Efferaldol 650 mg tablets

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Efferaldol 650 mg tablets

paracetamol

Please read this entire leaflet carefully before you start taking this medicine, because it contains important information for you.

Follow exactly the instructions for use provided in this leaflet or those given 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 adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.
• You should consult a doctor if you worsen or do not improve after 3 days of fever or 5 days of pain.

Contents of the leaflet

1. What Efferaldol is and what it is used for
2. What you need to know before taking Efferaldol
3. How to take Efferaldol
4. Possible side effects
5. How to store Efferaldol
6. Contents of the pack and other information

1. What Efferaldol is and what it is used for

Paracetamol is effective in reducing pain and fever.

It is indicated for the symptomatic relief of mild to moderate occasional pain and in febrile conditions in adults and adolescents over 15 years of age (body weight over 50 kg).

2. What you need to know before taking Efferaldol

Do not take Efferaldol:

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

Warnings and precautions

Consult your doctor or pharmacist before starting to take paracetamol.

• Do not take more medicine than the recommended dose stated in section 3, How to take Efferaldol.
• if you have liver problems, including liver problems due to excessive alcohol consumption (3 or more alcoholic drinks per day);
• if you have kidney problems;
• if you have glucose-6-phosphate dehydrogenase deficiency;
• if you suffer from anorexia, bulimia, cachexia, or chronic malnutrition;
• if you are dehydrated or have hypovolemia;
• if you are taking a medicine to treat epilepsy, you should consult your doctor before taking this medicine, as its simultaneous use may reduce effectiveness and increase the hepatotoxicity of paracetamol, especially with high-dose paracetamol treatments (see below in this section under Other medicines and Paracetamol);
• if you have Gilbert's disease (also known as Meulengracht's disease);
• if you have heart failure, respiratory failure, or anemia; in these situations, administration should be under medical supervision and only for short periods;
• if you have asthma and are sensitive to acetylsalicylic acid;
• Paracetamol may 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 the medicine should be discontinued at the first sign of a skin rash or any other sign of hypersensitivity.
• The total daily dose of paracetamol must not exceed 3 g.
• Concomitant use of this medicine with other medicines containing paracetamol, such as cold and flu remedies, should be avoided, as high doses may cause liver damage. Do not use more than one paracetamol-containing medicine without consulting your doctor.
• In case of overdose, seek immediate medical attention (see "If you take more paracetamol than you should").
• Chronic alcoholics should be careful not to exceed 2 grams of paracetamol in 24 hours.

If pain persists for more than 5 days, fever for more than 3 days, or if pain or fever worsen or new symptoms appear, your clinical condition should be evaluated by your doctor. This medicine should not be used for self-treatment of high fever (over 39°C), fever lasting more than 3 days, or recurrent fever, unless directed by your doctor, as these conditions may require medical evaluation and treatment.

Administration of paracetamol doses higher than recommended carries a significant risk of severe liver injury. Medicines containing paracetamol should not be taken for longer than a few days or at high doses unless directed by your doctor.

Prolonged use of analgesics or inappropriate use of high doses may cause headache, which should not be treated with higher doses of the medicine.

During treatment with Efferaldol, inform your doctor immediately if:

• You have serious conditions such as severe renal failure or sepsis (when bacteria and their toxins circulate in the blood, causing organ damage), or if you suffer from malnutrition, chronic alcoholism, or are also taking flucloxacillin (an antibiotic). A serious condition called metabolic acidosis (an abnormality in blood and body fluids) has been reported in patients in these situations when paracetamol is used at regular doses over a prolonged period or when paracetamol is taken together 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

This medicine must not be used in children under 15 years of age or weighing less than 50 kg.

Other medicines and Efferaldol

Inform your doctor or pharmacist if you are currently taking, have recently taken, or might need to take any other medicines.

In particular, if you are taking any of the following medicines, as it may be necessary to adjust the dose or discontinue treatment:

• Medicines to prevent blood clotting: oral anticoagulants (acenocoumarol, warfarin).
• Medicines to treat epilepsy: antiepileptic drugs (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 blood cholesterol levels: (cholestyramine).
• Medicines to increase urine excretion (loop diuretics such as furosemide).
• Medicines used to treat gout (probenecid and sulfinpyrazone).
• Medicines used to prevent nausea and vomiting: metoclopramide and domperidone.
• Medicines for treating high blood pressure (hypertension) and heart rhythm disorders (cardiac arrhythmias): propranolol.
• Salicylamide, a medicine used to treat fever and pain, may prolong the elimination half-life of paracetamol.
• Medicines used to treat HIV infection (zidovudine).

Inform your doctor or pharmacist if you are taking:

Flucloxacillin (antibiotic), due to a serious risk of blood and fluid imbalance (known as metabolic acidosis with high anion gap), which requires urgent treatment (see section 2).

Interference with laboratory tests:

If you are scheduled for any laboratory tests (including blood and urine tests, etc.), inform your doctor that you are taking this medicine, as it may alter test results. Paracetamol may affect analytical results for uric acid and glucose.

Taking Efferaldol with food, drinks, and alcohol

The use of paracetamol in patients who habitually consume alcohol (3 or more alcoholic drinks per day: beer, wine, spirits, etc.) may cause liver damage.

Taking this medicine with food does not affect its efficacy.

