Procto-gliovenol - instructions for use, dose, side effects, contraindications

Active substanceTribenozide + LidocaineTribenozide + Lidocaine

Similar drugsTo uncover

Procto-gliwenol®

suppositories rect.

RECORDATA Ireland Co., Ltd. Ireland

Procto-gliwenol®

cream rect.

RECORDATA Ireland Co., Ltd. Ireland

Dosage form: & nbspSuppositories rectal.

Composition:

1 the suppository contains

Active substances: tribenozide 400.00 mg, lidocaine base 40.00 mg.

Excipients: suppository mass n ⁰ 1 (Vitessol E85) 305, 00 mg, suppository mass n ° 2 (Witepsol W35) 1255.00 mg.

Description:Solid rectal suppositories torpedo-shaped, without cracks, slightly greasy to the touch, yellowish white, with a weak specific odor.

Pharmacotherapeutic group:A remedy for hemorrhoids.

ATX: & nbsp

C.05.A.X.03 Preparations for the treatment of hemorrhoids and anal fissures in combination

Pharmacodynamics:Combined antihemorrhoidal agent. Tribenozide reduces the permeability of capillaries 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 weakening of symptoms caused by hemorrhoids (pain, itching and skin tension).

Pharmacokinetics:Systemic bioavailability of tribenozide from the suppository reaches 30% of the amount absorbed when taking the drug inside (in the form of capsules).Achieving maximum plasma concentration of 1 μg / ml (tribenoside+ metabolites) is observed 2 hours after the rectal administration of 1 suppository (400 mg tribenozide). Tribenozide is largely metabolized in the liver. 20-27% of the administered dose is excreted in the urine in the form of metabolites.

Indications:Hemorrhoids (inner and outer).

Contraindications:Hypersensitivity to the components of the drug, liver failure, pregnancy (I trimester).

Pregnancy and lactation:It is necessary to consider the possible risk to the fetus or child during pregnancy and breastfeeding.

Dosing and Administration:Rectally. With severe clinical symptoms, 1 suppository is administered in the morning and in the evening. When regression of acute symptoms - 1 suppository every 1 day.

Side effects:

From the immune system:

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

From the skin and subcutaneous tissues:

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.

Overdose:

Cases of drug overdose are not registered.

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

Interaction:The cases of interaction are not registered.

Special instructions:If the existing symptoms of the disease do not decrease during treatment or if new unusual sensations appear, you should consult a doctor.

When using Procto-Glivenol®, you must monitor the hygiene of the anal area, avoid excessive tension, take measures to maintain a soft consistency of the stool.

Effect on the ability to drive transp. cf. and fur:In dosages not exceeding recommended, the drug does not affect the ability to perform work associated with the need for concentration of attention, rapid mental and motor reactions.

Form release / dosage:

Suppositories rectal.

Packaging:

For 5 suppositories in a strip of combined material (polyethylene / polypropylene / aluminum foil). 2 strips together with instructions for use are placed in a cardboard pack.

Storage conditions:At a temperature of no higher than 30 ° C. Keep out of the reach of children.

Shelf life:5 years. Do not use after the expiry date indicated on the package.

Terms of leave from pharmacies:Without recipe

Registration number:P N008856 / 01

Date of registration:10.06.2010

The owner of the registration certificate:RECORDATA Ireland Co., Ltd.RECORDATA Ireland Co., Ltd. Ireland

Manufacturer: & nbsp

DELPHARM HUNINGUE, S.A.S. France

Representation: & nbspNOVARTIS CONSUMER HELS S.A. (part of Novartis groups) NOVARTIS CONSUMER HELS S.A. (part of Novartis groups) Switzerland

Information update date: & nbsp24.09.2015

Illustrated instructions

Instructions

Procto-gliwenol® (Procto-Glyvenol®)