Dicetel® (Dicetel®)

Composition Pharmacodynamics Indications Carefully Contraindications Dosing and Administration Side effects Form release / dosage
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Active substancePinaveria bromidePinaveria bromide
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  • Dicetel®
    pills inwards 
    Abbot Helskea SAS     France
    • Dosage form: & nbspFilm-coated tablets
    Composition:
    Composition 1 tablet, film-coated, contains:
    Active substance: pinaverium bromide - 50 mg (for a dosage of 50 mg), 100 mg (for a dosage of 100 mg).
    Auxiliary substances: silicon dioxide colloid - 1.00 mg (2.00 mg), microcrystalline cellulose -79.35 mg (158.70 mg), talc - 3.00 mg (6.00 mg), magnesium stearate - 1, 50 mg (3.00 mg), pregelatinized starch -17.00 mg (34.00 mg), lactose monohydrate-18.15 mg (36.30 mg).
    Film coating: butyl methacrylate copolymer basic - 8.176 mg (16.352 mg), sodium lauryl sulfate - 0.818 mg (1.636 mg), talc 6.473 mg (12.946 mg), stearic acid 1.192 mg (2.384 mg), dryers 3203 0.341 mg 0.682 mg) (hypromellose (E 464) -55.0-65.0%, microcrystalline cellulose (E460) -5.0- 15.0%, titanium dioxide (E171) -
    20,0- 30,0%, dye solar sunset yellow (lacquer aluminum) (E 110) - 3.0%).

    Description:
    50 mg tablets
    Round biconvex tablets covered with a film shell of orange color, engraved "50" on one side and a "V" icon under the letter "S" on the other side.
    Tablets 100 mg
    Round biconvex tablets covered with a film shell of orange color, with an engraving "100" on one side and a "V" icon under the letter "S" on the other side.

    Pharmacotherapeutic group:antispasmodic
    ATX: & nbsp

    A.03.A.X.04   Pihaveria

    Pharmacodynamics:
    Spasmolytic agent with selective action on the gastrointestinal tract. Inhibits the flow of calcium into the cells of the smooth muscles of the intestine. Studies in animals have shown that pinaverium bromide reduces the effects of stimulation of sensitive neurons. Does not possess anticholinergic action. Does not affect the cardiovascular system.
    Pharmacokinetics:
    After oral administration pinaverium bromide quickly absorbed and reaches the maximum concentration in the plasma after one hour. Pinaveria bromide has a high ability to bind to plasma proteins (95-96%).
    The drug is actively metabolized in the liver. Half-life is 1.5 hours. Absolute bioavailability is very low (less than 1%). It is excreted mainly from the body with feces.

    Indications:
    - Symptomatic treatment of pain, transit disorders of intestinal contents and discomfort associated with functional bowel movement disorders;
    - Symptomatic treatment of pain associated with functional disorders of the biliary tract;
    - Preparing for a roentgenological examination of the gastrointestinal tract with the use of bariumsulfate.

    Contraindications:
    - Hypersensitivity to any of the components of the drug.
    - Deficiency of lactase, intolerance to galactose, glucose-galactose malabsorption.
    Due to the lack of data on efficacy and safety, the use of the drug in children under 18 years of age is not recommended.

    Pregnancy and lactation:
    There is insufficient data on the use of pinaverium bromide by pregnant women. The potential risk to humans is unknown. The use of the drug during pregnancy is allowed if the benefit from the use for the mother exceeds the potential risk to the fetus.
    In addition, it should be taken into account that the composition of the drug includes bromine. In this regard, the appointment of pinaverium bromide at the end of pregnancy can cause neurological disorders (lowering blood pressure, sedation) in a newborn.
    There is insufficient information on the excretion of the drug Dicetel® with mother's milk. The physico-chemical and accessible data on the pharmacodynamics and toxicology of the Dicetel® drug indicate the excretion of the drug with the mother's milk, and therefore the risk to the infant can not be ruled out.
    Dicetel® should not be used during lactation.

    Dosing and Administration:
    The drug is intended for oral administration. Tablets are taken with food wholly, without chewing and not dissolving, with a glass of water to prevent the contact of pinaverium bromide with the mucosa of the esophagus (see section "Special instructions"). Dicetel®, film-coated tablets, 50 mg.
    The recommended daily dose is 1 tablet 3 times a day or 2 tablets 2
    times a day. If necessary, the daily dose can be increased to 2 tablets 3 times a day. When preparing for X-ray examination - 2 tablets 2 times a day for 3 days before the test.
    Dicetel®, tablets, coated with a film coat, 100 mg.
    The recommended daily dose is 1 tablet 2 times a day. If necessary, the daily dose can be increased to 1 tablet 3 times a day. When preparing for X-ray examination - 1 tablet 2 times a day for 3 days before the test.
    Side effects:
    During the post-marketing application, the following undesirable
    phenomena. Messages were of a spontaneous nature, and for an accurate assessment of the frequency of the cases of available data is not enough.
    Disorders from the gastrointestinal tract:
    Pain in the abdomen, diarrhea, nausea, vomiting, dysphagia. If the product is administered improperly, the mucosa of the esophagus may be damaged (see section "Special instructions").
    Disturbances from the skin and subcutaneous tissues:
    Rash, itching, hives, erythema.
    Immune system disorders:
    Hypersensitivity.
    Overdose:
    Symptoms: Overdose can lead to gastrointestinal disorders, such as flatulence and diarrhea.
    Treatment: a special antidote is unknown. Symptomatic treatment is recommended.
    Interaction:
    Clinical studies have not identified any interactions of pinaverium bromide with cardiac glycosides, oral hypoglycemic agents, insulin, oral anticoagulants, and heparin.
    Simultaneous administration of anticholinergics can increase the cramping of spasms.
    No effect of the drug on the results of laboratory tests for determining the concentration of drugs was noted.

    Special instructions:
    In connection with the risk of damage to the mucous membrane of the esophagus, you must carefully follow the recommendations for use.Patients with esophagitis and / or hernia of the esophagus should pay special attention to the correct use of the drug.

    Effect on the ability to drive transp. cf. and fur:
    Studies on the effect of the drug on the ability to drive and other mechanisms were not carried out.

    Form release / dosage:
    Tablets film-coated 50 mg, 100 mg.
    Packaging:
    Film-coated tablets 50 mg.
    For 20 tablets in PVC / Alu blister. 1 blister with instructions for use in a cardboard package.
    Film coated tablets 100 mg.
    For 15 or 20 tablets in PVC / Alu blister. 1 blister (20 tablets each) or 2 blisters (15 tablets each) together with instructions for use in a cardboard package.
    Storage conditions:
    List B.
    Store in a dry, dark place at a temperature of no higher than 30 ° C.
    Keep out of the reach of children!

    Shelf life:
    5 years.
    The drug should not be used after the expiry date indicated on the package.

    Terms of leave from pharmacies:On prescription
    Registration number:П N014873 / 01
    Date of registration:13.08.2008
    The owner of the registration certificate:Abbot Helskea SASAbbot Helskea SAS France
    Manufacturer: & nbsp
    Representation: & nbspEBOBOT PRODUKTS LLCEBOBOT PRODUKTS LLCRussia
    Information update date: & nbsp04.06.2012.
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