ACTRON COMPUESTO 267 mg/133 mg/40 mg EFFERVSCENT TABLETS

1. What Actron Compuesto is and what it is used for

It is indicated for the symptomatic relief of occasional mild or moderate pain such as headaches, toothaches, menstrual cramps, and febrile states in adults and adolescents from 16 years of age.

You should consult a doctor if your condition worsens or does not improve after 5 days of treatment or if the fever continues after 3 days of treatment.

2. What you need to know before taking Actron Compuesto

Do not take Actron Compuesto

• if you are allergic (hypersensitive) to acetylsalicylic acid, paracetamol, caffeine (or its derivatives, aminophylline, theophylline...), or any of the other components of this medication (listed in section 6).
• if you have presented 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.
• if you suffer from stomach ulcers, intestinal ulcers, or recurring gastric discomfort.
• if you suffer from asthma.
• if you suffer from nasal polyps associated with asthma that are induced or increased by acetylsalicylic acid.
• if you suffer from hemophilia or other blood coagulation problems.
• if you are being treated with medications for circulation (oral anticoagulants).
• if you suffer from kidney and/or liver disease (renal and/or hepatic insufficiency).
• if you are under 16 years of age, as the use of acetylsalicylic acid has been linked to Reye's syndrome, a rare but serious disease.
• if you are in your third trimester of pregnancy.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Actron Compuesto

• If you have high blood pressure, if you have reduced kidney, heart, or liver function, or if you have blood coagulation disorders.
• If you are being treated with anticoagulants.
• If you suffer from or have suffered from rhinitis or urticaria.
• In the case of continued administration, you should inform your doctor or dentist before possible surgical interventions.
• Do not take Actron Compuesto to prevent possible discomfort caused by vaccinations.
• Avoid excessive alcohol consumption during treatment with Actron Compuesto.
• If you have a cardiac arrhythmia, have increased thyroid function, or suffer from an anxious syndrome, take this medication with caution and always at low doses (maximum 2 tablets per day) or consult your doctor.

• If you are diabetic, keep in mind that caffeine can increase blood sugar levels.

• If you are allergic to xanthines (aminophylline, theophylline...), you should not take Actron Compuesto, as you may also be allergic to caffeine.
• If you notice redness on the skin, rash, blisters, or peeling, interrupt treatment and consult your doctor.
• If you are over 65 years old.
• The simultaneous use of this medication with other medications that contain paracetamol should be avoided, as high doses can lead to liver damage. Do not use more than one medication that contains paracetamol without consulting your doctor.

During treatment with Actron Compuesto, inform your doctor immediately if you have serious diseases, such as severe renal insufficiency or sepsis (when bacteria and their toxins circulate in the blood, causing damage to organs), or if you suffer from malnutrition, chronic alcoholism, or if you are also taking flucloxacillin (an antibiotic). A serious disease called metabolic acidosis (an anomaly in the blood and fluids) has been reported in patients in these situations when paracetamol is used at regular doses for a prolonged period or when paracetamol is taken with flucloxacillin. The symptoms of metabolic acidosis may include: severe breathing difficulties with deep and rapid breathing, drowsiness, feeling unwell (nausea) and vomiting.

Children

Do not administer to children under 16 years of age.

Over 65 years old

Elderly people should not take this medication without consulting their doctor, as they are more likely to suffer from its side effects.

Taking Actron Compuesto with other medications:

Certain medications, including those purchased without a prescription, homeopathic remedies, herbal medicines, and other health-related products, may interact with Actron Compuesto. In these cases, it may be necessary to change the dose or interrupt treatment with one of the medications, so they should not be used without consulting a doctor.

This is especially important in the case of:

• other analgesics (pain relievers) or non-steroidal anti-inflammatory drugs (muscle inflammation reducers)
• anticoagulants (medications used to "thin" the blood and prevent clot formation) such as warfarin
• medications to lower blood sugar levels (oral antidiabetics)
• barbiturates (medications used to treat seizures)
• corticosteroids, as they may increase the risk of gastrointestinal bleeding
• cimetidine and ranitidine (used for stomach acidity)
• digoxin (heart medication)
• high blood pressure (diuretics and ACE inhibitors)
• phenytoin and valproic acid (antiepileptics)
• lithium (used for depression)
• cancer or rheumatoid arthritis (methotrexate)
• medications used to treat gout (probenecid)
• the antibiotic vancomycin and sulfonamides (used for infections)
• zidovudine (used in the treatment of HIV infections)
• medications used to prevent transplant rejection (cyclosporine and tacrolimus)
• flucloxacillin (antibiotic), due to a serious risk of alteration of the blood and fluids (called metabolic acidosis) that requires urgent treatment (see section 2).

Combined therapies with more than one analgesic should be avoided due to the lack of evidence of additional benefits for the patient and the generally additive incidence of side effects.

Interference with diagnostic tests

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

Additionally, diabetic patients should keep in mind that caffeine can increase blood glucose levels.

Taking Actron Compuesto with food, drinks, and alcohol

Take this medication after meals or with some food.

