ASPIRINA PLUS 500 mg / 50 mg TABLETS

Introduction

Package Leaflet: Information for the User

ASPIRINA PLUS 500 mg/ 50 mg tablets

Acetylsalicylic Acid/ Caffeine

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

Follow the administration instructions for the medication contained in this package leaflet or as indicated by your doctor or pharmacist.

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

Contents of the Package Leaflet

1. What Aspirina Plus is and what it is used for
2. What you need to know before taking Aspirina Plus
3. How to take Aspirina Plus
4. Possible side effects.
5. Storage of Aspirina Plus
6. Package contents and additional information

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

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

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

2. What you need to know before taking Aspirina Plus

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 stomach ulcers, intestinal ulcers, or recurring gastric discomfort,

• you have had allergic reactions of an asthmatic type (difficulty breathing, shortness of breath, bronchospasm, and in some cases cough or wheezing when breathing) when taking anti-inflammatory drugs, 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 blood coagulation problems,

• 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 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 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 blood coagulation disorders,
• if you are being treated with anticoagulants,
• if you are taking anti-inflammatory drugs or other types of medications, as certain medications can interact with Aspirina Plus and produce undesirable effects (see "Use of other medications"),
• if you have had stomach ulcers or intestinal ulcers,
• if you have a glucose-6-phosphate dehydrogenase deficiency,
• if you have or have had rhinitis or urticaria,
• if you have recently undergone or are going to undergo surgery in the next 7 days, including dental surgery,
• if you are in the first or second trimester of pregnancy,
• do not systematically administer to prevent possible discomfort caused by vaccinations,

if you have a cardiac arrhythmia, have increased thyroid function, or have an anxious 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 myocardial infarction, do not take this medication until several weeks have passed since the accident,

if you have had heart diseases or disorders (cardiac arrhythmia, myocardial ischemia, angina pectoris...),

• if you are diabetic, keep in mind 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 when taking this medication.

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

Use of other medications:

Inform your doctor or pharmacist if you are using or have recently used other medications, including those purchased without a prescription, homeopathic products, herbal remedies, 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 in the case of:

• other analgesics or non-steroidal anti-inflammatory drugs (medications used to treat pain and/or muscle inflammation),
• certain antidepressants, such as selective serotonin reuptake inhibitors, as they increase the risk of bleeding,
• anticoagulants (medications used to "thin" the blood and prevent the formation of clots) such as warfarin,
• oral contraceptives,
• oral antidiabetics (medications to lower blood sugar levels),
• antihistamines (used to reduce the symptoms of allergic reactions),
• anti-infective quinolones or erythromycin (antibiotics to treat infections),
• barbiturates (medications used to treat convulsions),
• beta-blockers (medications to control hypertension),
• bronchodilators (medications to treat bronchial asthma),
• cimetidine and ranitidine (used for stomach acidity and stomach ulcers),
• medications used to prevent transplant rejection (cyclosporine and tacrolimus),
• corticosteroids, as they 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 in the treatment of epilepsy),
• iron (for the treatment of anemia), it is recommended to space out the intake by at least 2 hours,
• interferon alpha (used in the treatment of certain viral and tumor infections),
• lithium (used in certain psychiatric illnesses),
• 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),
• thyroxine (used in the treatment of thyroid deficiency diseases),
• vancomycin (antibiotic used for infections),
• zidovudine (used in the treatment of patients infected with the human immunodeficiency virus, the cause of AIDS).

Interference with diagnostic tests:

If you are going to have any diagnostic tests (including blood tests, urine tests, 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 - beer, wine, liquor, ... - per day), taking Aspirina Plus may cause a stomach hemorrhage.

Limit your consumption of beverages that contain caffeine (coffee, tea, chocolate, and cola-based 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 - last 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 can cause kidney and heart problems in the fetus. It may affect your tendency to bleed and that of your baby, causing a possible delay in delivery or prolonging it more than expected.

Pregnancy - first and second trimester

Do 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 become pregnant, the dose will be limited to the lowest possible during the shortest time possible.

If you take this medication for several days from the 20th week of pregnancy, it may cause kidney problems in the fetus that could lead to low levels of amniotic fluid (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 monitoring.

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 (around 1%), it can accumulate in the infant.

Driving and using machines:

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

3. How to take Aspirina Plus

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

Consult your doctor or pharmacist if you have doubts.

The normal dose is:

Adults and children over 16 years old: 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 old.

Use in adults over 65 years

Older adults should not take this medication without consulting their doctor, as they are more likely to experience side effects.

Method of administration:

This medication is administered orally.

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

The administration of this preparation is subject to the appearance of painful or febrile symptoms. As these symptoms disappear, this medication should be discontinued.

If the pain persists for more than 5 days, the fever for more than 3 days, or the symptoms worsen or new ones appear, you should interrupt the 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 acetylsalicylic acid 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 convulsions. Treatment of the overdose is more effective if performed within the first 4 hours after taking this medication.

It is recommended to take the package and package leaflet of the medication 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 forget to take Aspirina Plus:

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

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

4. Possible side effects

Like all medications, Aspirina Plus can have side effects, although not everyone experiences them.

Common side effects (observed in 1 to 10 out of every 100 people):

• Gastrointestinal disorders, such as stomach ulcers, intestinal ulcers, gastrointestinal bleeding, abdominal pain, indigestion, heartburn, acidity, gastric discomfort, nausea, and vomiting.
• Respiratory disorders, such as difficulty breathing (asthma, bronchospasm), 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 disorder) when administered in high doses.

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

• Reye's syndrome in children under 16 years old with febrile processes, flu, or chickenpox (see "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 cannot be established with precision: dizziness, ringing in the ears, deafness, sweating, headache, confusion, renal insufficiency, and acute interstitial nephritis.

If you observe the appearance of:

• Discomfort or stomach pain, gastrointestinal bleeding, or black stools.
• Skin disorders, such as rashes or redness.
• Difficulty breathing.
• Unforeseen 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 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 cannot be established: insomnia, restlessness, and nervousness, and headache. Nausea, vomiting, and stomach irritation have also been observed. In some cases, hyperglycemia or hypoglycemia (increased or decreased blood sugar) may also occur.

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 side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is not listed in this package leaflet. You can also report them directly through the Spanish Medication Surveillance System for Human Use: https://notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Aspirina Plus

Keep out of the reach and sight of children.

Do not store above 30°C.

Expiration date

Do not use Aspirina Plus after the expiration date shown on the package, after the abbreviation CAD. The expiration date is the last day of the month indicated.

Medications should not be thrown down the drain or into the trash. Deposit the packages and medications you no longer need in the Sigre Point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the packages and medications you no longer need. This way, you will help protect the environment.

6. Package contents and additional information

Composition of Aspirina Plus:

Each tablet contains:

• As active ingredients: Acetylsalicylic Acid, 500 mg, and Caffeine, 50 mg.
• Other components (excipients) are: cornstarch and cellulose powder.

Appearance of the product and package contents

This medication is round and white tablets. It is presented in packages containing 20 tablets.

Marketing authorization holderManufacturer

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 last revision of this package leaflet:October 2023

Detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/