Acetylsalicylic acid
This medicine should always be used exactly as described in the patient leaflet or as directed by a doctor or pharmacist.
Acetylsalicylic acid, the active substance in Alka-Seltzer, has analgesic, anti-inflammatory, and antipyretic effects. Sodium citrate, which is formed after the tablet is dissolved in water, has buffering properties, which neutralizes excess hydrochloric acid in the stomach.
Before starting to take Alka-Seltzer, the patient should discuss it with their doctor or pharmacist:
Drugs containing acetylsalicylic acid should not be taken by women in the first and second trimester of pregnancy, unless it is absolutely necessary. Acetylsalicylic acid may cause bronchospasm and trigger asthma attacks or other hypersensitivity reactions. Patients with asthma, chronic respiratory diseases, hay fever, and nasal polyps, as well as those with allergic reactions to other substances (e.g., skin reactions, itching, hives), are particularly at risk of such reactions. Patients undergoing surgical procedures (including minor procedures, e.g., tooth extraction) should inform their doctor about taking Alka-Seltzer. Acetylsalicylic acid, even in small doses, reduces the excretion of uric acid from the body. In patients with a tendency to reduced uric acid excretion, the drug may cause a gout attack. Drugs containing acetylsalicylic acid should not be given to children and adolescents during viral infections (with or without fever) without consulting a doctor. During some viral diseases, especially influenza A and B and chickenpox, there is a risk of developing Reye's syndrome - a rare but life-threatening disease that requires immediate medical attention. The risk of developing Reye's syndrome during viral infections may increase if acetylsalicylic acid is taken at the same time, although a causal link has not been proven. Persistent vomiting during an infection may indicate the onset of Reye's syndrome. Long-term use of drugs containing acetylsalicylic acid may cause headaches that worsen with each subsequent dose. Long-term use of painkillers, especially those containing multiple active substances, may lead to severe kidney dysfunction and kidney failure.
The patient should tell their doctor or pharmacist about all the medicines they are currently taking or have recently taken, as well as any medicines they plan to take. Special caution should be exercised when taking Alka-Seltzer with the following medicines, as acetylsalicylic acid enhances:
Special caution should be exercised when taking Alka-Seltzer with the following medicines, as acetylsalicylic acid weakens:
Alka-Seltzer can be taken with the above-mentioned medicines (except for methotrexate in doses of 15 mg per week or higher) only after consulting a doctor.
See section 3 of the leaflet. Warning: Alcohol may increase the risk of adverse reactions from the gastrointestinal tract, such as stomach ulcers or bleeding.
In pregnancy, breastfeeding, or if pregnancy is suspected, or if the patient is planning to become pregnant, they should consult their doctor or pharmacist before taking the medicine. Alka-Seltzer is contraindicated in the third trimester of pregnancy, as it may cause complications during the perinatal period, both in the mother and the newborn. Drugs containing acetylsalicylic acid should not be taken by women in the first and second trimester of pregnancy, unless it is absolutely necessary. If acetylsalicylic acid needs to be taken by women trying to conceive or in the first and second trimester of pregnancy, the smallest possible dose should be taken for the shortest possible time. Acetylsalicylic acid passes into breast milk in small amounts. Alka-Seltzer belongs to a group of medicines that may adversely affect female fertility. This effect is temporary and disappears after the end of therapy.
The medicine has no effect.
One Alka-Seltzer tablet contains 477 mg of sodium (the main component of common salt). This corresponds to 24% of the maximum recommended daily sodium intake in the diet for adults. The maximum daily dose of this product is equivalent to 288% of the WHO-recommended maximum daily sodium intake.
This medicine should always be used exactly as described in the patient leaflet or as directed by a doctor or pharmacist. In case of doubt, the patient should consult their doctor or pharmacist. The recommended dose of Alka-Seltzer is: Adults: Take 1 to 3 effervescent tablets at a time (324 to 972 mg of acetylsalicylic acid). If necessary, the single dose may be repeated, but not more than every 4-8 hours. Do not take more than 12 effervescent tablets (approximately 4000 mg of acetylsalicylic acid) per day. Adolescents over 12 years of age: The medicine may be used in adolescents over 12 years of age only on the advice of a doctor. Take 1 effervescent tablet at a time (324 mg of acetylsalicylic acid). If necessary, the single dose may be repeated up to 3 times a day, but not more than every 4-8 hours. Do not take more than 3 effervescent tablets (972 mg of acetylsalicylic acid) per day. The tablets should be dissolved in a glass of water and the effervescent liquid should be drunk. Take after meals. The medicine should not be used for more than 3-5 days without consulting a doctor.