Limit the consumption of beverages that contain caffeine (coffee, tea, chocolate, and cola-based drinks) while taking this medication.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medication.

Pregnancy - last trimester

Do not take Actron Compuesto 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 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 Actron Compuesto 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 the 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 women should consult their doctor before using this medication, as both acetylsalicylic acid, paracetamol, and caffeine pass into breast milk.

Driving and using machines

Some patients may experience drowsiness or dizziness when taking medications that contain paracetamol, so if you notice these symptoms, do not drive or use machines.

Actron Compuesto contains sodium: This medication contains 472 mg of sodium (main component of table salt/cooking salt) per effervescent tablet. This is equivalent to 24% of the maximum recommended daily sodium intake for an adult.

Consult your doctor or pharmacist if you need to take 1 or more tablets per day for a prolonged period, especially if you have been recommended a low-salt diet (sodium).

3. How to take Actron Compuesto

Follow the administration instructions for the medication contained in this package leaflet or as indicated by your doctor or pharmacist. In case of doubt, ask your doctor or pharmacist

This medication is administered orally.

The recommended dose is:

Adults and adolescents from 16 years of age: 1 tablet every 8 hours. In no case should you exceed 3 tablets in 24 hours.

Always use the lowest effective dose.

Use in children and adolescents

Do not use this medication in children or adolescents under 16 years of age.

Patient with reduced liver or kidney function: should consult their doctor.

How to take: The tablets are taken completely dissolved in a glass of water when the bubbling has stopped. Do not take this medication on an empty stomach, so it is recommended to take the medication with meals or with some food, especially if you notice digestive discomfort.

The administration of this medication is subject to the appearance of pain or fever. As these disappear, you should stop taking this medication.

You should consult a doctor if your condition worsens or does not improve after 5 days of treatment or if the fever continues after 3 days.

If you take more Actron Compuesto than you should

The main symptoms of overdose are: headache, dizziness, ringing in the ears, blurred vision, drowsiness, insomnia, restlessness, sweating, nausea, vomiting, loss of appetite, yellowing of the skin and eyes (jaundice), abdominal pain, and occasionally diarrhea.

In case of overdose, go to a medical center immediately, even if you do not have symptoms, as they often do not appear until 3 days after ingestion of the overdose, even in cases of severe poisoning.

Treatment of overdose is most effective if started within 4 hours after taking the overdose of the medication.

Patient taking barbiturates or chronic alcoholics may be more susceptible to the toxicity of a paracetamol overdose.

In case of overdose or accidental ingestion, go to a medical center immediately or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

4. Possible side effects

Like all medications, Actron Compuesto can cause side effects, although not everyone will experience them.

The most common ones are: gastrointestinal discomfort, skin rashes, breathing difficulties, dizziness, and anxiety or feeling of unease.

Common side effects: may affect up to 1 in 10 people

• Gastrointestinal disorders, such as gastric ulcers, duodenal ulcers, gastrointestinal bleeding, abdominal pain, gastric discomfort, nausea, vomiting.

• Respiratory disorders, such as difficulty breathing, bronchospasm, rhinitis (itching and watery nasal discharge).
• Urticaria, skin rashes, angioedema (inflammation and swelling that affects the deep layers of the skin).
• Hypoprothrombinemia (coagulation disorder) when administered in high doses.
• Anxiety or feeling of unease.

Uncommon side effects: may affect up to 1 in 100 people

• Reye's syndrome in children under 16 years of age with febrile processes, flu, or chickenpox (see "What you need to know before taking Actron Compuesto").
• Liver disorders, especially in patients with juvenile arthritis.

Rare side effects: may affect up to 1 in 10,000 people

• Severe skin reactions.

Side effects of unknown frequency: cannot be estimated from available data

• A serious disease that can make the blood more acidic (called metabolic acidosis) in patients with serious diseases who use paracetamol (see section 2).

This medication may damage the liver or kidneys at high doses or with prolonged treatment.

If you notice the appearance of:

• Discomfort or abdominal pain, gastrointestinal bleeding or intestinal bleeding, or black stools.
• Skin disorders, such as rashes or redness.
• Breathing difficulties.
• Unforeseen changes in the amount or appearance of urine.
• Swelling of the face, feet, or legs.

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

Reporting side effects:

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

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5. Storage of Actron Compuesto

Keep out of sight and reach of children.

Store in the original package. Do not store at a temperature above 25°C.

Do not take Actron Compuesto after the expiration date indicated 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 at the Sigre Point in the pharmacy. If in doubt, ask your pharmacist how to dispose of the packages and medications you no longer need. This will help protect the environment.

6. Package contents and additional information

Composition of Actron Compuesto

• Each effervescent tablet contains as active ingredients 267 mg of acetylsalicylic acid, 133 mg of paracetamol, and 40 mg of caffeine.
• The other components (excipients) are: sodium hydrogen carbonate and citric acid.

Appearance of the product and package contents

Round white effervescent tablets.

Presented in a strip formed by an aluminum sheet. Packages with 10 and 20 effervescent tablets.

Marketing authorization holder:Manufacturer:

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:January 2025

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/