Febrectal Adultos 600 mg suppositories
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the user
Febrectal adults 600 mg Suppositories
Paracetamol
Read the entire leaflet carefully before you start using 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 should 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 worsens or new symptoms appear.
Leaflet contents:
- What Febrectal adults is and what it is used for
- What you need to know before using Febrectal adults
- How to use Febrectal adults
- Possible side effects
- How to store Febrectal adults
- Contents of the pack and other information
1. What Febrectal adults is and what it is used for
Febrectal adults 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. Particularly in adults and adolescents in whom oral administration is difficult: for example, due to nausea, vomiting.
2. What you need to know before using Febrectal adults
Do not use Febrectal adults
- if you are allergic to paracetamol or to any of the other ingredients of this medicine (listed in section 6).
Warnings and precautions
Talk to your doctor or pharmacist before using Febrectal adults.
Do not use more medicine than the recommended dose stated in section 3 “How to use Febrectal adults”. The simultaneous 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 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 medicines for epilepsy, consult your doctor before taking this medicine, as concomitant use may reduce efficacy and increase the hepatotoxicity of paracetamol, especially with high-dose paracetamol regimens.
In chronic alcoholics, caution should be taken not to administer more than 3 suppositories of 600 mg paracetamol in 24 hours.
The use of suppositories is not recommended in case of diarrhoea.
Medical advice is recommended if treatment lasts longer than 3 days.
During treatment with Febrectal adults, 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 under these circumstances 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
For children and adolescents under 15 years of age, consult your doctor or pharmacist, as other formulations with doses appropriate for these patients may be available.
Interference with laboratory tests
If you are due to have any laboratory tests (including blood and urine tests, skin tests using allergens, etc.), inform your doctor that you are using this medicine, as it may alter the results of such tests.
Paracetamol may alter the analytical values of uric acid and glucose measurements.
Use of Febrectal adults with other medicines
Tell 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 used to prevent blood clots: oral anticoagulants (acenocoumarol, warfarin)
- Medicines used to treat epilepsy: antiepileptics (lamotrigine, phenytoin or other hydantoins, phenobarbital, methylphenobarbital, primidone, carbamazepine)
- Medicines used to treat tuberculosis: isoniazid, rifampicin
- Medicines used to treat depression and seizures: barbiturates (used as hypnotics, sedatives and anticonvulsants)
- Medicines used to increase urine elimination (loop diuretics such as furosemide)
- Medicines used in the treatment of gout (probenecid and sulfinpyrazone)
- Medicines used to treat 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 (medicines that reduce pain) without consulting your doctor.
Occasional use as a preferred analgesic may be acceptable in patients receiving treatment with oral anticoagulants.
Use of Febrectal adults 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.
If necessary, Febrectal may be used during pregnancy.
Paracetamol passes into breast milk; therefore, women who are breastfeeding should consult their doctor before using this medicine.
Driving and using machines
The effect of paracetamol on the ability to drive and operate machinery is negligible or none at all.
3. How to use Febrectal adults
Follow exactly the instructions for use provided in this leaflet or as directed by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
Recommended dose:
Adults and adolescents over 15 years of age (and weighing more than 50 kg): 1 suppository (600 mg of paracetamol) may be administered every 4 or 6 hours as needed, while symptoms persist, up to a maximum of 3 g paracetamol per day (5 suppositories).
Adults and adolescents over 12 years of age (and weighing more than 40 kg): 1 suppository (600 mg of paracetamol) may be administered every 6 hours as needed, while symptoms persist, up to a maximum of 2,400 mg paracetamol per day (4 suppositories).
Adults and adolescents weighing less than 40 kg may require other formulations with paracetamol doses adjusted to their recommended posology. They should consult their doctor or pharmacist.
High daily doses of paracetamol should be avoided over prolonged periods, as this increases the risk of adverse effects such as liver damage.
Patients with liver disease: Should consult their doctor before using this medicine. They must not exceed the administration of 3 suppositories per day, and the interval between each dose must be at least 8 hours.
Patients with kidney disease: This medicine does not meet the recommended dosing guidelines for these patients. They should consult their doctor.
Elderly patients: Should consult their doctor.
Administration of the medicine should be based on the presence of painful or febrile symptoms. As symptoms subside, treatment should be discontinued.
Children: Use is not recommended due to the paracetamol dose it contains (see Warnings and precautions).
Systematic use helps prevent fluctuations in pain or fever.
If pain persists for more than 5 days (more than 3 days in children), or for sore throat for more than 2 days, or if fever lasts more than 3 days, or if pain or fever worsen or new symptoms appear, treatment must be stopped and a doctor consulted.
Method of administration
Rectal use.
After removing the suppository from its packaging, insert it deeply into the rectum. If the suppository is too soft to use, cool it in the refrigerator for 30 minutes or hold it under cold running water before removing the wrapper, or if necessary afterwards, to prevent softening.
The entire suppository must be used. Do not divide or split suppositories before administration.
Delay bowel evacuation as long as possible to allow the medicine to take effect. If resistance is felt during administration, discontinue the procedure, as it may be harmful, and consult your doctor.
If you use more Febrectal adults than you should
In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service at: 915 620 420 (indicating the medicine and amount administered).
Overdose is uncommon via rectal route, and occurs much more frequently following oral intake.
Symptoms of overdose include dizziness, vomiting, loss of appetite, and abdominal pain. If an overdose has been administered (more than 6 g in a single dose), go to hospital immediately, even if no symptoms are present, as severe symptoms may appear several days after administration.
Treatment of poisoning includes hemodialysis and administration of acetylcysteine at appropriate doses. Gastric lavage and oral administration of activated charcoal are also appropriate when overdose has occurred via the oral route.
If you forget to use Febrectal adults
Do not administer a double dose to make up for missed doses. Simply take the missed dose as soon as you remember, and continue with the next doses at the recommended intervals (always more than 4 hours apart).
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.
4. Possible adverse effects
Like all medicines, Febrectal adults may produce adverse effects, although not everyone experiences them.
Rare adverse effects (may affect up to 1 in 1,000 people) include: malaise, decreased blood pressure (hypotension), and increased levels of transaminases in the blood.
Very rare adverse effects (may affect up to 1 in 10,000 people) include: kidney disorders, cloudy urine, serious 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 the 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 damage the liver 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 may 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 adults
Keep this medicine out of the sight and reach of children.
No special storage conditions are required.
Do not use this medicine after the expiry date which is 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 drains or household waste. Unused containers and medicines should be taken to the SIGRE Point at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.
6. Contents of the pack and other information
Composition of Febrectal Adults
The active substance is paracetamol. Each suppository contains 600 mg of paracetamol.
The other components are colloidal anhydrous silica and solid semisynthetic glycerides.
Appearance of the product and contents of the pack
Febrectal Adults 600 mg Suppositories are presented as white, waxy, ovoid suppositories in packs containing 6 suppositories.
Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
Laboratorios Almirall, S.L.
General Mitre, 151
08022 - Barcelona (Spain)
Manufacturer
KERN PHARMA, S.L
Polígono Ind. Colón II Venus, 72
08228 Terrassa (Barcelona) Spain
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 and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/