Procto-Glyvenol^® (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; other agents for the treatment of hemorrhoids and anal fissures for topical use

Pharmacological Action

Combined antihemorrhoidal drug.

Tribenoside reduces capillary permeability and improves vascular tone, antagonistically affecting 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 rapid relief 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 a sensation of skin tightness.

Apply specifically for the symptomatic treatment of hemorrhoidal disease where the combination of venotonic, anti-inflammatory, and local anesthetic effects is therapeutically indicated.

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.

Administer rectally. Apply the cream or insert one suppository one to two times per day, depending on the severity of symptoms.

Adjust the frequency of application based on clinical response and symptom relief. Do not exceed the recommended daily frequency. Follow proper hygiene before application.

Adverse Reactions

Immune system reactions, occurring very rarely, include anaphylactic reactions, angioedema, facial edema, bronchospasm, and cardiovascular disorders.

Local skin reactions, occurring rarely, include burning, rash, itching, and urticaria at the application site; these symptoms may extend beyond the initial area of contact.

Drug Interactions

Formal studies of drug interactions have not been conducted. Exercise caution with concurrent use of other locally acting anesthetics, as the effects may be additive.

Be aware of potential interactions with other medications applied to the same anal area, which could alter absorption or increase the risk of local adverse reactions.

Contraindications

Hypersensitivity to tribenoside, lidocaine, or any other component of the drug.
Hepatic insufficiency of any severity due to the metabolic pathway of tribenoside.
The first trimester of pregnancy due to potential risks to fetal development.

Overdose

Overdose from topical rectal use is unlikely due to limited systemic absorption. In case of accidental ingestion, monitor for systemic effects of lidocaine, such as CNS depression or excitation, and cardiovascular effects.

Provide symptomatic and supportive care. There is no specific antidote; treatment should focus on managing symptoms resulting from excessive systemic exposure to the active substances.

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 taken into account.

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 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.

Medical Disclaimer

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

Procto-Glyvenol^® [Recordati Ireland Ltd. (Ireland)]
Rectal cream 5 g+2.12 g/100 g: tube 30 g complete with tip and cap-applicator

Marketing Authorization Holder

Recordati Ireland Ltd. (Ireland)

Manufactured By

Recordati Ilac Sanayi Ve Ticaret A.S. (Turkey)

Recordati Industria Chimica E Farmaceutica S.p.A. (Italy)

Dosage Form

Procto-Glyvenol^®

Rectal cream 5 g+2.12 g/100 g: tube 30 g complete with tip and cap-applicator

Dosage Form, Packaging, and Composition

Rectal cream homogeneous, white in color, with a slight characteristic odor.

	100 g
Tribenoside	5 g
Lidocaine hydrochloride monohydrate	2.12 g,
Which corresponds to the content of anhydrous lidocaine hydrochloride	2 g

Excipients: macrogol cetostearyl ether – 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, liquid sorbitol, non-crystallizing – 6 g, stearic acid – 9 g, water – 54.65 g.

30 g – aluminum tubes (1) complete with a polyethylene tip and a polyethylene or polypropylene cap-applicator – cardboard packs.

Procto-Glyvenol^® [Recordati Ireland Ltd. (Ireland)]
Rectal suppositories: 10 pcs.