EFFERALDOL 500 mg EFFERVESCENT TABLETS

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

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

Contents of the Package Leaflet

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

1. What is Efferaldol and what is it used for

Paracetamol is effective for reducing pain and fever.

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

You should consult a doctor if your condition worsens or if the fever persists after 3 days or the pain after 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

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 Efferaldol

• The simultaneous use of this medicine with other medicines containing paracetamol, such as flu and cold medicines, should be avoided, as high doses can lead to liver damage. Do not use more than one medicine containing paracetamol without consulting your doctor.
• Chronic alcoholics should be cautious not to take more than 2g/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 the medicine.
• Patients with kidney, liver, heart, or lung disease, and patients with anemia, should consult their doctor before taking the medicine.
• When being treated with any medicine for epilepsy, consult your doctor before taking this medicine, as the efficacy of paracetamol may be decreased and hepatotoxicity increased, especially with high doses of paracetamol.
• Asthmatic patients 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 should discontinue the use of the medicine at the first symptom of skin rash or any other sign of hypersensitivity.
• Frequent use of analgesics for a long time 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 dose of analgesics, but consult your doctor.

During treatment with Efferaldol, inform your doctor immediately if:

• You have severe diseases, such as severe renal failure or sepsis (when bacteria and their toxins circulate in the blood, causing damage to organs), or if you suffer from malnutrition, chronic alcoholism, or are also taking flucloxacillin (an antibiotic). A serious disease called metabolic acidosis (an anomaly in blood and fluids) has been reported in patients in these situations when paracetamol is used at regular doses for a prolonged period or when paracetamol is taken with flucloxacillin. The symptoms of metabolic acidosis may include: severe breathing difficulties with deep and rapid breathing, drowsiness, feeling unwell (nausea) and vomiting.

Interactions with analytical tests

If you are going to have any analytical test (including blood, urine, etc.), inform your doctor that you are taking this medicine, as it may alter the results.

Paracetamol may alter the values of 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 take any other medicine.

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:

• Medicine to prevent blood clots: 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 cholesterol levels in the blood: 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
• Flucloxacillin (antibiotic): due to a serious risk of alteration of blood and fluids (called metabolic acidosis with high anion gap) that should be treated urgently (see section 2).

Taking Efferaldol with food, drinks, and alcohol

Taking this medicine with food does not affect its efficacy.

Pregnancy and Breastfeeding

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

If necessary, paracetamol 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 or midwife if the pain or fever does not decrease or if you need to take the medicine more frequently.

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 paracetamol on the ability to drive and use machines is negligible or non-existent.

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 told you that you (or your child) have an intolerance to certain sugars, or have been diagnosed with hereditary fructose intolerance (HFI), a rare genetic disease, consult your doctor before taking this medicine.

This medicine contains 197 mg of sodium (main component of table salt) in each tablet. This is equivalent 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 old).

This medicine contains 0.96 mg of fructose in each tablet.

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

3. How to Take Efferaldol

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

The score line allows you to divide the tablets 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: 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 grams of paracetamol in 24 hours, divided into several doses.

Patients with kidney disease:

Before taking this medicine, they must consult their doctor.

Take a maximum of 500 milligrams of paracetamol per dose.

Depending on the disease, your doctor will indicate if 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 old.

Children:

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

Children from 6 to 11 years old (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 old (weight 43 - < 64 kg):1 tablet (500 mg of paracetamol), every 4-6 hours; maximum 5 doses in 24 hours.

Elderly patients:

It is usually not necessary to adjust the dose in elderly patients. However, other concurrent risk factors, some of which are more frequent in the elderly, should be taken into account, and may require a dose adjustment.

This medicine is taken orally.

The effervescent tablets should be dissolved in a glass of water, if necessary after having broken the scored tablet in half. Do not ingest until the bubbling has completely stopped.

The tablets should not be chewed or swallowed.

Always take the lowest effective dose.

Treatment with this medicine is subject to the appearance of pain or fever, and as they disappear, treatment should be discontinued.

High daily doses of paracetamol should be avoided for prolonged periods, 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 worsens, or other symptoms appear, treatment should be discontinued and your doctor consulted.

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

If you take more Efferaldol than you should

Consult your doctor or pharmacist immediately.

The 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.
• A disease in which small clots form in the bloodstream that obstruct blood vessels.
• Rare cases of pancreatitis.

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

When an overdose has been taken, treatment of the overdose is more effective if started within 4 hours after taking the medicine.

Patients treated 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 Side Effects

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

The possible side effects of this medicine are:

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).

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), and a serious disease that can make the blood more acidic (called metabolic acidosis) in patients with severe disease using paracetamol (see section 2).

Paracetamol may cause liver damage when taken in high doses or for prolonged treatment.

Reporting of Side Effects

If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. You can also report them directly through the Spanish Medicines Monitoring System: www.notificaRAM.es. By reporting side 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 special storage conditions.

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 should not be disposed of via wastewater or household waste. Return any unused medicine to a pharmacy for proper disposal. Ask your pharmacist how to dispose of medicines no longer needed. This will help protect the environment.

6. Contents of the Pack and Further Information

Composition of Efferaldol

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

The other ingredients (excipients) are citric acid, sodium bicarbonate, sodium carbonate, sorbitol (E-420), sodium docusate, povidone, sodium saccharin, sodium benzoate (E-211), grapefruit-orange flavor (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

Effervescent tablets, white to off-white, flat, and round, with beveled edges and a score line.

The tablet can be divided into equal doses.

It is available in packs of 20 effervescent tablets, packaged in aluminum strips in a cardboard box.

Marketing Authorization Holder

UPSA SAS

3 rue Joseph Monier

92500 Rueil-Malmaison

France

Manufacturer

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

O

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

Local Representative

NEWLINE PHARMA, S.L.U.

Calle Tarragona 151-157, Planta 11, Puerta 1, Bloque A

08014 Barcelona (Spain)

Tel.: 931851380

Date of Last Revision of this Leaflet:June 2025

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