Paracetamol Accord 1 g effervescent tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Paracetamol Accord 1 g effervescent tablets EFG

Read the entire leaflet carefully before you start taking this medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to others, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents

1. What Paracetamol Accord is and what it is used for
2. What you need to know before taking Paracetamol Accord
3. How to take Paracetamol Accord
4. Possible side effects
5. How to store Paracetamol Accord
6. Contents of the pack and other information

1. What Paracetamol Accord is and what it is used for

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

This medicine is used in adults and adolescents over 15 years of age (and weighing more than 50 kg) for the treatment of symptoms of mild to moderate pain and fever.

2. What you need to know before taking Paracetamol Accord

Do not take Paracetamol Accord

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

Warnings and precautions

Consult your doctor or pharmacist before starting to take this medicine:

• Do not take more than the recommended dose stated in section 3. How to take Paracetamol Accord.
• You should avoid taking this medicine simultaneously with other medicines containing paracetamol, such as cold and flu remedies, because high doses may cause liver damage. Do not use more than one medicine containing paracetamol without consulting your doctor.
• Patients with kidney disease should not take this medicine due to its 1 g paracetamol content. Patients with liver, heart, or lung disease, or those with anaemia, should consult their doctor before taking this medicine.
• If you are being treated with medicines for epilepsy, consult your doctor before taking this medicine, as concomitant use may reduce efficacy and increase the hepatotoxic potential of paracetamol, especially with high-dose paracetamol regimens.
• In chronic alcoholics, caution should be taken not to exceed 2 g of paracetamol in 24 hours.
• Alcohol consumption is not recommended during treatment.
• Patients with chronic malnutrition, anorexia, cachexia, bulimia, or fasting should consult their doctor before taking this medicine.
• In asthmatic patients sensitive to acetylsalicylic acid, consult your doctor before taking this medicine.
• Paracetamol may cause serious skin reactions such as acute generalized exanthematous pustulosis (AGEP), Stevens-Johnson syndrome (SJS), and toxic epidermal necrolysis (TEN), which may be fatal. Patients should be informed about the signs of serious skin reactions, and treatment should be discontinued at the first sign of skin rash or any other sign of hypersensitivity.
• Frequent long-term use of analgesics may cause or worsen headaches. If you suffer from chronic headaches and have been taking analgesics for more than 3 months, at least on alternate days, do not increase the analgesic dose but consult your doctor.

During treatment with paracetamol, inform your doctor immediately if:

• you have serious conditions such as severe renal failure or sepsis (when bacteria and their toxins circulate in the blood, causing organ damage), or if you suffer from malnutrition, chronic alcoholism, or are also taking flucloxacillin (an antibiotic). A serious condition called metabolic acidosis (an abnormality in blood and body fluids) has been reported in patients under these conditions when paracetamol is used at regular doses for prolonged periods or when paracetamol is taken concomitantly with flucloxacillin. Symptoms of metabolic acidosis may include: severe breathing difficulties with deep and rapid breathing, drowsiness, malaise (nausea), and vomiting.

Children and adolescents

Due to the paracetamol dose, this medicine should not be used in children or adolescents under 15 years of age (and weighing less than 50 kg). Ask your pharmacist about available formulations that allow appropriate dosing for these patients.

Interference with diagnostic tests

If you are undergoing any diagnostic tests (including blood and urine tests, skin tests using allergens, etc.), inform your doctor that you are taking this medicine, as it may alter the results of such tests.

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

Other medicines and Paracetamol Accord

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

In particular, if you are taking any of the following medicines, dose adjustments or discontinuation of treatment may be necessary:

• Medicines to prevent blood clots: oral anticoagulants (acenocoumarol, warfarin),
• Medicines for epilepsy: antiepileptics (lamotrigine, phenytoin or other hydantoins, phenobarbital, methylphenobarbital, primidone, carbamazepine),
• Medicines for tuberculosis: (isoniazid, rifampicin),
• Medicines for depression and seizures: barbiturates (used as hypnotics, sedatives, and anticonvulsants),
• Medicines to lower blood cholesterol levels: (cholestyramine),
• Medicines used to increase urine elimination (loop diuretics such as furosemide),
• Medicines used in the treatment of gout (probenecid and sulfinpyrazone),
• Medicines used to prevent nausea and vomiting: metoclopramide and domperidone,
• Medicines used to treat high blood pressure (hypertension) and heart rhythm disorders (cardiac arrhythmias): propranolol,
• Flucloxacillin: flucloxacillin (antibiotic), due to a serious risk of blood and fluid imbalance (metabolic acidosis with high anion gap) that requires urgent treatment (see section 2).

Taking Paracetamol Accord with food, drinks, and alcohol

The use of paracetamol in patients who habitually consume alcohol 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 are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

Pregnancy

Paracetamol may be used during pregnancy if necessary. Use the lowest effective dose needed to relieve pain or fever, and use it for the shortest possible time. Contact your doctor or midwife if pain or fever does not improve or if you need to take the medicine more frequently.

Consult your doctor or pharmacist before using any medicine.

Breastfeeding

Consult your doctor or pharmacist before using any medicine.

Paracetamol passes into breast milk; therefore, women who are breastfeeding should consult their doctor or pharmacist before taking this medicine.

Driving and using machines

The effect of this medicine on the ability to drive and use machines is negligible or none.

Paracetamol Accord contains sodium and sorbitol (E-420)

This medicine contains 100 mg of sorbitol per tablet. If your doctor has told you that you have an intolerance to certain sugars, consult him before taking this medicine.

