Description
Instruction for medical use of
Alka-Seltzer ®
Trade name
Alka-Seltzer®
International nonproprietary name
No
Dosage form
Effervescent tablet
Composition
One tablet includes:
active substance:acetylsalicylic acid 324 mg, ahydrous lemon acid 965 mg, sodium carbonate 1743.87 mg (corresponding to dry sodium carbonate 1625 mg).
adjuvants: povidone 25, calcium silicate, dimeticone, sodium docusate, sodium benzoate, sodium saccharinate, lemon flavor, lime flavor.
Description
White round plain tablets with mark ALKA SELTZER on one side and with cut on other side.
Pharmacotherapeutic group
Analgesics, alexipyretics, other. Salicylic acid and its derivatives.
Acetylsalicylic acid in combination with other drugs (except for neuroleptics)
Code АТХ N02BА51
Pharmacological properties
The combined drug, activity of which is based on included active substances.
Acetylsalicylic acid has anaesthetic, antifebrile and antiphlogistic effect that is based on inhibition of enzymes of cyclooxygenase participation in synthesis of prostaglandins; inhibits aggregation of thrombocytes blocking synthesis of thromboxane А2.
Sodium carbonate neutralizes free hydrochloric acid in stomach that decreases irritant action of the drug.
Lemon acid supports faster absorption of the drug.
Indications
For symptomatic relief:
- headache including in case of alcohol withdrawal syndrome
- toothache
- sore throat and myodynia
- joint pain
- menstrual pain.
- high body temperature.
For elimination of symptoms of acute respiratory viral infection, flue and other infectious inflammatory diseases
Dosage and methods of use
Ingest, 1 tablet up to 6 tablets per day. In case of intense pain and high temperature – 2-3 tablets; maximal daily dose shall not exceed 8 tablets (2.5 g).
Before ingest, please, dissolve tablet/tablets in cup of water (200 ml). Frequency and time of receipt: interval between the drug use shall be at least 4 hours. Regular compliance with receiving mode allows avoiding accidental increase of temperature and decrease of intensity of pain syndrome.
For elderly persons: standard dose is 1 tablet, in case of more intense pain or fever it is required to ingest 2 tablets. In both cases ingest repeatedly, but not earlier than in 4 hours. Maximum daily dose is 4 tablets. Dissolve tablet/tablets in cup of water and drink.
Period of treatment (without consultation with a doctor) shall not exceed 5 days in case of prescription as anaesthetic and more than 3 days – in case of febrifuge agent.
Adverse reaction
- stomach ache, hearburn, nausea, vomit
- increased risk of bleeding (gastro-intestinal, nasal);
- individual cases - liver function abnormality (increased activity of liver transaminase)
- renal disorder and acute renal insufficiency
- skin rash, bronchospasm, Quincke's disease, anaphylactic reaction
- hemolysis and hemolytic anemia for patients with serious deficit of glucose-6-phosphate dehydrogenase
- headache, dizziness, hearing loss, buzzing in ears tinnitus ) and clouding of consciousness.
- increased individual sensibility to components of the drug;
- asthma caused by acetylsalicylic acid or its derivative
- erosive ulcerous damage of gastrointestinal system (in the attack phase)
- bleeding diathesis
- combined use with methotrexate in dose of 15 mg per week and more;
- pregnancy (I-III trimester) and lactation period.
