IBUPROFENO BENEL 20 mg/ml ORAL SUSPENSION

Introduction

Package Leaflet: Information for the User

Ibuprofen Benel 20 mg/ml Oral Suspension

Ibuprofen

Read the package leaflet carefully before starting to take 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 symptoms worsen or if fever persists for more than 3 days or pain for more than 5 days in children or 10 days in adults, consult your doctor.
• If you experience side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. See section 4.

Contents of the Package Leaflet

1. What is Ibuprofen Benel 20 mg/ml Oral Suspension and what is it used for
2. What you need to know before taking Ibuprofen Benel 20 mg/ml Oral Suspension
3. How to take Ibuprofen Benel 20 mg/ml Oral Suspension
4. Possible side effects
5. Storage of Ibuprofen Benel 20 mg/ml Oral Suspension
6. Package contents and additional information

1. What is Ibuprofen Benel 20 mg/ml Oral Suspension and what is it used for

It is an oral suspension. It comes in 100, 150, and 200 ml packages, including a 5 ml oral syringe with a 0.5 ml graduated scale.

Ibuprofen is effective in reducing pain and fever.

Ibuprofen Benel is indicated 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. Before taking Ibuprofen Benel 20 mg/ml Oral Suspension

Do not takeIbuprofen Benel 20 mg/mlOral Suspension if:

• you are allergic to ibuprofen or any of the components of the medicine
• you have a stomach or duodenal ulcer
• you have had allergic reactions of an asthmatic type when taking anti-inflammatory drugs, acetylsalicylic acid, or other analgesics
• you have asthma, rhinitis, or urticaria
• you have a severe liver, kidney, or heart disease
• you have bleeding or blood coagulation disorders
• you vomit blood, have black stools, or bloody diarrhea
• you are in the last trimester of pregnancy.

Warnings and precautions:

• ibuprofen belongs to a group of medicines that can decrease female fertility. This effect is reversible when the medicine is stopped
• do not exceed the recommended dose in section 3 (How to take Ibuprofen Benel 20 mg/ml Oral Suspension)

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.

You should discuss your treatment with your doctor or pharmacist before taking Ibuprofen Benel 20 mg/ml 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.
• you have an infection; see the "Infections" section below.

Ibuprofen Benel 20 mg/ml may mask the signs of an infection, such as fever and pain. Consequently, Ibuprofen Benel 20 mg/ml 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 medicine while having an infection and the symptoms of the infection persist or worsen, consult a doctor without delay.

Skin reactions:

Severe skin reactions have been reported with Ibuprofen Benel 20 mg/ml treatment. Stop taking Ibuprofen Benel 20 mg/ml and consult a doctor immediately if you experience any skin rash, mucous membrane lesions, blisters, or other signs of allergy, as these may be the first signs of a severe skin reaction. See section 4.

Taking Ibuprofen Benel 20 mg/ml Oral Suspension with food and drinks:

Take this medicine with meals or with milk.

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

Pregnancy:

Ibuprofen use should be avoided during the first and second trimester of pregnancy and as indicated by your doctor. If considered essential, the doctor will prescribe the lowest effective dose and for the shortest possible time.

It should not be used in the last trimester of pregnancy. It may cause kidney and heart problems in the fetus. It may affect your and your baby's tendency to bleed and delay or prolong labor more than expected. From the 20th week of pregnancy, ibuprofen benel may cause kidney problems in the fetus if taken for more than a few days, which can cause low levels of amniotic fluid surrounding the baby (oligohydramnios). If you need treatment for more than a few days, your doctor may recommend additional checks.

Consult your doctor or pharmacist before using a medicine

Important for women:

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

Breastfeeding:

Consult your doctor or pharmacist before using a medicine

Women who are breastfeeding should consult their doctor or pharmacist before taking this medicine.

Use in children:

• Do not administer to children under 2 years without consulting a doctor.

Use in adults over 65 years:

Elderly people are more likely to experience side effects, so the dose may need to be reduced. Consult your doctor.

Driving and using machines:

Although no effects are expected, use with caution if you experience drowsiness or dizziness.

