Picloptik eye drops solution 0.5 mg/ml bottle 10 ml

Instructions for use: Picloptik eye drops solution 0.5 mg/ml bottle 10 ml

Composition

active ingredient: picloxidin;

1 ml of solution contains 0.5 mg of picloxidin dihydrochloride (equivalent to 0.434 mg of picloxidin);

Excipients: anhydrous glucose, polysorbate 80, purified water.

Dosage form

Eye drops, solution.

Main physicochemical properties: colorless or slightly yellowish transparent solution, practically free from particles.

Pharmacotherapeutic group

Means used in ophthalmology. Antimicrobial agents. Picloxidin.

ATX code S01AX16

Pharmacological properties

Pharmacodynamics. Picloxidin is a broad-spectrum antiseptic, bacteriostatic.

Pharmacokinetics: No data available.

Indication

For the treatment of superficial infections of the eye and its appendages.

Contraindication

Hypersensitivity to the active substance or to any of the excipients.

Interaction with other medicinal products and other types of interactions

If more than one topical ophthalmic drug is used, the drugs should be administered at least 15 minutes apart.

Application features

If vision is impaired or symptoms worsen during therapy, you should stop using the medicine and consult a doctor.

Use during pregnancy or breastfeeding

Use with caution during pregnancy and breastfeeding due to lack of sufficient clinical data.

Ability to influence reaction speed when driving vehicles or other mechanisms

Temporary discomfort in the eye may occur after instillation of the eye drops. If blurred vision occurs during instillation, the patient should wait until the vision clears before driving or operating other machinery.

Method of administration and doses

Dosage

One drop in the affected eye(s) two to six times daily.

The duration of treatment should not exceed 10 days. After this time, the treatment should be reviewed.

Method of application

For topical use in the eye.

Children. The drug Picloptik is not used in children.

Overdose

In case of an overdose of Picloptik, the solution can be washed out of the eye with sterile physiological saline.

Side effects

Local intolerance reactions (irritation or sensitization) may occur.

Reporting of suspected adverse reactions

Reporting adverse reactions after the registration of a medicinal product is important. This allows monitoring of the benefit/risk ratio when using this medicinal product. Medical and pharmaceutical professionals, as well as patients or their legal representatives, should report all cases of suspected adverse reactions and lack of efficacy of the medicinal product via the Automated Information System for Pharmacovigilance at the link: https://aisf.dec.gov.ua.

Expiration date

2 years.

The shelf life of the medicine after first opening the bottle is 28 days.

Storage conditions

Store in the original packaging at a temperature not exceeding 25 °C.

Incompatibility

Soap, anionic surfactants (surfactants).

Packaging

10 ml in a bottle with a dropper stopper in a cardboard box.

Vacation category

Without a prescription.

Producer

K.T. Rompharm Company S.R.L.

Location of the manufacturer and address of its place of business. Str. Eroilor No. 1A, Otopeni, 075100, Ilfov County, Romania – Building Romfarm 1 and Romfarm 2.