Package leaflet: information for the patient

Warning! Keep this leaflet! Information on the immediate packaging in a foreign language.
Alka-Seltzer
324 mg, effervescent tablets
Acidum acetylsalicylicum
Please read the entire leaflet carefully before taking this medicine, as it contains
important information for the patient.
This medicine should always be used exactly as described in this patient leaflet or as directed by a
doctor or pharmacist.

Keep this leaflet, so that you can read it again if necessary.
If you need advice or further information, please consult your pharmacist.
If you experience any adverse reactions, including any possible adverse reactions not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.
If there is no improvement or if you feel worse after 3-5 days, consult your doctor.

Table of contents of the leaflet:

What Alka-Seltzer is and what it is used for
Important information before taking Alka-Seltzer
How to take Alka-Seltzer
Possible side effects
How to store Alka-Seltzer
Contents of the pack and other information

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

Acetylsalicylic acid, the active substance in Alka-Seltzer, has analgesic, anti-inflammatory, and antipyretic effects. Sodium citrate, formed after dissolving the tablet in water, has buffering properties and thus neutralizes excess hydrochloric acid in the stomach.
Indications:

Mild to moderate pain, such as headache, muscle pain (including general malaise), toothache,
Pain and fever associated with colds and influenza.

2. Important information before using Alka-Seltzer

When not to use 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 tendency,
if the patient has acute gastric or duodenal ulcer,
if the patient has severe heart failure, severe liver failure, or severe renal failure,
if the patient has previously experienced asthma attacks induced by salicylates or substances with similar action, particularly nonsteroidal anti-inflammatory drugs (NSAIDs),
if the patient is concurrently taking methotrexate (used, among others, in cancer treatment) at doses of 15 mg per week or higher,
if the woman is in the third trimester of pregnancy,
in children under 12 years of age.

Warnings and precautions
Before starting to use Alka-Seltzer, consult a doctor or pharmacist:

if the patient has hypersensitivity to nonsteroidal anti-inflammatory and antirheumatic drugs or other allergenic substances,
if the patient is concurrently taking anticoagulant medicines,
if the patient has impaired liver function,
if the patient has impaired kidney function or circulatory disorders (e.g. renal vessel disease, congestive heart failure, reduced circulating blood volume, sepsis, severe bleeding), as acetylsalicylic acid may further increase the risk of kidney function disturbances and severe renal failure,
if the patient has a history of (chronic or recurrent) peptic ulcer disease or gastrointestinal bleeding,
if the patient suffers from a genetic disorder involving deficiency of the enzyme glucose-6-phosphate dehydrogenase, as administration of acetylsalicylic acid may trigger hemolysis or hemolytic anemia,
if the patient is breastfeeding.

Medicines containing acetylsalicylic acid should not be used in women during the first and second trimesters of pregnancy unless absolutely necessary.
Acetylsalicylic acid may cause bronchoconstriction and provoke asthma attacks or other hypersensitivity reactions. Patients with bronchial asthma, chronic respiratory diseases, hay fever, nasal polyps, or those who experience allergic reactions to other substances (e.g. skin reactions, itching, urticaria) 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 predisposed to reduced uric acid excretion, the medicine may trigger an attack of gout.
Medicines containing acetylsalicylic acid should not be given to children and adolescents during viral infections (with or without fever) without medical consultation. During certain viral illnesses, particularly influenza A and B viruses and varicella (chickenpox), there is a risk of Reye's syndrome – a rare but life-threatening condition requiring immediate medical attention.
The risk of Reye's syndrome during viral infections may increase if acetylsalicylic acid is administered concurrently, although a causal relationship has not been proven. Persistent vomiting during an infection may indicate the onset of Reye's syndrome.
Prolonged use of medicines containing acetylsalicylic acid may cause headache that worsens with continued dosing.
Long-term use of analgesic medicines, particularly those containing multiple active ingredients, may lead to severe kidney function impairment and renal failure.

