Label: information for the user

Aspirin 500 mg powder

Acetylsalicylic acid

1. Contents of the package and additional information

The active ingredient, acetylsalicylic acid, 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 pain, such as headaches, toothaches, menstrual cramps, muscle pain (muscle spasms) or back pain (lower back pain) and fever 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, intestinal, orrecurring gastrointestinal problems,
• you have had allergic reactions of the asthmatic type (difficulty breathing, choking, bronchospasm, and in some cases, coughing or wheezing) when taking anti-inflammatory agents, acetylsalicylic acid, other analgesics, as well as tartrazine dye,
• you have or have had 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 stomach or intestinal ulcers,
• if you are taking anticoagulants, you should consult your doctor before taking this medication,
• if you are taking anti-inflammatory agents or other types of medications, as certain medications may interact with Aspirin 500 mg granulated and produce undesirable effects (see "Use of other medications"),
• if you are allergic to other anti-inflammatory agents or antirheumatics,
• 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 in 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 non-steroidal 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 agents (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 (ciclosporin 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 (probenecid),
• vancomycin (antibiotic used for infections),
• zidovudine (used in the treatment ofpatients infected with the human immunodeficiency virus, the cause of 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 Aspirinmay cause stomach bleeding.

Pregnancy

Consult your doctor or pharmacist beforeusingany medication.

If you are pregnant or think you may be pregnant, consult your doctor before taking this medication.

Pregnancy – last trimester

Do not take Aspirin if you are in the last 3 months of pregnancy, as it may harm the fetus or cause problems during delivery. This medication may cause kidney and heart problems in the fetus. It may affect your bleeding tendency and that of your baby, causing a possible delay in delivery or prolonging it longer than expected.

Pregnancy – first and second trimester

Do not take Aspirin during the first 6 months of pregnancy unless absolutely necessary and advised by your doctor. If you need treatment during this period or while trying to become pregnant, the dose will be limited to the lowest possible for the shortest time possible.

If you take Aspirin for several days from week 20 of pregnancy, it may cause kidney problems in the fetus that may lead to low amniotic fluid levels (oligohydramnios) or narrowing of a blood vessel (ductus arteriosus) in the baby's heart. If you need treatment for several days, your doctor may recommend additional follow-up.

Lactation

Consult your doctor or pharmacist beforeusingany medication.

Women in the lactation period 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 of advanced age 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 have been described on the ability to drive or operate machinery.

Aspirin contains phenylalanine and sodium

This medication contains 5 mg of aspartame in each sachet. Aspartame contains a source of phenylalanine that may be harmful in the case of phenylketonuria (PKU), a rare genetic disorder in which phenylalanine accumulates because the body is unable to eliminate it correctly.

This medication contains less than 1 mmol of sodium (23 mg) per sachet; it is essentially "sodium-free".

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: 1 tablet (500 mg of acetylsalicylic acid) every 4 or 6 hours, if necessary. Do not exceed 8 tablets (4 gof acetylsalicylic acid) in 24 hours.

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

The granule should be placed directly on thetongue.It disperses in the saliva before swallowing, so it is not necessary to take water at the same time.

Take the medication with meals or with food, especially if digestive discomfort is noted.

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, mental confusion, nausea, vomiting, and occasionally diarrhea.

It is recommended to bring the packaging and the 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 Toxicological 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, acidity, 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 can cause difficulty swallowing or breathing) and itching.
• Hypoprothrombinemia (coagulation alteration) when administered in high doses.

Less frequent 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 noises, 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, gastric or intestinal hemorrhage, or black stools,
• skin disorders, such as rashes or redness,
• difficulty breathing,
• unexpected change in the amount or appearance of urine,
• swelling of the face, feet, or legs,
• hearing loss, ear ringing, 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 at a temperature above 25°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 in the 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 blister pack contains as active ingredient: acetylsalicylic acid, 500 mg. The other components (excipients) are: mannitol (E-421), aspartame (E-951), sodium hydrogen carbonate, sodium dihydrogen citrate, ascorbic acid (E-300), citric acid, orange and cola flavor.

Appearance of Aspirin and content of the packaging

White to slightly yellowish granule.

It is presented in packaging that contains 2, 10 or 20 blister packs. Some packaging sizes may only be marketed.

Marketing Authorization Holder

Bayer Hispania, S.L

Av. 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:October 2023

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