Procto-Glivenol, rectal 10 pcs

Pharmacotherapeutic group: treatment of hemorrhoids.< br>
ATX code: C05AX03.

Pharmacological properties

A combined anti-hemorrhoid drug. Tribenoside decreases capillary permeability and improves vascular tone; has antagonistic effect on some endogenous substances that mediate inflammation and pain. Lidocaine has a local anesthetic effect. The drug causes rapid relief of symptoms caused by hemorrhoids (pain, itching and skin tension).

Pharmacokinetics.

The systemic bioavailability of tribenoside from the suppository is up to 30% of the amount that is absorbed when the drug is taken orally (as capsules). Reaching a maximum plasma concentration of 1 µg/ml (trybenoside + metabolites) is observed 2 hours after rectal administration of 1 suppository (400 mg of trybenoside). Tribenoside is largely metabolized in the liver. 20-27% of the administered dose is excreted in the urine as metabolites.

Indications

Hemorrhoids (internal and external).

Pharmacological effect

Pharmacotherapeutic group: treatment of hemorrhoids.

ATX code: C05AX03.

Pharmacological properties

Combined antihemorrhoidal agent. 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 rapid relief of symptoms caused by hemorrhoids (pain, itching and skin tension).

Pharmacokinetics.

The systemic bioavailability of tribenozide supplied from a suppository reaches 30% of the amount that is absorbed when the drug is taken orally (in capsule form). Achieving a maximum plasma concentration of 1 mcg/ml (tribenoside + metabolites) is observed 2 hours after rectal administration of 1 suppository (400 mg tribenoside).

Tribenoside is largely metabolized in the liver. 20-27% of the administered dose is excreted in the urine in the form of metabolites.

Special instructions

If the existing symptoms of the disease do not decrease during treatment or new unusual sensations appear, you should consult a doctor. When using Procto-glivenol®, it is necessary to monitor the hygiene of the anal area, avoid excessive strain, and take measures to maintain a soft stool consistency.

Impact on the ability to drive vehicles and machinery:

In dosages not exceeding the recommended ones, the drug does not affect the ability to perform work associated with the need to concentrate attention, rapid mental and motor reactions.

Active ingredient

Lidocaine, Tribenoside

Composition

1 suppository contains

Active substances:

tribenozide 400.00 mg,

lidocaine base 40.00 mg.

Excipients:

suppository mass n° 1 (Vitepsol E85) 305.00 mg, suppository mass n° 2 (Vitepsol W35) 1255.00 mg.

Pregnancy

Use caution during pregnancy, especially in the first trimester.

During breastfeeding, use is possible without stopping breastfeeding if the expected effect of therapy outweighs the potential risk to the child.

Contraindications

Hypersensitivity to the components of the drug, liver failure, pregnancy (first trimester).

Side Effects

From the immune system:

Very rare (<1/10,000): anaphylactic reactions including angioedema, facial edema, bronchospasm and cardiovascular disorders.

For the skin and subcutaneous tissues:

Rarely (>1/10,000, <1/1,000): skin reactions at the application site (burning, rash, itching and urticaria).

These symptoms may spread beyond the site of application.

Interaction

No cases of interaction have been reported.

Overdose

There have been no cases of drug overdose.

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

Storage conditions

At a temperature not exceeding 30 °C. Keep out of the reach of children.

Shelf life

5 years. Do not use after the expiration date indicated on the packaging.

Manufacturer

Delpharm Unige SAS, France