Poisoning with the active substance of Alka-Seltzer can be caused by prolonged use of the medicine (mild poisoning) or overdose (severe poisoning), which can be life-threatening, e.g., after accidental ingestion by children or the elderly. Symptoms of mild poisoning are: dizziness (including vertigo), tinnitus, hearing loss, excessive sweating, nausea, and vomiting, headache, confusion (disorders of consciousness with disorientation, thinking, and speech disorders, delusions, hallucinations, anxiety, and psychomotor agitation), accelerated breathing, deep breathing, and symptoms of respiratory alkalosis (spots before the eyes, fainting). In the case of severe poisoning, the following may also occur: high fever, respiratory disorders (up to respiratory arrest and suffocation), cardiac and vascular disorders (from irregular heartbeat, low blood pressure to cardiac arrest), fluid and electrolyte loss (from dehydration, oliguria [reduced urine output below 400-500 ml in adults] to kidney failure), increased or decreased blood glucose levels (especially in children), ketoacidosis, gastrointestinal bleeding, coagulation disorders, neurological disorders manifesting as lethargy, confusion, and up to coma and convulsions. In case of taking a higher dose of the medicine than recommended, the patient should immediately consult a doctor or pharmacist, and in case of severe poisoning, the patient should be taken to the hospital immediately. Treatment of poisoning involves gastric lavage, administration of activated charcoal, and alkaline diuresis. In severe cases, forced alkaline diuresis, peritoneal dialysis, or hemodialysis may be necessary.
In case of missing a dose and persistence of symptoms, the next dose of Alka-Seltzer should be taken. A double dose should not be taken to make up for the missed dose.
In case of any further doubts related to the use of this medicine, the patient should consult their doctor or pharmacist.
Like all medicines, Alka-Seltzer can cause side effects, although not everybody gets them. Note:
Gastrointestinal disorders: stomach pain and abdominal pain, heartburn, nausea, vomiting, indigestion, inflammation of the gastrointestinal tract, potentially life-threatening gastrointestinal bleeding: overt (bloody vomit, black stools) or occult (bleeding occurs more frequently the higher the dose); stomach or duodenal ulcer, perforation. Hepatobiliary disorders: In rare cases, transient liver function disorders (increased aminotransferase activity) have been reported. Nervous system disorders: dizziness and tinnitus, usually symptoms of overdose. Blood and lymphatic system disorders: increased risk of bleeding, bleeding (postoperative, nasal, gingival, genitourinary), hematomas, prolonged bleeding time, prothrombin time, thrombocytopenia. As a result of bleeding, acute or chronic iron deficiency anemia or acute post-hemorrhagic anemia may occur, manifested by asthenia, pallor, hypoperfusion, and abnormal laboratory test results. Hemolysis and hemolytic anemia in patients with severe glucose-6-phosphate dehydrogenase deficiency. Vascular disorders: cerebral hemorrhage (especially in patients with uncontrolled hypertension and/or concomitantly taking other anticoagulant drugs) potentially life-threatening. Renal and urinary disorders: kidney function disorders and severe kidney failure. Immune system disorders: hypersensitivity reactions with clinical symptoms and abnormal laboratory test results, such as asthma, mild to moderate skin reactions, respiratory, cardiovascular, and allergic reactions, including symptoms such as rash, urticaria, edema (including angioedema), respiratory and cardiac disorders, rhinitis, nasal congestion, and very rarely severe reactions, including anaphylactic shock. Respiratory disorders: asthma.
If any side effects occur, including any side effects not listed in the leaflet, the patient should tell their doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products Al. Jerozolimskie 181C 02-222 Warsaw tel.: +48 (22) 49 21 301 fax: +48 (22) 49 21 309 website: https://smz.ezdrowie.gov.pl By reporting side effects, more information can be collected on the safety of the medicine.
Do not store above 25°C. The medicine should be stored out of sight and reach of children. Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the month. Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer used. This will help protect the environment.
The active substance of Alka-Seltzer is acetylsalicylic acid (Acidum acetylsalicylicum). The other ingredients of the medicine are anhydrous citric acid, sodium hydrogen carbonate, and sodium carbonate.
One double sachet contains 2 effervescent tablets. 1, 3, 5, or 20 double sachets, each containing 2 effervescent tablets, in a cardboard box. For more detailed information, the patient should contact the marketing authorization holder or the parallel importer.
Bayer Healthcare SAS 220 avenue de la Recherche 59 120 Loos France
Bayer Bitterfeld GmbH Ortsteil Greppin Salegaster Chaussee 1 06803 Bitterfeld-Wolfen Germany
Delfarma Sp. z o.o. ul. Św. Teresy od Dzieciątka Jezus 111 91-222 Łódź
Delfarma Sp. z o.o. ul. Św. Teresy od Dzieciątka Jezus 111 91-222 Łódź Authorization number in France, the country of export: 340 648-7 34009 340 648 7 6 329 267-0 34009 329 267 0 1 300 267-2 34009 300 267 2 4 329 268-7 34009 329 268 7 9 320 120-7 34009 320 120 7 7 300 266-6 34009 300 266 6 3 329 110-4 34009 329 110 4 2
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