Leaflet: information for the user

Efferalgan 500 mg hard capsules

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 you get worse or if the fever does not improve after 3 days or the pain lasts for 5 days.

Paracetamolis a pain reliever that alsohasantipyretic properties.

This medication is usedfor symptomatic treatment of occasionalmild ormoderate pain, in adults and children aged 12 years and above.

You should consult your doctor if the condition worsens or if the fever persists after 3 days or the pain lasts for 5 days.

Do not take Efferalgan:

• if you are allergic (hypersensitive) to paracetamol or to any of the other ingredients 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 of the medicine than recommended in section 3 How to take Efferalgan.

• Concomitant use of this medicine with other medicines containing paracetamol, such as cold and flu medicines, may lead to liver damage. Do not take more than one medicine containing paracetamol without consulting your doctor.
• Chronic alcoholics should be careful not to take more than 2 g/24 hours of paracetamol.
• Do not consume alcohol 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 diseases and patients with anemia should consult their doctor before taking this medicine.
• When taking antiepileptic medicines, consult your doctor before taking this medicine, as the efficacy and hepatotoxicity of paracetamol may be reduced or increased, especially at high doses.
• Patients sensitive to acetylsalicylic acid should consult their doctor before taking this medicine.
• Paracetamol may cause severe skin reactions, such as acute generalized pustular psoriasis (PEAG), Stevens-Johnson syndrome (SJS), and toxic epidermal necrolysis (NET), which can be fatal. Patients should be informed about the signs of severe skin reactions, and the use of the medicine should be discontinued at the first sign of skin eruption or any other sign of hypersensitivity.
• The frequent use of analgesics over a long period 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 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 respiratory distress with deep and rapid breathing, drowsiness, 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 medicine may affect 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 using, have used recently or may need to use any other medicine.

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

• Medicines 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 lower cholesterol levels in the blood: Cholestyramine
• Medicines used to increase urine elimination (diuretics 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 serious risk of blood and fluid imbalance (metabolic acidosis with high anion gap) that must be treated urgently (see section 2).

Taking Efferalgan with food, drinks and alcohol

The use of paracetamol in patients who regularly consume alcohol may cause liver damage.

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

Pregnancy and Breastfeeding

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

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 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 azorubin and sodium

This medicine contains 0.51 mg of azorubin. This medicine may cause allergic reactions. It may cause asthma, especially in patients allergic to acetylsalicylic acid.

This medicine contains less than 1 mmol of sodium (23 mg) per capsule; it is essentially "sodium-free".

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

The recommended dose is:

Adults:

1 capsule every 4-6 hours or 2 capsules every 6-8 hours as needed. Do not exceed 2 capsules per dose in any case.

Do not take more than 3 grams of paracetamol in 24 hours.

Use in children and adolescents

Adolescents12-14 years

1 capsule every 4-6 hours as needed. Do not take more than 5 capsules in 24 hours.

Children under 12 years old cannot take this medication.

Older patients:

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

Patients with liver disease:

Before taking this medication, they must consult their doctor.

They should take the amount of medication prescribed by their doctor with a minimum interval of 8 hours between each dose.

They should not take more than 4 capsules in 24 hours, divided into several doses.

Patients with kidney disease:

Before taking this medication, they must consult their doctor.

Take a maximum of 1 capsule per dose.

Depending on their disease, their doctor will indicate whether they should take their medication with a minimum interval of 6 or 8 hours.

Always take the lower dose that is effective.

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

It is recommended to avoid the use of high daily doses of paracetamol for prolonged periods of time, as this increases the risk of adverse effects such as liver damage.

If the pain persists for more than 5 days, the fever for more than 3 days, or if the pain or fever worsen or other symptoms appear, treatment should be interrupted and the doctor consulted.

For throat pain, the medication should not be taken for more than 2 consecutive days without consulting a doctor.

Administration form

The capsules are administered orally.

They should be swallowed with a liquid, preferably water.

If you take moreEfferalgan 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 correctly.

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

- Rare cases of pancreatitis inflammation.

If an overdose has been ingested, 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, even in cases of severe poisoning.

The treatment of an overdose is more effective if it is initiated within 4 hours of medication ingestion.

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.

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

The possible adverse effects of this medication are:

Rare adverse 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 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 breathing difficulty) and a severe disease that can make the blood more acidic (designated 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 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.

Do not store at a temperature above 30°C.

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.

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 point at 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 ofEfferalgan

Each capsule contains 500 mg of paracetamol as the active ingredient.

The other components are: Magnesium stearate.

Components of the capsule: Gelatin, azorubine (E-122) and titanium dioxide (E-171).

AppearanceofEfferalgan and content of the packaging

Hard capsules with a translucent red cap and a white opaque body.

It is presented in packaging containing 24 capsules.

Holder of the marketing authorization

UPSA SAS

3 rue Joseph Monier

92500 Rueil-Malmaison

France

Responsible for manufacturing

UPSA

304, Avenue du Doctteur Jean Bru

47000 Agen (France)

or

UPSA

979, Avenue des Pyrenes (Le Passage)

47520 - 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 the last review of this leaflet: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/