Label: information for the user

Febrectal Adults 600 mg Suppositories

Paracetamol

Read this label carefully before starting to use this medication, as it contains important information for you.

1.What is Febrectal Adults and what it is used for

2.What you need to know before starting to use Febrectal Adults

3.How to use Febrectal Adults

4.Possible side effects

1. Storage of Febrectal Adults
2. Contents of the package and additional information

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.Especially in adults and adolescents where oral administration is difficult: for example, nausea, vomiting.

No use Febrectal adultos

• 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 use Febrectal adults.

Do not use more of the medication than recommended in section 3 “How to use Febrectal adults”. Avoid using this medication with other medications that contain paracetamol, such as cold and flu medications, as high doses may cause liver damage. Do not use more than one medication that contains paracetamol without consulting your doctor.

If you have asthma and are 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, with or without a decrease in red blood cells), or chronic malnutrition or dehydration, consult your doctor before taking this medication.

If you are being treated with medication for epilepsy, consult your doctor before taking this medication, as it may decrease the effectiveness and increase the hepatotoxicity of paracetamol, especially with high doses of paracetamol.

In chronic alcoholics, be cautious not to administer more than 3 suppositories of 600 mg of paracetamol in 24 hours.

In cases of diarrhea, the use of suppositories is not recommended.

It is recommended to consult your doctor in treatments lasting more than 3 days.

During treatment with Febrectal adults, 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 difficulty breathing with deep and rapid breathing, drowsiness, feeling unwell (nausea) and vomiting.

Children and Adolescents

In children and adolescents under 15 years, consult your doctor or pharmacist, as there may be other presentations available with doses adapted to these patients.

Interference with Analytical Tests

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

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

Use of Febrectal adults with other Medications

Inform your doctor or pharmacist that you are using, have used recently, or may need to use 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 used to increase urine elimination (diuretics such as furosemide)
• Medications used to treat gout (probencid and sulfinpyrazone)
• Medications used to treat high blood pressure 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.

Use of Febrectal adults 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, etc.) may cause liver damage.

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

Pregnancy, Lactation, and Fertility

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

In cases where necessary, Febrectal may be used during pregnancy.

Paracetamol passes into breast milk, so women in the lactation period should consult their doctor before using this medication.

Driving and Operating Machines

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

Follow exactly the administration instructions of the medication contained in this leaflet or those 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 old(and weight over50 Kg): You can administer 1suppository (600 mg of paracetamol) every 4 or 6 hours as needed, while symptoms persist, up to a maximum of3 gof paracetamol per day (5 suppositories).

Adults and adolescents over 12 years old(and weight over40 Kg): You can administer 1suppository (600 mg of paracetamol) every 6 hours as needed, while symptoms persist, up to a maximum of2.400 mgof paracetamol per day (4 suppositories).

Adults and adolescents with a weight of less than 40 kg may require other presentations with paracetamol doses adjusted to their recommended posology. They should consult their doctor or pharmacist.

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

Patients with liver disease: They should consult their doctor before using this medication. They should not exceed the administration of 3 suppositories per day and the interval between each use will be at least 8 hours.

Patients with kidney disease: This medication does not follow the recommended dose for these patients. They should consult their doctor.

Older adults: They should consult their doctor.

The administration of the medication is subject to the appearance of painful or feverish symptoms. As these symptoms disappear, this medication should be discontinued.

Children:This use is not recommended due to the paracetamol dose it contains (see Warnings and precautions).

Systematic use allows avoiding pain or fever oscillations.

If pain persists for more than 5 days (more than 3 days in children) or 2 days for throat pain, fever for more than 3 days, or pain or fever worsen or other symptoms appear, treatment should be interrupted and the doctor consulted.

Administration form

Rectal route.

After removing the suppository from the packaging, introduce it deeply into the rectum. If the suppository is too soft to use, refrigerate it for 30 minutes or place it under cold running water before removing the packaging or, if necessary afterwards, to avoid softening.

The suppository should be used in its entirety. Do not break the suppositories before administration.

Try to hold back as much as possible to allow the medication to take effect. If you experience resistance at the time of administration, discontinue it, as it may be harmful, consult your doctor.

If you use more Febrectal adults than you should

Incase of overdose or accidental ingestionconsult your doctor or pharmacist immediately or call the Toxicological Information Service, phone:915 620 420(indicating the medication and the amount administered).

Rectal administration is not usually a cause of overdose, which occurs much more frequently orally.

The symptoms of overdose includedizziness, vomiting, loss of appetite, and abdominal pain. If an overdose (more than6 gin a single dose) has been administered, go to the hospital even if you do not notice the symptoms, as these, very serious, may appear several days after administration.

The treatment of intoxication includes hemodialysis and administration of acetaminophen at adequate doses. Gastric lavage and oral administration of activated charcoal are also suitable when the overdose has been produced orally.

If you forgot to use Febrectal adults

Do not administer a double dose to compensate for the missed doses, simply administer the missed dose when you remember and the subsequent doses with the indicated interval between administrations (interval always greater than 4 hours).

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

Like all medications, Febrectal Adults 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, leukopenia, 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 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 treatments.

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.

Medicines should not be disposed of through drains or in the trash. Dispose ofthe packaging and medications you no longer need at the SIGRE collection pointat 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 for adults

The active ingredient is paracetamol. Each suppository contains 600 mg of paracetamol.

The other components areanhydrous colloidal silica and semisynthetic solid glycerides.

Appearance of the product and content of the packaging

Febrectal for adults 600 mg Suppositories are presented in the form of white creamy-colored, oval-shaped suppositories, in packaging containing 6 suppositories.

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

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)

Last review date of this leaflet: February 2025

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