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Dosage form: & nbspcapsules
Composition:

Per one capsule:

Capsule A

active ingredients: ascorbic acid 300 mg, acetylsalicylic acid 250 mg, rutoside trihydrate (in terms of rutoside) 20 mg.

Excipients: calcium stearate 1.0 mg, potato starch 9.0 mg;

hard gelatin capsule: gelatin 90.723 mg, dye azorubin (E 122) 0.003 mg, dye diamond black (E 151) 0.184 mg, blue patented dye (E 131) or brilliant blue (E 133) 0.315 mg, quinoline yellow color (E 104) 2.207 mg , titanium dioxide (E 171) 2.560 mg.

Capsule B

active ingredients: metamizole sodium monohydrate 250 mg, calcium gluconate monohydrate 100 mg, diphenhydramine hydrochloride 20 mg;

Excipients: calcium stearate 3.8 mg, potato starch 6.2 mg;

hard gelatin capsule: gelatin 91.944 mg, titanium dioxide (E 171) 4.055 mg.

Description:

Capsules A - Hard gelatinous No. 0 green. Contents of capsules - a mixture of crystalline and amorphous powder from light yellow to yellow with a greenish tinge, it is allowed to have lumps and single inclusions of a darker color.

Capsules B - Hard gelatinous No. 0 white. The contents of capsules - a mixture of powder and granules of white or white with a yellowish tint of color, the presence of lumps is allowed.

Pharmacotherapeutic group:ORZ and "colds" of symptoms remedy
ATX: & nbsp
  • Other combined drugs used for catarrhal diseases
  • Pharmacodynamics:

    Combined drug, has antipyretic, anti-inflammatory, analgesic, angioprotective, anticongestive action. Pharmacological activity of the drug is due to the properties of the active substances that make up its composition.

    Acetylsalicylic acid suppresses anti-inflammatory factors, exudative and proliferative phases of inflammation due to inhibition of cyclo-genase, inhibits synthesis or inactivates mediators of inflammation. It has analgesic, antipyretic and anti-inflammatory action, inhibits platelet aggregation.

    Ascorbic acid takes part in many types of oxidation-reduction reactions in the body, inhibits the processes of peroxidation of lipids, proteins and other components of the cell, thus protecting it from damage. Ascorbic acid increases the concentration of interferon in the blood, this is associated with its membrane-stabilizing effect and immunomodulating effect. Ascorbic acid is able to accumulate in leukocytes, increasing their phagocytic activity, which increases antimicrobial and antiviral protection. Activates the biosynthesis of corticoid hormones in the adrenal cortex and thereby stimulates the adaptive processes of the body under stress.

    Rutozid angioprotective agent. Belongs to a group of bioflavonoids that can be used to build biologically important compounds in a cell, in particular ubiquinone. It is able to reduce capillary bleeding by strengthening the walls of blood vessels, the permeability of which increases during a viral infection. Rutozid has a beneficial effect on maintaining a normal level of the immune system.

    Metamizol sodium - an analgesic non-narcotic agent, a derivative of pyrazolone, non-selectively blocks COX (cyclooxygenase) and reduces the formation of prostaglandins from arachidonic acid. It prevents painful impulses, raises the threshold of excitability of thalamic centers of pain sensitivity, increases heat transfer. Has analgesic, antipyretic and some spasmolytic (with respect to the smooth muscles of the urinary and biliaryways) action.

    Diphenhydramine - competitive blocker H1-gistaminovyh receptors. It has a pronounced antihistaminic activity (weakens the body's response to endogenous and exogenous histamine). In addition, it has a local anesthetic effect, relaxes smooth muscles as a result of direct spasmolytic action, blocks to a moderate extent the cholinergic receptors of vegetative nervous nodules. Reduces the permeability of capillaries, prevents histamine edema of tissues and histamine hypotension and thereby reduces vascular permeability, eliminates edema and hyperemia of the nasal mucosa, perspiration in the throat, allergic reactions from the upper respiratory tract. An important feature of diphenhydramine is its sedative effect.

    Calcium gluconate -Sa2+-containing drug. Calcium ions are necessary for the implementation of the process of transmission of nerve impulses, reduction of skeletal and smooth muscles, the activity of the heart muscle, the formation of bone tissue, clotting of blood. Calcium ions reduce the permeability of cells and the vascular wall, prevent the development of inflammatory reactions, increase the resistance of the body to infections.

    Indications:

    Symptomatic treatment in adults for "cold" diseases, ARVI and influenza, accompanied by fever, headache, chills, nasal congestion.

    Contraindications:

    Hypersensitivity to the components of the drug; erosive and ulcerative lesions (in the phase of exacerbation) of the gastrointestinal tract; gastrointestinal bleeding; increased tendency to bleeding; oppression hemopoiesis (agranulocytosis, neutropenia, leukopenia); hereditary hemolytic anemia associated with a deficiency of glucose-6-phosphate dehydrogenase; hemorrhagic diathesis (hemophilia, von Willebrand's disease, telangiectasia, thrombocytopenic purpura); hypoprothrombinemia; thrombocytopenia; deficiency of vitamin K; bronchial asthma; diseases accompanied by bronchospasm; "Aspirin asthma": severe violations of the liver or kidney; hypercalcemia (concentration of calcium ions should not exceed 12 mg% or 6 mEq / l); nephrolithiasis (calcium); calciuria; sarcoidosis; simultaneous reception of cardiac glycosides (risk of arrhythmias); exfoliating aortic aneurysm; portal hypertension; deficiency of glucose-6-phosphate dehydrogenase,pregnancy and the period of breastfeeding, children and adolescence up to 18 years.

