Package Insert: Information for the User

ASPIRINA PLUS 500 mg/ 50 mg Tablets

Acetylsalicylic Acid/Caffeine

Read this entire package insert carefully before starting to take this medication, as it contains important information for you.

Follow exactly the administration instructions for the medication contained in this package insert or those indicated by your doctor or pharmacist.

- Keep this package insert, as you may need to refer to it again.

- If you need advice or more information, consult your pharmacist.

- If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.

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

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

2. What you need to know before starting to take Aspirina Plus

3. How to take Aspirina Plus

4. Possible adverse effects.

5. Storage of Aspirina Plus

6. Contents of the package and additional information

This medication contains acetylsalicylic acid and caffeine as active ingredients. The acetylsalicylic acid acts by reducing pain and fever, and caffeine has a stimulating effect on the nervous system.

Aspirina Plus is indicated in adults and children over 16 years old for symptomatic relief of occasional mild or moderate pains, such as headaches, dental pain, menstrual pain, muscle cramps (contractures) or back pain (lumbalgia). Feverish states.

Do not take Aspirina Plus if:

- you are allergic (hypersensitive) or have had an allergic reaction to acetylsalicylic acid, caffeine, or any other component of this medication,

- you have a stomach ulcer, intestinal ulcer, or recurring stomach or intestinal discomfort,

- you have had an allergic reaction of an 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 taking oral anticoagulant medications,

- you have kidney or liver disease (renal or hepatic insufficiency),

- you have heart disease,

- you have severe high blood pressure,

- you are under 16 years old, as the use of acetylsalicylic acid has been linked to Reye's Syndrome, a rare but serious disease,

- you are in your third trimester of pregnancy.

Be especially careful with Aspirina Plus:

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 are taking anticoagulants,
• if you are taking anti-inflammatory medications or other types of medications, as certain medications may interact with Aspirina Plus and produce undesirable effects (see "Use of other medications"),
• if you have had a stomach or intestinal ulcer,
• 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 are scheduled to undergo surgery, including dental surgery, within the next 7 days,
• if you are in the first or second trimester of pregnancy,
• do not take this medication systematically to prevent potential discomfort caused by vaccinations,

vaccinations,

• if you have heart arrhythmia, increased thyroid function, or anxiety syndrome, take this medication with cautionand always at low doses (maximum 2 tablets per day) or consult your doctor,
• if you have recently had a heart attack, do not take this medication until several weeks have passed since the incident,

since the incident,

• if you have had heart diseases or disorders (cardiac arrhythmia, myocardial ischemia, angina pectoris…),
• if you are diabetic, note that caffeine can alter blood sugar levels,
• if you are allergic to xanthines (aminophylline, theophylline…), you should not take this

medication, as you may also be allergic to caffeine.

It is recommended to limit the use of products containing caffeine while taking this medication.

In people with difficulty sleeping, it is recommended not to take this medication in the hours leading up to bedtime, to avoid insomnia.

Use of other medications:

Inform your doctor or pharmacist if you are using or have recently used other medications, even those purchased without a prescription, homeopathic, herbal, or other health-related products, as it may be necessary to interrupt treatment or adjust the dose for any 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 contraceptives,

- oral antidiabetic medications (medications to reduce blood sugar levels),

- antihistamines (used to reduce the symptoms of allergic reactions),

- quinolone or erythromycin antibiotics (antibiotics used to treat infections),

- barbiturates (medications used to treat seizures),

- beta-blockers (medications used to control high blood pressure),

- bronchodilators (medications used to treat asthma),

- cimetidine and ranitidine (used to treat stomach acid and ulcers),

- medications used to prevent transplant rejection (cyclosporine and tacrolimus),

- corticosteroids, as it may increase the risk of gastrointestinal bleeding,

- digoxin (medication for the heart),

- disulfiram (used in the treatment of recovering alcoholics),

- high blood pressure (diuretics and ACE inhibitors),

- phenytoin and valproic acid (used to treat epilepsy),

- iron (for the treatment of anemia), it is recommended to take it at least 2 hours apart,

- interferon-alpha (used to treat certain viral and tumor infections),

- lithium (used in some psychiatric disorders),

- cancer or rheumatoid arthritis (methotrexate),

- mexiletine (used to correct heart rhythm disorders, such as cardiac arrhythmias),

- medications used to treat gout (probenecid),

- sympathomimetics (used to increase blood pressure),

- thyroid hormone (used to treat thyroid-related diseases),

- vancomycin (antibiotic used to treat infections),

- zidovudine (used to treat patients infected with the human immunodeficiency virus, which causes AIDS).

