Label: information for the user

Antidol 500 mg granulated

Paracetamol

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

Follow exactly the administration instructions of the medicine contained in this label or those indicated by your doctor or pharmacist.

• Keep this label, 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 or pharmacist, even if they are not listed in this label. See section 4.
• You should consult a doctor if your fever worsens or does not improve after 3 days, or if your pain does not improve after 5 days.

Paracetamol is effective in reducing pain and fever.

This medication is used in adults and adolescents over 44 kg (from 12 years old) for symptomatic treatment of occasional mild or moderate pain, such as headache, toothache, muscle pain (contractures) or back pain (lumbago) and fever.

Do not takeAntidol

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

Warnings and precautions

• Do not take more than the recommended dose in section 3. Taking a higher dose does not increase pain relief but may damage the liver. Liver damage symptoms may occur after a few days. If you have taken more paracetamol than indicated in this leaflet, it is essential to consult your doctor as soon as possible.
• Avoid taking this medication with other medications containing paracetamol, such as cold and flu medications, as high doses may cause liver damage. Do not take more than one medication containing paracetamol without consulting your doctor.
• Consult your doctor or pharmacist before starting to take this medication.
• If you have kidney, liver, heart, or lung diseases, or patients with anemia (decreased hemoglobin levels in the blood, due or not due to a decrease in red blood cells).
• If you have chronic malnutrition or dehydration.
• If you are being treated with any medication for epilepsy, consult your doctor before taking this medication, as when used together, it may decrease the effectiveness and increase the hepatotoxicity of paracetamol, especially in high-dose treatments.
• If you are an asthmatic sensitive to acetylsalicylic acid.
• Chronic alcoholics should be careful not to take more than2 gof paracetamol in 24 hours.
• If you have severe diseases, such as severe renal insufficiency or sepsis (when bacteria and their toxins circulate in the blood, causing damage to organs), or if you have chronic malnutrition, alcoholism, or are also taking flucloxacillin (an antibiotic). A severe disease called metabolic acidosis (a blood and fluid anomaly) has been reported in patients in these situations when using paracetamol at regular doses for a prolonged period or when taking paracetamol with flucloxacillin. Metabolic acidosis symptoms may include: severe respiratory difficulty with deep and rapid breathing, drowsiness, feeling unwell (nausea), and vomiting.

Children and adolescents

Do not use in children weighing less than 44 kg (approximately under 12 years old) as it does not allow for dosing of doses less than 1 tablet per dose (500 mg).

In children and adolescents under 12 years old, consult your doctor or pharmacist as there may be other presentations available with doses adapted to these patients.

Other medications and Antidol

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

Particularly, if you are using medications containing the following active ingredients, as it may be necessary to reduce the dose of some of them or interrupt treatment:

• Ethyl alcohol
• Oral anticoagulants (acenocoumarol, warfarin)
• Anticonvulsants (phenytoin, phenobarbital, methylphenobarbital, primidone)
• Isoniazid
• Rifampicin
• Lamotrigine
• Metoclopramide and domperidone (used to prevent nausea and vomiting)
• Probenecid
• Propranolol used in the treatment of high blood pressure (hypertension) and heart rhythm disorders (cardiac arrhythmias)
• Ion exchange resins (colestiramine)

Also inform your doctor or pharmacist if you are taking:

-flucloxacillin (antibiotic), due to a severe risk of blood and fluid imbalance (denominated metabolic acidosis with high anion gap) that must be treated urgently (see section 2).

Interference with analytical tests:

If you are to undergo any analytical test (including blood, urine, etc) inform your doctor that you are taking this medication, as it may alter the results of these tests.

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

Use of Antidol with food, drinks, and alcohol

The use of paracetamol in patients who regularly consume alcohol (3 or more alcoholic beverages per day) may cause liver damage.

Taking this medication with food does not affect its efficacy.

Pregnancy and lactation

If you are pregnant or think you may be pregnant, consult your doctor before taking this medication. Taking medications during pregnancy can be hazardous to the embryo or fetus and should be monitored by your doctor.

If necessary, paracetamol can be used during pregnancy. Use the lowest possible dose that reduces pain or fever and use it for the shortest time possible. Contact your doctor if the pain or fever does not decrease or if you need to take the medication more frequently.

Paracetamol is excreted in breast milk, so women in the lactation period should consult their doctor or pharmacist before using this medication.

Driving and operating machinery

The influence of this medication on the ability to drive and operate machinery is negligible or insignificant.

Antidol contains aspartame (E-951), sodium, and saccharose

• This medication contains 23.62 mg of aspartame (E-951) in each tablet. Aspartame contains a source of phenylalanine that may be harmful in cases of phenylketonuria (PKU), a rare genetic disease in which phenylalanine accumulates due to the body's inability to eliminate it correctly.
• This medication contains 115 mg of sodium (main component of table salt/cooking salt). This is equivalent to 5.75% of the maximum daily sodium intake recommended for an adult.
• This medication contains saccharose. If your doctor has indicated that you have an intolerance to certain sugars, consult with them before taking this medication. It may cause tooth decay.

