Efferaldol 500 mg effervescent tablets

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Efferaldol 500 mg effervescent tablets

paracetamol

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

Follow exactly the instructions for administration of the medicine contained in this leaflet or as indicated by your doctor or pharmacist.

• Keep this leaflet, as you may need to read it again.
• If you need advice or more information, consult your pharmacist.
• 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.
• You should consult your doctor if you worsen or if fever does not improve after 3 days or pain after 5 days.

Contents of the leaflet

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

1. What Efferaldol is and what it is used for

Paracetamol is effective in reducing pain and fever.

This medicine is used for the symptomatic relief of mild to moderate occasional pain in adults and children from 6 years of age.

You should consult a doctor if symptoms worsen or if fever persists beyond 3 days or pain beyond 5 days.

2. What you need to know before taking Efferaldol

Do not take Efferaldol

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

Warnings and precautions

Talk to your doctor or pharmacist before taking this medicine.

Do not take more of the medicine than the recommended dose stated in section 3, How to take Efferaldol.

• Concomitant use of this medicine with other medicines containing paracetamol, such as cold and flu remedies, should be avoided, as high doses may cause liver damage. Do not use more than one medicine containing paracetamol without consulting your doctor.
• Chronic alcoholics should take care not to exceed 2 g/24 hours of paracetamol.
• Alcohol consumption is not recommended during treatment.
• Patients with chronic malnutrition, anorexia, cachexia, bulimia, or fasting should consult their doctor before taking this medicine.
• Patients with kidney, liver, heart, or lung disease, or those with anemia, should consult their doctor before taking this medicine.
• If you are taking any medicine for epilepsy, consult your doctor before taking this medicine, as concomitant use may reduce efficacy and increase the hepatotoxicity of paracetamol, especially with high-dose paracetamol regimens.
• Patients with asthma who are sensitive to acetylsalicylic acid should consult their 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 can 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 symptom 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, on alternate days or more frequently, do not increase the dose of analgesics but consult your doctor.

During treatment with Efferaldol, 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 circumstances when paracetamol is used at regular doses over a prolonged period or when paracetamol is taken together with flucloxacillin. Symptoms of metabolic acidosis may include: severe difficulty breathing with deep and rapid breathing, drowsiness, malaise (nausea), and vomiting.

Interference with laboratory tests

If you are scheduled for any laboratory tests (including blood and urine tests), inform your doctor that you are taking this medicine, as it may alter test results.

Paracetamol may interfere with analytical determinations of uric acid and glucose.

Other medicines and Efferaldol

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, dosage 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 (antibiotic): due to a serious risk of blood and fluid disturbances (called metabolic acidosis with high anion gap), which requires urgent treatment (see section 2).

Taking Efferaldol with food, drinks, and alcohol

Taking this medicine with food does not affect its efficacy.

Pregnancy and Lactation

If you are pregnant, think you may be pregnant, or are planning to become pregnant, consult your doctor before taking this medicine.

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

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

Driving and Use of Machinery

The influence of paracetamol on the ability to drive and operate machinery is none or negligible.

Efferaldol contains sorbitol (E-420), sodium, sodium benzoate (E-211), fructose, glucose, and sucrose

This medicine contains 126 mg of sorbitol (E-420) in each tablet.

Sorbitol is a source of fructose. If your doctor has informed you (or your child) that you have an intolerance to certain sugars, or if you have been diagnosed with hereditary fructose intolerance (HFI), a rare genetic disorder in which patients cannot metabolize fructose, consult your doctor (or your child’s doctor) before taking this medicine.

This medicine contains 197 mg of sodium (the main component of table/cooking salt) in each tablet. This corresponds to approximately 10% of the maximum recommended daily intake of sodium for an adult.

This medicine contains 50 mg of sodium benzoate (E-211) in each tablet. Sodium benzoate may increase the risk of jaundice (yellowing of the skin and eyes) in newborns (up to 4 weeks of age).

This medicine contains 0.96 mg of fructose in each tablet.

This medicine contains glucose and sucrose. If your doctor has informed you of an intolerance to certain sugars, consult your doctor before taking this medicine.

3. How to take Efferaldol

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

The score line allows the tablets to be divided into equal doses.

