ANTIDOL 1 G TABLETS

Introduction

Package Leaflet: Information for the User

Antidol 1gTablets

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

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

This medicine can be obtained without a prescription. Nevertheless, to obtain the best results, it should be used with care.

• 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 side effects, consult your doctor, pharmacist, or nurse, even if they are side 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 the pain lasts for more than 5 days.

Contents of the Package Leaflet

1. What Antidol 1g is and what it is used for
2. What you need to know before taking Antidol 1g
3. How to take Antidol 1g
4. Possible side effects
5. Storage of Antidol 1g
6. Contents of the pack and further information

1. What Antidol 1g is and what it is used for

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

Paracetamol is used for the treatment of moderate pain and fever in adults and adolescents from 16 years old (or with a body weight over 50 kg).

2. What you need to know before taking Antidol 1g

Do not takeAntidol 1g

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

Be cautious withAntidol 1g

• Do not take more medicine than recommended in section 3. How to take Antidol 1g.
• Avoid simultaneous use of this medicine with other medicines containing paracetamol, such as flu and cold medicines, as high doses can lead to liver damage. Do not use more than one medicine containing paracetamol without consulting your doctor.
• In asthmatic patients sensitive to acetylsalicylic acid, consult your doctor before taking this medicine.
• If you have liver, kidney, heart, or lung disease, or have anemia (reduced hemoglobin levels in the blood), you should consult your doctor before taking this medicine.
• When being treated with epilepsy medication, consult your doctor before taking this medicine, as the efficacy of paracetamol may be reduced and hepatotoxicity increased, especially with high doses of paracetamol.
• Chronic alcoholics should be cautious not to take more than 2g of paracetamol in 24 hours.
• 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 your doctor and reassess the clinical situation.
• In adolescents under 16 years old, consult your doctor or pharmacist, as there are other presentations with doses suitable for this group of patients.
• If you have severe diseases, such as severe renal insufficiency or sepsis (when bacteria and their toxins circulate in the blood, causing organ damage), or if you have 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 using paracetamol at regular doses for a prolonged period or when taking paracetamol with flucloxacillin. The symptoms of metabolic acidosis may include: severe breathing difficulties with deep and rapid breathing, drowsiness, feeling unwell (nausea) and vomiting.

Other medicines andAntidol 1g

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

Paracetamol may interact with the following medicines:

• Blood clot prevention medicines: oral anticoagulants (acenocoumarol, warfarin).
• Medicines for treating epilepsy: antiepileptics (lamotrigine, phenytoin, or other hydantoins, phenobarbital, methylphenobarbital, primidone, carbamazepine).
• Medicines for treating tuberculosis: isoniazid, rifampicin.
• Medicines for treating depression and convulsions: barbiturates (used as hypnotics, sedatives, and anticonvulsants).
• Medicines for reducing blood cholesterol levels: colestyramine.
• Medicines used to increase urine elimination (loop diuretics such as furosemide).
• Medicines used for treating gout: probenecid and sulfinpyrazone.
• Medicines used to prevent nausea and vomiting: metoclopramide and domperidone.
• Medicines 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 gap) that must 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 undergo any analytical tests (including blood tests, urine tests, skin tests using allergens, etc.), inform your doctor that you are taking this medicine, as it may alter the results of these tests.

TakingAntidol 1gwith 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 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.

Small amounts of paracetamol may appear in breast milk; therefore, it is recommended that you consult your 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.

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

3. How to take Antidol 1g

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

The normal dose is:

Adults and adolescents over 16 years old:

The usual dose is 1 tablet (1g of paracetamol) 3 times a day. The doses should be spaced at least 4 hours apart. Do not take more than 3 grams (3 tablets) in 24 hours.

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 worsen or other symptoms appear, you should stop treatment and consult your doctor.

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

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

Do not take more than 2 paracetamol tablets in 24 hours, divided into 2 doses.

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

Due to the dose, 1g of paracetamol 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 16 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 should be used that adapt to the required dosage.

If you take moreAntidol 1gthan you should

Consult your doctor or pharmacist immediately.

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 of taking the medicine.

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 (telephone 91 562 04 20), indicating the medicine and the amount ingested.

If you forget to takeAntidol 1g

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

4. Possible side effects

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

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

Very rare side 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, leucopenia, neutropenia, hemolytic anemia), and hypoglycemia (low blood sugar). Very rare cases of severe skin reactions have been reported.

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

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).

Reporting side effects

If you experience any side effects, consult your doctor or pharmacist, even if they are possible side effects not listed in this package leaflet. You can also report them directly through the Spanish Medicines and Health Products Agency's website: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Antidol 1g

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 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. 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. Contents of the pack and further information

Composition ofAntidol 1g

The active ingredient is paracetamol. Each tablet contains 1g of paracetamol.

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

Appearance of the product and pack contents

Antidol 1g is presented in tablets for oral administration.

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

The packaging is 10 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 medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/