FUSIDIC ACID Sterile viscous eye drops Ref.[6875] Active ingredients: Fusidic acid

Contact lenses should not be worn/used when Fusidic acid eye drops are used. The microcrystalline fusidic acid may cause scratches in the contact lens or cornea. Contact lenses are kept out until all symptoms of the infection have gone.

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.

Excipients warning: Fusidic acid eye drops contain benzalkonium chloride, which may cause eye irritation and discolour soft contact lenses.

No interaction studies have been performed. Systemic interactions are unlikely since systemic exposure after application of Fusidic acid eye drops is negligible.

Pregnancy

No effects during pregnancy are anticipated, since systemic exposure to Fusidic acid eye drops is negligible. Fusidic acid eye drops can be used during pregnancy.

Breast-feeding

No effects on the breast-fed new-born/infant are anticipated since the systemic exposure of the breast-feeding woman to fusidic acid is negligible. Fusidic acid eye drops can be used during breast-feeding.

Fertility

There are no clinical studies with Fusidic acid eye-drops regarding fertility. No effects on women of childbearing potential are anticipated, since systemic exposure to Fusidic acid eye-drops is negligible.

Fusidic acid eye drops has no or negligible influence on the ability to drive or use machines. Fusidic acid eye drops may, however, cause a blurring of vision following application and patient should take this into account.

The estimation of the frequency of undesirable effects is based on a pooled analysis of data from clinical trials and spontaneous reporting.

Based on pooled data from clinical studies, including 2,499 patients with eye infections including acute conjunctivitis, who received Fucithalmic eye drops, the frequency of undesirable effects was 11.3%.

The most frequently reported adverse reactions during treatment are various application site reactions such as pain, pruritus and irritation/discomfort in/around the eyes, which occurred in approximately 8.5% of patients, followed by blurring of vision, which occurred in approximately 1.2% of patients. Angioedema has been reported in a few patients post marketing.

Undesirable effects are listed by MedDRA SOC and the individual undesirable effects are listed starting with the most frequently reported. Within each frequency grouping, adverse reactions are presented in the order of decreasing seriousness.

Very common (≥1/10)
Common (≥1/100 and <1/10)
Uncommon (≥1/1,000 and <1/100)
Rare (≥1/10,000 and <1/1,000)
Very rare (<1/10,000)
Not known (cannot be estimated from the available data)

Immune system disorders

Uncommon: Hypersensitivity

Eye disorders

Common: Vision blurred (transient)

Uncommon: Eyelid oedema, Lacrimation increased

Rare: Conjunctivitis aggravated

Skin and subcutaneous tissue disorders

Uncommon: Rash, Angioedema

Rare: Urticaria

General disorders and administration site conditions

Common: Application site pain (including eye burning and eye stinging), Application site pruritus, Application site discomfort/irritation

Paediatric population

The observed safety profile is similar in children and adults.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme website: www.mhra.gov.uk/yellowcard.

Not applicable.