Alka-Seltzer and other medicines
Inform your doctor or pharmacist about all medicines currently or recently taken, as well as any medicines planned for future use.
Particular caution is required when using Alka-Seltzer with the following medicines, as acetylsalicylic acid enhances:

the toxic effect of methotrexate on bone marrow; acetylsalicylic acid should not be used concurrently with methotrexate administered at doses of 15 mg per week or higher; concurrent use of methotrexate at doses lower than 15 mg per week requires special caution;
the effect of anticoagulants, thrombolytic drugs (clot-dissolving agents), and antiplatelet agents, which may increase the risk of prolonged bleeding time and hemorrhage;
the risk of peptic ulcer disease and gastrointestinal bleeding when used concurrently with corticosteroids, other nonsteroidal anti-inflammatory drugs (including other salicylates at high doses), or when alcohol is consumed during treatment; after discontinuation of systemic glucocorticoids (except hydrocortisone used as replacement therapy in Addison's disease), the risk of salicylate overdose increases;
the effect of digoxin (a medicine used in heart diseases), as it increases its plasma concentration;
the effect of antidiabetic medicines, e.g. insulin, sulfonylurea derivatives;
the toxic effect of valproic acid (a medicine used, among others, in epilepsy), which in turn enhances the antiplatelet effect of acetylsalicylic acid;
the effect of selective serotonin reuptake inhibitors (antidepressant medicines).

Particular caution is required when using Alka-Seltzer with the following medicines, as acetylsalicylic acid weakens their effect:

uricosuric agents used in the treatment of gout that increase uric acid excretion from the body (e.g. benzbromarone, probenecid), which may exacerbate symptoms of gout;
diuretic medicines;
certain antihypertensive medicines (from the group of so-called angiotensin-converting enzyme inhibitors), particularly if acetylsalicylic acid is used in high doses.

Alka-Seltzer may be used concurrently with the above-mentioned medicines (except methotrexate at doses of 15 mg per week or higher) only after consultation with a doctor.

Alka-Seltzer with food, drink, or alcohol
See section 3 of the leaflet.
Warning! Alcohol may increase the risk of adverse effects on the gastrointestinal tract, such as mucosal ulceration or bleeding.

Pregnancy, breastfeeding, and fertility
During pregnancy, breastfeeding, or if pregnancy is suspected or planned, consult a doctor or pharmacist before using this medicine.
Alka-Seltzer is contraindicated during the third trimester of pregnancy, as it may cause complications in the perinatal period for both mother and newborn.
Medicines containing acetylsalicylic acid should not be used in women during the first and second trimesters of pregnancy unless absolutely necessary. If acetylsalicylic acid must be used by women attempting to conceive or during the first and second trimesters of pregnancy, the lowest possible dose should be taken for the shortest possible duration.
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 reversible and resolves after discontinuation of therapy.

Driving and operating machinery
This medicine has no effect.

Alka-Seltzer contains sodium
One Alka-Seltzer tablet contains 477 mg of sodium (the main component of table salt). This corresponds to 24% of the maximum recommended daily dietary sodium intake for adults.
The maximum daily dose of this product is equivalent to 288% of the WHO recommended maximum daily sodium intake.

3. How to use Alka-Seltzer

This medicine should always be taken exactly as described in the patient information leaflet or as directed by a doctor or pharmacist.
If in doubt, consult a 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 needed, the single dose may be repeated no more frequently than every 4–8 hours. Do not take more than 12 effervescent tablets (approximately 4000 mg of acetylsalicylic acid) per day.
Children over 12 years of age:
This medicine may be used in children over 12 years of age only under medical supervision.
Take 1 effervescent tablet at a time (324 mg of acetylsalicylic acid). If needed, the single dose may be repeated up to 3 times daily, no more frequently 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 resulting effervescent solution drunk after meals.
Do not use this medicine for longer than 3–5 days without consulting a doctor.

