FUSIDIC ACID Sterile viscous eye drops (2018)
Βιβλιογραφική αναφορά
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Περιεχόμενα
Name of the medicinal product
Fucithalmic 1% w/w Viscous Eye Drops. Fusidic acid 1% w/w Viscous Eye Drops.
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.
Pharmaceutical form
Sterile viscous eye drops.
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.
Posology and method of administration
Posology 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 ...
Contraindications
Hypersensitivity to the active substance(s) or to any of the excipients listed in section 6.1.
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 ...
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.
Fertility, pregnancy and lactation
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 ...
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 ...
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 ...
Overdose
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 ...
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 ...
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 ...
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.
List of excipients
Benzalkonium chloride, disodium edetate, mannitol, carbomer, sodium hydroxide, water for injections.
Incompatibilities
Not applicable.
Shelf life
3 years.
Special precautions for storage
Store below 25°C. Keep the tube tightly closed. The tube should be discarded one month after opening.
Nature and contents of container
Available in 5g tubes.
Special precautions for disposal and other handling
Directions for use for administration As with any eye preparation, wash your hands before you administer FUCITHALMIC viscous eye-drops. Remove the cap from the tube. To administer FUCITHALMIC viscous eye-drops, ...
Marketing authorization holder
Amdipharm UK Limited, Capital House, 85 King William Street, EC4N 7BL, London, UK
Marketing authorization number(s)
PL 20072/0242
Date of first authorization / renewal of the authorization
United Kingdom 10.8.1987
Date of revision of the text
10/04/2018
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