Olopatallerg, eye drops 0.1% 5 ml

Increased tear production, Red eyes, Allergic conjunctivitis, Allergy, PollinosisTreatment of symptoms of seasonal allergic conjunctivitis.

Active ingredient

Composition

Interaction

Directions for use

Topically.

Push 1 drop into the conjunctival sac of the affected eye twice a day (8 hours apart).

The duration of treatment is up to four months.

If necessary, the drug can be used in combination with other drugs. In this case, the interval between their application should be at least 5 minutes.

Elderly people.

There is no need to adjust doses for elderly patients.

Children from 3 years of age.

Olopatallerg can be used in the same doses as in adults.

Renal or hepatic impairment

There have been no studies in patients with renal or hepatic impairment regarding the administration of Olopatadine in the form of eye drops. However, it is not expected that dose adjustments will be necessary in patients with renal or hepatic impairment.

Do not touch the tip of the vial to the eyelids, periorbital skin, or other surfaces to avoid microbial contamination of the drug. Close the cap tightly after use.

Special Instructions

Olopatadine hydrochloride is an anti-allergic/antihistamine drug for topical use in ophthalmology, and despite local use, it can be absorbed into the systemic bloodstream. If pronounced hypersensitivity reactions occur, the drug should be discontinued.

Olopatadine has no significant effect on the ability to operate vehicles, machinery. If blurred vision is noted immediately after instillation, it is necessary to wait until visual clarity is restored before driving vehicles and mechanisms.

Contraindications

Hypersensitivity to the drug components, pregnancy and breastfeeding, age under 3 years.

In patients with concomitant dry eye syndrome and corneal diseases.

Side effects

General information on the profile of adverse events

In clinical trials involving 1680 patients the dosing regimen was 1 to 4 drops per day, the duration of therapy was up to 4 months, and olopatadine was used both in monotherapy and together with loratadine in a dose of 10 mg. The overall incidence of adverse events was about 4.5%, while discontinuation of participation in a clinical trial due to adverse reactions was noted only in 1.6% of cases. No serious adverse events were observed in the clinical trials, either in the visual organ or in the body as a whole. The most frequent adverse reaction associated with the treatment was discomfort in the eye, this phenomenon was noted in 0.7% of patients.

Table data on adverse events

The following adverse events were observed during clinical studies and post-registration use of the drug and are classified according to the following frequency of adverse events: Very common (≥1/10), common (≥1/100 to <1/10), infrequent (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1000), very rare (<1/10,000), frequency unknown (incidence cannot be determined based on available data). Within each group, adverse events are listed in decreasing order of severity.

System-organ class

Frequency of occurrence

Overdose

Pregnancy use

Fertility

There have been no studies on the effect of topical use of Olopatadine in ophthalmology on human fertility.

Pregnancy

There are no or limited data on topical use of olopatadine in ophthalmology in pregnant women. Animal studies have reported toxic effects of olopatadine on reproductive function when used systemically. The use of olopatadine during pregnancy and by women of childbearing age who do not use contraception is not recommended.

Breast-feeding period

Olopatadine has been noted to be excreted into the breast milk when using the drug in animals. The risk to newborns and infants cannot be excluded. It is not recommended to use the drug Olopataller during breastfeeding.

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