Fusidic Acid 1% W/W Viscous Eye Drops
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Fucithalmic® 1% w/w Viscous Eye Drops Fusidic acid 1% w/w Viscous Eye Drops
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each gram contains fusidic acid, hemihydrate Ph.Eur. 10mg.
Excipient: 0.01% w/w benzalkonium chloride For full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Sterile viscous eye drops.
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
Fusidic acid eye drops are indicated for the topical treatment of bacterial conjunctivitis where the organism is known to be sensitive to the antibiotic.
4.2 Posology and method of administration
For ophthalmic use only.
For all ages: One drop of Fusidic acid eye drops to be instilled into the eye twice daily. Treatment should be continued for at least 48 hours after the eye returns to normal.
4.3
Contraindications
Hypersensitivity to fusidc acid/sodium fusidate, or any of the excipients.
4.4 Special warnings and precautions for use
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.
Fusidic acid eye drops contain benzalkonium chloride which may cause eye irritation and is also known to discolour soft contact lenses.
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.
4.5 Interaction with other medicinal products and other forms of interaction
None known.
4.6 Fertility, pregnancy and lactation
Pregnancy
Limited clinical data on exposed pregnancies is available, and animal studies and many years of clinical experience with systemic and topical fusidic acid suggest that fusidic acid is devoid of teratogenic effect. Consequently any risk to the foetus is unlikely using the very low doses of fusidic acid applied topically in Fusidic acid eye drops. Can be administered during pregnancy if considered necessary.
Lactation
No effects on the infant are anticipated since the systemic exposure of the breastfeeding woman to fusidic acid is negligible. Fusidic acid eye drops can be used during breastfeeding.
4.7 Effects on ability to drive and use machines
Fusidic acid eye drops may cause a transient blurring of vision following application. When vision is not affected, Fusidic acid eye drops have no or negligible influence on the ability to drive or to use machines.
4.8 Undesirable effects
Pooled data from clinical studies, including more than 2,600 patients with acute conjunctivitis, showed that undesirable effects occurred in approximately 10% of the patients; primarily short lasting local discomfort in the form of stinging and burning sensation.
The most frequently reported adverse drug reactions to Fusidic acid eye drops are various application site reactions such as transient stinging and burning sensation or transient blurring of vision.
Undesirable effects are listed by MedDRA SOC and the individual undesirable effects are listed starting with the most frequently reported.
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:
Rare
Hypersensitivity
Eye Disorders:
Common:
Administration site conditions including eye burning/stinging/discomfort/
smarting/irritation/itching/soreness/dryness
Transient blurring of vision
Uncommon
Watery Eyes/crying on application Not known
Conjunctivitis aggravated
Skin and subcutaneous disorders
Not known Pruritus
Periorbital oedema
Rash
Urticaria
Angioedema
4.9 Overdose
Overdosage is unlikely to occur.
Unless hypersensitivity to Fusidic acid or any of the excipients exists, accidental ingestion of Fusidic acid eye drops is unlikely to cause any harm. The total quantity of fusidic acid in one 5g tube of Fusidic acid eye drops (50mg) will not exceed the approved total daily oral dose of fusidic acid containing products. The concentration of the excipients is too low to constitute a safety risk.
5.1 Pharmacodynamic properties
Fusidic acid eye drops are active against a wide range of gram-positive organisms, particularly Staphylococcus aureus. Other species against which fusidic acid eye drops have been shown to have in vitro activity include Streptococcus, Neisseria, Haemophilus, Moraxella and Corynebacteria.
5.2 Pharmacokinetic properties
The sustained release formulation of Fusidic acid eye drops ensures a prolonged contact with the conjunctival sac. Twice daily application provides sufficient fusidic acid concentrations in all relevant tissues of the eye. Fusidic acid penetrates well into the aqueous humour.
5.3 Preclinical safety data
There are no pre-clinical data of relevance to the prescriber which are additional to that already included in other sections of the SPC.
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Benzalkonium chloride, disodium edetate, mannitol, carbomer, sodium hydroxide, water for injections.
6.2 Incompatibilities
None known.
6.3 Shelf life
3 years.
6.4 Special precautions for storage
Store below 25°C. Keep the tube tightly closed. The tube should be discarded one month after opening.
6.5 Nature and contents of container
Available in 5g tubes.
Special precautions for disposal
6.6
None.
7 MARKETING AUTHORISATION HOLDER
Amdipharm UK Limited
Capital House, 85 King William Street,
London EC4N 7BL, UK
8 MARKETING AUTHORISATION NUMBER(S)
PL 20072/0242
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
23/06/2008
10 DATE OF REVISION OF THE TEXT
02/04/2014