Febrirol 200 mg granules for oral solution

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Febrirol 200 mg granules for oral solution

Ibuprofen (arginine)

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

Follow exactly the administration instructions provided in this leaflet or as directed 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 adverse effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this leaflet. See section 4.
• You must consult a doctor if you worsen or do not improve, if fever persists for more than 3 days, or if pain lasts longer than 5 days.

Leaflet contents

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

1. What Febrirol is and what it is used for

Ibuprofen, the active ingredient in this medicine, works by reducing pain and fever.

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

2. What you need to know before taking Febrirol

Do not take Febrirol

• If you are allergic (hypersensitive) to ibuprofen, to other medicines in the group of non-steroidal anti-inflammatory drugs (NSAIDs), to aspirin, or to any of the other components of Febrirol. Signs of allergy may include: itchy skin rash, swelling of the face, lips or tongue, runny nose, breathing difficulties, or asthma.
• If you have severe liver or kidney disease.
• If you have had a stomach or duodenal ulcer or bleeding, or have experienced a perforation of the digestive tract.
• If you are vomiting blood.
• If you have black stools or bloody diarrhoea.
• If you have bleeding or blood clotting disorders, or are taking anticoagulants (medicines used to "thin" the blood). If anticoagulant medicines must be used together, 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 medicine.

• If you have oedema (fluid retention).

• If you have or have previously had heart problems or high blood pressure.

• If you have asthma or any other respiratory disorder.

• Inform your doctor if you are being treated with Febrirol, as it may mask fever, an important sign of infection, making diagnosis more 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 1–2 weeks), your doctor may need to carry out regular monitoring. Your doctor will advise you on how often these checks should be performed.

• If you experience symptoms of dehydration, e.g. severe diarrhoea or vomiting, drink plenty of fluids and contact your doctor immediately, as ibuprofen in such cases could lead to renal failure due to dehydration.

• If you have had or develop a stomach or duodenal ulcer, bleeding, or perforation, which may present as severe or persistent abdominal pain and/or black stools, or even without prior warning symptoms.

• This risk is higher when high doses or long-term treatment are used, in patients with a history of peptic ulcer, and in elderly patients. In such cases, your doctor may consider adding a stomach-protective medicine.

• If your doctor has prescribed an antiplatelet medicine (to prevent blood clots) containing acetylsalicylic acid, and you are also taking Febrirol, you must separate the administration of both medicines. Follow either of the following regimens:

• Take the dose of acetylsalicylic acid and wait at least half an hour before taking the oral dose of ibuprofen.

• Take the oral dose of ibuprofen at least 8 hours before taking acetylsalicylic acid.

• If you are taking other medicines that affect blood clotting, such as oral anticoagulants or antiplatelet agents like acetylsalicylic acid. You should also inform your doctor about the use of other medicines that could increase the risk of bleeding, such as corticosteroids and selective serotonin reuptake inhibitors (SSRIs).

• If you have Crohn's disease (a chronic condition in which the immune system attacks the intestine, causing inflammation and usually bloody diarrhoea) or ulcerative colitis, as medicines like ibuprofen may worsen these conditions.

• If you are taking diuretics (medicines to increase urination), because your doctor needs to monitor your kidney function.

• If you have systemic lupus erythematosus (a chronic disease affecting the immune system that can involve various vital organs, the nervous system, blood vessels, skin, and joints), as aseptic meningitis (inflammation of the meninges—the membranes protecting the brain and spinal cord—without bacterial infection) may occur.

• If you have acute intermittent porphyria (a metabolic disorder affecting the blood that may cause symptoms such as reddish urine, blood in urine, or liver disease), so your doctor can assess whether treatment with ibuprofen is appropriate.

• If you suffer from headaches after prolonged treatment, do not take higher doses of the medicine.

• Allergic reactions may occur with this medicine.

• Your doctor will perform stricter monitoring if you receive ibuprofen after major surgery.

• It is advisable not to take this medicine if you have chickenpox.

• If you have an infection, see the section «Infections» below.

• Allergic reactions to ibuprofen have been reported, including breathing problems, facial and neck swelling (angioedema), and chest pain. Stop using Febrirol immediately and contact your doctor or emergency medical services if you notice any of these signs.

Febrirol may mask signs of infection, such as fever and pain. Therefore, Febrirol may delay appropriate treatment of infection, increasing the risk of complications. This has been observed in bacterial pneumonia and bacterial skin infections associated with chickenpox. If you take this medicine during an infection and infection symptoms persist or worsen, consult a doctor immediately.

