PICLOPTIC

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT PICOLOPTIC (PICLOPTIC)

Composition:

Active substance: piquindone;

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

Excipients: anhydrous glucose, polysorbate 80, purified water.

Pharmaceutical form. Eye drops, solution.

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

Pharmacotherapeutic group. Agents used in ophthalmology. Antimicrobial agents. Piquindone.

ATC code S01AX16

Pharmacological properties

Pharmacodynamics. Picleodixin is a broad-spectrum antiseptic agent and bacteriostatic.

Pharmacokinetics. Data are lacking.

Clinical characteristics

Indications. For the treatment of superficial infections of the eye and its adnexa.

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

Interaction with other medicinal products and other forms of interaction. If more than one topical ophthalmic medicinal product is used, the products should be administered at least 15 minutes apart.

Special precautions for use.

If vision is impaired or symptoms worsen during treatment, discontinue use of the medicinal product and consult a physician.

Use during pregnancy or breastfeeding. Use with caution during pregnancy and breastfeeding due to insufficient clinical data.

Ability to influence the reaction rate when driving or operating machinery. Transient ocular discomfort may occur after instillation of eye drops. If blurred vision occurs during instillation, the patient should wait until vision clears before driving or operating machinery.

Dosage and Administration

Dosage

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

The duration of treatment should not exceed 10 days. After this period, the treatment should be re-evaluated.

Route of Administration

For topical ophthalmic use.

Children. The medicinal product Pilocoptic is not intended for use in children.

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

Side effects

Local intolerance reactions (irritation or sensitization) may occur.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorization of the medicinal product is important. It allows continued monitoring of the benefit-risk balance of the medicinal product. Medical and pharmaceutical professionals, as well as patients or their legal representatives, are encouraged to report any suspected adverse reactions and lack of efficacy via the Automated Pharmacovigilance Information System at the following link: https://aisf.dec.gov.ua.

Shelf life. 2 years.

The shelf life of the medicinal product after first opening the container is 28 days.

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

Incompatibilities. Soap, anionic surfactants.

Packaging. 10 ml in a bottle with dropper cap, in a cardboard carton.

Availability category. Over-the-counter.

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

Manufacturer's location and address of the site of operation. Strada Eroilor No. 1A, Otopeni, 075100, Ilfov County, Romania – Building Rompharm 1 and Rompharm 2.