Leaflet: information for the user

Efferaldol 500 mg effervescent tablets

paracetamol

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

Follow exactly the administration instructions for the medicine contained in this leaflet or those 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 side effects, consult your doctor or pharmacist, even if they are not listed in the leaflet. See section 4.
• You should consult your doctor if your fever worsens or does not improve after 3 days or if your pain persists for 5 days.

Paracetamolis effectivein reducingpain andfever.

This medication is used for symptomatic relief of occasionalmild or moderatepain, in adults and children aged 6 years and above.

Consult a doctor if the fever worsens or persists after 3 days or the pain lasts for 5 days.

Do not take Efferaldol

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

Warnings and precautions

Consult your doctor or pharmacist before starting to take this medication.

Do not take more than the recommended amount of medication as stated in section 3. How to take Efferaldol.

• Concomitant use of this medication with other medications containing paracetamol, such as cold and flu medications, may lead to liver damage. Do not take more than one medication containing paracetamol without consulting your doctor.
• Chronic alcoholics should be cautious not to take more than 2 g/24 hours of paracetamol.
• It is not recommended to consume alcohol during treatment.
• Patients with chronic malnutrition, anorexia, cachexia, bulimia, or fasting should consult their doctor before taking the medication.
• Patients with kidney, liver, heart, or lung diseases, and patients with anemia, should consult their doctor before taking the medication.
• When taking medications for epilepsy, consult your doctor before taking this medication, as concomitant use may decrease efficacy and increase hepatotoxicity of paracetamol, especially at high doses.
• Asthmatic patients sensitive to acetylsalicylic acid should consult their doctor before taking this medication.
• Paracetamol may cause severe 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 severe skin reactions, and the medication should be discontinued at the first sign of skin eruption or any other sign of hypersensitivity.
• 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 dose of analgesics, but consult your doctor.

Inform your doctor immediately if you experience any of the following during treatment with Efferaldol:

- 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 suffer from malnutrition, chronic alcoholism, or if you 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. Symptoms of metabolic acidosis may include: severe respiratory distress with deep and rapid breathing, somnolence, feeling unwell (nausea), and vomiting.

Interactions with laboratory tests

Inform your doctor if you are to undergo any laboratory tests (including blood and urine tests), as this medication may affect the results.

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

Other medications and Efferaldol

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

In particular, if you are taking any of the following medications, as it may be necessary to modify the dose of some of them or discontinue treatment:

• Medication to prevent blood clots: Oral anticoagulants (acenocoumarol, warfarin)
• Medications for treating epilepsy: Antiepileptic drugs (lamotrigine, phenytoin, or other hydantoins, phenobarbital, methylphenobarbital, primidone, carbamazepine)
• Medications for treating tuberculosis: Isoniazid, rifampicin
• Medications for treating depression and seizures: Barbiturates (used as hypnotics, sedatives, and anticonvulsants)
• Medications used to lower cholesterol levels in the blood: Cholestyramine
• Medications used to increase urine elimination (diuretics such as furosemide)
• Medications used to treat gout (probencid and sulfinpyrazone)
• Medications used to prevent nausea and vomiting: Metoclopramide and domperidone
• Medications used to treat high blood pressure and heart rhythm disorders (arrhythmias): Propranolol
• Flucloxacillin (antibiotic): due to a high risk of blood and fluid imbalance (metabolic acidosis with high anion gap) that must be treated urgently (see section 2).

Taking Efferaldol with food, drinks, and alcohol

The taking of this medication with food does not affect its efficacy.

Pregnancy and Breastfeeding

If you are pregnant or think you may be pregnant, or if you plan to become pregnant, consult your doctor before taking this medication.

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

Paracetamol passes into breast milk, so women breastfeeding should consult their doctor or pharmacist before taking this medication.

Driving and operating machinery

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

Efferaldol contains sorbitol, sodium, and sodium benzoate

This medication contains 300 mg of sorbitol in each effervescent tablet.

Sorbitol is a source of fructose. If your doctor has indicated that you (or your child) have a fructose intolerance or have been diagnosed with hereditary fructose intolerance (HFI), a rare genetic disorder in which the patient cannot break down fructose, consult your doctor before taking this medication.