Pregnancy, breastfeeding, and fertility

Consult your doctor or pharmacist before taking this medicine.

Pregnancy and breastfeeding

Paracetamol may be used during pregnancy if necessary. Use the lowest effective dose needed to relieve pain or fever, and use it for the shortest possible time. Contact your doctor if pain or fever does not subside or if you need to take the medicine more frequently.

Breastfeeding

Consult your doctor or pharmacist before taking this medicine.

Paracetamol passes into breast milk; therefore, women who are breastfeeding should consult their doctor or pharmacist before taking this medicine.

Fertility

No harmful effects on fertility are known with normal use of paracetamol.

Driving and using machines:

The effect of paracetamol on the ability to drive and operate machinery is negligible or none.

3. How to take Efferaldol

Follow exactly the instructions for use of this medicine as given by your doctor. If in doubt, consult your doctor or pharmacist.

Recommended dosage:

Adults and adolescents over 15 years of age (body weight over 50 kg): 1 tablet 3-4 times a day, depending on the intensity of symptoms.

Doses should be spaced at least 4 hours apart.

Maximum dosage: do not exceed 3 g of paracetamol (4 tablets) in 24 hours.

This medicine is not intended for children under 15 years of age or those weighing less than 50 kg. Consult your pharmacist.

Patients with liver disease: consult your doctor before taking this medicine.

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

They should not take more than 2 g of paracetamol (3 tablets) in 24 hours.

In chronic alcoholics, the daily dose should not exceed 2 g.

Patients with kidney disease: consult your doctor before taking this medicine.

In patients with moderate or severe renal impairment, the recommended dose is half a tablet (325 mg of paracetamol) every 6-8 hours, respectively.

This medicine is taken orally.

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

The tablets are scored, which allows them to be split in half. The tablet can be divided into equal doses.

Always use the lowest effective dose.

High daily doses of paracetamol should be avoided over prolonged periods, as this increases the risk of adverse effects such as liver damage.

Administration of this medicine should only occur when pain or fever is present. As these symptoms subside, treatment should be discontinued.

If pain persists for more than 5 days, fever for more than 3 days, or if pain or fever worsen or new symptoms appear, treatment should be stopped and medical advice sought.

If you take more paracetamol than you should

Consult your doctor or pharmacist immediately.

In case of overdose or accidental ingestion, go immediately to a medical center or call the Toxicology Information Service (telephone 91 562 04 20), indicating the medicine and the amount ingested. It is recommended to bring the medicine packaging and leaflet to the healthcare professional.

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

Symptoms of overdose may include: dizziness, vomiting, loss of appetite, yellowing of the skin and eyes (jaundice), and abdominal pain.

Treatment of overdose is most effective if started within 4 hours of taking the medicine.

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

If you forget to take paracetamol

Do not take a double dose to make up for missed doses. Simply take the missed dose when you remember, then take the following doses at the recommended intervals (at least 4 hours).

If you stop treatment with paracetamol

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, paracetamol can have adverse effects, although not everyone experiences them.

The following adverse effects have been reported:

Rare: may affect up to 1 in 1,000 people:

• malaise
• drop in blood pressure (hypotension)
• increased levels of transaminases in the blood.

Very rare: may affect up to 1 in 10,000 people:

• kidney disorders
• cloudy urine
• allergic dermatitis (skin rash)
• jaundice (yellowing of the skin)
• blood disorders (agranulocytosis, leucopenia, neutropenia, haemolytic anaemia)
• hypoglycaemia (low blood sugar)
• Very rare cases of serious skin reactions have been reported.

Frequency not known (cannot be estimated from the available data):

• a serious condition that may cause the blood to become more acidic (called metabolic acidosis) in patients with severe illness who are using paracetamol (see section 2).

Paracetamol can cause liver damage when taken in high doses or during prolonged treatment.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish System for Pharmacovigilance of Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Efferaldol

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

This medicine does not require any special storage conditions.

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Dispose of unused containers and medicines at the SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to properly dispose of unused containers and medicines. This will help protect the environment.

6. Contents of the pack and other information

Composition of Efferaldol

• The active substance is paracetamol. Each tablet contains 650 milligrams of paracetamol.
• The other components (excipients) are pregelatinized corn starch, stearic acid, povidone, crospovidone, microcrystalline cellulose, and vegetable-source magnesium stearate.

Appearance of the product and contents of the pack:

The tablets are oblong, biconvex, white in colour, and scored.

Efferaldol is available as oral tablets in packs of 20 and 40 tablets, presented in PVC-PVDC and aluminium blisters.

Marketing Authorization Holder:

UPSA SAS
3 rue Joseph Monier
92500 Rueil-Malmaison
France

Manufacturer responsible:

Toll Manufacturing Services, S.L.
C/ Aragoneses, 2
28108 Alcobendas (Madrid)
Spain

Or

Pharmex Advanced Laboratories S.L.
Ctra. A-431 Km.
Almodóvar del Río, 19
14720 Córdoba
Spain

Or

Farmalider, S.A.
C/ Aragoneses, 2
28108 Alcobendas (Madrid)
Spain

Local representative:

NEWLINE PHARMA, S.L.U.
Calle Tarragona 151-157, 11th Floor, Door 1, Block A
08014 Barcelona (Spain)
Tel.: 931851380

Date of latest review of this leaflet: June 2022

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/