Leaflet: information for the user

Efferalgan 1 g 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 have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed for you and should not be given to others, even if they have the same symptoms, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

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

This medicine is used for the symptomatic treatment of mild or moderate pain and fever in adults and adolescents 15 years of age and older and weighing more than 50 kg.

Do not take Efferalgan:

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

Warnings and precautions

Consult your doctor or pharmacist before starting to take Efferalgan.

• Do not take more of the medicine than recommended in section 3. How to take Efferalgan.
• Avoid taking this medicine with other medicines that contain paracetamol, such as cold and flu medicines, as high doses may cause liver damage. Do not take more than one medicine that contains paracetamol without consulting your doctor.
• Chronic alcoholics should be careful not to take more than 2 g/24 hours of paracetamol.
• Do not recommend the consumption of alcohol during treatment.
• Patients with chronic malnutrition, anorexia, cachexia, bulimia, or fasting should consult their doctor before taking the medicine.
• Patients with kidney disease due to the paracetamol content of 1 g cannot take this medicine. Those suffering from liver, heart, or lung diseases and patients with anemia should consult their doctor before taking this medicine.
• When taking any medicine for epilepsy, consult your doctor before taking this medicine, as when taken together, the efficacy is reduced and the hepatotoxicity of paracetamol is increased, especially in high-dose treatments with paracetamol.
• Inform your doctor before taking this medicine if you are an asthmatic patient sensitive to acetylsalicylic acid.
• Paracetamol can 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 use of the medicine should be interrupted at the first sign of skin rash or any other sign of hypersensitivity.
• The frequent use of analgesics over a long period 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.

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

• 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 difficulty breathing with deep and rapid breathing, drowsiness, feeling unwell (nausea), and vomiting.

Children and adolescents

Due to the paracetamol dose, 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.

Interactions with analytical tests

Inform your doctor that you are taking this medicine if you are to undergo any analytical test (including blood, urine, etc.), as it may alter the results.

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

Other medicines and Efferalgan

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

In particular, if you are taking any of the following medicines, as 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 to treat epilepsy: Antiepileptics (lamotrigine, phenytoin, or other hydantoins, phenobarbital, methylphenobarbital, primidone, carbamazepine)
• Medicines to treat tuberculosis: Isoniazid, rifampicin
• Medicines to treat depression and seizures: Barbiturates (used as hypnotics, sedatives, and anticonvulsants)
• Medicines to reduce blood cholesterol levels: Cholestyramine
• Medicines used to increase urine elimination (diuretics of the loop, 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 (arrhythmias): Propranolol

Flucloxacillin (antibiotic): due to a severe risk of blood and fluid alteration (denominated metabolic acidosis with high anion gap) that must be treated urgently (see section 2).

Taking Efferalgan with food, drinks, and alcohol

Taking paracetamol in patients who regularly 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, or if you think you may be pregnant, consult your doctor or pharmacist before using this medicine. If necessary, Efferalgan 1g can be used during pregnancy.

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 women breastfeeding should consult their doctor or pharmacist before taking this medicine.

Driving and operating machinery

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

Efferalgan contains sorbitol (E-420), sodium, and sodium benzoate (E-211)

This medicine contains 252 mg of sorbitol in each tablet.

Sorbitol is a source of fructose. If your doctor has told you (or your child) that you (or they) suffer from an intolerance to certain sugars, or if you (or they) have been diagnosed with hereditary fructose intolerance (HFI), a rare genetic disease in which the patient cannot break down fructose, consult your doctor (or your child) before taking this medicine.

This medicine contains 567 mg of sodium (main component of table salt/for cooking) in each tablet. This is equivalent to 113.4% of the recommended daily maximum sodium intake for an adult. Consult your doctor or pharmacist if you need 1 or more effervescent tablets per day for a prolonged period, especially if you have been recommended a low-sodium diet.

This medicine contains 120 mg of sodium benzoate in each tablet.

Follow exactly the administration instructions of this medication as indicated by your doctor. In case of doubt, consult your doctor again.

This medication is taken orally.

Dissolve the tablet in a glass of water and do not take until the bubbling has completely stopped.

Always take the lowest effective dose.

The recommended dose is:

Adults and adolescents over 15 years old (and weight over 50 kg)

1 tablet (1 g of paracetamol)every 6 - 8 hours,3 or 4 times a day.

Do not exceed 1 gram of paracetamol per dose. Do not take more than 4 g of paracetamol in 24 hours divided into 4 doses.

Older patients:

Your doctor will indicate the frequency and if you need to reduce the dose. Factors of concomitant risk, some of which are more frequently presented in the elderly, and that require a dose adjustment, must be taken into account.

Patients with liver disease:

Take the amount of medication prescribed by your doctor with a minimum interval of 8 hours between each dose.

Do not take more than2 gramsof paracetamol in 24 hours, divided into several doses.

Patients with kidney disease:

Since this medication contains1 gramof paracetamol per tablet, these patients cannot take this medication.

Use in children and adolescents

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

The taking of this medication is subject to the appearance of symptoms, pain or fever. As these 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, consult your doctor and reevaluate the clinical situation.

If you take more Efferalgan than you should

You should consult your doctor or pharmacist immediately.

The symptoms of overdose may be: dizziness, vomiting, loss of appetite, yellowish discoloration 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 properly.

- 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 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 overdose medication.

Patients undergoing barbiturate treatment or chronic alcoholics, a paracetamol overdose may be more toxic to them than to the rest of the patients.

Incase 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.

Like all medications, this medication may produce adverse effects, although not all people may experience them.

The possible adverse effects of this medication are:

Adverse effects that are rare and 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). Rarely, severe skin reactions have been reported.

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 (metabolic acidosis) in patients with severe disease who use paracetamol (see section 2).

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

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that does not appear in this prospectus..You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Usehttps://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information about 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 packaging, after CAD. The expiration date is the last day of the month indicated.

Medications should not be disposed of through drains or in the trash. Dispose of the packaging and medications you no longer need at the SIGRE collection point at the pharmacy. Ask your pharmacist how to dispose of the packaging and medications you no longer need. In this way, you will help protect the environment.

Composition of Efferalgan

The active ingredient is paracetamol. Each tablet contains 1 g of paracetamol.

The other components (excipients) are anhydrous citric acid, sodium bicarbonate, anhydrous sodium carbonate, sorbitol (E-420), sodium docusate, povidone K-30, sodium saccharin, sodium benzoate (E-211).

Appearance of Efferalgan and contents of the packaging

Effervescent white and scored tablets, packaged in aluminum strips.

It is presented in packaging of 8 or 20 effervescent tablets.

Not all packaging sizes may be marketed.

Holder of the marketing authorization

UPSA SAS

3 rue Joseph Monier

92500 Rueil-Malmaison

France

Responsible for manufacturing

UPSA

979, Avenue des Pyrénées

47520 Le Passage - 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

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