Important information about some of the components of Ibuprofen Benel 20 mg/ml Oral Suspension:

As it contains azorubine, it may cause allergic reactions. It may cause asthma, especially in patients allergic to acetylsalicylic acid.

This medicine contains 57.5 mg of sodium per 5 ml, which should be taken into account in patients with low-sodium diets.

This medicine contains liquid maltitol. If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medicine.

Using Ibuprofen Benel 20 mg/ml with other medicines:

Tell your doctor or pharmacist if you are using or have recently used any other medicine, including those obtained without a prescription.

Ibuprofen Benel 20 mg/ml may affect or be affected by other medicines. For example:

• Anticoagulant medicines (e.g., to treat coagulation problems/prevent coagulation, e.g., acetylsalicylic acid, warfarin, ticlopidine)
• Medicines that lower high blood pressure (ACE inhibitors such as captopril, beta-blockers such as atenolol, and angiotensin-II receptor antagonists such as losartan)
• Baclofen (used to treat involuntary and persistent muscle contractions)
• Cyclosporine and tacrolimus (used to prevent organ transplant rejection)
• Digoxin (used for the heart)
• Phenytoin (in the treatment of epilepsy)
• Furosemide and other thiazide diuretics (used for urine elimination)
• Lithium (used to treat depression)
• Methotrexate (used in cancer and rheumatoid arthritis treatment)
• Medicines used to decrease blood sugar levels, such as oral hypoglycemics or insulin
• Mifepristone (abortion inducer)
• Pentoxifylline (used in circulatory disorders)
• Probenecid (used in patients with gout or with penicillin in infections)
• Quinolones (used in infections)
• Ion exchange resins such as cholestyramine (used to decrease blood cholesterol levels)

• Sulfonamides (used in infections)
• Sulfinpyrazone (for gout)
• Tacrine (used in the treatment of Alzheimer's disease)
• Thrombolytics (medicines that dissolve or break down blood clots)
• Zidovudine (used in the treatment of patients infected with the human immunodeficiency virus, the cause of AIDS)
• Do not use with other analgesic and anti-inflammatory medicines (non-steroidal anti-inflammatory drugs and corticosteroids) that decrease pain and inflammation without consulting your doctor.
• Do not administer ibuprofen with alcohol to avoid damaging the stomach
• Taking ibuprofen with food delays its absorption.

Other medicines may also affect or be affected by treatment with Ibuprofen Benel 20 mg/ml. Therefore, you should always consult your doctor or pharmacist before using Ibuprofen Benel 20 mg/ml with other medicines.

Interference with diagnostic tests:

If you are going to have any diagnostic tests (including blood tests, urine tests, etc.), inform your doctor that you are taking this medicine.

3. How to take Ibuprofen Benel 20 mg/ml Oral Suspension

Follow these instructions unless your doctor has given you different instructions.

This medicine is administered orally.

Use the lowest effective dose for the shortest necessary time 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).

• Children from 1 to 12 years:

The doses for children under 2 years will always be established under medical criteria.

The doses in the following table can be repeated every 6-8 hours, without exceeding the daily amount shown in the third column

A dosing regimen of 5 to 10 mg/kg of body weight and per dose, every 6-8 hours, can also be established; maximum 20 mg/kg of body weight and per day.

• Young people from 12 to 18 years: take a dose of 10 ml (200 mg of ibuprofen) every 4-6 hours, if necessary. Do not take more than 6 doses of 10 ml (1200 mg of ibuprofen) in 24 hours.
• Adults: take a dose of 10 ml (200 mg of ibuprofen) every 4-6 hours, if necessary.

If pain or fever does not respond to the dose of 10 ml (200 mg of ibuprofen), doses of 20 ml (400 mg of ibuprofen) can be used every 6-8 hours.

Do not take more than 1200 mg in 24 hours.

• Adults over 65 years: the dosage should be established by the doctor, as it may be necessary to reduce the usual dose.
• Patient with kidney, liver, or heart disease: reduce the dose and consult your doctor.

Always use the lowest effective dose.

Take the medicine with meals or with milk, especially if you experience digestive discomfort.

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

If the pain persists for more than 10 days (5 days for children) or the fever for more than 3 days, consult your doctor.

