ANTIDOL 650 mg TABLETS

Introduction

Package Leaflet: Information for the User

Antidol 650 mg Tablets

Read the entire package leaflet carefully before starting to take this medication, as it contains important information for you.

Follow the administration instructions for the medication contained in this package leaflet or as indicated by your doctor, pharmacist, or nurse.

This medication can be obtained without a prescription. Nevertheless, to achieve the best results, it should be used with caution.

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

Contents of the Package Leaflet

1. What Antidol 650 mg is and what it is used for
2. What you need to know before taking Antidol 650 mg
3. How to take Antidol 650 mg
4. Possible adverse effects
5. Storage of Antidol 650 mg
6. Package contents and additional information

1. What Antidol 650 mg is and what it is used for

Paracetamol belongs to the group of medications called analgesics and antipyretics.

Paracetamol is used for the treatment of mild to moderate pain and febrile states in adults and adolescents over 15 years old (or with a body weight over 50 kg).

2. What you need to know before taking Antidol 650 mg

Do not takeAntidol 650 mg

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

Be cautious withAntidol 650 mg

• Do not take more medication than recommended in section 3. How to take Antidol 650 mg.
• The simultaneous use of this medication with other medications containing paracetamol should be avoided, such as medications for flu and colds, as high doses can lead to liver damage. Do not use more than one medication containing paracetamol without consulting your doctor.
• In asthmatic patients sensitive to acetylsalicylic acid, consult your doctor before taking this medication.
• If you have liver, kidney, heart, or lung disease, or if you have anemia (reduced hemoglobin levels in the blood, due to or not due to a reduction in red blood cells), you should consult your doctor before taking this medication.
• When being treated with medication for epilepsy, consult your doctor before taking this medication, as the efficacy of paracetamol may be decreased and hepatotoxicity may be increased, especially with high doses of paracetamol.
• In chronic alcoholics, caution should be exercised to not take more than 2 grams of paracetamol in 24 hours.
• If the pain persists for more than 5 days, the fever for more than 3 days, or if the pain or fever worsen or other symptoms appear, consult your doctor and reevaluate the clinical situation.
• 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 severe 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 respiratory distress with deep and rapid breathing, drowsiness, feeling of discomfort (nausea) and vomiting.

• In children and adolescents under 15 years old, consult your doctor or pharmacist, as there are other presentations with doses suitable for this group of patients.

Other medications andAntidol 650 mg

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

Paracetamol may interact with the following medications:

• Medication to prevent blood clots: oral anticoagulants (acenocoumarol, warfarin).
• Medications for treating epilepsy: antiepileptics (lamotrigine, phenytoin, or other hydantoins, phenobarbital, methylphenobarbital, primidone, carbamazepine).
• Medications for treating tuberculosis: isoniazid, rifampicin.
• Medications for treating depression and convulsions: barbiturates (used as hypnotics, sedatives, and anticonvulsants).
• Medications for reducing cholesterol levels in the blood: colestyramine.
• Medications used to increase urine elimination (loop diuretics such as furosemide).
• Medications used for treating gout: probenecid and sulfinpyrazone.
• Medications used to prevent nausea and vomiting: metoclopramide and domperidone.
• Medications used for treating 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 the 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 medications) without consulting your doctor.

As a general rule for any medication, it is recommended to systematically inform your doctor or pharmacist if you are being treated with another medication. 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 undergo any analytical test (including blood tests, urine tests, skin tests using allergens, etc.), inform your doctor that you are taking this medication, as it may alter the results of these tests.

TakingAntidol 650 mgwith food, drinks, and alcohol

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

Taking this medication 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 medication.

If necessary, this medication 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 medication more frequently.

Small amounts of paracetamol may appear in breast milk; therefore, it is recommended that you consult your doctor or pharmacist before taking this medication.

Driving and using machines

The influence of paracetamol on the ability to drive and use machines is negligible or nonexistent.

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

3. How to take Antidol 650 mg

Follow these instructions unless your doctor has given you different instructions. Remember to take your medication. Paracetamol should be taken orally.

The normal dose is:

Adults and adolescents over 15 years old:

The usual dose is 1 tablet (650 mg of paracetamol) every 4-6 hours. The doses should be spaced at least 4 hours apart. Do not take more than 3 grams (4 tablets) in 24 hours.

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 if the pain or fever worsen or other symptoms appear, you should stop treatment and consult your doctor.

Patient with liver disease: before taking this medication, they must consult their doctor.

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

Do not take more than 3 tablets of 650 mg of paracetamol in 24 hours.

Patient with kidney disease: before taking this medication, they must consult their doctor. Take a maximum of 500 mg per dose.

Due to the dose, 650 mg of paracetamol, it is not indicated for this group of patients.

Elderly patients: should consult their doctor.

Use in children and adolescents:

Do not use in children and adolescents under 15 years old.

If the effect of paracetamol is too strong or too weak, inform your doctor or pharmacist.

When lower doses of paracetamol are required per dose, other presentations of paracetamol that adapt to the required dosage should be used.

If you take moreAntidol 650 mgthan you should

Consult your doctor or pharmacist immediately.

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, you should 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 after ingestion of the medication.

Patient treated with barbiturates or chronic alcoholics may be more susceptible to the toxicity of a paracetamol overdose.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service (phone 91 562 04 20), indicating the medication and the amount ingested.

If you forget to takeAntidol 650 mg

Do not take a double dose to make up for forgotten doses; simply take the forgotten dose when you remember, taking the following doses with the indicated interval between doses (at least 4 hours).

4. Possible adverse effects

Like all medications, this medication can cause adverse effects, although not all people experience them.

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

Very rare adverse effects that may occur (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). Very rare cases of severe skin reactions have been reported.

Adverse 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 adverse effects

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

5. Storage of Antidol 650 mg

Keep this medication out of sight and reach of children.

This medication does not require special storage conditions.

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

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

6. Package contents and additional information

Composition ofAntidol 650 mg

The active ingredient is paracetamol. Each tablet contains 650 mg of paracetamol.

The other components are: sodium carboxymethyl starch (Type A) (potato), pregelatinized cornstarch, povidone K30 (E1201), stearic acid (E570), and crospovidone (E1202).

Appearance of the product and package contents

Antidol 650 mg is presented in oral tablets.

The tablets are oblong, biconvex, white, with a score line on one side and marked with PC on the other side.

The packaging is 20 tablets, packaged in PVC/PVDC/Aluminum blisters.

Marketing authorization holder and manufacturer

Marketing authorization holder

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Polígono Industrial Areta

31620 Huarte (Navarra) – Spain

Manufacturer:

SAG Manufacturing S.L.U

Crta. N-I, Km 36,

San Agustín de Guadalix,

28750 Madrid

Spain

or

Galenicum Health, S.L.U.

Sant Gabriel, 50,

Esplugues de Llobregat

08950 Barcelona

Spain

Date of the last revision of this package leaflet: February 2025

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