This medicine contains 435.25 mg of sodium (the main component of table salt) per tablet. This corresponds to 21.76% of the recommended daily sodium intake for an adult.

Consult your doctor if you need to take 1 or more tablets daily for a prolonged period, especially if you have been advised to follow a low-salt (low-sodium) diet.

It may cause allergic reactions (possibly delayed).

Consult your pharmacist or doctor if you need to take 4 or more tablets daily for a prolonged period, especially if you have been advised to follow a low-salt (low-sodium) diet.

3. How to take Paracetamol Accord

Follow exactly the instructions for use of this medicine as given by your doctor. If in doubt, consult your doctor or pharmacist again.

Instructions for use:

For oral administration.

Completely dissolve the effervescent tablet in a glass of water. The effervescence must have stopped before taking the medicine. Always take the lowest effective dose.

Recommended dose:

Adults and adolescents over 15 years of age (body weight above 50 kg): One tablet (1 g of paracetamol) 3 times a day, every 6–8 hours. Doses should be spaced at least 4 hours apart. Do not take more than 4 tablets (4 g) in 24 hours.

Elderly patients: Your doctor will determine the frequency and whether dose reduction is necessary. Concomitant risk factors, some of which are more common in the elderly, should be taken into account and may require dose adjustment.

Patients with liver disease: 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 grams of paracetamol in 24 hours, divided into 2 doses.

Patients with kidney disease: Due to the paracetamol dose (1 gram), this medicine should not be used in these patients.

Use in children and adolescents

Because of the paracetamol content per tablet (1 g), this medicine should not be used in patients under 15 years of age (see section 2).

This medicine should only be taken when symptoms appear—pain or fever. As symptoms subside, treatment should be discontinued.

Prolonged use of high daily doses of paracetamol should be avoided, 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 new symptoms appear, consult your doctor and reassess the clinical condition.

When doses lower than 1 g of paracetamol per dose are required, other formulations of paracetamol should be used.

If you take more Paracetamol Accord than you should

Consult your doctor or pharmacist immediately.

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

The following events have been observed after paracetamol overdose:

• Acute kidney failure.

• A condition in which small blood clots form in the bloodstream, blocking blood vessels (disseminated intravascular coagulation).

• Rare cases of inflammation of the pancreas.

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

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

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

Patients undergoing treatment with barbiturates or chronic alcoholics may be more susceptible to the toxicity of a paracetamol overdose.

If you forget to take Paracetamol Accord

Do not take a double dose to make up for missed doses. Simply take the missed dose as soon as you remember, and take the following doses at the recommended intervals (at least 4 hours apart).

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

Rare adverse effects (may affect up to 1 in 1,000 people): malaise, increased blood transaminase levels, anaphylactic reaction (including hypotension), anaphylactic shock, hypersensitivity, and angioedema.

Very rare adverse effects (may affect up to 1 in 10,000 people): Kidney disorders, cloudy urine, allergic dermatitis (skin rash), jaundice (yellowing of the skin), blood disorders (agranulocytosis, leucopenia, neutropenia, haemolytic anaemia), and hypoglycaemia (low blood sugar). Very rare cases of serious skin reactions have been reported.

Adverse effects with unknown frequency (cannot be estimated from the available data): Purpura, fixed drug eruption (red/purple skin patch that reappears in the same location), bronchospasm (excessive and prolonged contraction of the muscles in the airways causing difficulty in breathing), and a serious condition that may cause the blood to become more acidic (called metabolic acidosis) in patients with severe illness who use paracetamol (see section 2).

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

Reporting of 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 may also report them directly through the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaRAM.es.

By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Paracetamol Accord

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

No special storage conditions are required.

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date is the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at a pharmacy's SIGRE collection point. If you are in doubt, ask your pharmacist how to properly dispose of unused medicines and their containers. This will help protect the environment.

6. Contents of the pack and other information

Composition of Paracetamol Accord

• The active substance is paracetamol. Each tablet contains 1 gram of paracetamol.
• The other components are: Anhydrous citric acid, Sorbitol (E420), Sodium hydrogen carbonate, Anhydrous sodium carbonate, Povidone K25, Simeticone emulsion (30%), Sodium docusate, Sodium saccharin, Macrogol 6000, Glycine carbonate monosodium, Sodium benzoate, Lemon flavour.
• Composition of Simeticone emulsion (30%): Simeticone, sorbitan monostearate, methyl parahydroxybenzoate (E218), bronopol, polysaccharides, gum and purified water.
• Composition of lemon flavour: artificial and natural flavours, corn maltodextrin, gum arabic (E414), alpha tocopherol (E307) and purified water.

Appearance of Paracetamol Accord and contents of the pack

White or almost white, flat, round effervescent tablets, approximately 25 mm in diameter.

The tablets are packed in 4-layer blisters – paper/PE/Alu/Surlyn (copolymer of ethylene/methacrylic acid/zinc) and available in pack sizes of 8, 20 and 40 tablets.

Only some pack sizes may be marketed.

Marketing Authorization Holder

Accord Healthcare, S.L.U.

World Trade Center

Moll de Barcelona, s/n

Edifici Est, 6th floor

08039 Barcelona

Spain

Manufacturer:

Laboratori Fundació DAU

C/ C, 12-14 Pol. Ind. Zona Franca,

Barcelona, 08040

Spain

Date of the most recent revision of this leaflet: December 2025

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