Febrectal 650 mg tablets

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Febrectal 650 mg Tablets

Paracetamol

Read the entire package leaflet carefully before you start taking this medicine, as 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 adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet.
• You must consult a doctor and stop treatment if pain persists for more than 3 days in children or 5 days in adults (2 days for sore throat), fever lasts more than 3 days, or if pain or fever worsen or new symptoms appear.

Package leaflet contents:

1. What Febrectal is and what it is used for

2. What you need to know before taking Febrectal

3. How to take Febrectal

4. Possible side effects

   1. Storage of Febrectal

5. Contents of the pack and other information

1. What Febrectal is and what it is 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 to any of the other components of this medicine (listed in section 6).

Warnings and precautions

Talk to your doctor or pharmacist before taking Febrectal.

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

Concurrent use of this medicine with other medicines containing paracetamol (e.g. cold and flu remedies) should be avoided, as high doses may cause liver damage. Do not use more than one medicine containing paracetamol without consulting your doctor.

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

If you have liver, kidney, heart or lung disease, if you have anaemia (reduced haemoglobin levels in the blood, with or without a reduction in red blood cells), or if you suffer from chronic malnutrition or dehydration, consult your doctor before taking this medicine.

If you are being treated with antiepileptic medicines, consult your doctor before taking this medicine, since concomitant use may reduce efficacy and increase the hepatotoxic potential of paracetamol, especially with high-dose paracetamol regimens.

In chronic alcoholics, caution should be exercised not to exceed 3 tablets of 650 mg paracetamol in 24 hours.

During treatment with Febrectal, 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 have 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 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 (weighing less than 22 kg), as it does not allow administration of doses lower than 325 mg of paracetamol. In children and adolescents under 15 years of age, consult your doctor or pharmacist, as other formulations with paracetamol doses adapted to these patients may be available.

Interference with diagnostic tests

If you are scheduled to undergo any laboratory tests (including blood and urine analyses, skin tests using allergens, etc.), inform your doctor that you are taking this medicine, as it may alter the results of such tests.

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

Other medicines and Febrectal

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

Paracetamol may interact with the following medicines:

• Medicines to prevent blood clots: oral anticoagulants (acenocoumarol, warfarin)
• Medicines for epilepsy: antiepileptics (lamotrigine, phenytoin or other hydantoins, phenobarbital, methylphenobarbital, primidone, carbamazepine)
• Medicines for tuberculosis: isoniazid, rifampicin
• Medicines for depression and seizures: barbiturates (used as hypnotics, sedatives and anticonvulsants)
• Medicines to lower blood cholesterol levels: colestyramine
• Medicines used to increase urine elimination (loop diuretics such as furosemide)
• Medicines used in the treatment of gout: probenecid and sulfinpyrazone
• Medicines used to prevent nausea and vomiting: metoclopramide and domperidone
• Medicines used in the treatment of high blood pressure (hypertension) and heart rhythm disorders (cardiac arrhythmias): propranolol
• Flucloxacillin (antibiotic), due to a serious risk of blood and fluid imbalance (called metabolic acidosis with high anion gap) that requires urgent treatment (see section 2).

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

Occasional use as an analgesic of choice may be acceptable in patients receiving oral anticoagulant therapy.

Taking Febrectal with food, drinks and alcohol

The use of paracetamol in patients who habitually consume alcohol (three 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

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

Febrectal may be used during pregnancy if necessary.

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

Driving and using machines

The effect of paracetamol on the ability to drive and use machines is none or negligible.

Febrectal contains hydrogenated castor oil and sodium

This medicine may cause stomach discomfort and diarrhoea because it contains hydrogenated castor oil. This medicine contains less than 23 mg of sodium (1 mmol) per tablet; thus, it is essentially “sodium-free”.

3. How to take Febrectal

Follow exactly the instructions for administering the medicine provided in this leaflet or those given 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 weighing more than 50 kg): the recommended dose for adults is half to 1 tablet (325 to 650 mg of paracetamol) every 4–6 hours. Do not take more than 4 and a half tablets (approximately 3 g of paracetamol) in any 24-hour period.

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

In the case of underweight adults (40 kg or less), pediatric dosing recommendations may be followed, although other formulations with paracetamol doses adapted for these patients are available; consult your doctor or pharmacist.

Prolonged use of high daily doses of paracetamol should be avoided, as this increases the risk of adverse effects such as liver damage.

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

• Elderly patients: Must consult their doctor.

• Use in children and adolescents:

It is necessary to respect the doses defined according to body weight. The child's age in relation to weight is provided for informational purposes only.

The recommended daily dose of paracetamol is approximately 60 mg/kg/day, 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 of age: Must consult their doctor, as other formulations with doses adapted for these patients are available.

• Children weighing more than 22 kg up to 33 kg (approximately 6 to 9 years of age): half a 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 dose and the maximum daily dose will depend on the patient's weight.

• Children weighing more than 33 kg up to 43 kg (approximately 10–12 years of age): half a Febrectal tablet (325 mg of paracetamol) every 4–6 hours. The time interval between doses 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 more than 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 pain persists for more than 5 days (more than 3 days in children), or for sore throat beyond 2 days, or if fever lasts more than 3 days, or if pain or fever worsen or new symptoms appear, discontinue treatment and consult your doctor.

Method of administration

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

The tablet may be divided into equal doses.

For rapid pain relief, take the medicine without food.

If you feel that the effect 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, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone: 915 620 420 (indicating the medicine and the amount ingested).

If you have ingested an overdose, you must go quickly to a medical center even if you do not have symptoms, as symptoms often do not appear until after 3 days following 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 after taking the medicine.

Treatment includes:

• Gastric lavage.
• Oral administration of activated charcoal.
• Hemodialysis.
• Administration of acetylcysteine at appropriate doses.

Patients undergoing 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 missed doses. Simply take the missed dose as soon as you remember, and then take the following doses at the recommended intervals (4–6 hours).

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

4. Possible adverse effects

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

Rare adverse effects (may affect up to 1 in 1,000 people) are: malaise, drop in blood pressure (hypotension), and increased blood transaminase levels.

Very rare adverse effects (may affect up to 1 in 10,000 people) are: kidney disorders, cloudy urine, severe skin reactions, allergic dermatitis (skin rash), jaundice (yellowing of the skin), blood disorders (agranulocytosis, leucopenia, neutropenia, haemolytic anaemia), and hypoglycaemia (low blood sugar).

Adverse effects with unknown frequency (cannot be estimated from available data): A serious condition that may cause the blood to become more acidic (called metabolic acidosis) in patients with severe illness who use paracetamol (see section 2).

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

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for 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 Febrectal

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

Special storage conditions are not required.

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

6. Contents of the package and other information

Composition of Febrectal

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

The other components are hydrogenated castor oil, corn starch, povidone, tricalcium phosphate, sodium croscarmellose, talc, magnesium stearate, and stearic acid.

Appearance of the product and contents of the package

Febrectal 650 mg Tablets are presented as white, round, biconvex tablets, scored centrally on both sides, for oral administration. Each pack 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 most recent revision of this leaflet: February 2025

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