If the pain or fever worsens or if they or other symptoms appear, interrupt treatment and consult your doctor.

If you think the effect of this medicine is too strong or too weak, tell your doctor or pharmacist.

If you take more Ibuprofen Benel than you should:

If you have taken more medicine than you should, or if a child has accidentally ingested the medicine, 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 or call the Toxicology Information Service. Phone: 91 562 04 20, indicating the medicine and the amount ingested.

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

If you forget to take Ibuprofen Benel:

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

4. Possible side effects

Like all medicines, Ibuprofen Benel 20 mg/ml Oral Suspension can have side effects.

Frequent (in more than 1 in 100 patients, but in less than 1 in 10 patients): fatigue, headache, stomach and intestine disorders (heartburn, diarrhea, nausea, vomiting), skin disorders (rash, itching), and ringing in the ears.

Uncommon (in more than 1 in 1,000 patients, but in less than 1 in 100 patients): allergic reactions, asthma, rhinitis, and urticaria, gastrointestinal bleeding and ulcers, sleep disorders and mild restlessness, blurred vision, decreased visual acuity, or changes in color perception, and hearing disorders.

Rare (in more than 1 in 10,000 patients, but in less than 1 in 1,000 patients), the following can occur: edema (swelling due to fluid retention), blood disorders (leukopenia), stomach and intestine perforation, liver disorders (including jaundice), depression, kidney disorders [including acute interstitial nephritis with hematuria (blood in urine), proteinuria (protein elimination in urine), and occasionally nephrotic syndrome], vision disorders (vision loss), neck stiffness, and bronchospasm (sudden feeling of suffocation), dyspnea (difficulty breathing), and angioedema (circulatory reaction that affects the deep layers of the skin with inflammation and swelling).

Very rare (in less than 1 in 10,000 patients), the following can occur: aseptic meningitis (inflammation of the meninges not caused by bacteria), blood and coagulation disorders, severe skin, eye, and mucous membrane disorders, such as Stevens-Johnson syndrome (severe multiform erythema) and toxic epidermal necrolysis (skin and mucous membrane lesions that cause skin shedding) and multiform erythema.

Frequency "not known": generalized red scaly rash, with bumps under the skin and blisters located mainly in skin folds, trunk, and upper limbs, accompanied by fever at the start of treatment (acute generalized exanthematous pustulosis). Stop taking Ibuprofen Benel 20 mg/ml if you experience these symptoms and seek medical attention immediately. See also section 2.

Frequency not known: the skin becomes sensitive to light

Drug reaction with eosinophilia and systemic symptoms:

A severe skin reaction known as DRESS syndrome can occur. The symptoms of DRESS syndrome include: skin rash, lymph node inflammation, and elevated eosinophils (a type of white blood cell).

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 Monitoring System: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of Ibuprofen Benel 20 mg/ml Oral Suspension

Keep Ibuprofen Benel 20 mg/ml Oral Suspension out of the reach and sight of children. No special storage conditions are required.

Expiration date

Do not use Ibuprofen Benel 20 mg/ml Oral Suspension after the expiration date indicated on the package.

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. Container Content and Additional Information

Each 5 ml of oral suspension contains 100 mg of Ibuprofen as the active ingredient.

The other components (excipients) are: Sodium benzoate (E-211), anhydrous citric acid, sodium citrate, sodium saccharin (E-954), sodium chloride, hypromellose, xanthan gum, liquid maltitol (E-965), strawberry flavor, glycerol (E-422), and purified water.

Marketing Authorization Holder:

NUTRA ESSENTIAL OTC, S.L.

C/ La Granja, nº1

28108, Alcobendas (Madrid)

Spain

Manufacturer:

Laboratorios Farmalider, S.A.,

C/Aragoneses, nº 2

28108 Alcobendas (Madrid)

Spain

or

Laboratorios Farmasierra Manufacturing, S.L.

Ctra. Irún, Km 26,200

28700 San Sebastián de los Reyes (Madrid) Spain

or

Edefarm S.L.

Polígono Industrial Enchilagar del Rullo, 117

Villamarchante, 46191, Valencia

Spain

Date of the last revision of this leaflet: July2024

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/