Active substanceAcetylsalicylic acid + (Citric acid + Sodium bicarbonate)Acetylsalicylic acid + (Citric acid + Sodium bicarbonate)
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  • Alka-Seltzer®
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    Bayer Konsyumer Kare AG     Switzerland
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  • Dosage form: & nbsptablets, effervescent
    Composition:

    1 tablet contains:

    Active substances: acetylsalicylic acid - 324.00 mg, sodium hydrogen carbonate dried (sodium bicarbonate 87.5%, sodium carbonate 12.5%) - 1625.00 mg, citric acid - 965.00 mg;

    Excipients: povidone 25 2 mg, dimethicone / silicate * 1 mg, doss sodium sodium benzoate ** 0.10 mg, sodium saccharinate 2 mg, lemon flavor 1.95 mg, lime flavor 1.95 mg.

    * a mixture of dimethacon and calcium silicate in the ratio 70:30

    ** mixture of docusate sodium and sodium benzoate in the ratio 85:15

    Description:Round, flat white tablets, on one side engraving "ALKA SELTZER" In a convex circle projecting along the perimeter. The reverse side has a facet.
    Pharmacotherapeutic group:Analgesic combined (NSAIDs + antacids)
    ATX: & nbsp

    N.02.B.A.51   Acetylsalicylic acid in combination with other drugs, excluding psycholeptics

    Pharmacodynamics:

    Combined drug, the effect of which is due to its active components.

    Acetylsalicylic acid has an analgesic, antipyretic anti-inflammatory effect, which is due to the inhibition of cyclooxygenase enzymes involved in the synthesis of prostaglandins. Acetylsalicylic acid inhibits platelet aggregation by blocking the synthesis of thromboxane A2.

    Sodium bicarbonate neutralizes free hydrochloric acid in the stomach, which reduces the irritant effect of the drug.

    Lemon acid promotes a faster absorption of the drug.

    Pharmacokinetics:

    After oral administration ASA is rapidly completely absorbed from the gastrointestinal tract. During the absorption period and immediately after it, the ASA becomes the main active metabolite - salicylic acid. ASA reaches a maximum concentration in the blood plasma after 10-20 minutes, and salicylic acid - After 0,3-2 hours.

    About 80% of ASA and salicylic acid binds to plasma proteins and is quickly distributed into tissues. Salicylic acid metabolized in the liver With the formation of metabolites - salicylurate, salicyl-phenolic glucuronide, glucuronide, gentisine and gentisuric acids. It is excreted in breast milk and penetrates the placenta.

    Elimination of salicylic acid is dose-dependent. The half-life period varies from 2 to 3 hours when the drug is taken in low doses up to about 15 hours when high doses are used. Salicylic acid and its metabolites are excreted mainly by the kidneys.

    Indications:

    Symptomatic treatment of pain syndrome of mild and moderate severity: headache (including after consumption of alcohol), toothache, sore throat, back and muscle pain, joint pain, menstruation pain.

    The raised temperature of a body at cold and other infectious-inflammatory diseases (at adults and children is more senior 15 years).

    Contraindications:

    - Hypersensitivity to acetylsalicylic acid and other NSAIDs or other components of the drug;

    - erosive and ulcerative lesions of the gastrointestinal tract (in the phase of exacerbation);

    - hemorrhagic diathesis;

    - combined use of methotrexate in a dose of 15 mg per week or more;

    - complete and incomplete combination of bronchial asthma, recurrent nasal polyposis and paranasal sinuses and intolerance to acetylsalicylic acid or other non-steroidal anti-inflammatory drugs (including in the anamnesis);

    - pregnancy (I and III trimester), the period of breastfeeding.

    The drug is not prescribed for children under 15 with acute respiratory infections caused by viral infections, because of the risk of developing Reye's syndrome (encephalopathy and acute fatty liver disease with acute development of liver failure).

    Carefully:

    With concomitant therapy with anticoagulants, gout, peptic ulcer and / or duodenal ulcer (in the anamnesis), including chronic or recurrent peptic ulcer disease, or episodes of gastrointestinal bleeding; renal and / or hepatic insufficiency, deficiency of glucose-6-phosphate dehydrhenase, heart failure, pregnancy II term.

    Pregnancy and lactation:

    If you need to use the drug during lactation, breastfeeding should be discontinued.

    Dosing and Administration:

    The drug is intended for adults and children over 15 years.

    Inside, take a single dose of 1-3 tablets (the interval between doses should be 4-8 hours). The maximum daily dose should not exceed 9 tablets (3 g).

    Mode of application: dissolve beforehand 1-3 tablets in 1 glass (200 ml) of water.

    The duration of treatment (without consulting a doctor) should not exceed 5 days with an appointment as an anesthetic and more than 3 days - as an antipyretic.

    Side effects:

    From the gastrointestinal tract: abdominal pain, heartburn, nausea, vomiting, obvious (vomiting with blood, tarry stools) or hidden signs of gastrointestinal bleeding, which can lead to iron deficiency anemia, erosive-ulcerative lesions (including perforations) of the gastrointestinal tract , isolated cases - violations of the liver (increased activity of "liver" transaminases).

