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Description

The instruction for medical use

of ALKA-ZELTTSER® medicine

the Trade name
of Alka-Zelttser®

the International unlicensed name
Is not present

the Dosage form
of the Tablet sparkling

Structure
One tablet contains
active agents: acetylsalicylic acid of 324 mg,
anhydrous citric acid of 965 mg, Natrii hydrocarbonas of 1743.87 mg (corresponds to sodium to a hydrocarbonate of dry 1625 mg).
excipients: povidone 25, calcium silicate, dimetikon, sodium docusate, Natrium benzoicum, sodium saccharinate, fragrance lemon, fragrance lime

the Description
White round tablets, flat, with marking of ALKA SELTZER on one party, with a unilateral facet – on another.

Pharmacotherapeutic group
Analgetics antipyretics others. Salicylic acid and its derivatives.
The code of automatic telephone exchange N02BA51

the Pharmacological
The Combined Drug properties which action is caused by the active components which are its part.
Acetylsalicylic acid has anesthetic, febrifugal, anti-inflammatory effect that is caused by inhibition of enzymes of the cyclooxygenases participating in synthesis of prostaglandins inhibits aggregation of thrombocytes, blocking A2 thromboxane synthesis.
Sodium the carbonate neutralizes free hydrochloric acid in a stomach that reduces drug irritant action.
Citric acid promotes faster absorption of drug.

Indications
For symptomatic simplification:
– a headache, including at a hungover syndrome
– a toothache
– a sore throat
– a dorsodynia and muscles
– joint pains
– in menstrual pains.
For elimination of symptoms of a SARS, flu and other infectious and inflammatory diseases:
– the increased body temperature.

A route of administration and doses
Inside, on 1 tablet up to 6 times a day. In severe pains and high temperature on 2-3 tablets, the maximum daily dose should not exceed 9 tablets (3 g).
Before reception to dissolve tablets/tablets in a glass (200 ml) of water. Frequency and time of reception: the interval between administrations of drug has to make not less than 4 hours. Regular observance of the mode of administration of drug allows to avoid sharp temperature increase and to reduce intensity of a pain syndrome.
Treatment duration (without consultation with the doctor) should not exceed 5 days when assigning as anesthetic and more than 3 days – as febrifuge.

Side effect
– abdominal pain, heartburn, nausea, vomiting
– increase in risk of bleeding (gastrointestinal, nasal)
– isolated cases – abnormal liver functions (increase in activity of hepatic transaminases)
– skin rash, a bronchospasm, a Quincke’s edema, anaphylactic reactions

of the Contraindication
– the increased individual sensitivity to drug components
– asthma caused by intake of acetylsalicylic acid or its derivatives
– digestive tract erosive cankers (in an aggravation phase)
– hemorrhagic diathesis
– the combined use with a methotrexate in a dose of 15 mg a week and more
– pregnancy (I-III a trimester) and the lactation period
– children’s age up to 16 years in an acute respiratory disease, a virus etiology, because of risk of development of a syndrome to Reja (encephalopathy and acute fat dystrophy of a liver with acute development of a liver failure).

Medicinal interactions
At combined use of drug:
with a methotrexate in a dose of 15 mg a week or more: hemolytic cytotoxicity of a methotrexate (the renal clearance of a methotrexate decreases and the methotrexate is substituted with salicylates in connection with proteins of blood plasma), with anticoagulants increases, for example, heparin the risk of bleeding owing to inhibition of function of thrombocytes, damages mucous digestive tract, replacement of anticoagulants (peroral) of communication with proteins of blood plasma,
with other non-steroidal anti-inflammatory drugs and also with high doses of salicylates (3 g a day increases or more) as a result of synergy interaction, the risk of developing of an ulcer and bleeding, from urikozurata increases, for example, benzbromarony the uricosuric effect, with digoxin decreases, concentration of digoxin increases owing to decrease in renal excretion, with antidiabetic drugs, for example, insulin hypoglycemic effect of antidiabetic drugs owing to hypoglycemic effect of acetylsalicylic acid increases, with drugs of group of trombolitik the risk of developing of bleeding increases,
with diuretics (in a dose of 3 mg a day and more) glomerular filtration owing to decrease in synthesis of prostaglandins, with system glucocorticosteroids, excepting a hydrocortisone which is used as replacement therapy in Addison’s disease decreases, the level of salicylates in blood due to increase in removal of the last,
with angiotensin-converting enzyme inhibitors (in a dose of 3 g a day and more) decreases glomerular filtration at the expense of inhibition of prostaglandins and, as a result, decreases antihypertensive effect, with valproic acid raises toxicity of valproic acid, with ethanol increases risk damaging influences on mucous digestive tract decreases and the bleeding time increases.

Special instructions
Acetylsalicylic acid can cause a bronchospasm (in the presence in an anemneza of bronchial asthma, chronic bronchopulmonary diseases, nose polyps, allergic rhinitises).
Acetylsalicylic acid can increase tendency to bleeding that is connected with its inhibiting influence on aggregation of thrombocytes. It should be considered in need of surgical interventions, including such small interventions as odontectomy. Before surgical intervention, for reduction of bleeding during operation and in the post-operational period, it is necessary to cancel administration of drug in 5-7 days and to inform the doctor.
At treatment of vascular diseases the daily dose of acetylsalicylic acid makes from 75 to 300 mg.
Drug is appointed with care at the accompanying therapy by anticoagulants, gout (reduces removal of uric acid), a peptic ulcer of a stomach and/or a duodenum (in the anamnesis), including a chronic or recurrent course of a peptic ulcer, or episodes of gastrointestinal bleedings, a renal and/or liver failure, deficit glyukozo-6-fosfatdegidrogenazy.
One sparkling tablet Alka-Zelttser® contains 477 mg of sodium that should be considered at a diet with controlled consumption of sodium.
Features of influence of medicine on ability to run transport or potentially dangerous mechanisms

the Overdose
Symptoms does not influence: overdose of moderate severity: nausea, vomiting, sonitus, a hearing disorder, a headache, dizziness and confusion of consciousness – these symptoms pass at a drug dose decline.
Heavy overdose: fever, hyperventilation, ketosis, respiratory alkalosis, metabolic acidosis, coma, cardiogenic shock, respiratory insufficiency, expressed hypoglycemia.
Treatment: lavage, intake of activated carbon, monitoring of acid-base balance, an alkaline diuresis to receive rn urine between 7.5-8 (the forced alkaline diuresis is considered reached if concentration of salicylate in blood plasma makes more than 500 mg/l (3.6 mmol/l) at adults or children have 300 mg/l (2.2 mmol/l)), a hemodialysis, compensation of loss of liquid, symptomatic therapy.

A form of release and packing
On 2 tablets in planimetric bezjyacheykovy packing from the paper laminated by aluminum foil.
On 5 planimetric packs together with the instruction for use in the Russian and state languages place in a cardboard pack.

To Store storage conditions at a temperature not above 25 °C.
To store out of children’s reach!

3 years
not to use a period of storage after the expiration date specified on packing

Prescription status
Without prescription

the Name and the country
of the Bayer Bitterfeld GmbH manufacturing organization, Germany

the Name and the country of the owner of the registration certificate
of Bayer Konsyyumer Ker AG, Switzerland

the Address of the organization accepting in the territory of the Republic of Kazakhstan claims from consumers on quality of a product (goods): TOO Bayer KAZ Timiryazev St., 42, business center Expo-City, peahens. 15050057 Almaty, Republic of Kazakhstantel. +7 727 258 80 40 fax: +7 727 244 70 01 e-mail-mail

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