Procto-gliwenol® (Procto-Glyvenol®)

Composition Pharmacodynamics Indications Carefully Contraindications Dosing and Administration Side effects Form release / dosage
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Active substanceTribenozide + LidocaineTribenozide + Lidocaine
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  • Procto-gliwenol®
    suppositories rect. 
    RECORDATA Ireland Co., Ltd.     Ireland
  • Procto-gliwenol®
    cream rect. 
    RECORDATA Ireland Co., Ltd.     Ireland
    • Dosage form: & nbspRectal cream.
    Composition:

    100 g of cream contain

    Active substances: tribonoside 5.00 g, lidocaine hydrochloride 2.12 g.

    Excipients: cetomacrogol 1000 4.44 g, cetyl alcohol 5 g, isopropyl palmitate 2 g, paraffin liquid 10 g, methyl parahydroxybenzoate 0.18 g, propyl parahydroxybenzoate 0.05 g, sorbitan stearate 1.56 g, sorbitol 6 g, stearic acid acid 9 g, water 54.65 g.

    Description:Homogenous cream of white color with a weak characteristic 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:When topical application is absorbed from 2 to 20% of the tribenozide contained in the cream.In organism tribenoside is largely metabolized in the liver.
    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, the cream should be applied morning and evening.
    When regression of acute symptoms, the frequency of application is reduced to 1 time per day.
    With internal hemorrhoids, the cream is injected with a nozzle.
    30 g of cream (1 tube) is sufficient for approximately 20-30 applications.
    Side effects:

    From the immune system:

    Very rarely (<1/10 000): anaphylactic reactions, including angioedema

    edema, edema of the face, 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

    hives).

    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 symptoms of the disease do not weaken during treatment or if new unusual sensations appear, you should consult your doctor. When using Procto-gliwenol® cream, it is necessary to monitor the hygiene of the anal area, avoid excessive stress, take all measures to maintain a soft stool consistency.
    Effect on the ability to drive transp. cf. and fur:The drug does not affect the concentration of attention and rapidity of mental and motor reactions when used in recommended doses.
    Form release / dosage:Rectal cream.
    Packaging:30 g in an aluminum tube with a lid of polyethylene. Tube complete with a polyethylene tip and a lid-cap made of latex together with instructions for use packed in a cardboard box.
    Storage conditions:Store 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.
    Terms of leave from pharmacies:Without recipe
    Registration number:П N016204 / 01
    Date of registration:26.02.2010
    The owner of the registration certificate:RECORDATA Ireland Co., Ltd.RECORDATA Ireland Co., Ltd. Ireland
    Manufacturer: & nbsp
    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
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