FEBRECTAL 650 MG TABLETS

Introduction

Package Leaflet: Information for the User

Febrectal 650 mg Tablets

Paracetamol

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

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your pharmacist.
• If you get any side effects, talk to your doctor or pharmacist, even if you have not listed them in this leaflet.
• You should 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 worsens or other symptoms appear.

Contents of the package leaflet:

1. What is Febrectal and what is it used for
2. What you need to know before taking Febrectal
3. How to take Febrectal
4. Possible side effects
   1. Storage of Febrectal

1. Package contents and additional information

1. What is Febrectal and what is it used for

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.

2. What you need to know before taking Febrectal

Do not take Febrectal

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

Warnings and precautions

Consult your doctor or pharmacist before starting to take Febrectal.

Do not take more than the recommended dose of medicine in Section 3 "How to take Febrectal".

Avoid taking this medicine simultaneously with other medicines that contain paracetamol, such as flu and cold medicines, as high doses can lead to liver damage. Do not use more than one medicine that contains paracetamol without consulting your doctor.

In patients with asthma who are sensitive to acetylsalicylic acid, consult your doctor before taking this medicine.

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

When you are being treated with any medicine for epilepsy, consult your doctor before taking this medicine, as the efficacy of paracetamol may be decreased and hepatotoxicity may be increased, especially in high-dose paracetamol treatments.

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

During treatment with Febrectal, inform your doctor immediately if:

If you have severe illnesses, such as severe kidney failure or sepsis (when bacteria and their toxins circulate in the blood, causing damage to organs), or if you have malnutrition, chronic alcoholism, or are also taking flucloxacillin (an antibiotic). A serious disease called metabolic acidosis (an anomaly in the 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

This medicine 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 of age, consult your doctor or pharmacist, as other presentations with paracetamol doses adapted to these patients may be available.

Interference with laboratory tests

If you are going to have any laboratory tests (including blood tests, urine tests, skin tests that use allergens, etc.), inform your doctor that you are taking this medicine, as it may alter the results of these tests.

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

Other medicines and Febrectal

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

Paracetamol may interact with the following medicines:

• 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 the 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 (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).

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

In case of treatment with oral anticoagulants, it can be administered occasionally as the analgesic of choice.

Taking Febrectal with food, drinks, and alcohol

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

Taking this medicine with food does not affect its efficacy.

Pregnancy, breastfeeding, and fertility

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

In case of need, Febrectal can be used during pregnancy.

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

Driving and using machines

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

Febrectal contains hydrogenated castor oil and sodium

This medicine may cause stomach upset and diarrhea because it contains hydrogenated castor oil. This medicine contains less than 23 mg of sodium (1 mmol) per tablet; it is essentially "sodium-free".

3. How to take Febrectal

Follow 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 and adolescents over 15 years of age (and weight over 50 kg): the recommended dose for adults is 1/2 to 1 tablet (325 to 650 mg of paracetamol) every 4-6 hours. Do not take more than 4 and 1/2 tablets (approximately 3 g of paracetamol) every 24 hours.

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

In case of adults with low weight (40 kg or 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.

Avoid using high daily doses of paracetamol for prolonged periods, as the risk of adverse effects such as liver damage increases.

• Patient with liver or kidney disease: Consult your doctor.

• Elderly patients: Consult your doctor.
• Use in children and adolescents:

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

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

• Children under 6 years of age: Consult your doctor, as there are other presentations with doses adapted to these patients.

• Children weighing over 22 kg, up to 33 kg (approximately from 6 to 9 years): 1/2 tablet (325 mg of paracetamol), every 4-6 hours, depending on the child's weight; up to a maximum of 2 to 3 Febrectal tablets (1,300 mg-1,950 mg of paracetamol) every 24 hours, depending on the patient's weight. The time interval between each administration and the maximum daily dose will depend on the patient's weight.

• Children weighing over 33 kg, up to 43 kg (approximately from 10 to 12 years): 1/2 Febrectal tablet (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 Febrectal tablets (1,950 mg-2,600 mg of paracetamol) every 24 hours, depending on the patient's weight.

• Adolescents weighing over 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 worsens or other symptoms appear, stop treatment and consult your doctor.

Method of administration

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

The tablet can be divided into equal doses.

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

If you think the effect of Febrectal is too strong or too weak, tell 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 Toxicology Information Service, phone: 915 620 420 (indicating the medicine and the amount ingested).

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

The symptoms of overdose may be: 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 ingestion of the medicine.

Treatment includes:

• Stomach wash.
• Oral administration of activated charcoal.
• Hemodialysis.
• Administration of acetylcysteine in adequate doses.

Patient on treatment with barbiturates (a type of sedative medicine) 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 make up for forgotten doses; simply take the forgotten dose when you remember and take the next doses with the indicated time interval (4-6 hours).

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

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

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

Reporting of side effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse, even if they are not listed in this leaflet. You can also report them directly through the Spanish Medicines and Healthcare Products Agency's (AEMPS) website: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Febrectal

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

No special storage conditions are required.

Do not use this medicine after the expiration date stated on the packaging after EXP. The expiration 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. If in doubt, 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 Febrectal

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

The other ingredients are hydrogenated castor oil, cornstarch, povidone, tricalcium phosphate, sodium croscarmellose, talc, magnesium stearate, and stearic acid.

Appearance of the product and package contents

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

Marketing authorization holder and manufacturer

Marketing authorization holder

Laboratorios Almirall, S.L.

General Mitre, 151

08022 - Barcelona (Spain)

Manufacturer

Industrias Farmacéuticas Almirall, S.A.

Ctra. de Martorell, 41-61

08740 Sant Andreu de la Barca - Barcelona (Spain)

Date of the last revision of this leaflet: February 2025

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