Overdosage or accidental administration by mouth may cause depression of CNS, reduction of body temperature, bradycardia, sweating, drowsiness and coma, particularly in children. Hypertension may be followed by rebound hypotension. In addition, overdosage may cause increased redness of the eye. Treatment of side-effects is symptomatic.
Glaucoma, corneal damage, acute iritis and other serious eye disease.
Hypersensitivity to any ingredients.
Do not use at the same time as contact lenses. It is generally recommended that a short interval be allowed between the use of Fabozolina and replacement of contact lenses, and that the duration of this 'short interval' should be about 15 minutes.
This product should not be used prior to peripheral iridectomy in eyes susceptible to angle closure because mydriatic action may precipitate angle block.
None known.
May cause slight dilation of pupil.
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 national reporting system:
Yellow Card Scheme: Website: www.mhra.gov.uk/yellowcard
There are no pre-clinical data of relevance to the prescriber which are additional to that already included in other sections of the SmPC.
Redness and minor irritations of the eye caused by, for example, dusty atmosphere, wind, swimming, smoke, air pollutants, and close work.
ATC Code: S01GA01
Naphazoline is a sympathomimetic agent with marked alpha-adrenergic activity. It is a vasoconstrictor with a rapid and prolonged action in reducing swelling and congestion when applied to mucous membrane.
Absorbed following instillation into conjunctival sacs.
Fabozolina should not be used if there is an eye condition characterised by continued redness, pain or blurring of vision.
Fabozolina should not be used if there is raised pressure inside the eyeball (glaucoma), damage to the corneas, inflammation of the iris (acute iritis) or any other serious eye disease.
If there is any eye pain, vision changes, continued redness or irritation of the eye, or if the condition worsens or persists for more than 24 hours, use of the product should be discontinued and the doctor or pharmacist should be informed.
Discontinue use prior to use of anaesthetics which sensitise the myocardium to sympathomimetics (e.g. cyclopropane, halothane).
As with other sympathomimetics, use with caution in the presence of hypertension, diabetes, hyperthyroidism, cardiovascular abnormalities and arteriosclerosis.
Contains benzalkonium chloride which may cause eye irritation. Avoid contact with soft contact lenses; remove contact lenses prior to application and wait at least 15 minutes before re-insertion; known to discolour soft contact lenses.
Do not drive or operate machinery if vision is blurred.
Ocular
Adults and children 12 years and over
The recommended dosage is one or two drops into each eye two or three times daily.
Children under 12 years: Not recommended. There is no recorded experience with the product in this age group.
Do not use if the solution changes colour or becomes cloudy.
