Package Leaflet: Information for the User

Febrirol 200 mg Powder for Oral Solution

Ibuprofen (arginine)

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

Follow exactly the administration instructions contained in this leaflet or those given 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 any 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.

1. What is Febrirol and what it is 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 additional information

The ibuprofen, active ingredient of this medication, acts by reducing pain and fever.

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

Do not take Febrirol

- If you are allergic (hypersensitive) to ibuprofen, other nonsteroidal anti-inflammatory drugs (NSAIDs), aspirin, or any of the other components of Febrirol. Allergic reactions may include skin rash with itching, facial swelling, lip or tongue swelling, 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 bleeding, 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 or clotting disorders, or are taking anticoagulants (blood thinners). If necessary, your doctor will perform blood clotting 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 medication.

• If you have edema (fluid retention).
• If you have or have had any heart problems or high blood pressure.
• If you have asthma or any other respiratory problems.
• Inform your doctor if you are receiving treatment with Febrirol, as it may mask fever, an important sign of infection, making its diagnosis more difficult.
• If you have kidney or liver disease, are over 60 years old, or need to take the medication 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, such as severe diarrhea or vomiting, take plenty of fluid and immediately contact your doctor, as ibuprofen in this case may cause kidney failure as a result of dehydration.
• If you have had or develop a stomach or duodenal ulcer, bleeding, or perforation, which may manifest as severe abdominal pain or persistent pain and/or black stools, or even without previous warning symptoms.

• This risk is higher when using high doses and prolonged treatment, in patients with a history of peptic ulcer disease, and in elderly patients. In these cases, your doctor may consider associating a stomach protector medication.

• If your doctor has prescribed an antiplatelet medication (to prevent blood clots) containing acetylsalicylic acid, and you are also taking Febrirol, you must separate the intake of both medications. You can follow either of the following guidelines:

• Take the acetylsalicylic acid dose and wait at least 30 minutes before administering the ibuprofen oral dose.
• Take the ibuprofen oral dose at least 8 hours before administering the acetylsalicylic acid dose.

• If you are taking medications that alter blood clotting, such as oral anticoagulants, antiplatelet medications of the type acetylsalicylic acid. You should also inform your doctor about the use of other medications that may increase the risk of bleeding, such as corticosteroids and selective serotonin reuptake inhibitors (SSRIs).
• If you have Crohn's disease (a chronic disease in which the immune system attacks the intestine, causing inflammation that usually results in bloody diarrhea) or ulcerative colitis, as ibuprofen-type medications may worsen these conditions.
• If you are taking diuretics (medications 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, which are the membranes that protect the brain and spinal cord, not caused by bacteria).
• If you have intermittent acute porphyria (a metabolic disease that affects your blood and can cause symptoms such as red urine, bloody urine, or liver disease), so your doctor can assess the advisability or not of treatment with ibuprofen.
• If you experience headaches after prolonged treatment, do not take higher doses of the medication.
• It is possible to experience allergic reactions with this medication.
• Your doctor will perform a more strict control if you receive ibuprofen after undergoing major surgery.
• It is not recommended 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 emergency medical services if you observe any of these signs.

Febrirol may mask the signs of an infection, such as fever and pain. Therefore, it is possible that Febrirol may delay the appropriate treatment of the infection, which may increase the risk of complications. This has been observed in pneumonia caused by bacteria and 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 to use the smallest dose that relieves or controls pain and not to take this medication for longer than necessary to control your symptoms.

Cardiovascular precautions

Nonsteroidal anti-inflammatory drugs (NSAIDs) like ibuprofen may be associated with a small increase in the risk of suffering a heart attack or stroke, especially when used in high doses. Do not exceed the recommended dose or treatment duration.You should inform your doctor or pharmacist before taking Febrirol if:

• You have heart problems, including heart failure, angina (chest pain), or have had a heart attack, coronary artery bypass surgery, peripheral artery disease (problems with circulation 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, a family history of heart disease or stroke, or are a smoker.

These types of medications may also cause fluid retention, especially in patients with heart failure and/or high blood pressure (hypertension).

Skin reactions

Severe skin reactions associated with Febrirol treatment have been reported. Stop taking Febrirol immediately and see a doctor if you experience any skin rash, lesions on mucous membranes, blisters, or other signs of allergy, as these may 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), generalized acute pustular psoriasis (PEGA), have been associated with ibuprofen treatment. Discontinue Febrirol treatment and seek medical attention immediately if you notice any symptoms related to these severe skin reactions described in section 4.

Pregnancy, lactation, 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 predisposition and that of your baby to bleeding and delay or prolong delivery. 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 week 20 of pregnancy, ibuprofen may cause kidney problems in your fetus if taken for more than a few days, which may cause low amniotic fluid levels 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.

Women in the lactation period 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 lactation.

Therefore, if you become pregnant or are in the lactation period, consult your doctor.

IMPORTANT FOR WOMEN:

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

FebrirolFebrirol

Driving and operating machinery

Although no effects are expected, if you experience dizziness, vertigo, visual disturbances, or other symptoms while taking this medication, do not drive or operate hazardous machinery. If you only take a dose of Febrirol or for a short period, no special precautions are necessary.

