Aspirin effervescent

Package leaflet: Information for the patient

ASPIRIN effervescent, 500 mg, effervescent tablets
Acidum acetylsalicylicum
Please read the entire leaflet carefully before taking the medicine, as it contains
important information for the patient.
This medicine should always be used exactly as described in this patient information leaflet or as directed by a doctor or pharmacist.

• Keep this leaflet, as you may need to read it again.
• If you need advice or further information, please consult your pharmacist.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.
• If there is no improvement or if you feel worse after 3–5 days, you should consult a doctor.

Table of contents:

1. What Aspirin effervescent is and what it is used for
2. Important information before taking Aspirin effervescent
3. How to take Aspirin effervescent
4. Possible side effects
5. How to store Aspirin effervescent
6. Contents of the pack and other information

1. What Aspirin effervescent is and what it is used for

Aspirin effervescent contains acetylsalicylic acid, which has analgesic, anti-inflammatory, and antipyretic properties.
Indications for use:

• Mild to moderate pain: headaches of various origins (e.g. migraine), toothache, muscle pain,
• Pain and fever associated with colds and influenza.

2. Important information before using Aspirin musująca

When not to use Aspirin musująca

• 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 kidney failure,
• if the patient has previously experienced asthma attacks induced by salicylates or substances with similar effects, particularly non-steroidal 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 patient is in the last trimester of pregnancy,
• in children under 12 years of age.

Warnings and precautions
Before starting treatment with Aspirin musująca, discuss this with your 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 concurrently taking anticoagulant medicines,
• if the patient has impaired liver function,
• if the patient has impaired kidney function or circulatory disorders (e.g. renal vascular disease, congestive heart failure, reduced circulating blood volume, sepsis, severe bleeding), as acetylsalicylic acid may further increase the risk of kidney function disorders and severe kidney failure,
• if the patient has had a history of (chronic or recurrent) peptic ulcer 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 mucosa polyps, or those with allergic reactions to other substances (e.g. skin rashes, itching, urticaria) are particularly at risk.
Patients undergoing surgical procedures (including minor procedures such as tooth extraction) should inform their doctor about taking Aspirin musująca.
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.
During certain viral infections, particularly influenza A, influenza B, or varicella (chickenpox), mainly in children and adolescents, there is a risk of Reye's syndrome – a rare but life-threatening condition. Persistent vomiting during an infection may indicate the onset of Reye's syndrome, 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.
For these reasons, medicines containing acetylsalicylic acid should not be used in children under 12 years of age, and in adolescents over 12 years of age, such medicines should be used only on a doctor's advice.
Long-term use of medicines containing acetylsalicylic acid may cause headaches that worsen with each subsequent dose.
Prolonged use of analgesic medicines, particularly those containing multiple active substances, may lead to severe kidney function disorders and kidney failure.

Aspirin musująca with other medicines
Inform your doctor or pharmacist about all medicines currently taken or recently taken, as well as any medicines you plan to take.
Particular caution is required when using Aspirin musująca 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 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 platelet aggregation inhibitors, which may increase the risk of prolonged bleeding time and hemorrhage;
• the risk of peptic ulcer disease and gastrointestinal bleeding if used concurrently with corticosteroids, other non-steroidal anti-inflammatory drugs (including other salicylates), or if alcohol is consumed during treatment;
• after discontinuation of systemic-acting glucocorticosteroids (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 Aspirin musująca 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).

Aspirin musująca 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.

Aspirin musująca with food, drink, and 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 effect on fertility

If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult her doctor or pharmacist before using this medicine.

Pregnancy
Do not take Aspirin musująca during the last three months of pregnancy, as it may harm the unborn child or cause complications during delivery. The medicine may cause kidney and heart function disorders in the unborn child. It may also affect the tendency of both mother and child to bleed and may delay or prolong labor. Aspirin musująca should not be used during the first six months of pregnancy unless absolutely necessary and prescribed by a doctor. If treatment is required during this period or when trying to conceive, the lowest possible dose for the shortest possible time should be used. If Aspirin musująca is taken for longer than a few days after the 20th week of pregnancy, it may cause kidney function disorders in the unborn child, which may lead to reduced volume of amniotic fluid surrounding the fetus (oligohydramnios), or narrowing of the blood vessel (ductus arteriosus) in the child's heart. If prolonged treatment beyond a few days is necessary, the doctor may recommend additional monitoring.

Breastfeeding
Acetylsalicylic acid passes into breast milk in small amounts.

Fertility
Aspirin musująca 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 does not affect the ability to drive or operate machinery.

Aspirin musująca contains sodium
One effervescent tablet contains 543 mg of sodium (the main component of table salt). This corresponds to 27% of the maximum recommended daily dietary sodium intake for adults. The maximum daily dose of this product is equivalent to 216% of the WHO recommended maximum daily sodium intake. This should be taken into account in patients with reduced kidney function and in patients monitoring sodium intake in their diet.

3. How to take Aspirin musująca

This medicine should always be taken exactly as described in the patient leaflet or as directed by a doctor or pharmacist. If in doubt, consult a doctor or pharmacist.

