Cafiaspirina 500 mg/50 mg tablets

Patient Information Leaflet

Introduction

Patient Information Leaflet

CAFIASPIRINA 500mg/50mg tablets

Acetylsalicylic acid / Caffeine

Package leaflet

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

1. What Cafiaspirina 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, while caffeine has a stimulating effect on the central nervous system.

Cafiaspirina is indicated in adults and children over 16 years of age for the symptomatic relief of mild to moderate occasional pain, such as headache, toothache, menstrual pain, muscle pain (muscle spasms), or back pain (lumbago), as well as for febrile conditions.

2. What you need to know before starting to take Cafiaspirina

Do not take Cafiaspirina 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 currently have 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 the third trimester of pregnancy.

Take special care with Cafiaspirina:

You should consult your doctor if you need to take this medicine

• if you have high blood pressure, or impaired 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 Cafiaspirina 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 have or have previously 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 routinely administer this medicine to prevent discomfort following vaccinations,
• if you have a 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 had heart diseases or disorders (cardiac arrhythmia, myocardial ischaemia, angina pectoris, etc.),
• if you are diabetic, be aware that caffeine may increase 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 currently 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 antidiabetic agents (medicines to lower blood sugar levels),
• antihistamines (used to reduce symptoms of allergic reactions),
• anti-infective agents such as quinolones or erythromycin (antibiotics used to treat infections),
• barbiturates (medicines used to treat seizures),
• beta-blockers (medicines for blood pressure control),
• 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 and recovery of alcoholic patients),
• high blood pressure (diuretics and ACE inhibitors),
• phenytoin and valproic acid (used to treat epilepsy),
• iron supplements (for the treatment of anaemia); it is recommended to separate administration 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 to undergo any diagnostic tests (including blood and urine analyses, etc.), inform your doctor that you are taking this medicine, as it may alter test results.

Taking Cafiaspirina with food and drinks:

Take this medicine after meals or with food.

Pregnancy

Consult your doctor or pharmacist before using any medicine.

Pregnancy – third trimester

Do not take Cafiaspirina 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 unborn baby. It may also affect your bleeding tendency and that of your baby, potentially leading to delayed or prolonged labor.

Pregnancy – first and second trimester

You should not take Cafiaspirina 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 will be limited to the lowest possible for the shortest duration.

If you take this medicine for several days starting from week 20 of pregnancy, 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.

Breast-feeding

Consult your doctor or pharmacist before using any medication.

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 use of machines:

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

3. How to take Cafiaspirina

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

Consult your doctor or pharmacist if you have any doubts.

The usual dose is:

Adults and patients over 16 years: 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. Do not take this medicine on an empty stomach. Always use the lowest effective dose.

Administration of this preparation should be based on the presence of pain or fever symptoms. 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 Cafiaspirina than you should:

If you have taken more Cafiaspirina than recommended, consult your doctor or pharmacist immediately.

The main symptoms of acetylsalicylic acid overdose are: headache, dizziness, 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 if administered within the first 4 hours after ingestion of the medicine.

It is recommended to bring the medicine’s 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, or call the Toxicology Information Service at: 91 562 04 20, indicating the name of the medicine and the amount ingested.

If you forget to take Cafiaspirina:

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

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

4. Possible adverse effects

Like all medicines, Cafiaspirina may 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 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 patients under 16 years of age with fever, influenza, or varicella (see section “Before taking Cafiaspirina”).
• 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 experience any of the following:

• discomfort or stomach 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 immediately and consult your doctor without delay, as these may indicate adverse 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 reported. 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 Cafiaspirina

Keep out of the reach and sight of children.

Do not store above 30°C.

Expiry

Do not use Cafiaspirina after the expiry date shown on the packaging, following the abbreviation EXP. The expiry date refers to the last day of the month indicated.

Medicines should not be disposed of via wastewater drains or in household waste. Please return unused medicines and their packaging to the Sigre point at your pharmacy. If in doubt, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of Cafiaspirina:

Each tablet contains:

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

Appearance of the medicine and contents of the pack

This medicine consists of white, round tablets. It is available in packs containing 10 or 20 tablets. Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Bayer, Hispania S.L.
Bayer Bitterfeld GmbH
Av. Baix Llobregat, 3-5
OT Greppin
08970 Sant Joan Despí (Barcelona)
Spain

Salegaster 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 medicine is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es