Aspirina 500 mg effervescent tablets

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Aspirin 500 mg effervescent tablets

Acetylsalicylic acid

Package leaflet contents

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

1. What Aspirin is and what it is used for

Acetylsalicylic acid, the active ingredient in this medicine, belongs to a group of medicines known as non-steroidal anti-inflammatory drugs (NSAIDs). It relieves pain and reduces fever.

This medicine is used for the symptomatic relief of mild to moderate occasional pain, such as headaches, toothaches, menstrual pain, muscle pain (cramps), or back pain (lumbago), and for feverish conditions in adults and adolescents over 16 years of age.

You should consult a doctor if your condition worsens or does not improve after 5 days for pain or 3 days for fever.

2. What you need to know before taking Aspirin

Do not take Aspirin if

• you are allergic or have had an allergic reaction to acetylsalicylic acid or to any other component of this medicine (listed in section 6),
• you have a stomach or intestinal ulcer, or recurrent gastric discomfort,
• you have experienced allergic-type asthma reactions (difficulty breathing, suffocation, bronchospasms, and in some cases coughing or wheezing) when taking anti-inflammatory drugs, acetylsalicylic acid, other analgesics, or the tartrazine dye,
• you suffer from or have had asthma,
• you have nasal polyps associated with asthma that are caused or worsened by acetylsalicylic acid,
• you have haemophilia or other blood coagulation disorders,
• you are being treated with oral anticoagulant medications,
• you have kidney and/or liver disease (renal and/or hepatic insufficiency),
• you are under 16 years of age, as the use of acetylsalicylic acid has been linked to Reye's syndrome, a rare but serious illness,
• you are in the third trimester of pregnancy.

Take special care with Aspirin

• if you have high blood pressure, or reduced kidney, heart, or liver function, or have blood coagulation disorders,
• if you have previously suffered from a stomach or intestinal ulcer,
• if you are taking anticoagulants, you must consult your doctor before taking this medicine,
• if you are taking anti-inflammatory drugs or other medicines, as certain medications may interact with Aspirin 500 mg effervescent tablets and cause undesirable effects (see section “Other medicines and Aspirin”),
• if you are allergic to other anti-inflammatory or anti-rheumatic drugs,
• if you have glucose-6-phosphate dehydrogenase deficiency,
• if you suffer from or have had rhinitis or urticaria,
• if you have recently undergone or are scheduled to undergo surgery within the next 7 days, including dental surgery,
• if you are in the first or second trimester of pregnancy,
• do not administer systematically to prevent possible discomfort caused by vaccinations.

Other medicines and Aspirin

Inform your doctor or pharmacist if you are using or have recently used any other medicines, including those obtained without a prescription, homeopathic remedies, herbal medicines, and other health-related products, as it may be necessary to interrupt treatment or adjust the dose of one of them.

This is especially important in the case of:

• other analgesics or non-steroidal anti-inflammatory drugs (medicines used to treat pain and/or muscle inflammation),
• certain antidepressants, such as selective serotonin reuptake inhibitors, as they increase the risk of bleeding,
• anticoagulants (medicines used to “thin” the blood and prevent clot formation) such as warfarin,
• oral antidiabetic agents (medicines to lower blood sugar levels),
• barbiturates (medicines used to treat seizures),
• beta-blockers (medicines for controlling high blood pressure),
• cimetidine and ranitidine (used for stomach acidity),
• medicines used to prevent transplant rejection (cyclosporine and tacrolimus),
• corticosteroids, as they may increase the risk of gastrointestinal bleeding,
• digoxin (a heart medicine),
• high blood pressure (diuretics and ACE inhibitors),
• phenytoin and valproic acid (antiepileptics),
• interferon alfa (used in the treatment of certain viral infections and tumours),
• lithium (used in certain psychiatric conditions),
• cancer or rheumatoid arthritis (methotrexate),
• medicines used to treat gout (probenecid),
• vancomycin (an antibiotic used for infections),
• zidovudine (used in the treatment of patients infected with the human immunodeficiency virus, HIV).

Interference with diagnostic tests

If you are scheduled to undergo any diagnostic tests (including blood and urine tests, etc.), inform your doctor that you are taking this medicine, as it may alter test results.

Taking Aspirin with food, drinks, and alcohol

Take this medicine after meals or with food.

If you regularly consume alcohol (three or more alcoholic drinks – beer, wine, spirits, etc. – per day), taking Aspirin may cause stomach bleeding.

Pregnancy

Consult your doctor or pharmacist before using any medicine.

Breastfeeding

Consult your doctor or pharmacist before using any medicine.

Women who are breastfeeding should consult their doctor before using this medicine, as acetylsalicylic acid passes into breast milk.

Use in children

Do not administer to children under 16 years of age.

