Posiformin^® (Ointment) Instructions for Use

Marketing Authorization Holder

Ursapharm Arzneimittel, GmbH (Germany)

ATC Code

S01AX05 (Bibrocathol)

Active Substance

Bibrocathol (Rec.INN registered by WHO)

Dosage Form

Posiformin®

Eye ointment 2%: tube 5 g

Dosage Form, Packaging, and Composition

Eye ointment homogeneous, suspension, from yellow to grey-yellow in color.

Excipients: white soft paraffin – 666.4 mg, liquid paraffin – 245 mg, anhydrous lanolin – 68.6 mg.

5 g – aluminum tubes (1) – cardboard packs.

Clinical-Pharmacological Group

Drug with antimicrobial action for topical use in ophthalmology

Pharmacotherapeutic Group

Drugs for the treatment of eye diseases – other antimicrobial drugs

Pharmacological Action

Bibrocathol is a phenolic derivative of tetrabromopyrocatechol and bismuth hydroxide, possessing antiseptic and astringent properties, as well as the ability to inhibit the secretion of mucous membranes and wounds.

On the mucous membrane and wound surface, Bibrocathol causes protein precipitation and tightening of the superficial tissue layers. This leads to the formation of a protective layer that prevents the penetration of pathogenic microorganisms. Such an astringent effect causes non-specific inhibition of inflammation and secretion.

Pharmacokinetics

Bibrocathol is almost insoluble in water and therefore practically does not penetrate into the eye tissues and intraocular fluid.

The use of bibrocathol in ophthalmology is limited to the local treatment of non-specific irritations and inflammations, as well as the treatment of wounds of the external eye membranes. After topical ophthalmic application, significant systemic absorption of bibrocathol does not occur.

Indications

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

ICD codes

Dosage Regimen

Apply a small amount of ointment, approximately a 1 cm strip, into the conjunctival sac of the affected eye(s) or directly onto the affected eyelid margin.

Use the preparation three to five times daily at regular intervals.

Continue application until symptoms resolve completely.

Do not use for more than 14 consecutive days without re-evaluation by a physician.

No dose adjustment is required for elderly patients or for patients with renal or hepatic impairment.

Administer the ointment last if using multiple topical ophthalmic products; maintain a 5-minute interval between applications.

Wash hands thoroughly before and after application.

Avoid contact between the tube tip and the eye, eyelids, or any other surface to prevent contamination.

Adverse Reactions

Immune system disorders rarely – hypersensitivity reactions; eye irritation (itching, hyperemia or swelling of the eyes, eye pain, facial swelling, facial flushing).

Contraindications

Hypersensitivity to the active substance.

Use in Pregnancy and Lactation

Clinical data on the use of bibrocathol during pregnancy or breastfeeding are not available.

Use is only possible if the expected benefit to the mother outweighs the potential risk of side effects to the fetus and child.

Special Precautions

Contact lenses should not be worn during the course of treatment.

Effect on ability to drive vehicles and operate machinery

Immediately after application, due to the oily consistency, a short-term decrease in visual acuity is possible, which may affect the speed of reaction when driving vehicles or operating machinery.

Storage Conditions

Store at 2°C (36°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Rx Only

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.