PARACETAMOL ACCORD 1 g EFFERVSCENT TABLETS

Introduction

Package Leaflet: Information for the User

Paracetamol Accord 1 g Effervescent Tablets EFG

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

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

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

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

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

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

2. What you need to know before you take Paracetamol Accord

Do not take Paracetamol Accord

• If you are allergic (hypersensitive) to paracetamol or any of the other ingredients 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 in section 3. How to take Paracetamol Accord.
• You should avoid taking this medicine at the same time as other medicines that contain paracetamol, such as medicines for colds and flu, as high doses can lead to liver damage. Do not use more than one medicine that contains paracetamol without consulting your doctor.
• Patient with kidney disease due to its content of 1g of paracetamol cannot take this medicine. Those suffering from liver, heart or lung disease and patients with anemia should consult their doctor before taking this medicine.
• When being treated with any medicine for epilepsy, consult your doctor before taking this medicine, as when used at the same time, the efficacy is decreased and the toxicity of paracetamol on the liver is increased, especially in high-dose treatments of paracetamol.
• In chronic alcoholics, the precaution should be taken not to take more than 2g of paracetamol in 24 hours.
• Alcohol consumption is not recommended during treatment.
• Patient with chronic malnutrition, anorexia, cachexia, bulimia or fasting should consult their doctor before taking the medicine.
• In asthmatic patients sensitive to acetylsalicylic acid, consult your doctor before taking this medicine.
• Paracetamol can cause serious skin reactions, such as acute generalized exanthematous pustulosis (AGEP), Stevens-Johnson syndrome (SJS), and toxic epidermal necrolysis (TEN), which can be fatal. Patients should be informed about the signs of serious skin reactions and the use of the medicine should be discontinued at the first symptom of skin rash or any other sign of hypersensitivity.
• Frequent use of analgesics for a long time can 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 dose of analgesics, but consult your doctor.

Children and adolescents

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

Interference with laboratory tests

If you are going to have any laboratory tests (including blood tests, urine tests, skin tests that use allergens, etc.), inform your doctor that you are taking this medicine, as it may alter the results of these tests.

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

Other medicines and Paracetamol Accord

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

In particular, if you are taking 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 (hypertension) and heart rhythm disorders (cardiac arrhythmias): propranolol.
• Flucloxacillin: flucloxacillin (antibiotic), due to a serious risk of alteration of blood and fluids (metabolic acidosis with high anion gap) that should be treated urgently and that can occur especially in case of severe renal insufficiency, sepsis (when bacteria and their toxins circulate in the blood that causes organ damage), malnutrition, chronic alcoholism and when paracetamol is used at high doses and/or for a prolonged period.

Taking Paracetamol Accord with food, drinks and alcohol

The use of paracetamol in patients who habitually consume alcohol can 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 have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy

Paracetamol can be used during pregnancy if necessary. You should use the lowest possible dose that reduces pain or fever and use it for the shortest possible time. Contact your doctor or midwife if the pain or fever does not decrease or if you need to take the medicine more frequently.

Consult your doctor or pharmacist before taking any medicine.

Breastfeeding

Consult your doctor or pharmacist before taking any medicine.

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 this medicine on the ability to drive and use machines is negligible.

Paracetamol Accord contains sodium and sorbitol (E-420)

This medicine contains 100 mg of sorbitol in each tablet. If your doctor has told you that you have an intolerance to some sugars, consult with them before taking this medicine.

This medicine contains 435.25 mg of sodium (the main component of kitchen/table salt) in each tablet. This is equivalent to 21.76% of the recommended daily intake of sodium in 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 diet (sodium).

It can 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 diet (sodium).

3. How to take Paracetamol Accord

Always take this medicine exactly as your doctor has told you. If you are not sure, check with your doctor or pharmacist.

Method of administration:

For oral administration.

Dissolve the effervescent tablet completely in a glass of water. Before taking the medicine, it is necessary for the effervescence to cease. Always take the lowest effective dose.

The recommended dose is:

Adults and adolescents over 15 years (weighing more than 50 kg):One tablet (1 g of paracetamol) 3 times a day, every 6-8 hours. The 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 indicate the frequency and if the dose needs to be reduced. Concomitant risk factors should be taken into account, some of which are more frequent in the elderly, and which require a dose adjustment.

Patient with liver disease: They should take the amount of medicine prescribed by their doctor with a minimum interval between each dose of 8 hours. They should not take more than 2 grams of paracetamol in 24 hours, divided into 2 doses.

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

Use in children and adolescents

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

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

High daily doses of paracetamol should be avoided during prolonged periods of time, as the risk of adverse effects such as liver damage is increased.

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 consult your doctor and re-evaluate the clinical situation.

When lower doses of paracetamol are required per dose, other presentations of paracetamol should be used.

If you take more Paracetamol Accord than 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.

The following events have been observed after an overdose of paracetamol:

- Acute kidney failure.

- Disease in which small clots form in the bloodstream that obstruct blood vessels.

- Rare cases of pancreatitis

If you have taken an overdose, you should go to a medical center immediately, even if you do not notice symptoms, as they often do not appear until 3 days after ingestion of the overdose, even in cases of severe poisoning.

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

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 taken.

Patient being treated 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 forgotten doses, simply take the forgotten dose when you remember, taking the next doses with the separation between doses indicated in each case (at least 4 hours).

If you stop taking Paracetamol Accord

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

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: discomfort, increased levels of transaminases in the blood, anaphylactic reaction (including hypotension), anaphylactic shock, hypersensitivity, and angioedema.

Very rare side effects that may affect up to 1 in 10,000 people: 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 serious skin reactions have been reported.

Side effects with unknown frequency: purpura, fixed drug eruption (red/purple spot on the skin that reappears in the same place), bronchospasm (excessive and prolonged contraction of the muscles of the airways that causes difficulty breathing).

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

Reporting of side effects:

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaRAM.es.

By reporting side 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 which is stated on the carton after EXP. The expiry date is the last day of the month shown.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures 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 ingredients are: Anhydrous citric acid, Sorbitol (E420), Sodium hydrogen carbonate, Anhydrous sodium carbonate, Povidone K25, Simethicone emulsion (30%), Sodium docusate, Sodium saccharin, Macrogol 6000, Monosodium glycine carbonate, Sodium benzoate, Lemon flavor.
• Composition of Simethicone emulsion (30%): Simethicone, sorbitan monostearate, methylparaben (E218), bronopol, polysaccharides, gum and purified water.
• Composition of lemon flavor: artificial and natural flavors, corn maltodextrin, arabic gum (E414), alpha-tocopherol (E307) and purified water.

Appearance of Paracetamol Accord and contents of the pack

Effervescent tablets, white or almost white, flat and round, approximately 25 mm in diameter.

The tablets are packaged in 4-layer blister packs (paper/PE/Alu/Surlyn (copolymer of ethylene/methacrylic acid/zinc)) and are presented in packs of 8, 20 and 40 tablets.

Not all pack sizes may be marketed.

Marketing authorization holder

Accord Healthcare, S.L.U.

World Trade Center

Moll de Barcelona, s/n

Edifici Est, 6ª planta

08039 Barcelona

Spain

Manufacturer

Laboratori Fundació DAU

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

Barcelona, 08040

Spain

Date of last revision of this leaflet: December 2024

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