This medication contains 412 mg of sodium (main component of table salt/for cooking) in each effervescent tablet, which is equivalent to 20.6% of the maximum daily sodium intake recommended for an adult.

This medication contains 61 mg of sodium benzoate in each effervescent tablet. Sodium benzoate may increase the risk of jaundice (yellowing of the skin and eyes) in newborns (up to 4 weeks of age).

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

The groove 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.

If necessary, you could take 2 tablets (1g of paracetamol) every 6-8 hours, as needed.

Patients with liver disease:

Before taking this medication, you must consult your doctor.

You should take the amount of medication 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 medication, you must consult your doctor.

Take a maximum of 500 milligrams of paracetamol per dose.

Your doctor will indicate whether you should take your medication with a minimum interval of 6 or 8 hours, depending on your condition.

Use in children

Do not use in children under 6 years old.

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 old (weight 43 - <641 tablet (500 mg of paracetamol), every 4-6 hours; maximum 5 doses in 24 hours.

Patients of advanced age:

No adjustment of the dose is usually necessary in patients of advanced age. However, other concomitant risk factors, some of which are more frequent in the elderly, and which require dose adjustment, should be taken into account.

This medication is taken orally.

The effervescent tablets must be dissolved in a glass of water. Do not ingest until the bubbling has completely stopped.

Always take the smallest effective dose.

The taking of this medication is subject to the appearance of pain or fever as they disappear, treatment should be suspended.

It should be avoided to use high daily doses of paracetamol for prolonged periods of time, as the risk of suffering adverse effects such as liver damage increases.

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 interrupt treatment and consult your doctor.

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

If you take more Efferaldol than you should

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 a paracetamol overdose:

- Acute inability of the kidneys to function correctly.

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

- Rare cases of pancreatitis inflammation.

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

When you have taken an overdose, the treatment of the overdose is more effective if it is initiated within 4 hours of taking the medication.

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

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

Likeall medications, this medication mayproduceadverse effects, although not all people will experience them.

The possible adverse effects ofthis medicationare:

Rare adverse 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 adverse effects that may affect up to 1 in 10,000 people: kidney diseases, cloudy urine, allergic dermatitis (skin rash), jaundice (yellow discoloration of the skin), blood disorders (agranulocytosis, leucopenia, neutropenia, hemolytic anemia) and hypoglycemia (low blood sugar).

Adverse effects of unknown frequency: purpura, fixed drug eruption (reddish/purple patch on the skin that reappears in the same location), bronchospasm (excessive and prolonged contraction of the respiratory tract muscles that causes difficulty breathing) and a severe disease that can make the blood more acidic (known as metabolic acidosis) in patients with severe disease who use paracetamol (see section 2).

Paracetamolcan damage the liverwhen taken inhigh doses or prolonged treatments.

Reporting Adverse Effects

If you experienceany type of adverse effect,consult your doctor orpharmacist, even if it is apossibleadverse effect that does not appear in this leaflet.You can also report them directly through theSpanish System for Pharmacovigilance of Medicines for Human Use: www.notificaRAM.es.By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

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 indicated on the packagingafter CAD. The expiration date is the last day of the month indicated.

Medicines should not be disposed of through drains or in the trash. Dispose of packaging and medications you no longer need at the SIGRE collection pointat the pharmacy. Ask your pharmacist how to dispose of packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition ofEfferaldol

The active ingredient is paracetamol.

The other components (excipients) are anhydrous citric acid, sodium bicarbonate, anhydrous sodium carbonate, sorbitol (E-420), sodium docusate, polyvidone, sodium saccharin, and sodium benzoate (E-211).

AppearanceofEfferaldol and contents of the packaging

Effervescent and scored tablets with a white color and beveled edges.

They are presented in containers holding 20 effervescent tablets conditioned in aluminum strips.

Marketing Authorization Holder

UPSA SAS

3 rue Joseph Monier

92500 Rueil-Malmaison

France

Responsible for Manufacturing

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, Planta 11, Puerta 1, Bloque A

08014 Barcelona (Spain)

Tel.: 931851380

Date of the last review of this prospectus:January 2025

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