ANTIDOL 1 G EFFERVSCENT POWDER

2. What you need to know before taking Antidol

Do not takeAntidol

• If you are allergic to paracetamol or any of the other components of this medicine (listed in section 6).

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 medicine 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 medicine to treat epilepsy, you should consult your doctor before taking this medicine, as when used at the same time, the efficacy of paracetamol is decreased and hepatotoxicity is increased, especially in high-dose paracetamol treatments (see below in the section Other medicines and Antidol).
• If you have Gilbert's disease (also known as Meulengracht's disease).
• If you have heart, respiratory, or anemia failure; 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 serious skin reactions, such as acute generalized exanthematous pustulosis(AGEP), Stevens-Johnson syndrome (SJS), and Toxic Epidermal Necrolysis (TEN), which can be fatal. Patients should be informed about the signs of serious skin reactions, and the use of the medicine should be discontinued at the first symptom of skin rash or any other sign of hypersensitivity.
• The total dose of paracetamol should not exceed 3 g per day.
• Concomitant use of this medicine with other medicines containing paracetamol, such as flu and cold medicines, should be avoided, as high doses can cause liver damage. Do not use more than one medicine 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 its content of 1 g of paracetamol, you cannot take this medicine. Those with liver, heart, or lung disease and patients with anemia will need to consult their doctor before taking this medicine.
• If you have severe diseases, such as severe renal failure or sepsis (when bacteria and their toxins circulate in the blood, causing damage to organs), or if you have malnutrition, chronic alcoholism, or are also taking flucloxacillin (an antibiotic). A serious disease called metabolic acidosis (an anomaly in 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.

The administration of paracetamol doses higher than recommended implies a very serious risk of liver damage.

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

Prolonged use of analgesics or inadequate use of high doses can cause headaches, which should not be treated with higher doses of the medicine.

Children and adolescents

Due to the dose of paracetamol, this medicine should not be used in children or adolescents under 16 years old (and weight under 50 kg). Ask your pharmacist about the available presentations that allow for adequate dosing of these patients.

Interference with analytical tests

If you are going to have any analytical tests (including blood, urine, etc.), inform your doctor that you are taking this medicine, as it may alter the results.

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

Other medicines and Antidol

Inform your doctor or pharmacist if you are taking, have recently taken, or may need to take any other medicine.

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

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

Also inform your doctor or pharmacist if you are taking:

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

Taking Antidol with food, drinks, and alcohol

Taking paracetamol in patients who habitually consume alcohol (3 or more alcoholic beverages - beer, wine, liquor,... - per day) can cause liver damage.

Taking this medicine with food does not affect its efficacy.

Pregnancy and breastfeeding

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

If necessary, this medicine can be used during pregnancy. You should 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 does not decrease or if you need to take the medicine more frequently.

Paracetamol passes into breast milk, so breastfeeding women should consult their doctor or pharmacist before using this medicine.

Driving and using machines

The influence of paracetamol on the ability to drive and use machines is nil or insignificant.

Antidol contains sodium andsodium benzoate(E-211)

The maximum recommended dose of this medicine 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 sachets per day for a prolonged period, especially if you have been recommended a low-salt diet (sodium).

This medicine contains 150 mg of benzoic acid salt in each sachet.

3. How to take Antidol

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

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

The recommended dose is:

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

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

Do not exceed 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 medicine is subject to the appearance of symptoms, pain, or fever. As these disappear, treatment should be suspended.

High daily doses of paracetamol should be avoided during prolonged periods, as the risk of 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 worsens or other symptoms appear, you should consult your doctor and reevaluate the clinical situation.

Elderly patients: your doctor will indicate the frequency and if the dose needs to be reduced.

Patient with liver disease: they should take the amount of medicine prescribed by their doctor with a minimum interval between each dose of 8 hours.

They should not take more than 2 grams of 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.

Patient with kidney disease: this medicine does not adjust to the recommended dose for patients with moderate or severe disease.

Use in children and adolescents

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

If you take moreAntidolthan you should

You should consult your doctor or pharmacist immediately.

In case of overdose or accidental ingestion, go immediately to a medical center or call the Toxicology Information Service (telephone 91 562 04 20), indicating the medicine and the amount ingested. It is recommended to take the packaging and the leaflet of the medicine to the healthcare professional.

If you have ingested an overdose, you should go quickly to a medical center even if you do not have symptoms, as they often do not appear until 3 days after ingestion, even in cases of severe poisoning.

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

Treatment of overdose is more effective if started within 4 hours after ingestion of the medicine.

Patient taking barbiturates 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 make up for forgotten doses.

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

If you stop takingAntidol

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.

The possible side effects of paracetamol are:

Rare side 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 side effects (may affect up to 1 in 10,000 patients): kidney disease, cloudy urine, allergic dermatitis (skin rash), jaundice (yellowing of the skin), blood disorders (agranulocytosis, leucopenia, neutropenia, hemolytic anemia), and hypoglycemia (low blood sugar).

Side effects with unknown frequency (cannot be estimated from available data): a serious disease that can make the blood more acidic (called metabolic acidosis) in patients with severe disease using paracetamol (see section 2).

Very rare cases of serious skin reactions have been reported.

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

Reporting of 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 Medicines and Healthcare Products Agency (AEMPS) https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Antidol

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

This medicine does not require special storage conditions.

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

Medicines should not be disposed of through wastewater or household waste. Place the packaging and medicines you no longer need in the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This will help protect the environment.

6. Package contents and additional information

Composition ofAntidol

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

Appearance of Antidol and package contents

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

Each package contains 10 sachets.

Marketing authorization holder and manufacturer

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Polígono Industrial Areta

31620 Huarte (Navarra) - Spain

Date of last revision of this leaflet:February 2025

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

You can access detailed information about this medicine by scanning the QR code included in the leaflet and packaging with your mobile phone (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