Package Insert: Information for the User

Aspirin 500 mg Tablets

Acetylsalicylic Acid

Acetylsalicylic acid, the active ingredient of this medication, belongs to a group of medications known as nonsteroidal anti-inflammatory drugs (NSAIDs). It relieves pain and reduces fever.

This medication is used for the symptomatic relief of occasional mild to moderate pains, such as headaches, toothaches, menstrual cramps, muscle cramps (contractures) or back pain (lumbago) and febrile states in adults and adolescents over 16 years old.

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

Do not take Aspirin if

• you are allergicor have had an allergic reaction to acetylsalicylic acid or toany other component of this medication (listed in section 6),
• you have a stomach ulcer, intestinal ulcer, orrecurring stomach or intestinal discomfort,
• you have had an allergic reaction of the asthmatic type (difficulty breathing, choking, bronchospasm, and in some cases, coughing or wheezing) when taking anti-inflammatory medications, acetylsalicylic acid, other analgesics, as well as tartrazine dye,
• you have asthma,
• you have nasal polyps associated with asthma that are produced or increased by acetylsalicylic acid,
• you have hemophilia or other bleeding disorders,
• you are takingoral anticoagulants,
• you have kidney and/or liver diseases (renal and/or hepatic insufficiency),
• you are under 16 years old, as the use of acetylsalicylic acid has been associated with Reye's syndrome, a rare but serious disease,
• you are in your third trimester of pregnancy.

Be especially careful with Aspirin

You should consult your doctor if you need this medication:

• if you have high blood pressure,or have reduced kidney, heart, or liver function, or have bleeding disorders,
• if you have had a stomach or intestinal ulcer,
• if you are taking anticoagulants, you should consult your doctor before taking this medication,
• if you are taking anti-inflammatory medications or other types of medications, as certain medications may interact with Aspirin 500 mg tablets and produce undesirable effects (see "Use of other medications"),
• if you are allergic to other anti-inflammatory or antirheumatic medications,
• if you have a deficiency of glucose-6-phosphate dehydrogenase,
• if you have or have had rhinitis or urticaria,

• if you have recently undergone or will 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 medications and Aspirin

Inform your doctor or pharmacist if you are using or have recently used other medications, including those purchased without a prescription, homeopathic, herbal, 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 nonsteroidal anti-inflammatory drugs (medications used to treat pain and/or muscle inflammation),
• some antidepressants, such as selective serotonin reuptake inhibitors, as it increases the risk of bleeding,
• anticoagulants (medications used to "thin" the blood and prevent the formation of blood clots) such as warfarin,
• oral antidiabetic medications (medications to reduce blood sugar levels),
• barbiturates (medications used to treat seizures),
• beta-blockers (medications for blood pressure control),
• cimetidine and ranitidine (used for stomach acid),
• medications used to prevent transplant rejection (cyclosporine and tacrolimus),
• corticosteroids, as it may increase the risk of gastrointestinal bleeding,
• digoxin (heart medication),
• high blood pressure (diuretics and ACE inhibitors),
• phenytoin and valproic acid (antiepileptic medications),
• interferon alpha (used to treat certain viral and tumor infections),
• lithium (used in some psychiatric disorders),
• cancer or rheumatoid arthritis (methotrexate),
• medications used to treat gout (probencid),
• vancomycin (antibiotic used for infections),
• zidovudine (used in the treatment ofpatients infected with the human immunodeficiency virus, which causes AIDS).

Interference with diagnostic tests

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

Taking Aspirin with food, drinks, and alcohol

Take this medication after meals or with some food.

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

Pregnancy

Consult your doctor or pharmacist before using any medication.

Lactation

Consult your doctor or pharmacist before using any medication.

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

Use in children

Do not administer to children under 16 years old.

Use in people over 65 years old

People over 65 years old should not take this medication without consulting their doctor, as they are more prone to experiencing its adverse effects.

Driving and operating machinery

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

Follow exactly the medication administration instructions contained in this leaflet or those indicated by your doctor or pharmacist. If in doubt, ask your doctor or pharmacist.

This medication is administered orally.

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

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

Tablets should be taken with a glass of water, after meals or with some food.

Do not take this medication on an empty stomach.

Always use the lowest effective dose.

The administration of this preparation is subject to the appearance of painful or febrile symptoms. As these symptoms disappear, discontinue this medication.

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

If you take more Aspirin than you should

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

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

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

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

Frequent side effects (may affect up to 1 in 10 people):

• Gastrointestinal disorders, such as stomach ulcers, intestinal ulcers, gastrointestinal bleeding, abdominal pain, heavy digestion, heartburn, acid reflux, stomach discomfort, nausea, and vomiting.

• Respiratory disorders, such as difficulty breathing (asthma, bronchial spasm), nasal congestion, and rhinitis.
• Urticaria, skin rashes, angioedema (inflammation and swelling that affects the face, lips, mouth, tongue, or throat, which may cause difficulty swallowing or breathing) and itching.
• Hypoprothrombinemia (coagulation alteration) when administered in high doses.

Rare side effects (may affect up to 1 in 100 people):

• Reye's syndrome in children under 16 years with feverish processes, flu, or chickenpox (see section "Before starting to take Aspirin").

• Liver disorders, especially in patients with juvenile arthritis.
• Anemia.

With prolonged doses of acetylsalicylic acid, the following side effects have been observed, whose frequency has not been established with precision: dizziness, ear ringing, hearing loss, sweating, headache, confusion, renal insufficiency, and acute interstitial nephritis (inflammation at the kidney level).

If you notice the appearance of:

• uncomfort or stomach pain, gastrointestinal bleeding or intestinal, or black stools,
• skin disorders, such as rashes or redness,
• difficulty breathing,
• unpredictable change in the amount or appearance of urine,
• swelling of the face, feet, or legs,
• hearing loss, ear buzzing, or dizziness,

stop taking the medicine and consult your doctor immediately, as they may indicate the appearance of side effects that require urgent medical attention.

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is possible side effects that do not appear in this prospectus. You can also report them directly through the Spanish System of Pharmacovigilance of Medicines for Human Use:https://notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Do not store above 86°F (30°C).

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

Do not use this medication after the expiration date that appears on the packaging, following the CAD abbreviation. The expiration date is the last day of the month indicated.

Medications should not be disposed of through drains or trash. Dispose of packaging and medications you no longer need at the Sigre Point of your pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Aspirin

Each tablet contains as active ingredient: acetylsalicylic acid, 500 mg. The other components (excipients) are: powdered cellulose and cornstarch.

Appearance of Aspirin and content of the packaging

Round tablets of white color with the Bayer cross logo on one face and Aspirin 0.5 on the other.

Presented in propylene and aluminum blisters with 10 tablets.

Available in packaging with 10 or 20 tablets.

Only some packaging sizes may be commercially marketed.

Marketing Authorization Holder

Bayer Hispania, S.L

Avenida Baix Llobregat, 3-5

08970 Sant Joan Despí (Barcelona)

Spain

Responsible for Manufacturing

Bayer Bitterfeld GmbH

OT Greppin

Salegaster Chausee, 1

06803 Bitterfeld-Wolfen

Germany

Last review date of this leaflet:October2023

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es