Treatment of ocular signs and symptoms of seasonal allergic conjunctivitis Pack size: 5ml
Treatment of ocular signs and symptoms of seasonal allergic conjunctivitis
Posology and method of administration
The dose is one drop of OPATANOL in the conjunctival sac of the affected eye(s) twice daily (8 hourly). Treatment may be maintained for up to four months, if considered necessary.
To prevent contamination of the dropper tip and solution, care must be taken not to touch the eyelids, surrounding areas, or other surfaces with the dropper tip of the bottle. Keep the bottle tightly closed when not in use.
In case of concomitant therapy with other topical ocular medicines, an interval of five to ten minutes should be allowed between successive applications.
Use in elderly
No dosage adjustment in elderly patients is necessary.
OPATANOL may be used in paediatric patients (three years of age and older) at the same dose as in adults.
Use in hepatic and renal impairment
Olopatadine in the form of eye drops (OPATANOL) has not been studied in patients with renal or hepatic disease. However, no dosage adjustment is expected to be necessary in hepatic or renal impairment (see section 5.2).
Special warnings and precautions for use
OPATANOL is an antiallergic/antihistaminic agent and, although administered topically, is absorbed systemically. If signs of serious reactions or hypersensitivity occur, discontinue the use of this treatment.
Benzalkonium chloride, which is commonly used as a preservative in ophthalmic products, has been reported to cause punctate keratopathy and/or toxic ulcerative keratopathy. Since OPATANOL contains benzalkonium chloride, close monitoring is required with frequent or prolonged use in dry eye patients, or in conditions where the cornea is compromised.
Patients should be instructed to wait 10-15 minutes after instillation of OPATANOL before inserting contact lenses. OPATANOL should not be administered while wearing contact lenses.
Pregnancy and lactation
For olopatadine, no clinical data on exposed pregnancies are available.
Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/foetal development, parturition or postnatal development (see section 5.3).
Caution should be exercised when prescribing to pregnant women.
OPATANOL is not recommended for breast-feeding mothers.
Olopatadine has been detected in the milk of nursing rats following oral administration. Studies in animals have shown reduced growth of nursing pups of dams receiving systemic doses of olopatadine well in excess of the maximum level recommended for human ocular use. It is not known whether topical administration to humans could result in sufficient systemic absorption to produce detectable quantities in human breast milk.
Effects on ability to drive and use machines
As with any eye drop, temporary blurred vision or other visual disturbances may affect the ability to drive or use machines. If blurred vision occurs at instillation, the patient must wait until the vision clears before driving or using machinery.
General disorders and administration site conditions
Not known (cannot be estimated from the available data):
Adverse reactions identified from post-marketing experience that have not been reported previously in clinical trials with OPATANOL include those detailed below. Unlike data from clinical trials, due to the nature of post-marketing surveillance, the frequency at which these events occur is not known and cannot be estimated based upon the available data.
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