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

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

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

Acetylsalicylic acid/Paracetamol/Caffeine

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

Always follow exactly the instructions for use of this medicine as described in this leaflet or as directed by your doctor or pharmacist.

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

Package leaflet:

1. What Actron Compound is and what it is used for
2. What you need to know before taking Actron Compound
3. How to take Actron Compound
   1. Possible side effects
   2. Storage of Actron Compound
   3. Contents of the pack and other information

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

It is indicated for the symptomatic relief of mild to moderate occasional pain such as headache, dental pain, menstrual pain, and feverish conditions in adults and adolescents aged 16 years and older.

You should consult a doctor if symptoms worsen or do not improve after 5 days of treatment, or if fever persists after 3 days of treatment.

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

Do not take Actron Compound

• if you are allergic (hypersensitive) to acetylsalicylic acid, paracetamol, caffeine (or derivatives thereof, such as aminophylline, theophylline, etc.), or to any of the other components of this medicine (listed in section 6).
• if you have experienced allergic reactions of an asthmatic type (difficulty breathing, suffocation, bronchospasms, and in some cases coughing or wheezing) when taking anti-inflammatory drugs, acetylsalicylic acid, other analgesics, or when exposed to the tartrazine dye.
• if you have a stomach or intestinal ulcer, or recurrent gastric discomfort.
• if you currently have or have had asthma.
• if you have nasal polyps associated with asthma that are induced or worsened by acetylsalicylic acid.
• if you have hemophilia or other blood coagulation disorders.
• if you are undergoing treatment with blood circulation medications (oral anticoagulants).
• if you have 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 associated with Reye's syndrome, a rare but serious illness.
• if you are in the third trimester of pregnancy.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Actron Compound

• If you have hypertension, impaired kidney, heart, or liver function, or blood coagulation disorders.

• If you are being treated with anticoagulants.

• If you currently have or have had rhinitis or urticaria.

• If treatment is prolonged, inform your doctor or dentist before any surgical procedures.

• Do not take Actron Compound to prevent discomfort associated with vaccinations.

• Avoid excessive alcohol consumption during treatment with Actron Compound.

• If you have a cardiac arrhythmia, hyperactive thyroid function, 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 are diabetic, be aware that caffeine may increase blood sugar levels.

• If you are allergic to xanthines (aminophylline, theophylline, etc.), you should not take Actron Compound, as you may also be allergic to caffeine.

• If you notice skin redness, rash, blisters, or peeling, stop treatment immediately and consult your doctor.

• If you are over 65 years of age.

• Concurrent use of this medicine with other medicines containing paracetamol should be avoided, as high doses may cause liver damage. Do not use more than one paracetamol-containing medicine without consulting your doctor.

During treatment with Actron Compound, inform your doctor immediately if you develop serious conditions such as severe renal failure or sepsis (when bacteria and their toxins circulate in the blood, causing organ damage), or if you suffer from malnutrition, chronic alcoholism, or are also taking flucloxacillin (an antibiotic). A serious condition known as metabolic acidosis (an abnormality in blood and body fluids) has been reported in patients under these conditions when paracetamol is used regularly over a prolonged period or when paracetamol is taken together with flucloxacillin. Symptoms of metabolic acidosis may include: severe breathing difficulty with deep and rapid breathing, drowsiness, malaise (nausea), and vomiting.

Children

Do not administer to children under 16 years of age.

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.

Taking Actron Compound with other medicines:

Certain medicines, including over-the-counter products, homeopathic remedies, herbal medicines, and other health-related products, may interact with Actron Compound. In such cases, it may be necessary to adjust the dose or discontinue one of the treatments. Therefore, they should not be used without consulting a doctor.

This is especially important with:

• other analgesics (pain relievers) or non-steroidal anti-inflammatory drugs (reduce inflammation)
• anticoagulants (medicines used to "thin" the blood and prevent clots), such as warfarin
• medications to lower blood sugar (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 (a heart medication)
• high blood pressure medications (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 HIV infection treatment)
• medications used to prevent transplant rejection (cyclosporine and tacrolimus)
• flucloxacillin (antibiotic), due to a serious risk of blood and fluid imbalance (called metabolic acidosis) requiring urgent treatment (see section 2).

Long-term combination therapies involving more than one analgesic should be avoided, as there is little evidence of additional benefit for the patient, and the incidence of adverse effects is generally additive.

