Leaflet: information for the user

Febrectal 650 mg Tablets

Paracetamol

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

• 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 this leaflet.
• You must consult a doctor and stop treatment if the pain persists for more than 3 days in children or 5 days in adults (2 days for sore throat), fever for more than 3 days, or if the pain or fever worsen or other symptoms appear.

1.What is Febrectal and what it is used for

2.What you need to know before starting to take Febrectal

3.How to take Febrectal

4.Possible side effects

1. Storage of Febrectal

6. Contents of the pack and additional information

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

This medicine is used for the occasional treatment of mild to moderate pain and fever.

Do not take Febrectal

• if you are allergic 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 Febrectal.

Do not take more medication than recommended in the section 3 “How to take Febrectal”.

Concomitant use of this medication with other medications containing paracetamol, such as cold and flu medications, may lead to liver damage. Do not use more than one medication containing paracetamol without consulting your doctor.

If you have asthma sensitive to acetylsalicylic acid, consult your doctor before taking this medication.

If you have liver, kidney, heart, or lung disease, anemia (decreased hemoglobin levels in the blood, due or not to a decrease in red blood cells), or chronic malnutrition or dehydration, consult your doctor before taking this medication.

If you are being treated with an antiepileptic medication, consult your doctor before taking this medication, as concomitant use may decrease its efficacy and increase the risk of hepatotoxicity, especially with high doses of paracetamol.

In chronic alcoholics, be cautious not to take more than 3 tablets of 650 mg of paracetamol in 24 hours.

During treatment with Febrectal, immediately inform your doctor 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 have 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, somnolence, feeling unwell (nausea), and vomiting.

Children and adolescents

This medication should not be used in children under 6 years of age (weight less than 22 kg) as it does not allow for the administration of doses less than 325 mg of paracetamol.In children and adolescents under 15 years, consult your doctor or pharmacist as there may be other presentations available with paracetamol doses adapted to these patients.

Interference with analytical tests

If you are to undergo any analytical test (including blood, urine, skin tests using allergens, etc.), inform your doctor that you are taking this medication, as it may alter the results of these tests.

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

Other medications and Febrectal

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

Paracetamol may interact with the following medications:

• Medications to prevent blood clots: oral anticoagulants (acenocoumarol, warfarin)
• Medications to treat epilepsy: antiepileptics (lamotrigine, phenytoin, or other hydantoins, phenobarbital, methylphenobarbital, primidone, carbamazepine)
• Medications to treat tuberculosis: isoniazid, rifampicin
• Medications to treat depression and seizures: barbiturates (used as hypnotics, sedatives, and anticonvulsants)
• Medications to lower cholesterol levels in the blood: cholestyramine
• Medications used to increase urine elimination (diuretics such as furosemide)
• Medications used to treat gout (probencid and sulfinpyrazone)
• Medications used to prevent nausea and vomiting: metoclopramide and domperidone
• Medications used to treat high blood pressure (hypertension) and heart rhythm disorders (arrhythmias): propranolol
• Flucloxacillin (antibiotic), due to a severe risk of blood and fluid imbalance (metabolic acidosis with high anion gap) that must be treated urgently (see section 2).

Do not use with other analgesics (pain-relieving medications) without consulting your doctor.

In cases of treatment with oral anticoagulants, it may be administered occasionally as the preferred analgesic.

Taking Febrectal with food, drinks, and alcohol

The use of paracetamol in patients who regularly consume alcohol (three or more alcoholic beverages per day: beer, wine, liquor...) may cause liver damage.

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

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or intend to become pregnant, consult your doctor or pharmacist before using this medication.

Febrectal may be used during pregnancy if necessary.

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

Driving and operating machinery

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

Febrectal contains hydrogenated ricin oil and sodium

This medication may cause stomach discomfort and diarrhea due to the presence of hydrogenated ricin oil.This medication contains less than 23 mg of sodium (1 mmol) per tablet; it is essentially “sodium-free”.

Follow exactly the medication administration instructions contained in this leaflet or those indicated by your doctor or pharmacist. If in doubt, ask your doctor or pharmacist.

The recommended dose is:

•Adults and adolescents over 15 years of age (and weight over50 Kg): the recommended dose for adults is half to 1 tablet (325 to650 mg of paracetamol) every 4-6 hours. Do not take more than 4 and a half tablets (approximately3 gof paracetamol) every 24 hours.

The minimum interval between doses will not be less than 4 hours.