The recommended dose is:

Adults :

Take 1 tablet (500 mg of paracetamol) every 4-6 hours as needed. Do not exceed 6 tablets/24 hours. Do not take more than 3 grams of paracetamol in 24 hours.

Patients with liver disease: you must consult your doctor before taking this medicine.

You should take the amount of medicine prescribed by your doctor, with a minimum interval of 8 hours between each dose.

Do not take more than 2 grams of paracetamol in 24 hours, divided into several doses.

Patients with kidney disease:

Before taking this medicine, you must consult your doctor.

Take a maximum of 500 milligrams of paracetamol per dose.

Depending on your condition, your doctor will advise whether you should take your medicine with a minimum interval of 6 or 8 hours.

Use in children

Do not use in children under 6 years of age.

Children:

The following doses may be repeated with a minimum interval of 4 hours, without exceeding a total of 5 doses in 24 hours.

Children aged 6 to 11 years (weight 21.5 - 43 kg): half a tablet (250 mg of paracetamol) every 4-6 hours; maximum 5 doses of ½ tablet in 24 hours.

Adolescents from 12 years of age (weight 43 - < 64 kg): 1 tablet (500 mg of paracetamol) every 4-6 hours; maximum 5 doses in 24 hours.

Elderly patients:

Dosage adjustment is usually not necessary in elderly patients. However, concomitant risk factors, some of which are more frequent in the elderly, should be taken into account, as they may require dosage adjustment.

This medicine is taken orally.

Effervescent tablets must be dissolved in a glass of water, and if necessary, after splitting the scored tablet in half. Do not swallow until the fizzing has completely stopped.

The tablets must not be chewed or swallowed whole.

Always take the lowest effective dose.

Treatment with this medicine should be based on the presence of pain or fever; when these symptoms subside, treatment should be discontinued.

The use of high daily doses of paracetamol over prolonged periods 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, treatment should be stopped and a doctor consulted.

For sore throat, do not take the medicine for more than 2 consecutive days without consulting a doctor.

If you take more Efferaldol 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 to function properly.
• A disease in which small blood clots form in the bloodstream, blocking blood vessels.
• 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 have symptoms, as these often do not appear until 3 days after the overdose, even in cases of severe poisoning.

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

Patients undergoing treatment with barbiturates 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 Toxicology Information Service (telephone 91 562 04 20), indicating the medicine and the amount ingested.

4. Possible adverse effects

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

The possible adverse effects of this medicine are:

Rare adverse effects affecting 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 affecting 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).

Adverse effects with unknown frequency: 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 breathing difficulty), and a serious condition that may cause the blood to become more acidic (called metabolic acidosis) in severely ill patients using paracetamol (see section 2).

Paracetamol may cause liver damage when taken at 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 can also report them directly through the Spanish Pharmacovigilance System for Human Medicines: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Efferaldol

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

This medicine does not require any special storage conditions.

Do not use this medicine after the expiry date stated on the pack after EXP. The expiry date refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at a SIGRE collection point at your pharmacy. Ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Package contents and other information

Composition of Efferaldol

The active substance is paracetamol. Each tablet contains 500 mg of paracetamol.

The other components (excipients) are citric acid, sodium bicarbonate, sodium carbonate, sorbitol (E-420), sodium docusate, povidone, sodium saccharin, sodium benzoate (E-211), grapefruit-orange flavour (contains fructose, glucose, sucrose). See section 2: Efferaldol contains sorbitol (E-420), sodium, sodium benzoate (E-211), fructose, glucose and sucrose.

Appearance of Efferaldol and contents of the pack

White to almost white, flat, round, effervescent, scored tablets with bevelled edges and a central groove.

The tablet can be divided into equal doses.

Packaged in packs of 20 effervescent tablets, presented in aluminium blisters within a cardboard box.

Marketing Authorisation Holder

UPSA SAS
3 rue Joseph Monier
92500 Rueil-Malmaison
France

Manufacturer

UPSA 979, Avenue des Pyrénées - Le Passage - 47520 France

or

UPSA 304, Av. Dr. Jean Bru, Agen – France

Local representative

NEWLINE PHARMA, S.L.U.
Calle Tarragona 151-157, 11th Floor, Door 1, Block A
08014 Barcelona (Spain)
Tel.: 931851380

Date of latest revision of this leaflet: June 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/