Interference with diagnostic tests:

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

Taking Aspirina Plus with food and drinks:

Take this medication after meals or with some food.

If you regularly consume alcohol (three or more alcoholic beverages per day), taking Aspirina Plus may cause stomach bleeding.

Limit your consumption of caffeinated beverages (coffee, tea, chocolate, and cola drinks) while taking this medication.

Pregnancy

Consult your doctor or pharmacist before using any medication.

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

medication.

Pregnancy – third trimester

Do not take Aspirina Plus 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

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

If you take this medication for several days from week 20 of pregnancy, it may cause kidney problems in the fetus that could 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 before using any medication.

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

Driving and operating machinery:

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

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

Consult your doctor or pharmacist if you have any doubts.

The usual dose is:

Adults and individuals over 16 years old: 1 tablet every 4 or 6 hours as needed. Do not exceed 8 tablets in 24 hours.

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

Use in children:

Do not administer to individuals under 16 years old.

Use in individuals over 65 years old

Older individuals should not take this medication without consulting their doctor, as they are more prone to experiencing adverse effects.

Administration method:

This medication 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 digestive discomfort is experienced. Do not take this medication on an empty stomach. Always use the smallest effective dose.

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

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

If you take more Aspirina Plus than you should:

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

The 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 more effective if performed within the first 4 hours following ingestion of this medication.

It is recommended to bring the packaging and medication leaflet 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.

If you forgot to take Aspirina Plus:

Do not take a double dose to compensate for the missed doses.

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

Like all medications, Aspirina Plus may have side effects, although not everyone will experience them.

Some people may not experience side effects.

Frequent side effects (observed in 1 to 10 out of 100 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 can cause difficulty swallowing or breathing) and itching.
• Hypoprothrombinemia (coagulation alteration) when administered in high doses.

Rare side effects (observed in 1 to 100 out of 1,000 people):

• Reye's syndrome in children under 16 years old with fever, flu, or chickenpox (see section “Before taking Aspirina Plus”).
• 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:

• Abdominal discomfort or stomach pain, gastrointestinal 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, ear ringing, or dizziness.

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

Due to the presence of caffeine in this medication, the following side effects may appear, for which the exact frequency has not been established: insomnia, restlessness, and nervousness, and headache. Also, nausea, vomiting, and stomach irritation have been observed. In some cases, it may also cause hyperglycemia or hypoglycemia (increase or decrease in blood glucose).

The treatment should be suspended immediately if the patient experiences any episode of dizziness or palpitations.

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

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does 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 medication.

Keep out of reach and sight of children.

Do not store at a temperature above 30°C.

Expiration Date

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

Medicines should not be disposed of through drains or in the trash. Dispose of the packaging and the

medicines you no longer need at the Sigre point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and the medicines you no longer need. In this way, you will help protect the environment.

Composition of Aspirin Plus:

Each tablet contains:

- As active principles: Acetylsalicylic acid, 500 mg, and Caffeine, 50 mg.

- The other components (excipients) are: Cornstarch and powdered cellulose.

Appearance of the product and contents of the packaging

This medication is round white tablets. It is presented in packaging that contains 20 tablets.

Holder of the marketing authorizationResponsible for manufacturing

Bayer Hispania, S.LBayer Bitterfeld GmbH

Av. Baix Llobregat, 3-5OT Greppin

08970 Sant Joan Despí (Barcelona)Salegaster Chaussee, 1

Spain06803 Bitterfeld-Wolfen (Germany)

Last review date of this leaflet:October 2023

The 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/