Use in elderly (over 65 years)

Elderly individuals should not take this medicine without consulting their doctor, as they are more likely to experience adverse effects.

Driving and use of machines

No effects on the ability to drive or operate machinery have been reported.

Aspirin contains sodium

This medicine contains 543 mg of sodium (the main component of table/cooking salt) per tablet. This corresponds to 27% of the maximum daily intake of sodium recommended for an adult.

Consult your doctor or pharmacist if you need to take one or more tablets daily for a prolonged period, especially if you have been advised to follow a low-salt (low-sodium) diet.

3. How to take Aspirin

Follow exactly the dosage instructions provided in this leaflet or those given by your doctor or pharmacist. If in doubt, ask your doctor or pharmacist.

This medicine is taken orally.

Adults and adolescents over 16 years of age: 1 effervescent tablet (500 mg acetylsalicylic acid) every 4 to 6 hours, if necessary. Do not exceed 8 effervescent tablets (4 g acetylsalicylic acid) in 24 hours.

Patients with reduced liver or kidney function: consult your doctor, as the dose should be reduced.

Completely dissolve the effervescent tablet in a glass of water and drink the entire contents of the glass once the fizzing has completely stopped.

Take the medicine after meals or with food, especially if you experience gastrointestinal discomfort.

Do not take this medicine on an empty stomach.

Always use the lowest dose that is effective.

Administration of this preparation should be based on the presence of pain or fever symptoms. As these symptoms subside, treatment should be discontinued.

If pain persists for more than 5 days, fever for more than 3 days, or if symptoms worsen or new symptoms appear, discontinue treatment and consult your doctor.

If you take more Aspirin than you should

The main symptoms of overdose are: headache, dizziness, tinnitus (ringing in the ears), blurred vision, drowsiness, sweating, rapid breathing, confusion, nausea, vomiting, and occasionally diarrhea.

It is recommended to bring the medicine packaging and leaflet to the healthcare professional.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately, go immediately to a medical center, or call the Toxicology Information Service at: 91 562 04 20, indicating the medicine and the amount ingested.

4. Possible adverse effects

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

Common adverse effects (may affect up to 1 in 10 people):

• Gastrointestinal disorders, such as stomach ulcer, intestinal ulcer, gastrointestinal bleeding, abdominal pain, indigestion, burning sensation, acid reflux, gastric discomfort, nausea, and vomiting.

• Respiratory disorders, such as difficulty breathing (asthma, bronchospasm), nasal congestion, and rhinitis.

• Urticaria, skin rashes, angioedema (swelling and inflammation affecting the face, lips, mouth, tongue, or throat, which may cause difficulty swallowing or breathing), and itching.

• Hypoprothrombinemia (a blood coagulation disorder) when administered at high doses.

Uncommon adverse effects (may affect up to 1 in 100 people):

• Reye's syndrome in children under 16 years of age with fever, influenza, or varicella (see section “Before taking Aspirin”).

• Liver disorders, especially in patients with juvenile arthritis.

• Anaemia.

With prolonged use of acetylsalicylic acid, the following adverse effects have been observed, although their frequency cannot be precisely estimated: dizziness, tinnitus, deafness, sweating, headache, confusion, renal failure, and acute interstitial nephritis (inflammation at the kidney level).

If you notice any of the following:

• stomach discomfort or pain, gastric or intestinal bleeding, or black stools,
• skin disorders such as rashes or redness,
• difficulty breathing,
• unexpected changes in the amount or appearance of urine,
• swelling of the face, feet, or legs,
• deafness, ringing in the ears, or dizziness,

stop taking the medicine and consult your doctor immediately, as these may indicate adverse effects requiring urgent medical attention.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicines: https://notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Aspirin

Do not store above 25°C.

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the packaging, following the abbreviation EXP. The expiry date refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the Punto Sigre collection point at your pharmacy. If you are unsure how to dispose of unused medicines and their packaging, ask your pharmacist for advice. This helps protect the environment.

6. Contents of the pack and other information

Composition of Aspirin

Each effervescent tablet contains as the active substance: acetylsalicylic acid, 500 mg. The other components (excipients) are: sodium citrate, sodium hydrogen carbonate, citric acid and sodium carbonate.

Appearance of Aspirin and contents of the pack

Round, white effervescent tablets with the Bayer cross anagram on one side and "Aspirin 0.5" on the other.

Available in packs containing 2, 10 and 20 effervescent tablets. Only certain pack sizes may be marketed.

Marketing Authorisation Holder

Bayer Hispania, S.L
Av. Baix Llobregat, 3-5
08970 Sant Joan Despí (Barcelona)
Spain

Manufacturer

Bayer Bitterfeld GmbH
OT Greppin
Salegaster Chausee, 1
06803 Bitterfeld-Wolfen (Germany)

Date of the most recent revision of this leaflet: October 2023

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es