Package Insert: Information for the User

CAFIASPIRINA 500mg/50mg Tablets

Acetylsalicylic Acid / Caffeine

This medication contains acetylsalicylic acid and caffeine as active principles. Acetylsalicylic acid acts by reducing pain and fever, and caffeine has a stimulating action on the nervous system.

Cafiaspirina 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 pain (contractures) or back pain (lumbalgia).Fever states.

Do not take Cafiaspirina: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 the asthmatic type (difficulty breathing, choking, bronchospasm, and in some cases, coughing or ringing in the ears) when taking anti-inflammatory medications, acetylsalicylic acid, other analgesics, as well as the 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 Cafiaspirina:

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 Cafiaspirina 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 will 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 systemically to prevent possible discomfort caused by vaccinations,
• If you have heart arrhythmia, increased thyroid function, or anxiety syndrome, take this medication with caution and 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,
• If you have had heart diseases (heart arrhythmia, myocardial ischemia, angina pectoris, etc.),
• If you are diabetic, note that caffeine can increase blood sugar levels,

• If you are allergic to xanthines (aminophylline, theophylline, etc.), 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 used recently other medications, even those purchased without a prescription, homeopathic, herbal, and 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),
• Antibiotics of the quinolone or erythromycin type (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),
• Phenobarbital and valproic acid (used to treat epilepsy),
• Iron (used to treat 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 arrhythmias),
• Medications used to treat gout (probenecid),
• Sympathomimetics (used to increase blood pressure),
• Thyroxine (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 Cafiaspirina with food and drinks:

Take this medication after meals or with food.

Pregnancy:

Consult your doctor or pharmacist before using any medication.

Last trimester of pregnancy:

Do not take Cafiaspirina 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 beyond what is expected.

First and second trimester of pregnancy:

Do not take Cafiaspirina during the first 6 months of pregnancy unless it is absolutely necessary and your doctor advises you to do so. 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 possible time.

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.

Breastfeeding:

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 Cafiaspirina than you should:

If you have taken more Cafiaspirina 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 the 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 Cafiaspirina:

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

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

Like all medications, Cafiaspirina may have adverse effects, although not all people may experience them.

Frequent adverse effects (observed in 1 to 10 of every 100 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 eruptions, 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 adverse effects (observed in 1 to 100 of every 1,000 people):

• Reye's syndrome in children under 16 years with feverish processes, flu, or chickenpox (see section “Before taking Cafiaspirina”).
• Liver disorders, especially in patients with juvenile arthritis.
• Anemia.

With prolonged doses of acetylsalicylic acid, the following adverse 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:

• unpleasant stomach sensations, 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 buzzing, or dizziness,

stop taking the medication and consult your doctor immediately, as they may indicate the onset of adverse effects that require urgent medical attention.

Due to the presence of caffeine in this medication, the following adverse 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 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 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 adverse 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 86°F (30°C).

Expiration Date

Do not use Aspirin 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 packaging and unused medicines at the pharmacy's Punto Sigre. If in doubt, ask your pharmacist how to dispose of unused packaging and medicines. By doing so, you will help protect the environment.

Cafiaspirina Composition:

Each tablet contains:

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

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

Product appearance and packaging contents

This medication is round white tablets. It is presentedin packaging that contains 10 or20 tablets. Some packaging sizes may be marketed.

Marketing Authorization Holder Responsible for manufacturing

Bayer, Hispania S.LBayer Bitterfeld GmbH

Av. Baix Llobregat, 3-5 OT Greppin

08970 Sant Joan Despí (Barcelona) Salegaster Chausee, 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