FEBRIROL 200 MG ORAL SOLUTION GRANULES

Introduction

Package Leaflet: Information for the User

Febrirol 200 mg Granules for Oral Solution

Ibuprofen (arginine)

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

Follow exactly the administration instructions of the medicine contained in this leaflet or as indicated by your doctor, pharmacist, or nurse.

• Keep this 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, pharmacist, or nurse, even if they are not listed in this leaflet. See section 4.
• You should consult a doctor if your condition worsens or does not improve, if the fever persists for more than 3 days or the pain for more than 5 days.

Contents of the Package Leaflet

1. What is Febrirol and what is it used for
2. What you need to know before taking Febrirol
3. How to take Febrirol
4. Possible side effects
5. Storage of Febrirol
6. Contents of the pack and further information

1. What is Febrirol and what is it used for

Ibuprofen, the active ingredient of this medicine, acts by reducing pain and fever.

It is indicated in adults and children over 8 years for the symptomatic relief of occasional mild or moderate pain, such as headaches, dental pain, menstrual pain, muscle pain (cramps) or back pain (lumbago), as well as in febrile states.

2. What you need to know before taking Febrirol

Do not take Febrirol

• If you are allergic (hypersensitive) to ibuprofen, to other non-steroidal anti-inflammatory drugs (NSAIDs), to aspirin, or to any of the other components of Febrirol. Allergic reactions may include: skin rash with itching, swelling of the face, lips, or tongue, nasal discharge, difficulty breathing, or asthma.
• If you have a severe liver or kidney disease.
• If you have had a stomach or duodenal ulcer or have suffered a perforation of the digestive tract.
• If you vomit blood.
• If you have black stools or bloody diarrhea.
• If you have bleeding disorders or blood coagulation disorders, or are taking anticoagulants (medicines used to "thin" the blood). If it is necessary to use anticoagulant medications at the same time, your doctor will perform blood coagulation tests.
• If you have severe heart failure.

If you are in the third trimester of pregnancy.

Warnings and precautions

You should consult your doctor, pharmacist, or nurse before starting to take this medicine.

• If you have edema (fluid retention).
• If you have or have had heart disorders or high blood pressure.
• If you have asthma or any other respiratory disorder.
• Tell your doctor if you are receiving treatment with Febrirol, as it may mask fever, which is an important sign of infection, making diagnosis difficult.
• If you have kidney or liver disease, are over 60 years old, or need to take the medicine for a prolonged period (more than 1 to 2 weeks), your doctor may need to perform regular checks. Your doctor will indicate the frequency of these checks.
• If you experience symptoms of dehydration, e.g., severe diarrhea or vomiting, take plenty of fluids and contact your doctor immediately, as ibuprofen may cause kidney failure due to dehydration.
• If you have had or developed an ulcer, bleeding, or perforation in the stomach or duodenum, which may be manifested by intense or persistent abdominal pain and/or black stools, or even without previous warning symptoms.

• This risk is higher when high doses and prolonged treatments are used, in patients with a history of peptic ulcers, and in elderly patients. In these cases, your doctor will consider the possibility of associating a stomach protective medication.

• If your doctor has prescribed an antiplatelet medication(to prevent the formation of blood clots) that contains acetylsalicylic acid, and you also take Febrirol, you should separate the intake of both medications. To do this, you can follow either of the following guidelines:

• Take the dose of acetylsalicylic acid and wait at least half an hourbefore administering the dose of oral ibuprofen.
• Take the dose of oral ibuprofen at least 8 hours beforeadministering acetylsalicylic acid.

