Aspirina Plus 500 mg/50 mg tablets

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

ASPIRIN PLUS 500 mg/50 mg tablets

Acetylsalicylic acid / Caffeine

Read the entire leaflet carefully before you start taking this medicine because it contains important information for you.

Follow exactly the instructions for administration of the medicine contained in this leaflet or those indicated by your doctor or pharmacist.

• Keep this leaflet, as you may need to read it again.
• If you need advice or more information, consult your pharmacist.
• If you experience adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.
• You must consult a doctor if you worsen or do not improve after 5 days for pain or 3 days for fever.

Contents of the leaflet

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

1. What Aspirina Plus is and what it is used for

This medicine contains acetylsalicylic acid and caffeine as active substances. Acetylsalicylic acid works by reducing pain and fever, and caffeine has a stimulant effect on the central nervous system.

Aspirina Plus is indicated in adults and children over 16 years of age for the symptomatic relief of mild to moderate occasional pain, such as headaches, toothaches, menstrual pain, muscle pain (cramps), or back pain (lumbago), as well as for feverish conditions.

2. What you need to know before taking Aspirina Plus

Do not take Aspirina Plus if:

• you are allergic (hypersensitive) or have had any allergic reaction to acetylsalicylic acid, caffeine, or any other component of this medicine,
• 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 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 have heart disease,
• you have severe hypertension,
• 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 your third trimester of pregnancy.

Take special care with Aspirina Plus:

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 coagulation disorders,
• if you are being treated with anticoagulants,
• if you are taking anti-inflammatory drugs or other medicines, as certain medications may interact with Aspirina Plus and cause undesirable effects (see section “Use with other medicines”),
• if you have previously had a stomach or intestinal ulcer,
• if you have glucose-6-phosphate dehydrogenase deficiency,
• if you suffer from or have suffered from rhinitis or urticaria,
• if you have recently undergone or are scheduled for surgery within the next 7 days, including dental surgery,
• if you are in the first or second trimester of pregnancy,
• do not systematically administer it to prevent discomfort caused by vaccinations,
• if you have cardiac arrhythmia, hyperthyroidism, or an anxiety syndrome, take this medicine with caution and always at low doses (maximum 2 tablets per day), or consult your doctor,
• if you have recently suffered a myocardial infarction, do not take this medicine until several weeks have passed since the event,
• if you have previously suffered heart diseases or disorders (cardiac arrhythmia, myocardial ischaemia, angina pectoris, etc.),
• if you are diabetic, bear in mind that caffeine may alter blood sugar levels,
• if you are allergic to xanthines (aminophylline, theophylline, etc.), you should not take this medicine, as you may also be allergic to caffeine.

It is recommended to limit the use of products containing caffeine while being treated with this medicine.

In individuals with sleep difficulties, it is recommended not to take this medicine in the hours before bedtime to avoid possible insomnia.

Use with other medicines:

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 or more 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 contraceptives,
• oral antidiabetics (medicines to lower blood sugar levels),
• antihistamines (used to reduce symptoms of allergic reactions),
• quinolone or erythromycin-type anti-infectives (antibiotics used to treat infections),
• barbiturates (medicines used to treat seizures),
• beta-blockers (medicines for controlling hypertension),
• bronchodilators (medicines used to treat bronchial asthma),
• cimetidine and ranitidine (used for stomach acidity and stomach ulcers),
• medicines used to prevent transplant rejection (cyclosporine and tacrolimus),
• corticosteroids, as they may increase the risk of gastrointestinal bleeding,
• digoxin (a heart medicine),
• disulfiram (used in the treatment of alcohol recovery),
• high blood pressure (diuretics and ACE inhibitors),
• phenytoin and valproic acid (used in the treatment of epilepsy),
• iron (used to treat anaemia); it is recommended to separate intake by at least 2 hours,
• alpha interferon (used to treat certain viral and tumour infections),
• lithium (used in certain psychiatric conditions),
• cancer or rheumatoid arthritis (methotrexate),
• mexiletine (used to correct heart rhythm disorders, such as cardiac arrhythmias),
• medicines used to treat gout (probenecid),
• sympathomimetics (used to increase blood pressure),
• thyroxine (used to treat diseases caused by thyroid deficiencies),
• vancomycin (an antibiotic used for infections),
• zidovudine (used in the treatment of patients infected with the human immunodeficiency virus, HIV, which causes AIDS).

Interference with diagnostic tests:

If you are scheduled for 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 Aspirina Plus with food and drinks:

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 Aspirina Plus may cause stomach bleeding.

Limit consumption of beverages containing caffeine (coffee, tea, chocolate, and cola drinks) while taking this medicine.