It is important to use the lowest effective dose that relieves or controls your pain and to avoid taking this medicine longer than necessary to control your symptoms.

Cardiovascular precautions

Anti-inflammatory/analgesic medicines such as ibuprofen may be associated with a small increased risk of heart attack or stroke, especially when used at high doses. Do not exceed the recommended dose or duration of treatment. Discuss your treatment with your doctor or pharmacist before taking Febrirol if:

• You have heart problems, including heart failure, angina (chest pain), a previous heart attack, bypass surgery, peripheral arterial disease (circulation problems in legs or feet due to narrowed or blocked arteries), or any type of stroke (including a "mini-stroke" or transient ischaemic attack "TIA").
• You have high blood pressure, diabetes, high cholesterol, a family history of heart disease or stroke, or if you smoke.

In addition, these medicines may cause fluid retention, particularly in patients with heart failure and/or high blood pressure (hypertension).

Skin reactions

Serious skin reactions have been reported with Febrirol treatment. Stop taking Febrirol and contact your doctor immediately if you develop any skin rash, mucosal lesions, blisters, or other signs of allergy, as these may be early signs of a severe skin reaction. See section 4.

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

Precautions during pregnancy and in women of childbearing age

Because the use of medicines like ibuprofen has been associated with an increased risk of congenital malformations or miscarriage, administration during the first and second trimesters of pregnancy is not recommended unless strictly necessary. In such cases, the dose and duration should be kept to a minimum.

Administration of ibuprofen is contraindicated during the third trimester of pregnancy.

For women of childbearing age, it should be noted that medicines like ibuprofen have been associated with reduced fertility.

Interference with diagnostic tests:

If you are undergoing any diagnostic tests (including blood or urine tests), inform your doctor that you are taking this medicine, as it may alter test results.

Use of Febrirol with other medicines

Inform your doctor or pharmacist if you are currently using, have recently used, or might need to use any other medicines.

Febrirol may interact with or be affected by other medicines. For example:

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

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

If your doctor has prescribed an antiplatelet medicine (to prevent blood clots) containing acetylsalicylic acid, and you are also taking Febrirol, you must separate the administration of both medicines (see section Special caution with Febrirol).

Other medicines may also interact with or be affected by Febrirol treatment. Therefore, always consult your doctor or pharmacist before using Febrirol with other medicines.

Taking Febrirol with food, drinks, and alcohol:

Febrirol You may take it alone or with food. It is generally recommended to take it during meals or with milk to reduce the possibility of stomach discomfort.

Do not take ibuprofen with alcohol, to avoid stomach damage.

The use of ibuprofen in patients who regularly consume alcohol (three or more alcoholic drinks—beer, wine, spirits—per day) may cause stomach bleeding.

Pregnancy, breastfeeding, and fertility:

Consult your doctor or pharmacist before using any medicine.

Do not take ibuprofen during the last three months of pregnancy, as it may harm the fetus or cause delivery complications. It may cause kidney and heart problems in your unborn baby. It may affect your and your baby's tendency to bleed and may delay or prolong labour. Do not take ibuprofen during the first six months of pregnancy unless clearly necessary and as directed by your doctor. If treatment is needed during this period or while trying to become pregnant, take the lowest possible 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, leading to low levels of amniotic fluid surrounding the baby (oligohydramnios) or narrowing of a blood vessel (ductus arteriosus) in the baby's heart. If treatment is needed for longer than a few days, your doctor may recommend additional monitoring.

Breastfeeding women should consult their doctor or pharmacist before taking this medicine. Although only small amounts of the medicine pass into breast milk, prolonged use of ibuprofen during breastfeeding is not recommended.

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

IMPORTANT FOR WOMEN:

If you are pregnant or think you might be pregnant, consult your doctor before taking this medicine. Taking medicines during pregnancy may be harmful to the embryo or fetus and should be monitored by your doctor.

FebrirolFebrirol

Driving and use of machines:

Although such effects are not expected, if you experience dizziness, vertigo, visual disturbances, or other symptoms while taking this medicine, you should not drive or operate dangerous machinery. If you take only a single dose of Febrirol or use it for a short period, no special precautions are necessary.

Febrirol contains aspartame, sucrose, and sodium

This medicine contains less than 23 mg of sodium (1 mmol) per sachet, i.e., essentially "sodium-free".

This medicine contains 10 mg of aspartame per sachet. Aspartame is a source of phenylalanine, which may be harmful in individuals with phenylketonuria (PKU), a rare genetic disorder in which phenylalanine accumulates because the body cannot properly eliminate it.

