Actron compuesto 267 mg/133 mg/40 mg comprimidos efervescentes

Leaflet: information for the user

Actron Compound 267 mg / 133 mg / 40 mg effervescent tablets

Acetylsalicylic acid/Paracetamol/Caffeine

Read this leaflet carefully before you start taking this medicine, as it contains important information for you.

Follow exactly the administration instructions contained in this leaflet or those given by your doctor or pharmacist.

• Keep this leaflet, as you may need to read it again.
• For advice on any matter relating to this medicine or for information about any side effects, consult your pharmacist.
• Consult your doctor or pharmacist if you experience any side effects, even if they do not appear in this leaflet. See section 4.
• You must consult a doctor if your symptoms worsen or do not improve after 5 days for pain or 3 days for fever.

Contents of the leaflet:

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

2.What you need to know before starting to take Actron Compound

3.How to take Actron Compound

1. Possible side effects
2. Storage of Actron Compound
3. Contents of the package and additional information

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

Consult a doctor if it worsens, or if it does not improve after 5 days of treatment or if the fever continues after 3 days of treatment.

Do not take Actron Compuesto

• If you are allergic (hypersensitive) to acetylsalicylic acid, paracetamol, caffeine (or derivatives thereof, aminophylline, theophylline...) or to any of the other components of this medication (listed in section 6).
• If you have had allergic reactions of an asthmatic type (difficulty breathing, choking, bronchospasm and in some cases coughing or wheezing) when taking anti-inflammatory agents, acetylsalicylic acid, other analgesics, as well as tartrazine dye.
• If you have a stomach ulcer, intestinal ulcer or recurring stomach discomfort.
• If you have or have had asthma.
• If you have nasal polyps associated with asthma that are induced or increased by acetylsalicylic acid.
• If you have hemophilia or other bleeding disorders.
• If you are taking anticoagulant medications for circulation.
• If you have kidney and/or liver diseases (renal and/or hepatic insufficiency).
• If you are under 16 years old, as the use of acetylsalicylic acid has been associated with 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 hypertension, reduced kidney, heart or liver function, or altered blood coagulation.
• If you are taking anticoagulants.
• If you have or have had rhinitis or urticaria.
• In case of continuous administration, inform your doctor or dentist before any 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 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 are diabetic, note 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 observe redness of the skin, rash, blisters or peeling, interrupt treatment and consult your doctor.
• If you are over 65 years old.
• Avoid simultaneous use of this medication with other medications containing paracetamol, as high doses may cause liver damage. Do not use more than one medication containing paracetamol without consulting your doctor.

Inform your doctor immediately if you have severe diseases, such as severe kidney insufficiency or sepsis (when bacteria and their toxins circulate in the blood, causing damage to organs), or if you have malnutrition, chronic alcoholism, or if you are also taking flucloxacillin (an antibiotic). A serious disease called metabolic acidosis (a blood and fluid anomaly) has been reported in patients in these situations when using paracetamol at regular doses for a prolonged period or when taking paracetamol with flucloxacillin. Symptoms of metabolic acidosis may include: severe respiratory difficulty with deep and rapid breathing, drowsiness, feeling unwell (nausea) and vomiting.

Children

Do not administer to children under 16 years old.

Seniors over 65 years old

People of advanced age should not take this medication without consulting their doctor, as they are more prone to experiencing its adverse effects.

Taking Actron Compuesto with other medications:

Certain medications, including those purchased without a prescription, homeopathic, herbal, and other health-related products, may interact with Actron Compuesto, in which case it may be necessary to change the dose or discontinue 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 agents (muscle inflammation reducers).
• Anticoagulants (medications used to "thin" the blood and prevent the formation of blood clots) such as warfarin.
• Oral antidiabetic medications (blood sugar level reducers).
• Barbiturates (medications used to treat seizures).
• Corticosteroids, as it may increase the risk of gastrointestinal bleeding.
• Cimetidine and ranitidine (used for stomach acid reduction).
• Digoxin (heart medication).
• High blood pressure medications (diuretics and ACE inhibitors).
• Antiepileptic medications (phenytoin and valproic acid).
• Lithium (used for depression).
• Cancer or rheumatoid arthritis (methotrexate).
• Medications used to treat gout (probenecid).
• Vancomycin (antibiotic) and sulfonamides (used for infections).
• Zidovudine (used to treat HIV infections).
• Medications used to prevent transplant rejection (cyclosporine and tacrolimus).
• Flucloxacillin (antibiotic), due to a serious risk of blood and fluid alteration (metabolic acidosis) that requires urgent treatment (see section 2).

Avoid continuous combined therapy with more than one analgesic, as there is very little evidence of additional benefit for the patient and the incidence of adverse effects is generally additive.

Interference with diagnostic tests

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

Additionally, diabetic patients should note 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 your consumption of caffeine-containing beverages (coffee, tea, chocolate, and cola drinks) while taking this medication.

Pregnancy, lactation, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or intend 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 bleeding tendency and that of your baby, causing a possible delay in delivery or prolonging it beyond what is 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 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 may 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.

Women who are breastfeeding should consult their doctor before using this medication, as both acetylsalicylic acid, paracetamol, and caffeine pass into breast milk.

Driving and operating machinery

Some patients may experience drowsiness or dizziness with paracetamol-containing medications, so if you notice these symptoms, do not drive or operate machinery.

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

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

Follow exactly the medication administration instructions contained in this leaflet or those 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 16 years of age and older: 1 tablet every 8 hours. In no case should more than 3 tablets be taken 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.

Patients with reduced liver or kidney function: should consult a doctor.

How to take:The tablets should be 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 digestive discomfort is noted.

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

Consult a doctor if it worsens, or if it 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 immediately to a medical center, even if there are no symptoms, as they often do not appear until 3 days after the overdose, even in cases of severe poisoning.

The treatment of an overdose is more effective if it is initiated within 4 hours of taking the overdose of the medication.

Patients undergoing barbiturate treatment 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 Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

Like all medicines, 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 uneasy.

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

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

• Respiratory disorders, such as difficulty breathing, bronchial spasm, rhinitis (itching and watery nasal discharge).
• Urticaria, skin rashes, angioedema (inflammation and swelling affecting the deeper layers of the skin).
• Hypoprothrombinemia (coagulation disorder) when administered in high doses.
• Anxiety or feeling uneasy.

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

• Reye's syndrome in children under 16 years with fever, flu, or chickenpox (see “What you need to know before starting to take Actron Compuesto”).
• Liver disorders, especially in patients with juvenile arthritis.

Very 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 condition that can make the blood more acidic (known as metabolic acidosis) in patients with severe illness using paracetamol (see section 2).

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

If you notice the appearance of:

• Abdominal discomfort or pain, gastric or intestinal bleeding, or black stools.
• Skin disorders, such as rashes or redness.
• Difficulty breathing.
• Unexpected changes in urine quantity or appearance.
• Swelling of the face, feet, or legs.

Stop taking the medicine and consult your doctor immediately, as they may indicate the onset 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 not listed in this leaflet.You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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Keep out of sight and reach of children.

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

Do not take Actron Compound after the expiration date indicated on the packaging, after the abbreviation CAD. 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 medicines you no longer need at the Pharmacy Take-Back Point. If in doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need.This will help protect the environment.

Composition of Actron Compound

• 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 contents of the packaging

Round white effervescent tablets.

Presented in a strip made of aluminum foil. Containers with 10 and 20 effervescent tablets.

Holder of the marketing authorization:Responsible for manufacturing:

Bayer Hispania, S.L.Bayer 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:January 2025

Detailed and updated information on this medication is available onthe websiteofthe Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/