Aspirin 500 mg granules

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Aspirin 500 mg granules

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 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 (muscle spasms), or back pain (lumbago), and for fever 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 have 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 previously had 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 medicines may interact with Aspirin 500 mg granules 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 currently using, have recently used, or might use 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 with:

• 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 clots), such as warfarin,
• oral antidiabetics (medicines to lower blood sugar levels),
• barbiturates (medicines used to treat seizures),
• beta-blockers (medicines for blood pressure control),
• 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 scheduled for 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 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.

If you are pregnant or think you might be, consult your doctor before taking this medicine.

Pregnancy – third trimester

Do not take Aspirin during the last three months of pregnancy, as it may harm the fetus or cause complications during delivery. This medicine may cause kidney and heart problems in the fetus. It may also affect your tendency to bleed and that of your baby, potentially delaying or prolonging labour.

Pregnancy – first and second trimesters

You should not take Aspirin during the first six months of pregnancy unless absolutely necessary and advised by your doctor. If treatment is required during this period or while trying to conceive, the dose should be limited to the lowest possible for the shortest possible time.

If you take Aspirin for several days from week 20 of pregnancy onwards, it may cause kidney problems in the fetus, leading to low levels of amniotic fluid (oligohydramnios) or narrowing of a blood vessel (ductus arteriosus) in the baby's heart. If prolonged treatment is needed, your doctor may recommend additional monitoring.

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 people aged 65 years and over

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

Driving and using machines

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

Aspirin contains phenylalanine and sodium

This medicine contains 5 mg of aspartame per sachet. Aspartame is a source of phenylalanine, which may be harmful if you have phenylketonuria (PKU), a rare genetic disorder in which phenylalanine accumulates because the body cannot properly eliminate it.

This medicine contains less than 1 mmol of sodium (23 mg) per sachet; thus, it is essentially “sodium-free”.

3. How to take Aspirin

Follow exactly the dosage instructions for this medicine 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 sachet (500 mg acetylsalicylic acid) every 4 or 6 hours, if necessary. Do not exceed 8 sachets (4 g acetylsalicylic acid) in 24 hours.

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

The granules should be placed directly on the tongue. They disperse in saliva before swallowing, so simultaneous intake of water is not necessary.

Take the medicine with meals or food, especially if gastrointestinal discomfort is noticed.

Do not take this medicine on an empty stomach.

Always use the lowest effective dose.

This preparation should only be administered when pain or fever symptoms appear. As symptoms subside, this medication 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 package 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 telephone: 91 562 04 20, stating the medicine and the amount ingested.

4. Possible adverse effects

Like all medicines, this medicine can 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, heartburn, 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 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, deafness, sweating, headache, confusion, renal failure, and acute interstitial nephritis (inflammation of the kidney).

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 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 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 drains or household waste. Dispose of unused medicines and their packaging at the Sigre Point located at your pharmacy. If you are in doubt, ask your pharmacist how to properly dispose of medicines and packaging you no longer need. This way, you will help protect the environment.

6. Contents of the pack and other information

Composition of Aspirin

Each sachet contains as the active substance: 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 flavor, and cola flavor.

Appearance of Aspirin and pack contents

White to slightly yellowish granules.

It is available in packs containing 2, 10 or 20 sachets. Only certain pack sizes may be marketed.

Marketing Authorization Holder

Bayer Hispania, S.L.

Av. Baix Llobregat, 3-5

08970 Sant Joan Despí (Barcelona)

Spain

Manufacturer

Bayer Bitterfeld GmbH

OT Greppin

Salgaster Chausee, 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 of Medicines and Health Products (AEMPS) http://www.aemps.gob.es