Description
Latin name
ALKA SELTZER
Release form
effervescent tablets.
Round, flat white tablets, on one side engraving “ALKA SELTZER” in a convex circle protruding around the perimeter. The reverse side has a chamfer.
2 effervescent tablets 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
Packing
10 pcs
Pharmacological action
Analgesic combined (NSAID + antacid).
ATX code: N02 51
Combined preparation, the effect of which is due to its active components.
Acetylsalicylic acid has an analgesic, antipyretic anti-inflammatory effect due to the inhibition of cyclooxygenase enzymes involved in the synthesis of prostaglandins.
Acetylsalicylic acid inhibits platelet aggregation, blocking the synthesis of thromboxane A2. 2 Sodium bicarbonate neutralizes free hydrochloric acid in the stomach, which reduces the irritating effect of the drug.
Citric acid promotes faster absorption of the drug.
Pharmacokinetics of
After oral administration, ASA is rapidly completely absorbed from the gastrointestinal tract. During the absorption period and immediately after it, ASA turns into the main active metabolite – salicylic acid. ASA reaches its maximum plasma concentration 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 rapidly distributed in tissues.
Salicylic acid is metabolized in the liver with the formation of metabolites – salicylurate, salicylophenol glucuronide, salicylacyl glucuronide, gentisic and gentizuric acids. It is excreted in breast milk and crosses the placenta. The elimination of salicylic acid is dose dependent.
The elimination half-life varies from 2 3 hours when taking the drug in low doses to about 15 hours when using high doses.
Salicylic acid and its metabolites are excreted mainly by the kidneys.
Indications
Symptomatic treatment of mild to moderate pain:
headache (including after drinking alcohol),
sore throat,
sore throat,
back and muscle pain,
joint pain, srd during menstruation,
elevated body temperature in colds and other infectious and inflammatory diseases (in adults and children over 15 years of age).
Contraindications
hypersensitivity to acetylsalicylic acid and other NSAIDs or other components of the drug
erosive and ulcerative lesions of the gastrointestinal tract (in the acute phase)
hemorrhagic diathesis
combined more than once bronchial asthma, recurrent polyposis of the nose and paranasal sinuses and intolerance to acetylsalicylic acid or other non-steroidal anti-inflammatory drugs (including a history)
b V-belt (I and III trimester), lactation.
the drug is not prescribed for children under 15 years of age with acute respiratory infections, caused by viral infections, because of the risk of developing Reye’s syndrome 3 (encephalopathy and acute fatty degeneration of the liver with acute development of liver failure).
Use during pregnancy and lactation
During pregnancy (I and III trimester) and during breastfeeding – is contraindicated.
Composition
1 tablet contains:
Active ingredients:
acetylsalicylic acid – 324.00 mg, dried
sodium bicarbonate (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 benzoate ** 0.10 mg,
sodium saccharin 2 mg,
lemon flavor 1.95 mg,
lime flavor 1.95 mg.
* a mixture of dimethicone and calcium silicate in a ratio of 70:30
** a mixture of docusate sodium and sodium benzoate in a ratio of 85:15
Dosage and administration of
The drug is intended for adults and children over 15 years of age.
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).
Method of application: to dissolve previously 1-3 tablets in 1 glass (200 ml) of water.
The duration of treatment (without consulting a doctor) should not exceed 5 days when prescribed as an anesthetic and more than 3 days as an antipyretic.
Side effects
From the gastrointestinal tract: abdominal pain, heartburn, nausea, obvious vomiting (vomiting with blood, tarry stools) or latent signs of gastrointestinal bleeding, which can lead to iron deficiency anemia, erosive and ulcerative lesions (including perforation) of the gastrointestinal tract, isolated cases – liver dysfunction (increase activity of liver transaminases).
From the central nervous system: dizziness, tinnitus (usually 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 edema. If such symptoms appear, it is recommended to stop taking the drug and consult your doctor immediately.
Drug Interaction
Reduces the effect of anti-gout (including side effects), enhances – anticoagulants and oral hypoglycemic drugs, NSAIDs, side effects of methotrexate.
Overdose
Symptoms
Overdose of moderate severity: nausea, vomiting, tinnitus, hearing impairment, headache, dizziness and confusion. These symptoms go away when the dose is reduced. 4
Severe overdose: fever, hyperventilation, ketosis, respiratory alkalosis, metabolic acidosis, coma, cardiogenic shock, respiratory failure, severe hypoglycemia.
Treatment: hospitalization, lavage, activated carbon intake, acid-base balance monitoring, alkaline diuresis to obtain urine pH between 7.5-8 (forced alkaline diuresis is considered achieved if plasma salicylate concentration is greater 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
Storage conditions
At a temperature not exceeding 25 ° C.
Keep out of the reach of children
The Expiration of
is 3 years.
Do not use after the expiry date.
dosage form
dosage form
tablets soluble
Bayer Pharma AG, Germany
