ALKA-SELTZER 324 mg Tablets

Contents of the leaflet

1. Leaflet attached to the packaging: patient information
2. Warning! Keep the leaflet! Information on the immediate packaging in a foreign language.
3. Alka-Seltzer
4. 324 mg, effervescent tablets
   1. Read the leaflet carefully 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:
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:

Leaflet attached to the packaging: patient information

Warning! Keep the leaflet! Information on the immediate packaging in a foreign language.

Alka-Seltzer

324 mg, effervescent tablets

Acetylsalicylic acid

Read the leaflet carefully 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.

• Keep this leaflet, so you can read it again if you need to.
• If you need advice or additional information, consult a pharmacist.
• If the patient experiences any side effects, including any possible side effects not listed in the leaflet, they should inform their doctor, pharmacist, or nurse. See section 4.
• If there is no improvement after 3-5 days or if 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 neutralize excess stomach acid.

Indications:

• mild to moderate pain, such as headaches, muscle pain (including general feeling of being unwell), 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

• if the patient is allergic to the active substance - acetylsalicylic acid, other salicylates, or any of the other ingredients of this medicine (listed in section 6),
• if the patient has a bleeding disorder,
• if the patient has acute stomach or duodenal ulcer,
• if the patient has severe heart failure or severe liver or kidney failure,
• if the patient has ever had asthma attacks caused by taking salicylates or substances with similar effects, especially non-steroidal anti-inflammatory drugs,
• if the patient is taking methotrexate (used in cancer treatment) at doses of 15 mg per week or higher,
• if the patient is in the third trimester of pregnancy,
• 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:

• if the patient is hypersensitive to non-steroidal anti-inflammatory and anti-rheumatic drugs or other allergenic substances,
• if the patient is taking anticoagulant medications,
• if the patient has impaired liver function,
• if the patient has impaired kidney function or circulatory disorders (e.g., kidney vessel disease, congestive heart failure, decreased blood volume, extensive surgery, sepsis, severe bleeding), as acetylsalicylic acid may further increase the risk of kidney function disorders and severe kidney failure,
• if the patient has a history of (chronic or recurrent) stomach ulcers or gastrointestinal bleeding,
• if the patient has a genetic disorder involving a deficiency of the enzyme - glucose-6-phosphate dehydrogenase, as acetylsalicylic acid may cause hemolysis or hemolytic anemia,
• if the patient is breastfeeding.

Medicines 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, nasal polyps, and those with allergic reactions to other substances (e.g., skin reactions, itching, hives) are particularly at risk.
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 medicine may cause a gout attack.
Medicines containing acetylsalicylic acid should not be given to children and adolescents during viral infections (with or without fever) without consulting a doctor. In some viral diseases, especially in the case of influenza A and B virus infections 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 development of Reye's syndrome.
Prolonged use of medicines containing acetylsalicylic acid may cause headaches that worsen with each subsequent dose.
Prolonged use of painkillers, especially those containing multiple active substances, may lead to severe kidney function disorders and kidney failure.

Alka-Seltzer and other medicines

The patient should tell their doctor or pharmacist about all 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 at doses of 15 mg per week or higher; concurrent use of methotrexate at doses less than 15 mg per week requires special caution;
• the effect of anticoagulant medications, thrombolytic medications (dissolving blood clots), and antiplatelet agents, 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 antidiabetic medications, 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 uricosuric medications 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 medications (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 at 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.
Medicines 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 lowest 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 World Health Organization's 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 often 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 often than every 4-8 hours.
Do not take more than 3 effervescent tablets (972 mg of acetylsalicylic acid) per day.
Dissolve the tablets in a glass of water and drink the effervescent liquid. 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

Overdose of the active substance in Alka-Seltzer can be caused by prolonged use of the medicine (mild overdose) or overdose (severe overdose), which can be life-threatening, e.g., after accidental ingestion by children or the elderly.
Symptoms of mild overdose 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), rapid breathing, deep breathing, and symptoms of respiratory alkalosis (spots before the eyes, fainting).
In the case of severe overdose, 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 overdose, the patient should immediately consult a doctor or pharmacist, and in case of severe overdose, the patient should be taken to the hospital immediately.
Treatment of overdose 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

If a dose is missed and symptoms persist, 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 about 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.
Warning:

• If coffee grounds-like vomiting 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 dose of the medicine.

Gastrointestinal disorders:
Stomach and abdominal pain, heartburn, nausea, vomiting, indigestion, gastrointestinal inflammation, potentially life-threatening gastrointestinal bleeding: overt (coffee grounds-like vomiting, black tarry stools) or occult (bleeding occurs more frequently with higher doses); stomach or duodenal ulcers, perforation.
Liver and bile duct disorders:
In rare cases, transient liver function disorders (increased aminotransferase activity) have been reported.
Nervous system disorders:
Dizziness and tinnitus, which are 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.
The consequence of bleeding may be the development of acute or chronic iron deficiency anemia or acute post-hemorrhagic anemia, manifested by asthenia, pallor, hypoperfusion, as well as abnormal laboratory test results.
Hemolysis and hemolytic anemia in patients with severe glucose-6-phosphate dehydrogenase deficiency.
Vascular disorders:
Brain hemorrhage (especially in patients with uncontrolled hypertension and/or concomitant use of other anticoagulant medications) potentially life-threatening.
Renal and urinary disorders:
Renal 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, 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 inform their doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products 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.
Reporting side effects can help gather more information 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 stated.
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 needed. 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). Each effervescent tablet contains 324 mg of acetylsalicylic acid.
The other ingredients of the medicine are sodium hydrogen carbonate, sodium carbonate, citric acid.

What Alka-Seltzer looks like and what the package contains

One double sachet contains 2 effervescent tablets.
A cardboard box contains 6, 10, or 40 effervescent tablets in the form of 3, 5, or 20 double sachets, each containing 2 effervescent tablets.
Packages containing 2 effervescent tablets (1 double sachet) are also authorized.