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

This medication is taken orally.

Open the packet and empty the contents directly into the mouth. The granule disperses immediately in the saliva and is then swallowed.

It can be taken both with and without food.

The recommended dose is:

Adults: 1 packet (500 mg of paracetamol) every 4-6 hours as needed. If necessary, 2 packets of 500 mg every 6-8 hours may be taken.

Do not take more than 3 g of paracetamol (6 packets) in 24 hours. Doses should be spaced at least 4 hours apart.

Always take the smallest effective dose.

The use of this medication is subject to the appearance of pain or fever. As these symptoms disappear, treatment should be discontinued.

High daily doses of paracetamol should be avoided for prolonged periods of time as this increases the risk of adverse effects such as liver damage.

If pain persists for more than 5 days, fever for more than 3 days, or if pain or fever worsen or other symptoms appear, treatment should be interrupted and the doctor consulted.

For sore throat, the medication should not be taken for more than 2 consecutive days without consulting a doctor.

Use in children and adolescents

Adolescents over 44 kg (from 12 years): the recommended dose is 1 packet (500 mg of paracetamol) every 4-6 hours as needed, without exceeding 5 packets in 24 hours.

Children:

Do not use in children under 44 kg (approximately 12 years). Use of other presentations more suitable for this group of patients is recommended.

Patients with liver or kidney disease:should consult their doctor before taking this medication. If their doctor prescribes this medication, they should wait at least 8 hours between doses.

If you take more Antidol than you should

You should consult your doctor or pharmacist immediately.

If an overdose has been taken, go quickly to a medical center even if no symptoms are present, as they often do not appear until 3 days after ingestion of the overdose, even in cases of severe poisoning.

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

The treatment of an overdose is more effective if initiated within 4 hours of medication ingestion.

Patients on barbiturate treatment or chronic alcoholics may be more susceptible to the toxicity of a paracetamol overdose.

In case of overdose or accidental ingestion, go immediately to a medical center or call the Toxicological Information Service (phone 91 562 04 20), indicating the medication and the amount ingested.

If you forgot to take Antidol

Do not take a double dose to compensate for the missed doses.

Like all medications, this medication may produce adverse effects, although not all people may experience them.

The following adverse effects have been reported according to the frequencies detailed below:

Renal and Urinary Tract Disorders

Rare (may affect up to 1 in 1,000 people):kidney disorders; cloudy urine

Skin and Subcutaneous Tissue Disorders

Rare (may affect up to 1 in 1,000 people):allergic dermatitis (skin rash)

Very rare (may affect up to 1 in 10,000 people): severe skin reactions have been reported very rarely.

Hepatobiliary Disorders

Rare (may affect up to 1 in 1,000 people):jaundice (yellow discoloration of the skin)

Blood and Lymphatic System Disorders

Rare (may affect up to 1 in 1,000 people):blood abnormalities (agranulocytosis, leucopenia, neutropenia, thrombocytopenia, hemolytic anemia)

Metabolism and Nutrition Disorders

Rare (may affect up to 1 in 1,000 people):hypoglycemia (low blood sugar)

Unknown frequency (cannot be estimated from available data):a severe disease that can make the blood more acidic (designated as metabolic acidosis) in patients with severe disease who use paracetamol (see section 2).

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

If you consider that any of the adverse effects you experience are severe, or if you notice any adverse effect not mentioned in this leaflet, inform your doctor or pharmacist.

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 leaflet. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use (www.notificaram.es).

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

No special storage conditions are required.

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.

Do not dispose of medications through drains or in the trash. Dispose of packaging and unused medications at the SIGRE collection point at the pharmacy. Ask your pharmacist how to dispose of packaging and unused medications. This will help protect the environment.

Composition of Antidol

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

The other components are calcium carbonate, sodium hydrogen carbonate, anhydrous citric acid, anhydrous sodium citrate, aspartame (E-951), mask it (contains sucrose and aspartame (E-951)), mannitol (E-421), lemon aroma,amorphous silica, glycerol (E-422) diester type 1, sodium croscarmellose, sodium carboxymethylcellulose (type A) (from potato), ethylcellulose, hydroxypropyl methylcellulose, and polyethylene glycol 400.

Appearance of the product and contents of the packaging

White granule with a lemon-scented appearance, packaged in single-dose sachets.

Packed in boxes of 10 and 20 sachets.

Only some sizes of packaging may be commercially available.

Holder of the marketing authorization

Cinfa Laboratories, S.A.

Olaz-Chipi Road, 10. Areta Industrial Estate

31620 Huarte (Navarra)

Responsible for manufacturing

Farmalider, S.A.

Aragoneses Street, 2

28108 Alcobendas, Madrid

or

Edefarm, S.L

Enchilagar del Rullo Industrial Estate, 117

46191, Villamarchante, Valencia

Spain

Last review date of this leaflet: April 2025

Further detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/