Febrirol contains aspartame, saccharose, and sodium

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

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

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

The effective dose should be the lowest dose necessary to relieve symptoms. If you have an infection, consult a doctor immediately if symptoms (such as fever and pain) persist or worsen (see section 2).

The normal dose is:

• Adults and adolescents 12 years and older: take a dose of 200 mg every 4 or 6 hours, if necessary. If pain or fever does not respond to a 200 mg dose, 400 mg doses can be used every 6 or 8 hours (in adolescents with a body weight 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 8 to 12 years: take 1 tablet (200 mg of ibuprofen) every 6 or 8 hours if necessary. Do not take more than 4 tablets (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 dose to be taken should be established by the doctor, as it may be necessary to reduce the usual dose.

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

Administration form:

This medication is administered orally.

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

Dissolve the granule in a glass of water and shake until dissolved.

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

If symptoms worsen, if fever persists for more than 3 days, or pain lasts 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 (phone 91 562 04 20), indicating the medication and the amount ingested. It is recommended to bring the packaging and the medication leaflet 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 inform yourself about the risk and ask for advice on the measures to be taken.

The symptoms of overdose may include nausea, stomach pain, vomiting (which may contain blood-tinged mucus), headache, ringing in the ears, confusion, and involuntary eye movement. At high doses, symptoms of drowsiness, chest pain, palpitations, loss of consciousness, seizures (mainly in children), weakness, and dizziness have been reported.

Low potassium levels in the blood, chills, and breathing difficulties have also been reported.

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

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

If you forget to take Febrirol

Do not take a double dose to compensate for the missed dose.

If you forget to take your dose, take it as soon as you remember. However, if the next dose is due soon, skip the missed dose and take the next dose at its usual time.

If you have any other questions about the useof this medication, ask your doctor or pharmacist.

Like all medicines, Febrirol may cause side effects, although not everyone will experience them.

Side effects of medicines like Febrirol are more common in people over 65 years old.

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

Stop taking ibuprofen and seek medical attention immediately if you notice any of the following symptoms:

- Chest pain, which may be a sign of a potentially severe allergic reaction called Kounis syndrome.

- Flat, red spots, in the shape of a target or circles on the trunk, often with blisters in the center, skin peeling, mouth ulcers, throat, nose, genital, and eye ulcers. These severe skin eruptions may be preceded by fever and flu-like symptoms [dermatitis exfoliativa, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis].

- Generalized skin eruption, elevated body temperature, and swollen lymph nodes (DRESS syndrome).

- Generalized, red, scaly eruption, with bumps under the skin and blisters, accompanied by fever. Symptoms usually appear at the beginning of treatment (acute generalized pustular psoriasis).

Frequent (may affect up to 1 in 10 patients): fatigue, headache, stomach and intestinal disorders (heartburn, diarrhea, nausea, vomiting), skin disorders (skin eruptions, itching), and tinnitus.

Infrequent (may affect up to 1 in 100 patients): allergic reactions, asthma, rhinitis, and urticaria, bleeding and gastrointestinal ulcers, sleep disturbances and mild anxiety, 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 (leucopenia), stomach and intestinal perforation, liver disorders (including jaundice), kidney disorders consisting of: acute interstitial nephritis with hematuria (blood in urine), proteinuria (protein elimination through urine), and occasionally nephrotic syndrome; depression, vision disorders (obscuration of vision), neck stiffness, and bronchospasm (sudden sensation of choking), dyspnea (difficulty breathing), and angioedema (inflammation of the deep layers of the skin, which may cause facial, lip, tongue, or throat swelling, potentially causing 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 disorders (aplastic anemia and hemolytic anemia) and coagulation disorders, hypertension and heart failure, severe skin disorders (erythema multiforme), eye, and mucous membrane disorders such as Stevens-Johnson syndrome (erythema multiforme) and toxic epidermal necrolysis (skin and mucous membrane lesions that cause skin detachment) and erythema multiforme.

Frequency unknown, a severe skin reaction known as DRESS syndrome may occur. DRESS syndrome symptoms include: skin eruption, lymph node inflammation, and elevated eosinophils (a type of white blood cell).

Generalized, red, scaly eruption, with bumps under the skin and blisters, located mainly in skin folds, the trunk, and upper limbs, accompanied by fever at the beginning of treatment (acute generalized pustular psoriasis). Stop taking Febrirol if you experience symptoms and seek medical attention immediately. See section 2.

The skin becomes sensitive to light.

Reporting of side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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This medication does not require special storage conditions.

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

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.

Medications should not be disposed of through drains or in the trash. Dispose of the packaging and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need.This will help protect the environment.

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, mint flavor composed of aromatic components (natural flavor preparations, natural flavor substances, and flavor substances identical to natural ones), non-aromatic components (which contain modified cornstarch (E-1450), maltodextrin, triacetin (E-1518)) and active substances (menthol) and purified water.

Appearance of the product and content of the packaging

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

It is presented in packaging with 20 sachets.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization:

FARMALIDER S.A.,

c/ Aragoneses 15,

28108 Alcobendas (Madrid)

Spain

Responsible for manufacturing

Toll Manufacturing Services S.L.,

c/ Aragoneses, 2.

28108 Alcobendas (Madrid)

Spain

Last review date of this leaflet: November 2024

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/.