3. How to take Febrirol

Follow exactly the instructions for using this medicine unless your doctor has given you different advice. Consult your doctor or pharmacist if you have any doubts.

The lowest effective dose should be used for the shortest duration 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 of age: 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 may be used (in adolescents with body weight above 40 kg).

Do not exceed 1200 mg in 24 hours.

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

Always use the lowest dose that is effective.

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 of age without consulting a doctor.

Use in patients over 65 years of age

• Patients over 65 years: the dose should be determined by the doctor, as a reduction of the usual dose may be necessary.

Elderly patients are more likely to experience adverse effects, so the dose may sometimes need to be reduced. Consult your doctor.

Method of administration:

This medicine is taken orally.

Take the medicine with food or milk, especially if gastrointestinal discomfort is experienced.

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

Administration of this preparation should only occur when pain or fever are present. As these symptoms subside, treatment should be discontinued.

If symptoms worsen, if fever persists for more than 3 days, or if pain persists for more than 5 days, consult your 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 medicine and the amount ingested. It is recommended to bring the medicine packaging and leaflet to the healthcare professional.

If you have taken more Poindol than you should, or if a child has accidentally ingested the medicine, consult a doctor immediately or go to the nearest hospital to assess the risk and obtain advice on the measures to be taken.

Symptoms of overdose may include nausea, stomach pain, vomiting (which may contain blood-stained sputum), headache, tinnitus, confusion, and involuntary eye movements. At high doses, symptoms such as drowsiness, chest pain, palpitations, loss of consciousness, seizures (mainly in children), weakness, dizziness, blood in the urine, low blood potassium levels, chills, and breathing difficulties have been reported.

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

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

If you forget to take Febrirol

Do not take a double dose to make up for a missed dose.

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

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

4. Possible adverse effects

Like all medicines, Febrirol may have adverse effects, although not everyone experiences them.

Adverse effects of medicines such as Febrirol are more common in people over 65 years of age.

The incidence of adverse effects is lower with short-term treatment and when 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 may be a sign of a potentially serious allergic reaction called Kounis syndrome.
• Flat, red, target-shaped or circular spots on the trunk, often with blisters in the center, skin peeling, and ulcers in the mouth, throat, nose, genitals, and eyes. These severe skin rashes may 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).
• Generalized, red, scaly rash with bumps under the skin and blisters, accompanied by fever. Symptoms usually appear at the beginning of treatment (acute generalized exanthematous pustulosis).

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

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 auditory disturbances.

Rare (may affect up to 1 in 1,000 patients): edema (swelling due to fluid retention), blood disorders (leukopenia), stomach and intestinal perforation, liver disorders (including jaundice), kidney disorders such as acute interstitial nephritis with hematuria (blood in urine), proteinuria (excretion of protein in urine), and occasionally nephrotic syndrome; depression; vision disorders (blurred vision); neck stiffness; bronchospasm (sudden sensation of suffocation), dyspnea (difficulty breathing), and angioedema (swelling of the deeper layers of the skin, causing swelling of the face, lips, tongue, or throat, possibly leading to difficulty swallowing or breathing).

Very rare (reported in up to 1 in 10,000 patients): 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 (cutaneous erythema), and eye and mucous membrane disorders such as Stevens-Johnson syndrome (severe erythema multiforme), toxic epidermal necrolysis (skin and mucous membrane lesions causing skin detachment), and erythema multiforme.

Frequency not known: a severe skin reaction known as DRESS syndrome may occur. Symptoms of DRESS syndrome include rash, swollen lymph nodes, 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 beginning of treatment (acute generalized exanthematous pustulosis). Stop taking Febrirol if you experience these symptoms and seek immediate medical attention. See also section 2.

Skin becomes sensitive to light.

Reporting of adverse effects

If you experience any adverse effects, talk to your doctor, pharmacist, or nurse, even if they are possible adverse effects not listed in this leaflet. You can 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 Febrirol

No special storage conditions are required.

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

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to properly dispose of medicines and their containers that you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Febrirol

• The active substance 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, mint flavour composed of flavouring components (natural flavouring preparations, natural flavouring substances and nature-identical flavouring substances), non-flavouring components (containing modified corn starch (E-1450), maltodextrin, triacetin (E-1518)), active substances (pulegone), and purified water.

Presentation of the product and contents of the pack

Sachets containing granules for oral solution. It is presented as white granules with a characteristic mint odour, packed in paper/aluminium/polyethylene sachets.

Packaged in containers of 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 most recent revision of this leaflet: November 2024

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/.