Label: information for the user

Antidol1 geffervescent powder

Paracetamol

Follow exactly the medication administration instructions contained in this label or those indicated by your doctor or pharmacist.

• Keep this label, as you may need to read it again.
• If you need advice or more information, consult your pharmacist.

• Ifyou experience adverse effects, consult your doctor or pharmacist,even if they do not appear in this label. See section 4.
• You should consult a doctor if you worsen or do not improve after 5 days.

Antidol belongs to a group of medicines called analgesics and antipyretics.

This medicine is used for the symptomatic relief of occasional mild or moderate pains, such as headaches, toothaches, muscle pains (contractures) or back pain (lumbago), as well as in febrile states in adults and adolescents aged 16 years or older (or with a body weight of 50 kg or more).

Do not takeAntidol

Warnings and precautions

Consult your doctor or pharmacist before starting to take Antidol.

Paracetamol should be used with special caution in the following situations:

• Do not take more medication than recommended in section 3 How to take Antidol.
• If you have liver problems, including liver problems due to excessive alcohol consumption (3 or more alcoholic beverages per day).
• If you have a deficiency of glucose-6-phosphate dehydrogenase.
• If you have anorexia, bulimia, cachexia, or chronic malnutrition;
• If you suffer from dehydration or hypovolemia.
• If you are taking a medication to treat epilepsy, consult your doctor before taking this medication, as when used together, the efficacy is reduced and the hepatotoxicity of paracetamol is increased, especially in treatments with high doses of paracetamol (see more below in section Other medications and Antidol).
• If you have Gilbert's disease (also known as Meulengracht's disease).
• If you have heart, respiratory, or anemia insufficiency; in these situations, administration should be carried out under surveillance and only for short periods.
• If you have asthma and are sensitive to acetylsalicylic acid.
• Paracetamol can cause severe skin reactions, such asacute generalized exanthematous pustulosis (PEAG), Stevens-Johnson syndrome (SJS), and Toxic Epidermal Necrolysis (TEN), which can be fatal. Patients should be informed about the signs of severe skin reactions, and the use of the medication should be interrupted at the first sign of skin eruption or any other sign of hypersensitivity.
• The total dose of paracetamol should not exceed 3 g per day.
• The simultaneous use of this medication with other medications containing paracetamol, such as cold and flu medications, should be avoided, as high doses can cause liver damage. Do not use more than one medication containing paracetamol without consulting your doctor. If an overdose occurs, seek medical attention immediately (see "If you take more Antidol than you should").
• If you have kidney problems, due to the 1 g paracetamol content, you cannot take this medication. Those with liver, heart, or lung diseases, and patients with anemia, should consult their doctor before taking this medication.
• If you have severe diseases, such as severe renal insufficiency or sepsis (when bacteria and their toxins circulate in the blood, causing damage to organs), or if you have chronic malnutrition, alcoholism, or are also taking flucloxacillin (an antibiotic), a severe 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 distress with deep and rapid breathing, drowsiness, feeling unwell (nausea) and vomiting.

The administration of paracetamol doses higher than recommended involves a very high risk of severe liver damage.

Medications containing paracetamol should not be taken for more than a few days or at high doses unless indicated by your doctor. If the pain persists for more than 5 days, fever for more than 3 days, or if the pain or fever worsen or other symptoms appear, discontinue treatment and consult your doctor.

The prolonged use of analgesics or the inappropriate use of high doses can cause headaches, which should not be treated with higher doses of the medication.

Children and adolescents

Due to the paracetamol dose, this medication should not be used in children or adolescents under 16 years of age (and weighing less than 50 kg). Ask your pharmacist about the available presentations that allow for proper dosing of these patients.

Interference with analytical tests

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

Paracetamol may alter the values of uric acid and glucose determinations.

Other medications and Antidol

Inform your doctor or pharmacistif you are taking, have taken recently, or may need to take any other medication.

In particular, if you are taking any of the following medications, as it may be necessary to modify the dose of one of them or discontinue treatment:

• Medication to prevent blood clots: Oral anticoagulants (acenocoumarol, warfarin)
• Medications to treat epilepsy: Antiepileptics (lamotrigine, phenytoin, or other hydantoins, phenobarbital, methylphenobarbital, primidone, carbamazepine)
• Medications to treat tuberculosis: (isoniazid, rifampicin)
• Medications to lower cholesterol levels in the blood: Colestiramine
• Medications used to increase urine elimination (diuretics such as the furosemide group)
• Medications used to treat gout (probenecid)
• Medications used to prevent nausea and vomiting: Metoclopramide and domperidone
• Medications used to treat high blood pressure (hypertension) and heart rhythm alterations (cardiac arrhythmias): Propranolol

Inform your doctor or pharmacist if you are taking:

-flucloxacillin (antibiotic), due to a grave risk of alteration of the blood and fluids (denominated metabolic acidosis with high anion gap) that must be treated urgently (see section 2).

Taking Antidol with food, drinks, and alcohol

The taking of paracetamol in patients who habitually consume alcohol (3 or more alcoholic beverages - beer, wine, liquor, etc. - per day) may cause liver damage.

The taking of this medication with food does not affect the efficacy of the medication.