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 Aspirina Plus during the last three months of pregnancy, as it could harm the foetus or cause complications during childbirth. This medicine may cause kidney and heart problems in the foetus. It may affect your tendency to bleed and that of your baby, potentially delaying labour or prolonging it beyond the expected duration.

Pregnancy – first and second trimesters

You should not take Aspirina Plus 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 become pregnant, the dose should be limited to the lowest possible for the shortest possible time.

If you take this medicine for several days starting from week 20 of pregnancy, it may cause kidney problems in the foetus, which could lead to low levels of amniotic fluid (oligohydramnios) or narrowing of a blood vessel (ductus arteriosus) in the baby’s heart. If you require treatment for several days, your doctor may recommend additional monitoring.

Breast-feeding

Consult your doctor or pharmacist before using any medicine.

Women who are breast-feeding should consult their doctor before using this medicine, as acetylsalicylic acid and caffeine pass into breast milk. Although caffeine passes into breast milk in small amounts (approximately 1%), it may accumulate in the infant.

Driving and using machines:

No effects on the ability to drive or use machines have been reported.

3. How to take Aspirina Plus

Follow these instructions unless your doctor has given you different ones.

Ask your doctor or pharmacist if you have any doubts.

The usual dose is:

Adults and adolescents aged 16 years and over: 1 tablet every 4 or 6 hours, if necessary. Do not exceed 8 tablets in 24 hours.

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

Use in children:

Do not administer to children under 16 years of age.

Use in patients over 65 years of age:

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

Method of administration:

This medicine is administered orally.

It is recommended to take the tablets with plenty of water. The tablets should be taken with meals or food, especially if gastrointestinal discomfort is noticed. This medicine should not be taken on an empty stomach. Always use the lowest effective dose.

Administration of this preparation should be based on the occurrence of painful or febrile 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, you must stop treatment and consult your doctor.

If you take more Aspirina Plus than you should:

If you have taken more Aspirina Plus than recommended, consult your doctor or pharmacist immediately. The main symptoms of acetylsalicylic acid overdose are: headache, dizziness, tinnitus (ringing in the ears), blurred vision, drowsiness, sweating, rapid breathing, confusion, nausea, vomiting, and occasionally diarrhea.

Symptoms of caffeine overdose are characterized by an initial phase of excitement, followed by dizziness, insomnia, vomiting, diarrhea, abdominal pain, and seizures. Treatment of overdose is most effective when administered within the first 4 hours after ingestion of the medicine.

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.

If you forget to take Aspirina Plus:

Do not take a double dose to make up for missed doses.

If you have any questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, Aspirina Plus can have adverse effects, although not everyone experiences them.

Frequent adverse effects (observed in 1 to 10 out of every 100 people):

• Gastrointestinal disorders, such as stomach ulcer, intestinal ulcer, gastrointestinal bleeding, abdominal pain, indigestion, 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 blood coagulation disorder) when administered at high doses.

Uncommon adverse effects (observed in 1 to 100 out of every 1,000 people):

• Reye's syndrome in individuals under 16 years of age with fever, influenza, or chickenpox (see section “Before taking Aspirina Plus”).
• 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 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 side effects requiring urgent medical attention.

Due to the presence of caffeine in this medicine, the following adverse effects may occur, although their frequency cannot be established: insomnia, restlessness, nervousness, and headache. Nausea, vomiting, and stomach irritation have also been observed. In some cases, hyperglycaemia or hypoglycaemia (increased or decreased blood glucose levels) may also occur.

Treatment must be stopped immediately if the patient experiences episodes of dizziness or palpitations.

High doses of caffeine may cause palpitations, tachycardia, and increased blood pressure.

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 Medicines: https://notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Aspirina Plus

Keep out of the reach and sight of children.

Do not store above 30°C.

Expiry date

Do not use Aspirina Plus after the expiry date stated on the packaging, following the abbreviation CAD. 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 empty containers and unused medicines at the Sigre Collection Point at your pharmacy. If you are in doubt, please consult your pharmacist on how to properly dispose of unused medicines and their containers. This will help protect the environment.

6. Contents of the pack and other information

Composition of Aspirina Plus:

Each tablet contains:

• Active substances: Acetylsalicylic acid, 500 mg, and Caffeine, 50 mg.
• Other components (excipients): corn starch and powdered cellulose.

Appearance of the product and contents of the pack

This medicine consists of white, round tablets. It is available in packs containing 20 tablets.

Marketing Authorization HolderManufacturing Responsible Party

Bayer Hispania, S.L Bayer Bitterfeld GmbH

Av. Baix Llobregat, 3-5 OT Greppin

08970 Sant Joan Despí (Barcelona) Salegaster Chaussee, 1

Spain 06803 Bitterfeld-Wolfen (Germany)

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

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