ANTIDOL 500 MG ORAL SOLUTION

Introduction

Package Leaflet: Information for the User

Antidol500 mg Oral Solution

Paracetamol

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

Follow the instructions for administration 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 not listed in this leaflet. See section 4.
• You should consult a doctor if your symptoms worsen or if your fever persists for more than 3 days or your pain for more than 5 days.

Contents of the Package Leaflet

1. What is Antidol and what is it 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. Contents of the pack and further information

1. What is Antidol and what is it used for

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

It is used for the relief of occasional mild or moderate pain, such as headache, dental, muscular (cramps), or back (lumbago) pain, as well as in febrile conditions in adults and children weighing over 33 kg (10-12 years, approximately).

2. What you need to know before taking Antidol

Do not take Antidol

• 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 than the recommended dose of medicine as stated in section 3. How to take Antidol.
• Avoid taking this medicine simultaneously with other medicines that contain paracetamol, such as flu and cold medicines, as high doses can lead to liver damage. Do not use more than one medicine that contains 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 (decreased 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 may be increased, especially with high doses of paracetamol.
• Asthmatic patients sensitive to acetylsalicylic acid should consult their doctor before taking this medicine.
• If you have severe diseases, such as severe kidney 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 the 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

In children under 10-12 years, consult your doctor or pharmacist, as other presentations may be available with doses suitable for these patients.

Other medicines and Antidol

Tell your doctor or pharmacist if you are using, have recently used, or might 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 must be treated urgently (see section 2).

Do not use with other pain relievers (medicines that reduce pain) 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, 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.

Use of Antidol with 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 negligible or insignificant.

Antidol contains propylene glycol (E-1520), sodium, and azorubine (E-122)

This medicine contains 44.35 mg of propylene glycol in each sachet.

This medicine contains less than 23 mg of sodium (1 mmol) per sachet; i.e., 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 the instructions for administration of the medicine contained in this leaflet or as indicated by your doctor. In case of doubt, ask your doctor, pharmacist, or nurse.

The recommended dose is:

Adults and adolescents over 15 years (and 50 kg of weight):

Take 1 sachet (500 mg of paracetamol) every 4-6 hours as needed. If necessary, 2 sachets can be taken every 8 hours.

Do not take more than 3 g of paracetamol (6 sachets) in 24 hours. The doses should be spaced at least 4 hours apart. Always take the lowest effective dose.

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

Avoid using high daily doses of paracetamol for 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, discontinue treatment and consult your doctor.

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

Patients with kidney disease:

Before taking this medicine, consult your doctor. Take a maximum of 1 sachet per dose.

Depending on your disease, your doctor will indicate whether you should take your medicine with a minimum interval of 6 or 8 hours.

Patients with liver disease:

Consult your doctor before starting to take this medicine.

Take the amount of medicine prescribed by your doctor, with a minimum interval between each dose of 8 hours.

Do not take more than 2 g of paracetamol (4 sachets) in 24 hours, divided into several doses.

Children:

The recommended daily dose of paracetamol is approximately 60 mg/kg/day, divided into 4 or 6 daily doses, i.e., 15 mg/kg every 6 hours or 10 mg/kg every 4 hours.

It is necessary to respect the dosages defined according to weight.The age of the child according to weight is given for information purposes only.

• Children between 33 kg and 42 kg of weight (10-12 years, approximately): 1 sachet per dose, every 6 hours, up to a maximum of 4 sachets per day.
• Children between 42 kg and 50 kg of weight (12-14 years, approximately): 1 sachet per dose, every 4-6 hours as needed, up to a maximum of 5 sachets per day.

Do not use in children for more than 3 consecutive days without evaluating the clinical situation.

Do not use in children under 33 kg (10-12 years, approximately). The use of other presentations more suitable for the treatment of this group of patients is recommended.

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.

Once the sachet is opened, consume its entire contents.

If you take more Antidol than you should

Consult your doctor or pharmacist immediately. In case of overdose or accidental ingestion, go to a medical center or call the Toxicological Information Service (telephone 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 to a medical center immediately, 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 under treatment with barbiturates or chronic alcoholics may be more susceptible to the toxicity of a paracetamol overdose.

If you forget to take Antidol

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, leukopenia, neutropenia, hemolytic anemia), and hypoglycemia (low blood sugar) and severe skin reactions.

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).

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

Reporting of side effects

If you experience any side effects, consult your doctor or pharmacist, even if they are 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 stated 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. Place the packaging and any unused medicines in the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medicines. This will help protect the environment.

6. Contents of the pack and further information

The active ingredient is paracetamol. Each sachet contains 500 mg of paracetamol.

The other ingredients are: macrogol 400, glycerol (E-422), sodium saccharin, strawberry flavor, raspberry flavor (contains propylene glycol (E-1520)), taste masker (contains potato maltodextrin), azorubine (E-122), and purified water.

Appearance of Antidol and contents of the pack

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

Each pack contains 10 and 20 sachets with 5 ml of solution each, packaged in single-dose sachets made of PET/ALU/PET/PE.

Only some pack sizes may be marketed.

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/