• If you take medications that alter blood coagulation, such as oral anticoagulants, antiplatelet agents of the acetylsalicylic acid type. You should also discuss the use of other medications that may increase the risk of such bleeding, such as corticosteroids and selective serotonin reuptake inhibitor antidepressants.
• If you have Crohn's disease (a chronic disease in which the immune system attacks the intestine, causing inflammation that usually produces bloody diarrhea) or ulcerative colitis, as ibuprofen-type medications can worsen these conditions.
• If you are being treated with diuretics (medicines to increase urine production), as your doctor should monitor your kidney function.
• If you have systemic lupus erythematosus (a chronic disease that affects the immune system and can affect various vital organs, the nervous system, blood vessels, skin, and joints), as it may cause aseptic meningitis (inflammation of the meninges that protect the brain and spinal cord, not caused by bacteria).
• If you have acute intermittent porphyria (a metabolic disease that affects your blood and can cause symptoms such as reddish urine color, blood in urine, or liver disease), so that your doctor can assess the convenience or not of treatment with ibuprofen.
• If you experience headaches after prolonged treatment, do not take higher doses of the medication.
• It is possible that allergic reactions may occur with this medication.
• Your doctor will perform stricter control if you receive ibuprofen after undergoing major surgery.
• It is advisable not to take this medication if you have chickenpox.
• If you have an infection, see the "Infections" section later.
• With ibuprofen, signs of allergic reaction to this medication have been reported, such as respiratory problems, facial and neck swelling (angioedema), and chest pain. Stop using Febrirol immediately and contact your doctor or the emergency medical service immediately if you observe any of these signs.

Febrirol may hide the signs of an infection, such as fever and pain. Consequently, Febrirol may delay the appropriate treatment of the infection, which can increase the risk of complications. This has been observed in bacterial pneumonia and bacterial skin infections related to chickenpox. If you take this medication while having an infection and the symptoms of the infection persist or worsen, consult a doctor without delay.

It is essential that you use the smallest dose that relieves/controls the pain and do not take this medication for longer than necessary to control your symptoms.

Cardiovascular precautions

Anti-inflammatory/analgesic medications like ibuprofen may be associated with a small increased risk of suffering a heart attack or stroke, especially when used in high doses. Do not exceed the recommended dose or treatment duration.

Tell your doctor about your treatment with Febrirol before taking it if:

• You have heart problems, including heart failure, angina (chest pain), or if you have had a heart attack, bypass surgery, peripheral arteriopathy (circulation problems in the legs or feet due to narrowing or blockage of the arteries), or any type of stroke (including a "mini-stroke" or transient ischemic attack "TIA").
• You have high blood pressure, diabetes, high cholesterol, have a family history of heart disease or stroke, or are a smoker.

Similarly, these types of medications can cause fluid retention, especially in patients with heart failure and/or high blood pressure (hypertension).

Skin reactions

Severe skin reactions have been reported with Febrirol treatment. Stop taking Febrirol and consult your doctor immediately if you experience any skin rash, mucous membrane lesions, blisters, or other signs of allergy, as these can be the first signs of a severe skin reaction. See section 4.

Severe skin reactions, such as exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), and acute generalized exanthematous pustulosis (AGEP), have been reported in association with ibuprofen treatment. Discontinue Febrirol treatment and seek medical attention immediately if you notice any of the symptoms related to these severe skin reactions described in section 4.

Precautions during pregnancy and in women of childbearing age

Because the administration of ibuprofen-type medications has been associated with an increased risk of congenital anomalies/abortions, it is not recommended to administer it during the first and second trimester of pregnancy unless it is strictly necessary. In these cases, the dose and duration will be limited to the minimum possible.

In the third trimester, the administration of ibuprofen is contraindicated.

For women of childbearing age, it should be taken into account that ibuprofen-type medications have been associated with a decrease in fertility.

Interference with laboratory tests:

If you are going to have any diagnostic tests (including blood tests, urine tests, etc.), inform your doctor that you are taking this medication, as it may alter the results.

Use of Febrirol with other medications

Tell your doctor or pharmacist if you are using, have recently used, or may need to use any other medication.

Febrirol may affect or be affected by other medications. For example:

Other non-steroidal anti-inflammatory drugs, such as aspirin.

