EFFERALGAN 1 g EFFERVESCENT TABLETS

Introduction

Package Leaflet: Information for the User

Efferalgan 1 g Effervescent Tablets

paracetamol

Read the entire package leaflet carefully before starting to take this medication, as it contains important information for you.

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

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

Contents of the Package Leaflet

1. What is Efferalgan and what is it used for
2. What you need to know before taking Efferalgan
3. How to take Efferalgan
4. Possible side effects
5. Storage of Efferalgan
6. Package Contents and Additional Information

1. What is Efferalgan and what is it used for

Efferalgan belongs to the group of medications called analgesics and antipyretics.

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

2. What you need to know before taking Efferalgan

Do not take Efferalgan:

• 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 Efferalgan.

• Do not take more medication than recommended in section 3. How to take Efferalgan.
• The simultaneous use of this medication with other medications containing paracetamol, such as flu and cold medications, should be avoided, as high doses can lead to liver damage. Do not use 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.
• Alcohol consumption is not recommended during treatment.
• Patients with chronic malnutrition, anorexia, cachexia, bulimia, or fasting should consult their doctor before taking the medication.
• Patients with kidney disease due to the 1g paracetamol content cannot take this medication. Those with liver, heart, or lung disease and patients with anemia should consult their doctor before taking this medication.
• When being treated with medication for epilepsy, consult your doctor before taking this medication, as the efficacy of paracetamol may be decreased and hepatotoxicity may be increased, especially with high doses of paracetamol.
• Inform your doctor before taking this medication 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 should discontinue the use of the medication 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.

During treatment with Efferalgan, inform your doctor immediately 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 are also taking flucloxacillin (an antibiotic). A severe 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.

Children and Adolescents

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

Interactions with Analytical Tests

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

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

Other Medications and Efferalgan

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

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

• Medication to prevent blood clots: Oral anticoagulants (acenocoumarol, warfarin)
• Medications for treating epilepsy: Antiepileptics (lamotrigine, phenytoin or other hydantoins, phenobarbital, methylphenobarbital, primidone, carbamazepine)
• Medications for treating tuberculosis: isoniazid, rifampicin
• Medications for treating depression and convulsions: Barbiturates (used as hypnotics, sedatives, and anticonvulsants)
• Medications to lower cholesterol levels in blood: colestyramine
• Medications used to increase urine elimination (loop diuretics such as furosemide)
• Medications used to treat gout: probenecid and sulfinpyrazone
• Medications used to prevent nausea and vomiting: Metoclopramide and domperidone
• Medications used to treat high blood pressure (hypertension) and heart rhythm disorders (cardiac 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 Efferalgan with Food, Drinks, and Alcohol

Taking paracetamol in patients who habitually consume alcohol can cause liver damage.

Taking this medication with food does not affect its efficacy.

Pregnancy and Breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medication. If necessary, Efferalgan 1g 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 medication more frequently.

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

Driving and Using Machines

The influence of paracetamol on the ability to drive and use machines is zero or insignificant.

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

This medication contains 252 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 you have been diagnosed with hereditary fructose intolerance (HFI), a rare genetic disease, in which the patient cannot break down fructose, consult your doctor before taking this medication.

This medication contains 394 mg of sodium (main component of table salt/cooking salt) in each tablet. This is equivalent to approximately 20% of the maximum recommended daily sodium intake for an adult. Consult your doctor or pharmacist if you need to take 1 or more tablets daily for a prolonged period, especially if you have been recommended a low-salt diet (sodium).

This medication contains 100 mg of sodium benzoate (E-211) in each tablet. Sodium benzoate can increase the risk of jaundice (yellowing of the skin and eyes) in newborns (up to 4 weeks old).

This medication contains 1.93 mg of fructose in each tablet. This medication contains glucose and sucrose. If your doctor has told you that you have an intolerance to certain sugars, consult your doctor before taking this medication. Fructose, glucose, and sucrose can damage teeth in case of chronic or very prolonged treatments.

3. How to Take Efferalgan

Follow the administration instructions for this medication indicated by your doctor exactly. 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 stopped completely.

The tablets should not be chewed or swallowed.

Always take the lowest effective dose.

The recommended dose is:

Adults and adolescents over 15 years old (and weighing more than 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 in any case. Do not take more than 4 g of paracetamol in 24 hours, divided into 4 doses.

Elderly patients:

Your doctor will indicate the frequency and whether you need to reduce the dose. Concomitant risk factors, some of which are more frequent in the elderly, should be taken into account, and may require a dose adjustment.

Patients with liver disease:

They should take the prescribed amount of medication 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:

Due to the 1g paracetamol content per tablet, these patients cannot take this medication.

Use in Children and Adolescents

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

Taking this medication 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, as the risk of 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 worsens or other symptoms appear, you should 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, yellowing of the skin and eyes (jaundice), and abdominal pain.

The following events have been observed after a paracetamol overdose:

• 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 often do not appear until 3 days after ingestion of the overdose, 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 overdose of the medication.

Patients being treated with barbiturates or chronic alcoholics, a paracetamol overdose can be more toxic than in other patients.

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

4. Possible Side Effects

Like all medications, this medication can cause side effects, although not everyone experiences them.

The possible side effects of this medication are:

Rare side effects that may affect up to 1 in 1,000 people: discomfort, increased levels of transaminases in 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 severe 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), and a severe disease that can make the blood more acidic (called metabolic acidosis) in patients with severe disease using paracetamol (see section 2).

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

Reporting Side Effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect not listed in this package leaflet. You can also report them directly through the Spanish Medication Surveillance System for Human Use https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Efferalgan

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

This medication does not require special storage conditions.

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 wastewater or household waste. Deposit the packaging and medications you no longer need at the SIGRE collection point in the pharmacy. Ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Package Contents and Additional Information

Efferalgan Composition

The active ingredient is paracetamol. Each tablet contains 1 g 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 flavor (contains fructose, glucose, sucrose). See section 2 Efferalgan contains sorbitol (E-420), sodium, sodium benzoate (E-211), fructose, glucose, and sucrose.

Appearance of Efferalgan and Package Contents

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

The score line should not be used to split the tablet.

It is available in packages of 8 or 20 effervescent tablets, packaged in aluminum strips in a cardboard box.

Not all package sizes may be marketed.

Marketing Authorization Holder

UPSA SAS

3 rue Joseph Monier

92500 Rueil-Malmaison

France

Manufacturer

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 Revision of this Package Leaflet:June 2025

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