The recommended dose of Aspirin musująca is:

• Adults: 1 to 2 effervescent tablets (i.e. 500–1000 mg acetylsalicylic acid) as a single dose. If necessary, the single dose may be repeated no more frequently than every 4 to 8 hours. Do not exceed 8 effervescent tablets (i.e. 4000 mg acetylsalicylic acid) per day.
• Adolescents over 12 years of age: This medicine may be used in adolescents over 12 years of age only on a doctor's advice. Take 1 effervescent tablet (i.e. 500 mg acetylsalicylic acid) as a single dose. If necessary, the single dose may be repeated no more frequently than every 4 to 8 hours. Do not exceed 3 effervescent tablets (i.e. 1500 mg acetylsalicylic acid) per day. Do not use this medicine for longer than 3–5 days without consulting a doctor.

The effervescent tablets should be dissolved in a glass of water and the resulting effervescent solution drunk. Take after meals.

Taking more Aspirin musująca than recommended

Poisoning with the active substance in Aspirin musująca may result from long-term use of the medicine (mild poisoning) or overdose (severe poisoning), which may be life-threatening, e.g. after accidental ingestion by children or elderly persons.

Symptoms of mild poisoning include: dizziness (including labyrinthine vertigo), tinnitus, deafness, excessive sweating, nausea and vomiting, headache, confusion (disturbances of consciousness with disorientation, disturbances of thinking and speech, hallucinations, illusions, 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 occur: high fever, respiratory disorders (up to respiratory arrest and suffocation), disturbances of heart and blood vessel function (from irregular heartbeat and low blood pressure to cardiac arrest), fluid and electrolyte loss (from dehydration, oliguria [reduced daily urine output below 400–500 ml in adults] up to kidney failure), increased or decreased blood glucose concentration (especially in children), ketosis, gastrointestinal bleeding, blood clotting 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 case of severe poisoning, the patient must 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 necessary.

If you forget to take Aspirin musująca

If a dose is missed and symptoms persist, take the next dose of Aspirin musująca as scheduled. Do not take a double dose to make up for a missed dose.

Stopping Aspirin musująca

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

4. Possible adverse effects

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

• If frothy vomiting or black, tarry stools occur, discontinue the medicine and consult a doctor immediately.
• Severe hypersensitivity reactions may include: facial and eyelid swelling, swelling of the tongue and larynx with airway constriction, difficulty breathing, shortness of breath up to asthma attacks, rapid heartbeat, sudden drop in blood pressure up to life-threatening shock. In the event of any of these symptoms, 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 (bleeding occurs more frequently with higher doses); gastric or
duodenal ulcer disease, perforation, constrictive intestinal enteropathy (particularly during
long-term use).

Liver and biliary system disorders:
In rare cases transient disturbances in liver function (increased aminotransferase activity) have been reported.

Nervous system disorders:
Dizziness and tinnitus, typically symptoms of overdose.

Blood and lymphatic system disorders:
Increased risk of bleeding, haemorrhages (postoperative, epistaxis, gingival bleeding, urinary-genital bleeding),
bruising, prolonged bleeding time and prothrombin time, thrombocytopenia.
Bleeding may lead to iron deficiency anaemia or haemorrhagic anaemia, manifesting as asthenia, pallor, hypoperfusion, and abnormal laboratory test results.
Haemolysis and haemolytic anaemia in patients with severe glucose-6-phosphate dehydrogenase deficiency.

Vascular disorders:
Cerebral haemorrhage (particularly in patients with uncontrolled hypertension and/or concomitant use of other anticoagulant medicines), potentially life-threatening.

Renal and urinary disorders:
Renal function impairment and severe kidney damage.

Immune system disorders:
Hypersensitivity reactions with clinical symptoms and abnormal laboratory findings such as: respiratory disease exacerbated by acetylsalicylic acid intake, mild to moderate reactions affecting the skin, respiratory system, cardiovascular system with symptoms such as: rash, urticaria, angioedema (including vasomotor angioedema), breathing difficulties and cardiac disturbances, rhinitis, nasal mucosal congestion, and very rarely severe reactions, including anaphylactic shock.

Respiratory system disorders:
Bronchial asthma.

Reporting of adverse effects
If any adverse effects occur, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse.
Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions at 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
Adverse effects can also be reported to the marketing authorisation holder.
Reporting adverse effects helps to gather further information on the safety of the medicine.

5. How to store Aspirin musująca

Store below 25°C.
Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton following "EXP:".
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 Aspirin musująca contains

• The active substance is acetylsalicylic acid (Acidum acetylsalicylicum).
• The other ingredients are: sodium citrate, sodium bicarbonate, citric acid, sodium carbonate.

What Aspirin musująca looks like and contents of the pack
White, round effervescent tablets packed in sachets. The pack contains 10, 12 or 24 effervescent tablets.
Marketing Authorisation Holder:
Bayer Sp. z o.o.
Al. Jerozolimskie 158
02-326 Warsaw
Tel.: +48 22 572 35 00
Fax: +48 22 572 35 55
Manufacturer:
Bayer Bitterfeld GmbH
OT Greppin
Salegaster Chaussee 1
06803 Bitterfeld-Wolfen
Germany