EFFERALGAN 500 MG HARD CAPSULES

Introduction

Package Leaflet: Information for the User

Efferalgan 500 mg Hard Capsules

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 as 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 symptoms worsen or if your fever does not improve after 3 days or your pain after 5 days.

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 capsules
6. Package contents and additional information

1. What is Efferalgan and what is it used for

Paracetamol is an analgesic that also has antipyretic properties.

This medicine is used for the symptomatic treatment of occasional mild or moderate pain, in adults and children from 12 years of age.

You should consult your doctor if your symptoms worsen or if your fever persists after 3 days or your pain after 5 days.

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 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 Efferalgan".

• 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.
• Patient with chronic malnutrition, anorexia, cachexia, bulimia, or fasting should consult their doctor before taking the medicine.
• Patient with kidney, liver, heart, or lung disease, and patients with anemia, should consult their doctor before taking this medicine.
• When being treated with certain medicines 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 can 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 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 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 of discomfort (nausea) and vomiting.

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 medicine, 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 using, have recently used, or may need to use any other medicine.

In particular, if you are using any of the following medicines, it may be necessary to modify the dose of some of them or interrupt 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 convulsions: Barbiturates (used as hypnotics, sedatives, and anticonvulsants)
• Medicines to lower cholesterol levels in blood: Cholestyramine
• Medicines used to increase urine elimination (loop 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 and heart rhythm disorders: 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

The use of paracetamol in patients who habitually consume alcohol can cause liver damage.

Taking 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.

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 nil or insignificant.

Efferalgan contains azorubine and sodium

This medicine contains 0.51 mg of azorubine. This medicine may cause allergic reactions. It can 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".

3. How to take Efferalgan

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

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

Use in children and adolescents

Adolescents 12-14 years:

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

Children under 12 years of age cannot take this medicine.

Elderly patients:

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

Patient with liver disease:

Before taking this medicine, they must consult their doctor.

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

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

Patient with kidney disease:

Before taking this medicine, they must consult their doctor.

Take a maximum of 1 capsule per intake.

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

Always take the lowest effective dose.

The intake of this medicine is subject to the appearance of pain or fever. As they 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, treatment should be discontinued and your doctor consulted.

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

Method of administration

The capsules are administered orally.

They should be swallowed with a glass of liquid, preferably water.

If you take more Efferalgan 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 a paracetamol overdose:

• Acute kidney failure.
• A disease in which small clots form in the bloodstream that block blood vessels.
• Rare cases of pancreatitis.

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

Treatment of overdose is more effective if started within 4 hours of ingestion of the medicine.

Patient 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 to a medical center or call the Toxicological Information Service (telephone 91 562 04 20), indicating the medicine and the amount taken.

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 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 of unknown frequency: purpura, fixed drug eruption (red/purple patch 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 can damage the liver when taken in high doses or in prolonged treatments.

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 and Healthcare Products Agency (AEMPS) website: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Efferalgan

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

Do not store above 30°C.

Do not use this medicine after the expiry date indicated 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. Place the packaging and any unused medicines in the pharmacy's SIGRE collection point. Ask your pharmacist how to dispose of the packaging and any unused medicines. This will help protect the environment.

6. Package contents and additional information

Composition of Efferalgan

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

The other ingredients are: Magnesium stearate.

Capsule ingredients: Gelatin and azorubine (E-122).

Appearance of Efferalgan and package contents

Hard capsules with a translucent red head and a translucent body.

Available in packages containing 24 capsules.

Marketing authorization holder

UPSA SAS

3 rue Joseph Monier

92500 Rueil-Malmaison

France

Manufacturer

UPSA

304, Avenue du Docteur 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, Planta 11, Puerta 1, Bloque A

08014 Barcelona (Spain)

Tel.: 931851380

Date of the last revision of this leaflet:November 2024

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