• Antiplatelet agents (prevent the formation of blood clots) such as ticlopidine.
• Anticoagulant medications (e.g., to treat coagulation problems/prevent coagulation, e.g., acetylsalicylic acid, warfarin, ticlopidine).
• Baclofen (used to treat involuntary and persistent muscle contractions).
• Lithium (medication used to treat depression). Your doctor may adjust the dose of this medication.
• Methotrexate (to treat cancer and inflammatory diseases). Your doctor may adjust the dose of this medication.
• Mifepristone (abortion inducer).
• Digoxin and other cardiac glycosides (used to treat heart disorders).
• Hydantoins such as phenytoin (used to treat epilepsy).
• Sulfonamides such as sulfamethoxazole and cotrimoxazole (used to treat certain bacterial infections).
• Corticosteroids such as cortisone and prednisolone.
• Diuretics (medicines used to increase urine production).
• Pentoxifylline (to treat intermittent claudication).
• Probenecid (used in patients with gout or with penicillin in infections).
• Quinolone antibiotics such as norfloxacin.
• Ion exchange resins such as cholestyramine (used to decrease blood cholesterol levels).
• Sulfinpyrazone (for gout). Oral hypoglycemic agents (sulfonylureas) such as tolbutamide (for diabetes).
• Tacrine (used to treat Alzheimer's disease).
• Tacrolimus or cyclosporine (used in organ transplants to prevent rejection).
• Zidovudine (medication against the AIDS virus).
• Medications that lower high blood pressure (ACE inhibitors such as captopril, beta-blockers such as atenolol, and angiotensin-II receptor antagonists such as losartan).
• Thrombolytics (medications that dissolve blood clots).
• Aminoglycoside antibiotics such as neomycin.
• Herbal extracts: Ginkgo biloba tree.

If your doctor has prescribed an antiplatelet medication(to prevent the formation of blood clots) that contains acetylsalicylic acid, and you also take Febrirol, you should separate the intake of both medications (see the Special warnings and precautions for usesection).

Other medications may also affect or be affected by Febrirol treatment. Therefore, you should always consult your doctor or pharmacist before using Febrirol with other medications.

Taking Febrirol with food, drinks, and alcohol:

Febrirol can be taken alone or with food. In general, it is recommended to take it during meals or with milk to reduce the possibility of stomach upset.

Do not administer ibuprofen with alcohol to avoid damaging the stomach.

Taking ibuprofen in patients who habitually consume alcohol (three or more alcoholic beverages - beer, wine, liquor... per day) may cause stomach bleeding.

Pregnancy, breastfeeding, and fertility:

Consult your doctor or pharmacist before using any medication.

Do not take ibuprofen if you are in the last 3 months of pregnancy, as it may harm the fetus or cause problems during delivery. It may cause kidney and heart problems in your fetus. It may affect your and your baby's ability to bleed and delay or prolong labor more than expected. Do not take ibuprofen during the first 6 months of pregnancy unless it is clearly necessary and as indicated by your doctor. If you need treatment during this period or while trying to become pregnant, you should take the minimum dose for the shortest possible time. From the 20th week of pregnancy, ibuprofen may cause kidney problems in your fetus if taken for more than a few days, which can cause low levels of amniotic fluid surrounding the baby (oligohydramnios) or narrowing of a blood vessel (ductus arteriosus) in the baby's heart. If you need treatment for a period longer than a few days, your doctor may recommend additional checks.

Breastfeeding women should consult their doctor or pharmacist before taking this medication. Although only small amounts of the medication pass into breast milk, it is recommended not to take ibuprofen for prolonged periods during breastfeeding.

Therefore, if you become pregnant or are breastfeeding, consult your doctor.

IMPORTANT FOR WOMEN:

If you are pregnant or think you may be pregnant, consult your doctor before taking this medication. The use of medications during pregnancy can be hazardous to the embryo or fetus and should be monitored by your doctor.

Febrirol

Driving and using machines:

Although it is not expected to have effects in this sense, if you experience dizziness, vertigo, vision changes, or other symptoms while taking this medication, do not drive or use hazardous machinery. If you only take one dose of Febrirol or for a short period, it is not necessary to take special precautions.

