Proctan®

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT Proctan® (PROCTAN®)

Composition:

Active ingredients: sulfanilamide, camphora;

100 g of ointment contains: sulfanilamide – 5.4 g; racemic camphor – 1.8 g;

Excipients: butylhydroxytoluene (E 321), butylhydroxyanisole (E 320), white soft paraffin, purified pork fat.

Pharmaceutical form. Ointment.

Main physicochemical properties: ointment of white or light yellow color, viscous in consistency, with a characteristic camphor odor.

Pharmacotherapeutic group. Drugs for treatment of hemorrhoids and anal fissures for topical use. Other combinations. ATC code C05AX03.

Pharmacological properties.

Pharmacodynamics.

Proktan® ointment is a combined anti-hemorrhoidal agent that combines antimicrobial, anti-inflammatory, and analgesic properties.

The therapeutic efficacy of the drug in the treatment of proctological diseases is provided by streptocid and camphor, which are components of its composition. Streptocid is an antimicrobial agent, a short-acting sulfanilamide, which exerts a bacteriostatic effect against gram-positive (Staphylococcus aureus) and gram-negative (E. coli) microorganisms. The antimicrobial action of streptocid is enhanced by the antiseptic action of camphor. Camphor provides the anti-inflammatory and analgesic effects of Proktan® ointment.

Clinical characteristics.

Indications.

Local treatment of external hemorrhoids.

Contraindications.

Hypersensitivity to the components of the drug. Renal insufficiency, acute porphyria.

Interaction with other medicinal products and other forms of interaction.

During the use of the ointment, it is undesirable to take such drugs as digoxin, hydrochloric acid, caffeine, mesaton, phenobarbital, epinephrine hydrochloride. Procaine, which contains a para-aminobenzoic acid residue, reduces the effectiveness of the drug if these medicinal products are used immediately one after the other.

Instructions for use.

If an allergic reaction occurs at the site of ointment application, discontinue use of the drug. Premature discontinuation of treatment may lead to the development of sulfonamide-resistant microorganisms.

Use during pregnancy or breastfeeding.

Contraindicated.

Ability to affect reaction rate when driving or operating machinery.

Does not affect.

Dosage and Administration.

Apply after performing hygiene procedures. Adults should apply the ointment in the required amount as a thin layer to the affected area (anus, perianal skin) in the morning, in the evening, and after each bowel movement.

The duration of treatment is determined individually by a physician; usually the course lasts 10–14 days.

Children.

Do not use.

Overdose.

May enhance the manifestations of adverse reactions.

Side effects.

In individual cases, it may cause allergic manifestations such as urticaria, skin irritation, dermatitis, and adverse reactions requiring immediate discontinuation of the drug. Headache, dizziness, excitation.

If any undesirable effects occur, consult a physician.

Reporting of adverse reactions after drug registration is of great importance. It enables continuous monitoring of the benefit-risk balance of this medicinal product. Medical and pharmaceutical professionals, as well as patients or their legal representatives, should report all suspected adverse reactions and lack of efficacy via the Automated Information System for Pharmacovigilance at the following link: https://aisf.dec.gov.ua/

Shelf life. 3 years.

Storage conditions.

Store at a temperature not exceeding 25°C in the original packaging, in a place protected from light and inaccessible to children.

Packaging.

30 g of ointment in a tube, 1 tube per cardboard box.

Availability. Over-the-counter (without prescription).

Manufacturer.

LLC "Pharma Life".

Manufacturer's address and location of business activity.

2 D. Apostola Street, Lviv, 79040, Ukraine.

Marketing Authorization Holder.

LLC "Pharma Life".

Address of the Marketing Authorization Holder.

2 D. Apostola Street, Lviv, 79040, Ukraine.