Taking more Alka-Seltzer than recommended
Poisoning with the active substance in Alka-Seltzer may result from prolonged use (mild poisoning) or overdose (severe poisoning), which may be life-threatening, for example after accidental ingestion by children or elderly individuals.
Symptoms of mild poisoning include: dizziness (including vertigo), tinnitus, hearing loss, excessive sweating, nausea and vomiting, headache, confusion (mental disturbances with disorientation, impaired thinking and speech, hallucinations, delusions, anxiety, and psychomotor agitation), rapid breathing, deep breathing, and symptoms of respiratory alkalosis (visual disturbances such as spots before the eyes, fainting).
In cases of severe poisoning, additional symptoms may include: high fever, respiratory disturbances (up to respiratory arrest and suffocation), cardiovascular disturbances (from irregular heartbeat and low blood pressure to cardiac arrest), fluid and electrolyte loss (from dehydration and oliguria [reduced daily urine output below 400–500 ml in adults] up to kidney failure), increased or decreased blood glucose levels (especially in children), ketosis, gastrointestinal bleeding, blood coagulation disorders, and neurological disturbances manifesting as lethargy, confusion, up to coma and convulsions.
If more than the recommended dose has been taken, seek immediate medical advice from a doctor or pharmacist. In cases of severe poisoning, the patient should be taken immediately to hospital.
Treatment of poisoning includes gastric lavage, administration of activated charcoal, and alkaline diuresis. In severe cases, forced alkaline diuresis, peritoneal dialysis, or hemodialysis may be required.

Missed dose of Alka-Seltzer
If a dose is missed and symptoms persist, take the next dose of Alka-Seltzer as scheduled. Do not take a double dose to make up for a missed dose.

Stopping Alka-Seltzer
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
Warning:

If frothy vomiting or black, tarry stools occur, discontinue the medicine and consult a doctor immediately.
Signs of a severe hypersensitivity reaction may include: swelling of the face and eyelids, swelling of the tongue and larynx with airway constriction, breathing difficulties, shortness of breath up to asthma attacks, increased heart rate, sudden drop in blood pressure up to life-threatening shock. If any of these symptoms occur, immediate professional medical care must be provided. The above reactions may 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 (frothy vomiting,
tarry stools) or occult (the risk of bleeding increases with higher doses); gastric or duodenal ulcer disease, perforation.
Hepatic and biliary disorders:
Rarely, transient disturbances in liver function (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, haemorrhages (postoperative, epistaxis, gingival, urogenital), haematomas, prolonged bleeding time, prolonged prothrombin time, thrombocytopenia.
As a consequence of bleeding, acute or chronic iron-deficiency anaemia or acute haemorrhagic anaemia may occur, manifesting as asthenia, pallor, hypoperfusion, and abnormal laboratory findings.
Haemolysis and haemolytic anaemia in patients with severe glucose-6-phosphate dehydrogenase deficiency.
Vascular disorders:
Intracerebral haemorrhage (particularly in patients with uncontrolled hypertension and/or concurrently using other anticoagulant medicines), potentially life-threatening.
Renal and urinary disorders:
Renal function disturbances and severe renal failure.
Immune system disorders:
Hypersensitivity reactions with clinical symptoms and abnormal laboratory findings such as: asthma, mild to moderate reactions affecting the skin, respiratory system, cardiovascular system with symptoms including: rash, urticaria, angioedema (including vasomotor), respiratory and cardiac disturbances, rhinitis, nasal mucosal hyperaemia, and very rarely severe reactions, including anaphylactic shock.
Respiratory system disorders:
Bronchial asthma.
Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, phone: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl.
Reporting adverse reactions enables continuous monitoring of the benefit-risk balance of the medicine and helps to increase knowledge about its safety.

5. How to store Alka-Seltzer

Do not store above 25°C.
Keep the medicine 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 stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the pack and other information

What Alka-Seltzer contains
The active substance is acetylsalicylic acid (Acidum acetylsalicylicum). Each effervescent tablet contains 324 mg of acetylsalicylic acid.
Other components are: sodium hydrogen carbonate, sodium carbonate, citric acid.

What Alka-Seltzer looks like and contents of the pack
One double sachet contains 2 effervescent tablets.
The 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 available on the market.

For more detailed information, please contact the marketing authorisation holder or the parallel importer.

Marketing authorisation holder in France, the country of export:
Bayer Healthcare SAS
220, Avenue de la Recherche
59120 Loos
France

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

Parallel importer:
InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw
Poland

Repackaged in:
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Poland

Marketing authorisation numbers in France, the country of export: 329268-7
329110-4
Parallel import authorisation number: 49/13