- children up to 16 years in case of acute respiratory disease, viral etiology, due to risk of development ofReye's syndrome (encephalopathy and acute hepatic steatosis with acutehepatic failure)
- serious chronic kidney disease and/or hepatic failure
- serious chronic cardiac failure
Contraindications
Drug interaction
In case of joint use of the drug:
with methotrexate 15 mg per week and more: globulolytic cytotoxicity of methotrexate is increased (decrease in renal clearance of methotrexate and methotrexate is substituted with salycylates in connection with proteins of blood plasma); with anticlotting agents, for example, with heparin there is increased risk of bleeding as a result of inhibition of function of thrombocytes, damaged mucous of gastrointestinal system, displacement of anticlotting agents (oral) due to connection with proteins of blood plasma;
with other nonsteroidal anti-inflammatory drug, as well as with the most doses of salycylates (3 g per day or more) as a result of synergetic interaction, there is increased risk of occurrence of ulcer and bleeding; with uricosuric agents, for example with benzbromarone there is decreased uricosuric action; with digoxin, concentration of digoxin is increased as a result of decrease in renal excretion; with antidiabetic drugs, for example, with insulin there is increased hypoglycemic effect of antidiabetic drugs as a result of hypoglycemic action of acetylsalicylic acid; with the drug ofthrombolytics complex there is increased risk of occurrence of bleeding;
with diuretic (in dose – 3 mg per day and more) glomerular filtration is decreased as a result of synthesis of prostaglandins; with system glucocorticosteroids, excluding hydrocortisone used as a result of replacement therapy in case of Addison disease, there is decreased level of salycylates in blood due to increased excretion of the last one;
with inhibitors of angiotensin converting enzyme (in dose of 3 g per day and more), glomerular filtration is decreased due to inhibition of prostaglandins and as a result, antihypertensive response is decreased; with valproic acidtoxicity of valproic acid is increased; with etanol there is increased risk of damaging influence on mucous of gastrointestinal system and increased bleeding time.
Special indications
Acetylsalicylic acid can lead to bronchospasm (if in anamnesis of bronchial asthma, chronic bronchopulmonary diseases, nasal polypus, allergic rhinitis).
Acetylsalicylic acid can increase tendency to bleeding that is connected with its inhibiting influence on aggregation ofthrombocytes. It shall be taken into account in case of necessity of surgery including such minor surgical interference like extraction of a tooth. It is required to cancel use of the drug 5-7 days prior to surgical interference and in postsurgical period for decrease in bleeding during surgery and to inform a doctor.
In case of treatment of vascular disease, daily dose of acetylsalicylic acid is from 75 to 300 mg.
The drug shall be prescribed with caution in case of concomitant treatment with anticlotting agents, podagra (decreased excretion of uric acid), ulcer disease of stomach and/or dodecadactylon (in anamnesis), including chronic or recrudescent course of ulcer disease or episodes of gastrointestinal hemorrhage; renal insufficiency and/ or hepatic failure, deficit of glucose-6-phosphate dehydrogenase.
One effervescent tablet of Alka-Seltzer includes 477 mg of sodium that shall be taken into account in case of diet with controlled consumption of sodium.
Effects on ability to drive and use potentially dangerous machines
No effect.
Overdosage
Symptoms:
Overdosage of average severity level: nausea, vomit, buzzing in ears, hearing loss, headache, dizziness and clouding of consciousness – these symptoms are eliminated in case of decrease of the drug dose.
Serious overdosage: fever, hyperventilation, ketose, respiratory alkalosis, metabolic acidosis, coma, cardiogenic shock, respiratory insufficiency, expressed hypoglycaemia.
Treatment: lavage, use of absorbent carbon, monitoring of acid-alkaline balance, alcaline diuresis in order to receive pH of urine between 7.5-8 (it is considered that forced alcaline diuresis is reached if concentration of salicylate in blood plasma is more than 500 mg/l (3.6 mmol/l) for adult or 300 mmg/l (2.2 mmol/l) for children, hemodialysis, liquid loss recovery, symptomatic treatment.
Form of output and packing
2 tablets in blister made of laminated aluminium foil.
5 blisters together with instruction for medical use in Russian and Kazakh are placed in cardboard package.
Storage conditions
Do not store above 25 °C.
Keep out of the reach of children!
Shelf life
3 years.
Do not use after the expiration date indicated on the package.
Conditions for drug supply
Over-the-counter
Name and country of manufacturer
Bayer Bitterfeld GmbH, Germany
Name and country of the Registration Certificate holder
Bayer Consumer Care AG, Switzerland
Address of the organization receiving claims from consumers regarding the quality of products (goods) and responsible for post approval supervision over drug safety on the territory of the Republic of Kazakhstan
“Bayer KAZ” LLP.
Timiryazev Street, 42,Expo-City Business Center, Pav. 15
050057 Almaty, Republic of Kazakhstan
Tel: +7 701 715 78 46 – round the clock
Tel.: +7 727 258 80 40 (106) – during working hours
Fax: +7 727 244 70 01
e-mail: kz.claims@bayer.com
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