Proklifipin Advans (Ointment) Instructions for Use

Marketing Authorization Holder

Tula Pharmaceutical Factory, LLC (Russia)

ATC Code

C05AD03 (Benzocaine)

Active Substance

Benzocaine (Rec.INN registered by WHO)

Dosage Form

Proklifipin Advans

Ointment for rectal and external use 200 mg/g

Dosage Form, Packaging, and Composition

Ointment for rectal and external use

28.4 g – tubes – cardboard packs /in a set with an applicator-1 pc./ – Over-the-Counter

Pharmacotherapeutic Group

Angioprotectors; agents for the treatment of hemorrhoids and anal fissures for topical use; local anesthetics

Pharmacological Action

Local anesthetic for superficial anesthesia. It prevents the occurrence of pain sensations in the endings of sensory nerves and the conduction of pain impulses along nerve fibers.

It does not have a resorptive effect.

When applied to the oral mucosa, the effect develops within 1 minute.

It is believed that when taken orally, Benzocaine has an anorexigenic effect, which may be due to its effect on the gastrointestinal mucosa.

Pharmacokinetics

Benzocaine is poorly soluble in water, which causes its slow absorption. Like all ester derivatives of para-aminobenzoic acid, it is cleaved by esterase in blood plasma and the liver.

As a result, para-aminobenzoic acid and ethyl alcohol are formed, which is metabolized to acetyl coenzyme A. Para-aminobenzoic acid undergoes conjugation with glycine or is excreted by the kidneys unchanged.

Indications

As part of combination therapy for oral administration: anesthesia of mucous membranes during spasms and pain in the stomach (including peptic ulcer disease); hypersensitivity of the esophagus.

As part of combination therapy for external and topical use: pain in superficial lesions of the skin and mucous membranes, in myositis, diseases of superficial veins, hemorrhoids and perianal fissures.

ICD codes

Dosage Regimen

Apply the ointment externally to affected skin areas 2 to 4 times daily.

For rectal use in hemorrhoids and anal fissures, apply a thin layer to the cleansed perianal area.

Use the provided applicator for internal application; insert rectally after each bowel movement and at bedtime.

The maximum daily application frequency is 4 times.

Limit the duration of use to 7 days for self-medication.

Discontinue use and consult a physician if symptoms persist or worsen.

Avoid contact with eyes; in case of accidental contact, rinse thoroughly with water.

Do not apply to large areas of broken or damaged skin.

Wash hands thoroughly before and after each application.

Adverse Reactions

Possible allergic reactions.

Contraindications

Hypersensitivity to benzocaine.

Special Precautions

The correspondence of the used dosage form to the indications for use should be observed.

Drug Interactions

When used concomitantly with analgesic-antipyretics, cholinesterase inhibitors, the effect of benzocaine is enhanced.

When used concomitantly with benzocaine, the antibacterial activity of sulfonamides is reduced.

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

Over-the-Counter

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.