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Dosage form: & nbsppills
Composition:

1 tablet contains:

active substances: belladonna extract is thick (belladonna leaf extract is thick) - 10 mg, phenyl salicylate - 300 mg;

Excipients: potato starch - 28.992 mg, talc - 10.32 mg, stearic acid - 0.688 mg.

Description:

Round tablets of flat-cylindrical shape, light brown in color with a grayish or greenish tinge, with impregnations, with a weak specific odor, with a facet and a risk.

Pharmacotherapeutic group:Spasmolytic agent
ATX: & nbsp
  • Spasmolytics in combination with other drugs
  • Pharmacodynamics:

    Extract of belladonna leaves - a means of plant origin. Has mholinoblokiruyuschee and spasmolytic action. Prevents the stimulating effect of acetylcholine; reduces the secretion of salivary, gastric, bronchial, lacrimal, sweat glands. Reduces muscle tone of the gastrointestinal tract, bile ducts and gallbladder, but increase the tone of sphincters; causes tachycardia, raises atrioventricular (AV) conductivity. It dilates the pupils, hinders the outflow of the intraocular fluid, increases the intraocular pressure, causes paralysis of accommodation.

    Phenylsalicylate - antiseptic, hydrolyzed in the alkaline contents of the intestine with the release of salicylic acid and phenol. Salicylic acid has antipyretic and anti-inflammatory effect, phenol active in the pathogenic microflora of the intestine.

    Pharmacokinetics:

    Pharmacokinetics extract of belladonna leaves not studied.

    Phenylsalicylate. When ingestion is not exposed to the acidic environment of gastric juice, it is hydrolyzed in the alkaline environment of the intestine to phenol and salicylic acid. Phenol is excreted by the kidneys, creating high concentrations in the urinary tract. Salicylic acid is metabolized primarily in the liver with the formation of 4 metabolites found in many tissues and urine. It is excreted mainly by active secretion in the renal tubules in the form of salicylic acid proper (60%) and its metabolites. Removal of unchanged salicylate depends on the pH of the urine (with alkalinization of the urine, the ionization of salicylates increases, their reabsorption deteriorates and the excretion increases significantly). The rate of excretion depends on the dose: when taking small doses, the half-life period is 2-3 hours, with an increase in the dose it can increase to 15-30 hours.

    Indications:

    Diseases of the gastrointestinal tract, accompanied by spasms of smooth muscles of the abdominal cavity organs and intestinal dysbiosis.

    Contraindications:

    Hypersensitivity to the drug components, zakratougolnaya glaucoma, prostatic hyperplasia, gastrointestinal bleeding, chronic renal failure, children under 18 years.

    Carefully:

    Diseases of the cardiovascular system.

    Pregnancy and lactation:

    The safety of the drug during pregnancy is not established, so the use of the drug during pregnancy is contraindicated.

    If it is necessary to use the drug during lactation, breast-feeding should be stopped.

    Dosing and Administration:

    Assign adults 1 tablet 2-3 times a day.

    The maximum daily dose is 6 tablets.

    Doses and duration of application are set individually and depend on the course of the disease, its severity, the clinical effectiveness of the drug and the nature of the therapy (taking the drug alone or in combination with other drugs).

    The maximum duration of treatment is 7 days.

    Side effects:

    Side effects are effective, due to m-cholinoblocking action: dryness mucous membrane of the oral cavity, mydriasis, paresis of accommodation, intestinal atony, dizziness, tachycardia,retention of urine, hyperemia of the eyelid skin, photophobia.

    Allergic reactions: skin rash.

    Overdose:

    Symptoms: disturbance of accommodation, mydriasis, increased intraocular pressure, difficulty urinating (including acute urinary retention), intestinal atony, dysphagia, thirst, dry skin and mucous membranes, tachycardia, headache, dizziness, psychomotor agitation, delirium, convulsions.

    Treatment: cancellation of the drug. Therapy is symptomatic. Antidotes are cholinesterase inhibitors, for example, neostigmine methylsulfate or physostigmine.

    Interaction:

    Other drugs that have m-holinoblokiruyuschim action, enhance the pharmacological effects of the extract of leaves belladonna.

    Inhibitors of cholinesterase and m-cholinomimetics weaken the action of the extract of the belladonna leaves.

    Inhibition of intestinal peristalsis under the influence of the extract of the belladonna leaves can lead to a change in the absorption of other drugs.

    The simultaneous use of antacids and antidiarrhoeal drugs may lead to a decrease in the absorption of the active substances of the drug Besalol.

    Special instructions:

    Persons whose activities require increased visual acuity should avoid using the drug.

    It is possible to use the drug under the supervision of a doctor for diseases of the cardiovascular system, accompanied by bradycardia.

    The alkaloids of the extract of belladonna leaves can influence the results of such laboratory tests: a test for determining the acidity of the stomach; study of gastric emptying.

    Effect on the ability to drive transp. cf. and fur:

    During treatment, caution should be exercised in occupations requiring increased concentration of attention and speed of psychomotor reactions and visual acuity (driving, working with complex mechanisms).

    Form release / dosage:Pills.
    Packaging:

    6 tablets per contour non-jawed packaging.

    6 or 10 tablets per contour cell package.

    For 1 contour non-jawed packaging or contouring pack of 6 tablets together with instructions for medical use put in a pack of cardboard.

    For 1 or 2 contour packs of 10 tablets together with instructions for medical use are placed in a pack of cardboard.

    For 10 tablets per can of polymer BP-10 or 20 tablets into a plastic container for medicines, equipped with a lid with the control of the first opening. To a plastic can or plastic container, together with instructions for medical use, put in a pack of cardboard.
    Storage conditions:

    In a dry, dark place at a temperature of 8 to 15 ° C.

    Keep out of the reach of children.

    Shelf life:

    4 years.

    Do not use after the expiration date printed on the package.

    Terms of leave from pharmacies:Without recipe
    Registration number:LS-002621
    Date of registration:05.10.2011 / 18.07.2013
    Expiration Date:Unlimited
    The owner of the registration certificate:HEALTH PHARMACEUTICAL COMPANY, LTD. HEALTH PHARMACEUTICAL COMPANY, LTD. Ukraine
    Manufacturer: & nbsp
    Information update date: & nbsp23.01.2017
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