Proctogleal (Cream, Suppositories) Instructions for Use

Instructions
Dosage forms

ATC Code

C05AX03 (Preparations for the treatment of hemorrhoids and anal fissures in combination)

Active Substances

Tribenoside (Rec.INN registered by WHO)

Lidocaine (Rec.INN registered by WHO)

Clinical-Pharmacological Group

Drug with venotonic, anti-inflammatory, and local anesthetic action for topical use in proctology

Pharmacotherapeutic Group

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

Pharmacological Action

A combined antihemorrhoidal drug.

Tribenosidereduces capillary permeability and improves vascular tone, acting antagonistically against some endogenous substances that act as mediators in the development of inflammation and pain.

Lidocaine has a local anesthetic effect.

The use of this combination causes a rapid alleviation of symptoms caused by hemorrhoids (pain, itching, and skin tightness).

Pharmacokinetics

With topical application, from 2% to 20% of the tribenoside contained in the cream is absorbed.

In the body, Tribenoside is largely metabolized in the liver.

Indications

External and internal hemorrhoids for the relief of associated symptoms including pain, itching, and inflammation.

ICD codes

Open the list of ICD codes

ICD-10 code	Indication
K64	Hemorrhoids and perianal venous thrombosis

ICD-11 code	Indication
DB6Z	Hemorrhoids or perianal venous diseases, unspecified

Dosage Regimen

The method of application and dosage regimen for a specific drug depend on its form of release and other factors. The optimal dosage regimen is determined by the doctor. It is necessary to strictly adhere to the compliance of the dosage form of a specific drug with the indications for use and dosage regimen.

Apply the cream or suppository rectally1-2 times per day, depending on the severity of symptoms.

Ensure thorough hygiene of the anal area before each application. For the cream, apply a thin layer to the affected external area or gently introduce it into the anal canal using the supplied applicator.

For suppositories, insert one suppository fully into the rectum. The duration of treatment is determined by the physician based on clinical response.

Adverse Reactions

Immune system reactions are very rare but may include anaphylactic reactions, angioedema, facial edema, bronchospasm, and cardiovascular disturbances.

Local skin reactions at the application site, such as burning sensation, rash, itching, and urticaria, occur rarely. These localized symptoms have the potential to spread beyond the initial site of application.

Drug Interactions

Formal interaction studies have not been conducted for this topical combination product.

Exercise caution with concurrent use of other locally acting anesthetics, as the effects may be additive, potentially increasing the risk of systemic adverse effects.

Inform your physician about all other medications you are using before initiating treatment.

Contraindications

Hypersensitivity to tribenoside, lidocaine, any other local anesthetics of the amide type, or any of the excipients in the formulation.
Patients with significant hepatic insufficiency due to the role of the liver in metabolizing the active components.
Use during the first trimester of pregnancy is strictly contraindicated.

Overdose

Excessive topical application or accidental ingestion may lead to increased incidence of adverse reactions.

Symptoms are likely to be related to the systemic effects of lidocaine and may include CNS excitation (e.g., nervousness, dizziness, blurred vision, tremors, or convulsions) followed by depression, and cardiovascular effects (e.g., hypotension, bradycardia, cardiac arrest).

In case of suspected overdose, discontinue use immediately and initiate symptomatic and supportive therapy; there is no specific antidote.

Use in Pregnancy and Lactation

Use in the first trimester of pregnancy is contraindicated.

When used in the second and third trimesters of pregnancy, the possible risk to the fetus must be considered.

If it is necessary to use during breastfeeding, the expected benefit of therapy for the mother and the potential risk for the child should be weighed.

Use in Hepatic Impairment

The drug is contraindicated for use in cases of impaired liver function.

Special Precautions

If the symptoms of the disease do not subside during treatment or new unusual sensations appear, you should consult a doctor.

Storage Conditions

Store at 2°C (36°F) to 30°C (86°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.

Medical Disclaimer

Brand (or Active Substance), Marketing Authorisation Holder, Dosage Form

Proctogleal [Tula Pharmaceutical Factory, LLC (Russia)]
Rectal cream 5%+2%: tubes 10 g, 15 g, 20 g, 25 g, 30 g, 35 g, 40 g, 45 g, 50 g, 55 g, 60 g, 65 g, 70 g, 75 g, 80 g, 85 g, 90 g, 95 g, 100 g, 110 g or 150 g with applicator nozzle or without it

Marketing Authorization Holder

Tula Pharmaceutical Factory, LLC (Russia)

Dosage Form

Proctogleal

Rectal cream 5%+2%: tubes 10 g, 15 g, 20 g, 25 g, 30 g, 35 g, 40 g, 45 g, 50 g, 55 g, 60 g, 65 g, 70 g, 75 g, 80 g, 85 g, 90 g, 95 g, 100 g, 110 g or 150 g with applicator nozzle or without it

Dosage Form, Packaging, and Composition

Rectal cream white, homogeneous, with a faint characteristic odor.

	100 g
Tribenoside	5 g
Lidocaine hydrochloride	2.12 g,
Equivalent to lidocaine content	2 g

Excipients: cetomacrogol 1000 – 4.44 g, cetyl alcohol – 5 g, isopropyl palmitate – 2 g, liquid paraffin – 10 g, methylparaben – 0.18 g, propylparaben – 0.05 g, sorbitan stearate – 1.56 g, sorbitol – 4.44 g, stearic acid – 9 g, purified water – up to 100 g.

10 g – tubes^x(1) – cardboard packs.
15 g – tubes^x(1) – cardboard packs.
20 g – tubes^x(1) – cardboard packs.
25 g – tubes^x(1) – cardboard packs.
30 g – tubes^x(1) – cardboard packs.
35 g – tubes^x(1) – cardboard packs.
40 g – tubes^x(1) – cardboard packs.
45 g – tubes^x(1) – cardboard packs.
50 g – tubes^x(1) – cardboard packs.
55 g – tubes^x(1) – cardboard packs.
60 g – tubes^x(1) – cardboard packs.
65 g – tubes^x(1) – cardboard packs.
70 g – tubes^x(1) – cardboard packs.
75 g – tubes^x(1) – cardboard packs.
80 g – tubes^x(1) – cardboard packs.
85 g – tubes^x(1) – cardboard packs.
90 g – tubes^x(1) – cardboard packs.
95 g – tubes^x(1) – cardboard packs.
100 g – tubes^x(1) – cardboard packs.
110 g – tubes^x(1) – cardboard packs.
150 g – tubes^x(1) – cardboard packs.