ANTIDOL 1 G ORAL SOLUTION

Introduction

Leaflet: information for the user

Antidol 1 g oral solution

Paracetamol

Read this leaflet carefully before starting to take this medicine, as it contains important information for you.

Follow exactly the administration instructions of the medicine contained in this leaflet or as indicated by your doctor, pharmacist, or nurse.

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

Contents of the leaflet

1. What Antidol is and what it is used for
2. What you need to know before taking Antidol
3. How to take Antidol
4. Possible side effects
5. Storage of Antidol
6. Package contents and additional information

1. What Antidol is and what it is used for

This medicine contains paracetamol. Paracetamol is effective in reducing pain and fever.

It is used for the relief of occasional mild or moderate pain, such as headache, toothache, muscle pain (cramps) or back pain (lumbago), and in febrile conditions, in adults and adolescents over 15 years and weighing over 50 kg.

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, pharmacist, or nurse before starting to take Antidol.

• Do not take more medicine than recommended in section 3. How to take Antidol.
• The simultaneous use of this medicine with other medicines containing paracetamol, such as flu and cold medicines, should be avoided, as high doses can lead to liver damage. Do not use more than one medicine containing paracetamol without consulting your doctor.
• Chronic alcoholics should be cautious not to take more than 2 g/24 hours of paracetamol.
• Patient with kidney, liver, heart, or lung disease, and patients with anemia (decrease in hemoglobin levels in the blood, due to or not due to a decrease in red blood cells), or those patients who suffer from chronic malnutrition or dehydration, should consult their doctor before taking this medicine.
• When being treated with any medicine for epilepsy, consult your doctor before taking this medicine, as the efficacy of paracetamol may be decreased and hepatotoxicity increased, especially in high-dose paracetamol treatments.
• Asthmatic patients sensitive to acetylsalicylic acid should 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 suffer from 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 of discomfort (nausea) and vomiting.

Children and adolescents

Due to the dose, the use of this medicine is not indicated in children and adolescents under 15 years or weighing less than 50 kg.

Other medicines andAntidol

Tell your doctor or pharmacist if you are using, have recently used, or may need to use any other medicine.

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

• Medicines 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 treat depression and convulsions: Barbiturates (used as hypnotics, sedatives, and anticonvulsants).
• 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 and sulfinpyrazone).
• Medicines used to prevent nausea and vomiting: Metoclopramide and domperidone.
• Medicines used to treat high blood pressure and heart rhythm disorders (arrhythmias): Propranolol.

Tell 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 imbalance) that should be treated urgently (see section 2).

Do not use with other analgesics (pain-relieving medicines) without consulting your doctor.

As a general rule for any medicine, it is recommended to systematically inform your doctor or pharmacist if you are being treated with another medicine. In the case of treatment with oral anticoagulants, it can be administered occasionally as the analgesic of choice.

Interference with analytical tests

If you are going to have any analytical test (including blood, urine tests, etc.), tell 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.

Use ofAntidolwith food, drinks, and alcohol

Taking this medicine with food does not affect its efficacy.

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 medicine.

Taking medicines during pregnancy can be hazardous to the embryo or fetus and should be monitored by your doctor.

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

Driving and using machines

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

Antidolcontains propylene glycol (E-1520), sodium, and azorubine (E-122).

This medicine contains 88.7 mg of propylene glycol in each sachet.

This medicine contains less than 23 mg of sodium (1 mmol) per sachet; it is essentially "sodium-free".

This medicine may cause allergic reactions because it contains azorubine. It can cause asthma, especially in patients allergic to acetylsalicylic acid.

3. How to take Antidol

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

The recommended dose is:

Adults and adolescents over 15 years and weighing over 50 kg:

Take 1 g of paracetamol (1 sachet) every 6-8 hours, 3 times a day. Do not take more than 3 g of paracetamol (3 sachets) in 24 hours.

Always take the smallest effective dose.

Taking this medicine is subject to the appearance of pain or fever. As they disappear, treatment should be discontinued.

High daily doses of paracetamol should be avoided during prolonged periods, as the risk of side 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, treatment should be discontinued and your doctor consulted.

For throat pain, do not take the medicine for more than 2 consecutive days without consulting your doctor.

Patient with kidney disease:

This medicine does not adjust to the recommended dose for these patients.

Patient with liver disease:

Consult your doctor before starting to take this medicine.

They should take the amount of medicine prescribed by their doctor with a minimum interval of 8 hours between each dose.

They should not take more than 2 g of paracetamol (2 sachets) in 24 hours, divided into several doses.

Method of administration

This medicine is taken orally.

The contents of the sachet can be taken directly or diluted in a liquid, preferably water. Once the sachet is opened, consume its entire contents.

If you take moreAntidolthan 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, phone 91 562 04 20, indicating the medicine and the amount ingested.

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

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

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

Patient treated with 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.

4. Possible side effects

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

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

Very rare side effects that may affect up to 1 in 10,000 people are: 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) and 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 severe disease using paracetamol (see section 2).

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

Reporting of side effects

If you experience any side effects, consult your doctor or pharmacist, even if they are side effects not listed in this leaflet. You can also report them directly through the Spanish Medicines and Healthcare Products Agency (AEMPS) website: 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.

No special storage conditions are required.

Do not use this medicine after the expiration date shown on the packaging after "EXP.". The expiration date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Deposit the packaging and any unused medicines in the pharmacy's SIGRE collection point. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medicines. 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: macrogol 400, glycerol (E-422), sodium saccharin, strawberry flavor, raspberry flavor (contains propylene glycol (E-1520)), taste masking agent (azorubine (E-122)), and purified water.

Appearance ofAntidoland package contents

Oral solution of translucent red color, free of suspended particles, and with a characteristic strawberry/raspberry odor.

Each package contains 10 sachets with 10 ml of solution each, packaged in single-dose sachets made of PET/ALU/PET/PE complex.

Marketing authorization holder

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Polígono Industrial Areta

31620 Huarte (Navarra) – Spain

Manufacturer

Farmalider, S.A.

C/Aragoneses, 2

28108 Alcobendas, Madrid - Spain

or

Edefarm, S.L.

Polígono Industrial Enchilagar del Rullo, 117

46191, Villamarchante, Valencia - Spain

or

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