In the case of adults with low weight (40 kgor less) they may follow the dosage recommendations for children, although there are other presentations with paracetamol doses adapted for these patients, ask your doctor or pharmacist.

It should be avoided to use high daily doses of paracetamol for prolonged periods of time as it increases the risk of suffering adverse effects such as liver damage.

•Patients with liver or kidney disease: They must consult their doctor.

•Older patients: They must consult their doctor.

•Use in childrenand adolescents:

It is necessary to respect the doses defined according to weight. The age of the child according to weight is given for information purposes only.

The recommended daily dose of paracetamol is approximately 60 mg/kg/day, which is divided into 4 or 6 doses per day, that is 15 mg/kg every 6 hours or 10 mg/kg every 4 hours.

•Children under 6 years old: They must consult their doctor as there are other presentations with doses adapted to these patients.

•Children weighing over22 kg, up to33 kg(approximately from6 to9 years old):half a tablet(325 mg of paracetamol), every 4-6 hours according to the child's weight; up to a maximum of2 to3 tablets of Febrectal (1.300 mg-1.950 mg of paracetamol) every 24 hours according to the patient's weight.The time interval between each administration and the maximum daily dose will depend on the patient's weight.

•Children weighing over33 kg, up to43 kg(approximately from 10-12 years old):half a tabletof Febrectal (325 mg of paracetamol) every 4-6 hours.The time interval between each administration will depend on the patient's weight.The maximum dose will be 3-4 tablets of Febrectal (1.950 mg-2.600 mg of paracetamol) every 24 hours according to the patient's weight.

•Adolescentsover 43 kg (from 13 years of age): 1 tablet every 4-6 hours, not exceeding 4 tablets every 24 hours (2.600 mg of paracetamol).

If the pain persists for more than 5 days (more than 3 days in children) or 2 days for sore throat, fever for more than 3 days, or if the pain or fever worsen or other symptoms appear, discontinue treatment and consult your doctor.

Administration form

The tablets must be taken orally with a glass of water.

The tablet can be divided into equal doses.

For quick relief of pain, take the medication without food.

If you estimate that the action of Febrectal is too strong or too weak, inform your doctor or pharmacist.

If you take more Febrectal than you should

If you have taken more Febrectal than you should, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone:915 620 420(indicating the medication and the amount ingested).

If you have ingested an overdose, you must 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 intoxication.

The symptoms of an overdose may be: dizziness, vomiting, loss of appetite, yellowish discoloration of the skin and eyes (jaundice), and abdominal pain.

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

The treatment includes:

- Gastric lavage.

- Oral administration of activated charcoal.

- Hemodialysis.

- Administration of acetylcysteine at adequate doses

Patients undergoing barbiturate treatment(a type of sedative medication)or chronic alcoholics may be more susceptible to the toxicity of a paracetamol overdose.

If you forget to take Febrectal

Do not take a double dose to compensate for the missed doses, simply take the missed dose when you remember and take the next doses with the indicated interval (4-6 hours).

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

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

Rare adverse effects (may affect up to 1 in 1,000 people), are: discomfort, low blood pressure (hypotension), and increased levels of transaminases in the blood.

Very rare adverse effects (may affect up to 1 in 10,000 people) are: kidney diseases, cloudy urine, severe skin reactions, 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 (cannot be estimated from available data): A serious disease that can make the blood more acidic (designated as metabolic acidosis) in patients with severe disease who use paracetamol (see section 2).

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

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse even if it is possible adverse effects that do not appear in this prospectus. You can also report them directly through the Spanish System of Pharmacovigilance of Medicines for Human Use:https://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.

No special storage conditions are required.

Do not use this medication after the expiration date that appears 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 packaging and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medications. By doing so, you will help protect the environment.

Composition of Febrectal

The active ingredient is paracetamol. Each tablet contains 650 mg of paracetamol.

The other components arehydrogenated ricin oil, cornstarch, povidone, tricalcium phosphate, sodium croscarmellose, talc, magnesium stearate, and stearic acid.

Appearance of the product and content of the packaging

Febrectal 650 mg Tablets are presented in the form of white, round, biconvex tablets, engraved on the lower and upper parts with a central groove, for oral administration. Each package contains 20 tablets.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Laboratorios Almirall, S.L.

General Mitre, 151

08022 - Barcelona (Spain)

Responsible for manufacturing

Industrias Farmacéuticas Almirall, S.A.

Ctra. de Martorell, 41-61

08740 Sant Andreu de la Barca - Barcelona (Spain)

Last review date of this leaflet: February 2025

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