Interference with diagnostic tests

If you are scheduled for any diagnostic tests (including blood and urine tests), inform your doctor that you are taking this medicine, as it may alter test results.

Additionally, diabetic patients should be aware that caffeine may increase blood glucose levels.

Taking Actron Compound with food, drinks, and alcohol

Take this medicine after meals or with food.

Limit your consumption of beverages containing caffeine (coffee, tea, chocolate, and cola drinks) while taking this medication.

Pregnancy, breastfeeding, and fertility

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

Pregnancy – third trimester

Do not take Actron Compound if you are in the last three months of pregnancy, as it may harm the fetus or cause problems during delivery. This medicine may cause kidney and heart problems in the unborn baby. It may affect your bleeding tendency and that of your baby, potentially causing delayed or prolonged labor.

Pregnancy – first and second trimester

You should not take Actron Compound during the first six months of pregnancy unless absolutely necessary and advised by your doctor. If you require treatment during this period or while trying to become pregnant, the dose should 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, potentially 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.

Breastfeeding women should consult their doctor before using this medicine, as acetylsalicylic acid, paracetamol, and caffeine are excreted in breast milk.

Driving and use of machines

Some patients may experience drowsiness or dizziness when taking medications containing paracetamol; therefore, if you experience these symptoms, you should not drive or operate machinery.

Actron Compound contains sodium: This medicine contains 472 mg of sodium (the main component of table/cooking salt) per tablet. This corresponds to 24% of the maximum daily recommended sodium intake for an adult.

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

3. How to take Actron Compound

Follow exactly the dosing instructions provided in this leaflet or those given by your doctor or pharmacist. If in doubt, ask your doctor or pharmacist.

This medicine is administered orally.

The recommended dose is:

Adults and adolescents aged 16 years and older: 1 tablet every 8 hours. Under no circumstances 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 medicine in children or adolescents under 16 years of age.

Patients with impaired liver or kidney function: must consult their doctor.

How to take: The tablets should be completely dissolved in a glass of water and taken after the fizzing has stopped. Do not take this medicine on an empty stomach; it is recommended to take the medicine with food or during meals, especially if gastrointestinal discomfort occurs.

This medication should only be administered when pain or fever occurs. As these symptoms subside, the medication should be discontinued.

Consult a doctor if symptoms worsen, or if there is no improvement after 5 days of treatment, or if fever persists beyond 3 days.

If you take more Actron Compound 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, seek immediate medical attention even if there are no symptoms, as they often do not appear until 3 days after the overdose has been ingested, even in cases of severe poisoning.

Treatment of overdose is most effective if started within 4 hours after the overdose has been taken.

Patients undergoing treatment with barbiturates or chronic alcoholics may be more susceptible to the toxicity of a paracetamol overdose.

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

4. Possible adverse effects

Like all medicines, Actron Compuesto may cause adverse effects, although not everyone will experience them.

The most common adverse effects are: gastrointestinal discomfort, skin rashes, breathing difficulties, dizziness, anxiety, or restlessness.

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

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

• Respiratory disorders, such as difficulty breathing, bronchospasm, rhinitis (nasal itching and watery discharge).

• Urticaria, skin rashes, angioedema (inflammation and swelling affecting the deeper layers of the skin).

• Hypoprothrombinemia (a coagulation disorder) when administered at high doses.

• Anxiety or restlessness.

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

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

Very rare adverse effects: may affect up to 1 in 10,000 people

• Severe skin reactions.

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

• Serious illness that may increase blood acidity (called metabolic acidosis) in patients with severe illness who use paracetamol (see section 2).

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

If you notice any of the following symptoms:

• Stomach discomfort or 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.

Stop taking the medicine and consult your doctor immediately, as these may indicate adverse effects requiring urgent medical attention.

Reporting of adverse effects:

If you experience any type of adverse effect, talk to 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://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Actron Compound

Keep out of the sight and reach of children.

Store in the original container. Do not store above 25°C.

Do not use Actron Compound after the expiry date stated on the container, following the abbreviation EXP. The expiry date refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Return unused containers and unwanted medicines to the Sigre collection point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of unused containers and medicines. This will help protect the environment.

6. Contents of the pack and other information

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 pack

White, round effervescent tablets.

Presented in strips made of aluminum foil. Pack sizes of 10 and 20 effervescent tablets.

**Marketing Authorization Holder:Manufacturer responsible:

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 most recent review of this leaflet: January 2025

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/