Fusidic Acid 1% Viscous Eye Drops
Summary of Product Characteristics Updated 12-Apr-2018 | Concordia International - formerly AMCo
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 10mg.
Excipient with known effect: 0.01% w/w benzalkonium chloride
For the 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 all ages: One Fusidic acid drop to be instilled into the eye twice daily. Treatment should be continued
for at least 48 hours after the eye returns to normal.
Method of administration:
For ophthalmic use only.
Hypersensitivity to the active substance(s) or to any of the excipients listed in section 6.1.
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. 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.
Fusidic acid eye drops contain benzalkonium chloride, which may cause eye irritation and discolour soft
4.5 Interaction with other medicinal products and other forms of interaction
No interaction studies have been performed. Systemic interactions are unlikely since systemic exposure
after application of Fusidic acid eye drops is negligible.
4.6 Fertility, pregnancy and lactation
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.
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.
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.
4.7 Effects on ability to drive and use machines
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
4.8 Undesirable effects
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)
System organ class
Immune system disorders
Vision blurred (transient)
Eyelid oedema, Lacrimation increased
Skin and subcutaneous tissue
General disorders and
administration site conditions
Application site pain (including eye burning and
Application site pruritus
Application site discomfort/irritation
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:
The total quantity of fusidic acid in one 5 g tube of Fucithalmic eye drops (50 mg) does not exceed the
approved total daily oral dose of fusidic acid contain-ing products. The concentration of the excipients is
too low to constitute a safety risk. Therefore, overdose is unlikely to occur.
5. Pharmacological properties
5.1 Pharmacodynamic properties
Pharmacotherapeutic group: Antimicrobial, ATC code: S01AA13
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.
6.3 Shelf life
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.
6.6 Special precautions for disposal and other handling
DIRECTIONS FOR USE FOR ADMINISTRATION
1. As with any eye preparation, wash your hands before you administer FUCITHALMIC viscous eye-
2. Remove the cap from the tube. To administer FUCITHALMIC viscous eye-drops, stand or sit
comfortably and tilt your head backwards. Hold the tube above your eye.
3. Gently pull down your lower eyelid and squeeze one drop from the tube into your lower eyelid as
shown in the picture. You may find a mirror useful when administering the drops.
4. Be careful not to touch the tip of the tube to your eye or other surface, so as to avoid contamination of
5. FUCITHALMIC viscous eye-drops comes out of the tube as a single viscous drop, which quickly turns
to liquid in your eye.
6. If the drops are for children, you may put the drops in their eyes when they are lying down or asleep.
Any unused medicinal product or waste material should be disposed of in accordance with local
7. Marketing authorisation holder
Amdipharm UK Limited,
85 King William Street,
EC4N 7BL, London,
8. Marketing authorisation number(s)
9. Date of first authorisation/renewal of the authorisation
United Kingdom 10.8.1987
10. Date of revision of the text
Company Contact Details
Concordia International - formerly AMCo
Capital House, 1st Floor, 85 King William Street, London, EC4N 7BL, UK
+44 (0)208 588 9131
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