    Carefully:

    Hyperuricemia, urate nephrolithiasis, gout, peptic ulcer and / or duodenal ulcer (in the anamnesis), decompensated heart failure.

    Pregnancy and lactation:

    The use of the drug during pregnancy is contraindicated.

    If you need to use the drug during lactation, you should decide whether to stop breastfeeding.

    Dosing and Administration:

    Inside, after eating, with water, 2-3 times a day for 3-5 days until the symptoms disappear.

    Adults appoint 2 capsules per reception: 1 green capsule (from blister A) and 1 white capsule (from blister B).

    If there is no improvement in the state of well-being after a five-day use, stop taking the medication and consult a doctor.

    Side effects:

    Anorexia, nausea, vomiting, gastralgia, diarrhea, erosive-ulcerative lesions of the gastrointestinal tract, gastrointestinal bleeding, hepatic and / or renal insufficiency, increased blood pressure, tachycardia.

    Allergic reactions: skin rash, Quincke's edema, bronchospasm.

    With prolonged admission (more than 7 days) - dizziness, headache, visual impairment, tinnitus, leukopenia, thrombocytopenia, agranulocytosis; with inclination to bronchospasm may provoke an attack; reduction of platelet aggregation, hypocoagulation, hemorrhagic syndrome (epistaxis, bleeding gums, purpura, etc.), renal damage with papillary necrosis; deafness; anaphylactic shock, Stevens-Johnson syndrome, toxic epidermal necrolysis (Lyell syndrome). Reye's syndrome (hyperpyrexia, metabolic acidosis, disorders of the nervous system and psyche, vomiting, impaired liver function).

    There may be a violation of kidney function, oliguria, anuria, proteinuria, interstitial nephritis, staining of urine in red due to the release of a metabolite.

    All side effects (including those not mentioned above) should be reported to the doctor in charge and stop taking the drug.

    Overdose:

    Symptoms: nausea, vomiting, stomach pain, sweating, pallor of the skin, tachycardia. With light intoxication - ringing in the ears; severe intoxication - drowsiness, collapse, convulsions, bronchospasm, shortness of breath,anuria, bleeding, progressive respiratory paralysis and dissociation of oxidative phosphorylation, causing respiratory acidosis.

    If you suspect a poisoning, you should immediately seek medical help.

    Treatment: induce vomiting, make lavage of the stomach, take saline laxatives, Activated carbon. In the conditions of a medical institution - conducting forced diuresis, hemodialysis, with the development of convulsive syndrome - intravenous diazepam and barbiturates.

    Interaction:

    If it is necessary to share with other medications, consult a doctor beforehand.

    Enhances the effect of heparin, oralthTicoagulants, reserpine, steroid hormones and hypoglycemic agents.

    Reduces the effectiveness of spironolactone, furosemide, antihypertensive drugs, anti-arthritis agents that promote the excretion of uric acid.

    Increases the side effects of glucocorticosteroids, sulfonylurea derivatives, methotrexate, non-narcotic analgesics and non-steroidal anti-inflammatory drugs.

    It should be avoided combination of the drug with barbiturates, antiepileptic drugs, zidovudine, rifampicin and alcohol-containing drugs (increases pandsk hepatotoxhourabout effect).

    Ascorbic acid improves the absorption of iron in the intestine.

    Tricyclic antidepressants, contraceptives for oral administration and allopurinol disrupt metamizole metabolism in the liver and increase its toxicity.

    Metamizole sodium enhances the effects of alcohol-containing beverages.

    Radiocontrast agents, colloidal blood substitutes and penicillin should not be used during treatment with metamizole sodium.

    The simultaneous use of metamizole sodium with cyclosporine reduces the level of the latter in the blood.

    Thiamazole and sarcolysin increase the risk of developing leukopenia.

    Sedatives and tranquilizers increase the analgesic effect of metamizole sodium.

    Special instructions:

    Because the acetylsalicylic acid has an antiaggregatory effect, the patient, if he is to undergo surgery, should warn the doctor in advance about taking the drug.

    Acetylsalicylic acid in low doses reduces the excretion of uric acid. This can in some cases provoke a gout attack.

    During treatment, you should stop using alcohol-containing beverages (increased risk of gastrointestinal bleeding).

    In connection with the stimulating effect of ascorbic acid on the synthesis of corticosteroid hormones, it is necessary to monitor the kidney function and arterial pressure.

    Assigning ascorbic acid to patients with rapidly proliferating and intensely metastatic tumors can aggravate the course of the process.

    Ascorbic acid, as a reducing agent, can distort the results of various laboratory tests (blood glucose, bilirubin, activity of "liver" transaminases, LDH).

    In patients suffering from bronchial asthma and pollinosis, the development of hypersensitivity reactions is possible.

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

    During the use of the drug, caution should be exercised in managing the transport and in dealing with other potentially hazardous activities requiring increased concentration of attention and speed of psychomotor reactions.

    Form release / dosage:Capsules.
    Packaging:

    Capsules A. 10 capsules in a planar cell package.

    Capsules B. 10 capsules in a planar cell package.

    2 contoured cell packs (one with capsules A green, the second with capsules B white), along with instructions for use in a pack of cardboard.
    Storage conditions:

    In a dry, the dark place at a temperature of no higher than 25 ° C.

    Keep out of the reach of children.

    Shelf life:

    2 years.

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

    Terms of leave from pharmacies:Without recipe
    Registration number:LP-002908
    Date of registration:13.03.2015
    Expiration Date:13.03.2020
    The owner of the registration certificate:FarmSirma Soteks, ZAO FarmSirma Soteks, ZAO Russia
    Manufacturer: & nbsp
    Representation: & nbspPharm Company Sotex CJSC Pharm Company Sotex CJSC Russia
    Information update date: & nbsp06.09.2017
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