Procto-glivenol supp. rekt. No. 10

Release form, composition and packaging

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Rectal suppositories are solid, torpedo-shaped, without cracks, slightly greasy to the touch, yellowish-white in color, with a weak specific odor.

1 supp.

tribenoside 400 mg

lidocaine 40 mg

witepsol E85 (suppository n ° 1) - 305 mg, witepsol W35 (suppository n ° 2) - 1255 mg.

5 pieces.

- strips made of combined material (2) - cardboard packs.

pharmachologic effect

Combined anti-hemorrhoidal drug.

Tribenoside reduces capillary permeability and improves vascular tone, antagonistically affects some endogenous substances that act as mediators in the development of inflammation and pain.

Lidocaine has a local anesthetic effect.

The drug causes a rapid relief of symptoms caused by hemorrhoids (pain, itching and skin tightness).

Pharmacokinetics

Absorption The systemic bioavailability of tribenoside from the suppository reaches 30% of the amount absorbed when the drug is taken orally.

After rectal administration of 1 suppository (400 mg), Cmax of tribenoside in blood plasma is achieved after 2 hours and is 1 μg / ml (tribenoside + metabolites).

Metabolism Tribenoside is extensively metabolized in the liver.

Excretion 20-27% of the dose is excreted in the urine as metabolites.

Indications for use

- external and internal hemorrhoids.

Contraindications for use

- hypersensitivity to drug components

- liver failure

- I trimester of pregnancy.

Dosage regimen

Rectally.

With severe clinical symptoms, 1 suppository is administered in the morning and in the evening.

With regression of acute symptoms - 1 suppository 1 time / day.

Overdose

Cases of drug overdose have not been registered.

In case of accidental ingestion, gastrointestinal lavage is recommended, as well as symptomatic supportive therapy.

Side effect

From the immune system: very rarely (< 1/10 000) - anaphylactic reactions, including angioedema, facial edema, bronchospasm and cardiovascular disorders.

Skin and subcutaneous tissue disorders: rarely (> 1/10 000, < 1/1 000) - skin reactions at the site of application (burning, rash, itching and urticaria).

These symptoms can spread beyond the site of application.

Drug interactions

No interactions have been reported.

Application during pregnancy and lactation

Use in the first trimester of pregnancy is contraindicated. When using the drug in the II and III trimesters of pregnancy, the possible risk to the fetus must be taken into account. If it is necessary to use the drug during breastfeeding, the expected benefits of therapy for the mother and the potential risk for the child should be weighed.

If the existing symptoms of the disease do not diminish in the course of treatment or if new unusual sensations appear, consult a doctor.

When using Procto-Glivenol®, it is necessary to monitor the hygiene of the anal area, avoid excessive stress, and take measures to maintain a soft stool consistency.

Influence on the ability to drive vehicles and mechanisms When used in doses not exceeding the recommended ones, the drug has no effect on the ability to perform work associated with the need for concentration of attention, quick mental and motor reactions.

Name ENG

PROCTO-GLYVENOL

Clinical and pharmacological group

A drug with venotonic, anti-inflammatory and local anesthetic action for local use in proctology

ATX code

Other drugs and their combinations

Dosage

40mg + 400mg

Structure

Active ingredients: tribenoside 400 mg

lidocaine 40 mg

Storage conditions and periods

At a temperature not higher than 30 degrees.

Expiration date: 5 years

INN / Active ingredient

lidocaine, tribenoside

Specifications

Category

Hemorrhoids

Scope of the drug

Gastrointestinal tract

Release form

Suppositories

Manufacturer country

France

Package quantity, pcs

ten

Way of introduction

Rectally

Vacation conditions

Without recipe

Brand name

Recordati Industria Chimica & Farmaceutica

The amount of the dosage form in the primary package

5 pieces.

Primary packaging type

Cell-free contoured packaging (strip)

Type of consumer packaging

Pack of cardboard

Pharmaco-therapeutic group

Hemorrhoid remedy

Dosage form

Rectal suppositories

Expiration date in days

1825

Dosage (volume) of the substance in the preparation

tribenoside - 400 mg

lidocaine - 40 mg.

The target audience

Children

Package weight, g

fifty

Mode of application

:

Rectally.

Until acute symptoms disappear - 1 suppository or 1 dose of cream 2 times a day (morning and evening)

then the dose can be reduced and the drug should be administered once a day.

30 g of cream is enough for about 20-30 applications.

Anatomical and therapeutic characteristics

:

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