Composition, form of production and packaging
? The tablets are effervescent white, round, flat, engraved on one side with "ALKA SELTZER" in a convex round circle protruding around the perimeter; the reverse side has a bevel.
1 tab.
acetylsalicylic acid 324 mg
citric acid 965 mg
sodium bicarbonate 1.625 g
Excipients: povidone 25, siloxane / silicate, doss sodium bisoate, sodium saccharinate, lemon flavor, lime flavor.
2 pcs. - strips paper laminated (5) - packs cardboard.
10 pieces. - strips paper laminated (1) - packs cardboard.
10 pieces. - strips paper laminated (2) - packs cardboard.
INSTRUCTION FOR THE SPECIALIST.
Description of the drug approved by the manufacturer for the printed edition of 2014.
PHARMACHOLOGIC EFFECT
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 A 2 .
Sodium carbonate neutralizes free hydrochloric acid in the stomach, which reduces the irritant effect of the drug.
Citric acid promotes a faster absorption of the drug.
INDICATIONS
Symptomatic treatment of pain syndrome:
- headache (including after excessive consumption of alcohol);
- toothache;
- Sore throat;
- pain in the back and muscles;
- pain in the joints;
pain during menstruation.
The raised temperature of a body at cold and other infectious-inflammatory diseases (at adults and children is more senior 15 years).
DOSING MODE
The drug is intended for adults and children over 15 years.
Inside, adults and children over 15 take 1 tablet. up to 6 times / day. With severe pain and high temperature - 2-3 tablets; the maximum daily dose should not exceed 9 tab.
Method of use: dissolve the tablet / tablets in a glass (200 ml) of water.
The interval between doses of the drug should be at least 4 hours. Regular adherence to the regimen of taking the drug avoids a sharp increase in temperature and reduces the intensity of the pain syndrome.
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 EFFECT
From the digestive system: 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 and ulcerative lesions (including with perforation) of the gastrointestinal tract, in isolated cases - violations of the liver (increased liver transaminases).
From the side of the central nervous system : dizziness, noise in the ears (usually are signs of an overdose).
From the hemopoietic 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, Quincke's edema. When such symptoms appear, it is recommended to stop taking the drug and immediately consult a doctor.
CONTRAINDICATIONS
- hypersensitivity to acetylsalicylic acid and other NSAIDs or other components of the drug;
- erosive-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;
- asthma caused by the intake of salicylates or other NSAIDs;
- 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).
With caution: with concomitant therapy with anticoagulants, gout, peptic ulcer and / or duodenal ulcer (history), including chronic or recurrent peptic ulcer disease, or episodes of gastrointestinal bleeding; renal and / or hepatic insufficiency, deficiency of glucose-6-phosphate dehydrogenase.
PREGNANCY AND LACTATION
The drug is contraindicated for use in pregnancy (I and III trimesters).
If you need to use the drug during lactation, breastfeeding should be discontinued.
APPLICATION FOR FUNCTIONS OF THE LIVER
With caution: kidney failure.
APPLICATION FOR VIOLATIONS OF THE FUNCTION OF KIDNEYS
With caution: liver failure.
APPLICATION FOR CHILDREN
The drug is not prescribed for children under 15 years. 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.
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 surgical interventions are required, including minor interventions such as tooth extraction. Before surgical intervention 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.
In the treatment of vascular diseases, the daily dose of acetylsalicylic acid is 75 to 300 mg.
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 445 mg of sodium, which should be considered in a diet with controlled sodium intake.
Impact on the ability to drive vehicles and manage mechanisms
There was no evidence of the effect of drug administration on vehicle management and other mechanisms.
OVERDOSE
Symptoms : an overdose of moderate severity: nausea, vomiting, tinnitus, hearing loss, 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, reception of activated charcoal, monitoring of acid-base balance, alkaline diuresis in order to reach urinary pH between 7.5-8 (forced alkaline diuresis is achieved if the concentration of salicylate in the blood 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.
DRUG INTERACTION
Joint application:
with methotrexate at a dose of 15 mg per week or more: the hemolytic cytotoxicity of methotrexate is increased (decreased renal clearance of methotrexate and methotrexate is replaced by salicylates due to 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 plasma proteins;
with other NSAIDs, as well as with high doses of salicylates (3 g per day or more): as a result of synergistic interaction, the risk of ulceration and bleeding increases;
with uricosurates, for example benzbromaron: reduces the uricosuric effect;
with digoxin: the concentration of digoxin is increased due to decreased renal excretion;
with antidiabetic drugs, for example, insulin: hypoglycemic effect of antidiabetic drugs increases due to hypoglycemic effect of acetylsalicylic acid;
with preparations of the thrombolytics group: the risk of bleeding increases;
with diuretics at a dose of 3 mg per day or more: glomerular filtration decreases due to a decrease in the synthesis of prostaglandins;
with systemic SCS, excluding hydrocortisone used as a substitute therapy for Addison's disease: with the use of GCS, the level of salicylates in the blood decreases by increasing the excretion of the latter;
with ACE inhibitors: at a dose of 3 g per day and more glomerular filtration is reduced by inhibiting prostaglandins and, as a consequence, the antihypertensive effect decreases;
with valproic acid: the toxicity of valproic acid increases;
with ethanol: the risk of damaging effects on the gastrointestinal mucosa increases and bleeding time increases.
TERMS OF RELEASE FROM PHARMACY
The drug is approved for use as a means of OTC.
TERMS AND CONDITIONS OF STORAGE
At a temperature not higher than 25 В° C, out of the reach of children.
Shelf life - 3 years. Do not use after the time specified on the package.
