FEBRECTAL ADULTS 600 mg SUPPOSITORIES

Introduction

Package Leaflet: Information for the User

Febrectal Adults 600 mg Suppositories

Paracetamol

Read this package leaflet carefully before starting to use this medicine, as it contains important information for you.

• Keep this package leaflet, as you may need to read it again.
• If you need advice or more information, consult your pharmacist.
• If you experience side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet.
• You should consult a doctor and discontinue treatment if the pain persists for more than 3 days in children or 5 days in adults (2 days for throat pain), or if the fever persists for more than 3 days, or if the pain or fever worsen or other symptoms appear.

Contents of the Package Leaflet:

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

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

Febrectal Adults belongs to the 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: e.g., nausea, vomiting.

2. What you need to know before taking Febrectal Adults

Do not use Febrectal Adults

• 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 use Febrectal Adults.

Do not use more medicine than recommended in Section 3 "How to take Febrectal Adults". The simultaneous use of this medicine with other medicines that contain paracetamol, such as flu and cold medicines, should be avoided, as high doses can cause 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 (reduced hemoglobin levels in the blood, due to or not due to a decrease in red blood cells), or suffer from chronic malnutrition or dehydration, you should 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 treatments.

In chronic alcoholics, it should be taken into account not to administer more than 3 suppositories of 600 mg of paracetamol in 24 hours.

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

It is advised to consult your doctor for treatments lasting more than 3 days.

During treatment with Febrectal Adults, inform your doctor immediately if:

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

Children and Adolescents

In children and adolescents under 15 years of age, consult your doctor or pharmacist, as other presentations with doses suitable for these patients may be available.

Interference with Analytical Tests

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

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

Using Febrectal Adults with Other Medicines

Inform your doctor or pharmacist that you are using, have recently used, or may need to use 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 used to increase urine elimination (loop diuretics such as furosemide)
• Medicines used to treat gout (probenecid and sulfinpyrazone)
• 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 must 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.

Using Febrectal Adults 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.

The use of 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 necessity, Febrectal can be used during pregnancy.

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

Driving and Using Machines

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

3. How to Take Febrectal Adults

Follow the administration instructions of the medicine contained in this package 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 old (and weighing over 50 kg): 1 suppository (600 mg of paracetamol) can be administered every 4 or 6 hours as needed, while symptoms persist, up to a maximum of 3 g per day of paracetamol (5 suppositories).

Adults and adolescents over 12 years old (and weighing over 40 kg): 1 suppository (600 mg of paracetamol) can be administered every 6 hours as needed, while symptoms persist, up to a maximum of 2.4 g per day of paracetamol (4 suppositories).

Adults and adolescents weighing less than 40 kg may require other presentations with paracetamol doses that are suitable for their recommended dosage. They should consult their doctor or pharmacist.

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

Patients with liver disease: They should consult their doctor before using this medicine. 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 medicine does not meet the recommended dosage for these patients. They should consult their doctor.

Elderly patients: They should consult their doctor.

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

Children:Its use is not recommended due to the dose of paracetamol it contains (see Warnings and Precautions).

Systematic use allows avoiding fluctuations in pain or fever.

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

Method of Administration

Rectal route.

After removing the suppository from the package, insert it deeply into the rectum. If the suppository is too soft to use, cool it in the refrigerator for 30 minutes or put it under a stream of cold water before removing the wrapper or, if necessary, after, to avoid softening.

The entire suppository should be used. Do not fractionate the suppositories before administration.

Defecation should be delayed as long as possible so that the medicine can take effect. If you feel resistance during administration, it should be interrupted, as it may be harmful; 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, phone: 915 620 420 (indicating the medicine and the amount administered).

By rectal route, overdose is not usually common, which occurs much more frequently by oral route.

The symptoms of overdose include dizziness, vomiting, loss of appetite, and abdominal pain. If an overdose (more than 6 g in a single dose) has been administered, you should go to the hospital, even if you do not notice symptoms, as very serious symptoms may appear several days after administration.

Treatment of intoxication includes hemodialysis and administration of acetylcysteine in adequate doses. Gastric lavage and oral administration of activated charcoal are also suitable when the overdose has occurred by oral route.

If You Forget to Use Febrectal Adults

Do not administer a double dose to make up for forgotten doses; simply administer the forgotten dose when you remember and the following doses with the indicated interval between administrations (always more than 4 hours).

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

4. Possible Side Effects

Like all medicines, Febrectal Adults can cause side effects, although not everyone 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, leukopenia, 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 in prolonged treatments.

Reporting Side Effects

If you experience any side effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this package leaflet. You can also report them directly through the Spanish Medicines and Healthcare Products Agency (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 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 expiration date that appears on the package after CAD. The expiration date is the last day of the month indicated.

Medicines should not be disposed of through wastewater or household waste. Deposit the packages and medicines you no longer need in the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of packages and medicines you no longer need. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Febrectal Adults

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

The other ingredients are anhydrous colloidal silica and semi-synthetic solid glycerides.

Appearance of the Product and Package Contents

Febrectal Adults 600 mg Suppositories are presented in the form of white, ovoid suppositories, in packages 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 Last Revision of this Package Leaflet: February 2025

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