Pregnancy and lactation

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

In case of need, this medication can be used during pregnancy. Use the lowest possible dose that reduces pain or fever and use it for the shortest possible time. Contact your doctor if the pain or fever do not decrease or if you need to take the medication more frequently.

Paracetamol passes into breast milk, so women in the lactation period should consult their doctor or pharmacist before using this medication.

Driving and operating machinery

The influence of paracetamol on the ability to drive and operate machinery is negligible or insignificant.

Antidol contains sodium andbenzoate of sodium(E-211)

The maximum recommended dose of this medication contains 438 mg of sodium (present in table salt). This is equivalent to 21.9% of the maximum daily sodium intake recommended for an adult.

Consult your doctor or pharmacist if you need one or more daily packs for a prolonged period, especially if you have been recommended a low-sodium diet.

This medication contains 150 mg of sodium benzoate in each pack.

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

This medicationis taken orally, dissolving the contents of the sachet in a glass of water.

The recommended dose is:

Adults and adolescents over 16 years (and weight over 50 kg):

1 sachet (1 g of paracetamol) every 6 - 8 hours, up to 3 times a day.

Do not exceed in any case 1 gram of paracetamol per dose. Do not take more than 3 g of paracetamol in 24 hours divided into 3 doses.

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

It should be avoided the use of high daily doses of paracetamol for prolonged periods of time as the risk of suffering adverse effects such as liver damage increases.

If the pain persists for more than 5 days, the fever for more than 3 days, or the pain or fever worsen or other symptoms appear, consult the doctor and reevaluate the clinical situation.

Older patients:Your doctor will indicate the frequency and if you need to reduce the dose.

Patients with liver diseasesshouldtake the amount of medication prescribed by your doctor with a minimum interval of 8 hours between each dose.

They should not take more than2 gramsof paracetamol in 24 hours, divided into several doses.

Chronic alcoholics should be careful not to take more than 2 g of paracetamol in 24 hours.

Patients with kidney diseasesshould not use this medication as it does not adjust to the recommended dose for patients with severe or moderate disease.

Use in children and adolescents

Due to the content of paracetamol per sachet (1 g), this medication should not be used in patients under 16 years old (see section 2).

If you take moreAntidolthan you should

Consult your doctor or pharmacist immediately.

Incase of overdose or accidental ingestion, go immediately to a medical center or call the Toxicological Information Service (phone 91 562 04 20), indicating the medication and the amount ingested.It is recommended to bring the packaging and the leaflet of the medication to the healthcare professional.

If you have ingested an overdose, go quickly to a medical center 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 intoxication.

The symptoms of overdose may be: dizziness, vomiting, loss of appetite, yellowish discoloration of the skin and eyes (jaundice) and abdominal pain.

The treatment of overdose is more effective if it is initiated within 4 hours of medication ingestion.

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

If you forget to takeAntidol

Do not take a double dose to compensate for the missed doses.

If you forget to take a dose of paracetamol when it is due, take it as soon as you remember and then wait the indicated time between doses to take the next one.

If you interrupt the treatment withAntidol

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

Like all medications,this medicationcan produce adverse effects, although not all people will experience them.

The possible adverse effects of paracetamol are:

Rare adverse effects (may affect up to 1 in 1,000 patients): discomfort, low blood pressure (hypotension), and increased levels of transaminases in the blood.

Very rare adverse effects (may affect up to 1 in 10,000 patients): kidney diseases, cloudy urine, allergic dermatitis (skin rash), jaundice (yellow discoloration of the skin), blood disorders (agranulocytosis, leucopenia, neutropenia, hemolytic anemia) and hypoglycemia (low blood sugar).

Adverse effects of unknown frequency (cannot be estimated from available data): A serious disease that can make the blood more acidic (designated as metabolic acidosis) in patients with severe disease who use paracetamol (see section 2).

Severe skin reactions have been reported very rarely.

Paracetamol can damage the liver when taken in high doses or prolonged treatment.

Reporting Adverse Effects

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

Keep this medication out of the sight and reach of children.

This medication does not require special storage conditions.

Do not use this medication after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Medications should not be disposed of through drains or in the trash. Dispose of packaging and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medications. By doing so, you will help protect the environment.

Composition ofAntidol

• The active ingredient is paracetamol. Each sachet contains 1 g of paracetamol.
• The other components are: sodium hydrogen carbonate, anhydrous citric acid, mannitol (E-421), sodium benzoate (E-211), anhydrous sodium carbonate, povidone, sodium saccharin, and lemon aroma.

Appearance of Antidol and contents of the packaging

Homogeneous effervescent powder of white color, presented in single-dose sachets.

Each package contains 10 sachets.

Holder of the marketing authorization and responsible for manufacturing

LCinfa Laboratories, S.A.

Carretera Olaz-Chipi, 10. Areta Industrial Estate

31620 Huarte (Navarra) - Spain

Date of the last review of this leaflet:February 2025

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

You can access detailed information about this medication by scanning the QR code included in the leaflet and packaging with your smartphone. You can also access this information at the following internet address:https://cima.aemps.es/cima/dochtml/p/67964/P_67964.html

QR code to:https://cima.aemps.es/cima/dochtml/p/67964/P_67964.html