Aspirin 500 mg tablets

Patient Information Leaflet

Introduction

Patient Information Leaflet

Aspirin 500 mg 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 substance of 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 any 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 stomach 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 painkillers, or the tartrazine dye,
• you have 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 clotting disorders,
• you are being treated with oral anticoagulant medicines,
• 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

You should consult your doctor if you need this medicine:

• if you have high blood pressure, or reduced kidney, heart, or liver function, or have blood clotting disorders,
• if you have had a stomach or intestinal ulcer,
• if you are taking anticoagulants, you should consult your doctor before taking this medicine,
• if you are taking anti-inflammatory drugs or other medicines, as certain medicines may interact with Aspirin 500 mg 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 have 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 medicines, herbal remedies, 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 painkillers 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 to treat certain viral and tumour infections),
• 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 due to have any diagnostic tests (including blood and urine tests), 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 some food.

If you regularly consume alcohol (three or more alcoholic drinks – beer, wine, spirits, etc. – per day), taking Aspirin may cause you to develop 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 individuals under 16 years of age.

Use in individuals 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.

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, consult your doctor or pharmacist.

This medicine is taken orally.

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

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

The tablets should be taken with a glass of water, after meals or with food.

Do not take this medicine on an empty stomach.

Always use the lowest effective dose.

This medication should only be taken when pain or fever symptoms occur. As 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 include: 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, contact your doctor or pharmacist immediately, go to a medical center immediately, or call the Toxicology Information Service at: 91 562 04 20, stating the name of 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, dyspepsia, burning sensation, heartburn, 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 individuals 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 determined: dizziness, tinnitus, hearing loss, sweating, headache, confusion, renal failure, and acute interstitial nephritis (inflammation affecting the kidney).

If you experience 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,
• hearing loss, 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 via the Spanish Pharmacovigilance System for Human Medicinal Products: 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 30°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 should 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, ask your pharmacist how to properly dispose of unused medicines and their packaging. This way, you will help protect the environment.

6. Contents of the pack and other information

Composition of Aspirin

Each tablet contains as the active substance: acetylsalicylic acid, 500 mg. The other components (excipients) are: powdered cellulose and corn starch.

Appearance of Aspirin and contents of the pack

White, round tablets bearing the Bayer cross anagram on one side and "ASPIRIN 0.5" on the other.

Packaged in polypropylene and aluminum blisters containing 10 tablets.

Pack sizes: 10 or 20 tablets.

Only some pack sizes may be commercially available.

Marketing Authorization Holder

Bayer Hispania, S.L.

Av. Baix Llobregat, 3-5

08970 Sant Joan Despí (Barcelona)

Spain

Manufacturer

Bayer Bitterfeld GmbH

OT Greppin

Salgau Chaussee, 1

06803 Bitterfeld-Wolfen

Germany

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

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