Febrirol contains aspartame, sucrose, and sodium

This medication contains less than 23 mg of sodium (1 mmol) per sachet, which is essentially "sodium-free".

This medication contains 10 mg of aspartame in each sachet. Aspartame is a source of phenylalanine, which may be harmful in case of phenylketonuria (PKU), a rare genetic disease in which phenylalanine accumulates because the body is unable to eliminate it correctly.

3. How to take Febrirol

Follow the administration instructions for this medication exactly, unless your doctor has indicated otherwise. Consult your doctor or pharmacist if you have any doubts.

The lowest effective dose should be used for the shortest time necessary to relieve symptoms. If you have an infection, consult your doctor without delay if symptoms (such as fever and pain) persist or worsen (see section 2).

The normal dose is:

• Adults and adolescents from 12 years: take a dose of 200 mg every 4 or 6 hours, if necessary. If pain or fever does not respond to the 200 mg dose, doses of 400 mg every 6 or 8 hours can be used (in adolescents weighing over 40 kg).

Do not take more than 1200 mg in 24 hours.

• Patients with kidney, liver, or heart disease: reduce the dose and consult a doctor.

Always use the lowest effective dose.

Use in children

• Children from 8 to 12 years: 1 sachet (200 mg of ibuprofen) every 6 or 8 hours if necessary. Do not take more than 4 sachets (800 mg of ibuprofen) in 24 hours.

Do not administer to children under 8 years without consulting a doctor.

Use in people over 65 years

• People over 65 years: the amount to take should be established by the doctor, as it may be necessary to reduce the usual dose.

Elderly people are often more prone to adverse effects, so the dose may need to be reduced. Consult your doctor.

Method of administration:

This medication is administered orally.

Take the medication with meals or with milk, especially if digestive discomfort is noticed.

Dissolve the granulate from the sachet in a glass of water and stir until dissolved.

Administration of this preparation is subject to the appearance of pain or fever. As these disappear, the medication should be discontinued.

If symptoms worsen, if fever persists for more than 3 days or pain for more than 5 days, consult a doctor.

If you take more Febrirol than you should:

If you have taken more ibuprofen than you should, consult your doctor or pharmacist immediately, or call the Toxicology Information Service (telephone 91 562 04 20), indicating the medication and the amount ingested. It is recommended to take the packaging and the prospectus of the medication to the healthcare professional.

If you have taken more Poindol than you should, or if a child has accidentally ingested the medication, consult a doctor immediately or go to the nearest hospital to find out about the risk and ask for advice on the measures to be taken.

Symptoms of overdose may include nausea, stomach pain, vomiting (which may contain bloody sputum), headache, ringing in the ears, confusion, and involuntary eye movement. At high doses, symptoms of drowsiness, chest pain, palpitations, loss of consciousness, convulsions (mainly in children), weakness, and dizziness, blood in the urine, low potassium levels in the blood, chills, and breathing difficulties have been reported.

If a severe poisoning has occurred, the doctor will take the necessary measures.

In case of ingestion of significant amounts, activated charcoal should be administered. Gastric lavage will be considered if significant amounts have been ingested and within 60 minutes after ingestion.

If you forget to take Febrirol

Do not take a double dose to make up for the forgotten dose.

If you forget to take your corresponding dose, take it as soon as you remember. However, if the time of the next dose is very close, skip the forgotten dose and take the next dose at the usual time.

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

4. Possible adverse effects

Like all medications, Febrirol can have adverse effects, although not everyone experiences them.

Adverse effects of medications like Febrirol are more common in people over 65 years.

The incidence of adverse effects is lower in short treatments and if the daily dose is below the recommended dose.

Stop treatment with ibuprofen and seek immediate medical attention if you notice any of the following symptoms:

• Chest pain, which can be a sign of a potentially serious allergic reaction called Kounis syndrome.
• Reddish, non-raised spots, target-shaped or circular on the trunk, often with blisters in the center, skin peeling, mouth, throat, nose, genital, and eye ulcers. These severe skin rashes can be preceded by fever and flu-like symptoms [exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis].
• Widespread rash, high body temperature, and swollen lymph nodes (DRESS syndrome).
• Widespread, red, scaly rash, with bumps under the skin and blisters, accompanied by fever. Symptoms usually appear at the start of treatment (acute generalized exanthematous pustulosis).

