ALKA-SELTZER 324 mg Tablets

Contents of the leaflet

1. Leaflet attached to the packaging: patient information
2. Warning! The leaflet should be kept. Information on the immediate packaging in a foreign language.
3. Alka-Seltzer
4. 324 mg, effervescent tablets
   1. You should carefully read the contents of the leaflet before taking the medicine, as it contains important information for the patient.
   2. Table of contents of the leaflet:
5. What is Alka-Seltzer and what is it used for
   1. Indications for use:
6. Important information before taking Alka-Seltzer
   1. When not to take Alka-Seltzer
   2. Warnings and precautions
   3. Alka-Seltzer and other medicines
   4. Alka-Seltzer with food, drink, or alcohol
   5. Pregnancy, breastfeeding, and fertility
   6. Driving and using machines
   7. Alka-Seltzer contains sodium.
7. How to take Alka-Seltzer
   1. Taking a higher dose of Alka-Seltzer than recommended
   2. Missing a dose of Alka-Seltzer
   3. Stopping Alka-Seltzer treatment
8. Possible side effects
   1. Reporting side effects
9. How to store Alka-Seltzer
10. Package contents and other information
    1. What Alka-Seltzer contains
    2. What Alka-Seltzer looks like and what the package contains
    3. Marketing authorization holder in France, the country of export:
    4. Manufacturer:
    5. Parallel importer:
    6. Repackaged by:
    7. Parallel import authorization number: 743/12 Date of leaflet approval: 04.11.2022

Leaflet attached to the packaging: patient information

Warning! The leaflet should be kept. Information on the immediate packaging in a foreign language.

Alka-Seltzer

324 mg, effervescent tablets

Acetylsalicylic acid

You should carefully read the contents of the leaflet before taking the medicine, as it contains important information for the patient.

This medicine should always be used exactly as described in the patient leaflet or as directed by a doctor or pharmacist.

• The leaflet should be kept so that it can be re-read if necessary.
• If advice or additional information is needed, a pharmacist should be consulted.
• If the patient experiences any side effects, including any possible side effects not listed in the leaflet, they should tell their doctor, pharmacist, or nurse. See section 4.
• If there is no improvement after 3-5 days or the patient feels worse, they should contact their doctor.

Table of contents of the leaflet:

• 1. What is Alka-Seltzer and what is it used for
• 2. Important information before taking Alka-Seltzer
• 3. How to take Alka-Seltzer
• 4. Possible side effects
• 5. How to store Alka-Seltzer
• 6. Package contents and other information

1. What is Alka-Seltzer and what is it used for

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.

Indications for use:

• Painful conditions of mild and moderate severity, such as headaches, muscle pain (including a feeling of general malaise), toothaches
• Pain and fever in the course of a cold or flu

2. Important information before taking Alka-Seltzer

When not to take Alka-Seltzer

• in children under 12 years of age.

Warnings and precautions

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.

Alka-Seltzer and other medicines

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:

• the toxic effect of methotrexate on the bone marrow; acetylsalicylic acid should not be taken at the same time as methotrexate in doses of 15 mg per week or higher; concurrent use of methotrexate in doses less than 15 mg per week requires special caution;
• the effect of anticoagulant drugs, thrombolytic drugs (dissolving blood clots), and platelet aggregation inhibitors, which may increase the risk of prolonged bleeding time and bleeding;
• the risk of stomach ulcers and gastrointestinal bleeding if taken concurrently with corticosteroids, other non-steroidal anti-inflammatory drugs, including other salicylates in high doses, or if alcohol is consumed during treatment; after discontinuing systemic corticosteroids (except for hydrocortisone used as replacement therapy in Addison's disease), the risk of salicylate overdose increases;
• the effect of digoxin (a heart medication), as it increases its serum concentration;
• the effect of anti-diabetic drugs, such as insulin, sulfonylurea derivatives;
• the toxic effect of valproic acid (a medication used in epilepsy), which in turn enhances the anti-aggregatory effect of acetylsalicylic acid;
• the effect of selective serotonin reuptake inhibitors (antidepressants).

Special caution should be exercised when taking Alka-Seltzer with the following medicines, as acetylsalicylic acid weakens:

• the effect of anti-gout drugs used to treat gout, which increase uric acid excretion from the body (e.g., benzbromarone, probenecid), which may worsen gout symptoms;
• the effect of diuretics;
• the effect of certain antihypertensive drugs (from the group of so-called angiotensin-converting enzyme inhibitors), especially if acetylsalicylic acid is taken in high doses.

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.

Alka-Seltzer with food, drink, or alcohol

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.

Pregnancy, breastfeeding, and fertility

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.

Driving and using machines

The medicine has no effect.

Alka-Seltzer contains sodium.

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.

3. How to take Alka-Seltzer

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.

Taking a higher dose of Alka-Seltzer than recommended

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.

Missing a dose of Alka-Seltzer

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.

Stopping Alka-Seltzer treatment

In case of any further doubts related to the use of this medicine, the patient should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Alka-Seltzer can cause side effects, although not everybody gets them. Note:

• If bloody vomit or black, tarry stools occur, the medicine should be discontinued and a doctor consulted.
• A symptom of a severe hypersensitivity reaction may be: facial and eyelid edema, tongue and laryngeal edema with narrowing of the airways, difficulty breathing, shortness of breath up to asthma attacks, rapid heartbeat, sudden drop in blood pressure up to life-threatening shock. If any of these symptoms occur, immediate medical attention should be sought. These reactions can occur even after the first administration of the medicine.

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.

Reporting side effects

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.

5. How to store Alka-Seltzer

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.

6. Package contents and other information

What Alka-Seltzer contains

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.

What Alka-Seltzer looks like and what the package contains

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.

Marketing authorization holder in France, the country of export:

Bayer Healthcare SAS 220 avenue de la Recherche 59 120 Loos France

Manufacturer:

Bayer Bitterfeld GmbH Ortsteil Greppin Salegaster Chaussee 1 06803 Bitterfeld-Wolfen Germany

Parallel importer:

Delfarma Sp. z o.o. ul. Św. Teresy od Dzieciątka Jezus 111 91-222 Łódź

Repackaged by:

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

Parallel import authorization number: 743/12 Date of leaflet approval: 04.11.2022

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