minutes after discontinuation of treatment. Fucithalmic contains benzalkonium chloride which may cause eye irritation and discolour soft contact lenses.

Interactions:

No interaction studies have been conducted. Systemic infections are unlikely.

Pregnancy and lactation:

Can be used during pregnancy and lactation.

Undesirable effects:

Serious: Hypersensitivity, angioedema, aggravated conjunctivitis.
Common: Transient blurring of vision, administration site pain (including burning sensation and stinging in the eye), itching and irritation.

(Please refer to the Summary of Product Characteristics for detailed information)

Overdose:

Total quantity of fusidic acid in one 5g tube of Fucithalmic (50mg) will not exceed the approved total daily oral dose of fusidic acid. Overdosing is unlikely to occur as the concentration of the excipients is too low to constitute a safety risk.

Legal category:

POM

Pack size:

Tube of 5 grams

Marketing Authorisation Number:

9996

Marketing Authorisation Holder:

Amdipharm Limited (a member of the ADVANZ PHARMA group of companies),
Temple Chambers,
3 Burlington Road,
Dublin 4,
Ireland

Date of preparation:

May 2017

Date of revision:

November 2018 [Con/FUT/PI/0013]

Adverse events should be reported to the local regulatory authority. Reporting forms and information can be found at http://www.fimea/fi/. Adverse events should also be reported to ADVANZ PHARMA Medical Information via telephone on +44 (0) 8700 70 30 33 or via e-mail at medicalinformation@advanzpharma.com

Adverse events should be reported to the local regulatory authority.

Reporting forms and information can be found at http://www.fimea/fi/. Adverse events should also be reported to ADVANZ PHARMA Medical Information via telephone on +44 (0) 8700 70 30 33 or via e-mail at medicalinformation@advanzpharma.com