Posiformin

INSTRUCTION FOR MEDICINAL USE OF THE MEDICINAL PRODUCT POSIFORMIN (POSIFORMIN)

Composition:

Active substance: bibrocathol;

1 g of ointment contains 20 mg of bibrocathol;

Excipients: white soft paraffin, mineral oil, lanolin.

Pharmaceutical form. Ophthalmic ointment.

Main physicochemical properties: homogeneous ointment (in the form of a suspension) from yellow to grey-yellow in color.

Pharmacotherapeutic group. Agents used in ophthalmology. Other antibacterial agents. ATC code S01AX05.

Pharmacological properties.

Pharmacodynamics.

Bibrocathol is a bismuth compound with antiseptic and astringent properties, which is also capable of inhibiting secretory functions of mucous membranes and promoting wound healing. The mechanism of its action is determined by the structure of bibrocathol, which is a phenolic derivative of tetrabromopyrocatechin and bismuth hydroxide.

On mucous membranes and wounds, bibrocathol causes protein precipitation and contraction of superficial tissue layers. This leads to the formation of a protective layer that prevents penetration of pathogenic microorganisms. Such an astringent effect results in nonspecific inhibition of inflammation and secretory functions.

Pharmacokinetics.

Bibrocathol is practically insoluble in water and therefore does not penetrate into the intraocular fluid. Thus, its use in ophthalmology is limited to local treatment of nonspecific irritations and inflammations, as well as treatment of wounds of the external eye membranes.

After topical application to the eye, significant systemic absorption of bibrocathol does not occur.

Clinical characteristics.

Indications.

Non-specific irritations of the external eye membranes of non-infectious origin, chronic eyelid margin inflammation (chronic blepharitis), fresh non-infected corneal wounds.

Contraindications.

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

Interaction with other medicinal products and other forms of interaction.

Specific studies on drug interactions of the medicinal product have not been conducted.

When using the medicinal product simultaneously with other eye drops or ointments, an interval of at least 15 minutes should be maintained between applications. Posiformin should be administered last.

Usage Notes

The excipient lanolin may cause local skin reactions (e.g., contact dermatitis).

During treatment with this medicinal product, contact lenses must not be used.

When applying the eye ointment, care should be taken to avoid any contact between the tube tip and the eye or skin.

Use during pregnancy or breastfeeding

As there are no clinical data on the use of bibracatol-containing medicinal products during pregnancy or breastfeeding, the use of Posiformin eye ointment during these periods should only be considered after a careful assessment of the benefit-risk ratio.

Effect on the ability to drive or operate machinery

Due to its greasy consistency, the medicinal product may temporarily affect visual acuity immediately after application and, consequently, may impair the ability to drive or operate machinery.

Method of Administration and Dosage

A 0.5 cm strip of ointment is instilled into the conjunctival sac or applied to the affected eyelid 3–5 times daily. Dosage is the same for adults and children aged 6 years and older.

The drug should be used until symptoms disappear. Usually, the duration of treatment should not exceed 14 days.

Children.

Safety and efficacy of the drug have been established in children aged 6 years and older. There is no experience with the use of the drug for treatment of younger children.

Overdose.

Systemic effects after topical application are not expected due to the very low degree of penetration of betaxolol through biological membranes into the inner chamber of the eye.

Adverse reactions.

Immune system

Rare cases of hypersensitivity reactions (allergy) and eye irritation accompanied by the following symptoms: eye itching, eye swelling, eye pain, ocular hyperemia, facial swelling, facial flushing; contact dermatitis.

Shelf life. 3 years.

Do not use after the expiry date stated on the packaging.

Use no more than 4 weeks after first opening the tube.

Storage conditions.

Store at a temperature not exceeding 25 °C in a place inaccessible to children.

Packaging.

5 g of ophthalmic ointment in an aluminum tube with an internal protective lacquer coating, equipped with a tip and a tamper-evident cap (polyethylene). One tube per cardboard box.

Prescription category. Prescription only.

Manufacturer. URSAPHARM Arzneimittel GmbH.

Manufacturer's address and location of business operations.

Industriestrasse 35, 66129 Saarbrucken, Germany.