    From the central nervous system: dizziness, tinnitus (usually, are signs of an overdose).

    On the part of the hematopoiesis system: increased risk of bleeding, which is a consequence of the effect of acetylsalicylic acid on platelet aggregation.

    Allergic reactions: skin rash, anaphylactic reactions, bronchospasm, angioedema.

    When such symptoms appear, it is recommended to stop taking the drug and immediately consult a doctor.

    Overdose:

    Symptoms

    Overdose of moderate severity: nausea, vomiting, tinnitus, hearing impairment, headache, dizziness and confusion. These symptoms occur with a decrease in the dose of the drug.

    Severe overdose: fever, hyperventilation, ketosis, respiratory alkalosis, metabolic acidosis, coma, cardiogenic shock, respiratory failure, severe hypoglycemia.

    Treatment: hospitalization, lavage, activated charcoal, acid-base balance monitoring, alkaline diuresis in order to obtain a urine pH between 7.5-8 (forced alkaline diuresis is achieved if the salicylate concentration in the plasma is more than 500 mg / l (3, 6 mmol / l) in adults or 300 mg / l (2.2 mmol / L) in children), hemodialysis, fluid loss compensation, symptomatic therapy.

    Interaction:

    Joint application:

    with methotrexate at a dose of 15 mg per week or more: increases the hemolytic cytotoxicity of methotrexate (decreased renal clearance of methotrexate and methotrexate is replaced by salicylates in association with blood plasma proteins);

    with anticoagulants, for example, heparin: increased risk of bleeding due to inhibition of platelet function, damage to the mucosa of the gastrointestinal tract, displacement of anticoagulants (oral) from the connection with blood plasma proteins;

    with other non-steroidal anti-inflammatory drugs, as well as with high doses of salicylates (3 grams per day or more): as a result of synergistic interaction, the risk of ulcers of the stomach and duodenum and bleeding from the gastrointestinal tract increases;

    with uricosuric agents, for example benzbromarone: reduces the uricosuric effect;

    with digoxin: Digoxin concentration is increased due to decreased renal excretion;

    with hypoglycemic drugs, for example insulin - increased hypoglycemic effect of hypoglycemic drugs due to hypoglycemic effect of acetylsalicylic acid;

    with preparations of thrombolytics group: the risk of bleeding increases;

    with diuretics: decreased glomerular filtration due to reduced synthesis of prostaglandins;

    from systemic glucocorticosteroids, excluding hydrocortisone, used and quality of substitution treatment in case of illness Addison: when applying glucocorticosteroids reduces the concentration of salicylates in the blood by increasing the excretion of the latter;

    with inhibitors of angiotensin-converting enzyme: at a dose of 3 g per day and more glomerular filtration is reduced by inhibiting the action of prostaglandins and, as a consequence, the antihypertensive effect decreases;

    with valproic acid: increases the toxicity of valproic acid;

    with ethanol: the risk of damaging effects on the mucous membrane of the gastrointestinal tract increases and the bleeding time increases.

    Special instructions:

    Acetylsalicylic acid can cause bronchospasm, an attack of bronchial asthma or other hypersensitivity reactions. Risk factors are the presence of bronchial asthma, polyps of the nose, fever, chronic bronchopulmonary diseases, cases of allergy in the anamnesis (allergic rhinitis, rashes on the skin).

    Acetylsalicylic acid can increase the tendency to bleeding, which is due to its inhibitory effect on platelet aggregation. This should be taken into account when necessary surgical interventions, including such minor interventions as tooth extraction. Before surgery, to reduce bleeding during surgery and in the post-operation period, you should cancel taking the drug for 5-7 days and inform the doctor.

    Children should not be prescribed drugs containing acetylsalicylic acid, because in the case of a viral infection, the risk of developing Reye syndrome increases. Symptoms of Reye's syndrome include prolonged vomiting, acute encephalopathy, and enlargement of the liver.

    Acetylsalicylic acid reduces the excretion of uric acid from the body, which can cause an acute attack of gout in predisposed patients,

    In one effervescent Alka-Seltzer tablet contains 477 mg of sodium, which should be considered in a diet with controlled sodium intake.

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

    There was no evidence of the effect of taking the drug on driving (vehicle and other mechanisms.

    Form release / dosage:The effervescent tablets are 324 mg + 965 mg + 1625 mg.
    Packaging:

    2 tablets are effervescent in a strip of paper, laminated with aluminum foil; 1, 3, 5, 6 or 10 strips, together with instructions for use in a cardboard box.

    Storage conditions:

    At a temperature of no higher than 25 ° C.

    Keep out of the reach of children.

    Shelf life:

    3 years. Do not use after the expiration date.

    Terms of leave from pharmacies:Without recipe
    Registration number:П N014962 / 01
    Date of registration:04.04.2008 / 20.07.2016
    Expiration Date:Unlimited
    The owner of the registration certificate:Bayer Konsyumer Kare AGBayer Konsyumer Kare AG Switzerland
    Manufacturer: & nbsp
    Representation: & nbspBAYER, AOBAYER, AO
    Information update date: & nbsp07.07.2017
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