Frequent (may affect up to 1 in 10 patients): fatigue, headache, stomach and intestine disorders (heartburn, diarrhea, nausea, vomiting), skin disorders (rash, itching), and ringing in the ears.

Uncommon (may affect up to 1 in 100 patients): allergic reactions, asthma, rhinitis, and urticaria, gastrointestinal bleeding and ulcers, sleep disturbances and mild restlessness, blurred vision, decreased visual acuity, or changes in color perception, and hearing disturbances.

Rare (may affect up to 1 in 1,000 patients): edema (swelling due to fluid retention), blood disorders (leukopenia), stomach and intestine perforation, liver disorders (including jaundice), kidney disorders consisting of acute interstitial nephritis with hematuria (blood in urine), proteinuria (protein elimination in urine), and occasionally nephrotic syndrome; depression, vision disorders (visual impairment), neck stiffness, and bronchospasm (sudden feeling of suffocation), dyspnea (difficulty breathing), and angioedema (inflammation of the deep skin layers, which can cause swelling of the face, lips, tongue, or throat, potentially leading to difficulty swallowing or breathing).

Very rare (observed in up to 1 in 10,000 patients), the following may occur: aseptic meningitis (inflammation of the meninges not caused by bacteria), blood and coagulation disorders (aplastic anemia and hemolytic anemia), hypertension, and heart failure, severe skin, eye, and mucous membrane disorders (erythema cutaneum), such as Stevens-Johnson syndrome (severe erythema multiforme) and toxic epidermal necrolysis (skin and mucous membrane lesions causing skin shedding) and erythema multiforme.

Frequency not known, a severe skin reaction known as DRESS syndrome may occur. The symptoms of DRESS syndrome include: skin rash, lymph node inflammation, and elevated eosinophils (a type of white blood cell).

Generalized red scaly rash, with bumps under the skin and blisters, mainly located in skin folds, trunk, and upper limbs, accompanied by fever at the start of treatment (acute generalized exanthematous pustulosis). Stop taking Febrirol if you experience symptoms and seek immediate medical attention. See also section 2.

The skin becomes sensitive to light.

Reporting 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 prospectus. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

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5. Conservation of Febrirol

No special storage conditions are required.

Keep this medication out of sight and reach of children.

Do not use this medication after the expiration date shown on the packaging after CAD. The expiration date is the last day of the month indicated.

Medications should not be thrown down the drain or into the trash. Deposit the packaging and medications you no longer need at the SIGRE point in the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need.This way, you will help protect the environment.

6. Package contents and additional information

Composition of Febrirol

• The active ingredient is ibuprofen. Each sachet contains 200 mg of ibuprofen as 369 mg of ibuprofen (arginine).
• The other components are: arginine, aspartame (E-951), sucrose, sodium hydrogen carbonate, sodium saccharin, sodium lauryl sulfate, peppermint flavor composed of flavoring components (natural flavoring preparations, natural flavoring substances, and natural-identical flavoring substances), non-flavoring components (which contain modified cornstarch (E-1450), maltodextrin, triacetin (E-1518)), and active substances (pulegone) and purified water.

Appearance of the product and package contents

Sachets with granulate for oral solution. It is presented in the form of white granulate with a characteristic peppermint odor, packaged in paper/aluminum/polyethylene sachets.

It is presented in packages with 20 sachets.

Marketing authorization holder and manufacturer

Marketing authorization holder:

FARMALIDER S.A.,

c/ Aragoneses 15,

28108 Alcobendas (Madrid)

Spain

Manufacturer

Toll Manufacturing Services S.L.,

c/ Aragoneses, 2.

28108 Alcobendas (Madrid)

Spain

Date of the last revision of this prospectus: November 2024

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