Prospect: Information for the User

Ibudol Pediatric 20 mg/ml Oral Suspension

Ibuprofen

Read this entire prospect carefully before starting to take this medicine, as it contains important information for you.

Follow exactly the administration instructions for the medicine contained in this prospect or those indicated by your doctor or pharmacist.

• Keep this prospect, as you may need to read it again.
• If you need advice or more information, consult your pharmacist.
• If you experience adverse effects, consult your doctor or pharmacist, even if they do not appear in this prospect. See section 4.
• You should consult a doctor if your condition worsens or does not improve after 24 hours in infants aged 3 to 5 months or after 3 days in children over 6 months of age.

1. What is Ibudol Pediatric and for what it is used

2. What you need to know before starting to take Ibudol Pediatric

3. How to take Ibudol Pediatric

4. Possible adverse effects

5. Storage of Ibudol Pediatric

6. Contents of the package and additional information

Ibudol pediátrico contains ibuprofen and belongs to a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs).

This medicine is used for the symptomatic treatment of fever and occasional mild to moderate pain in children from 3 months up to 12 years.

Do not takeIbudol Pediátrico:

• If you are allergic (hypersensitive) to ibuprofen or any of the other components of this medication (listed in section 6) or to other nonsteroidal anti-inflammatory drugs (NSAIDs) or to aspirin. 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 (medications used to "thin" the blood). If you need to take anticoagulants, your doctor will perform blood clotting tests.
• If you have severe dehydration (caused by vomiting, diarrhea, or inadequate fluid intake).
• If you have severe heart failure.
• If you are in the third trimester of pregnancy.

Warnings and precautions

Signs of allergic reaction to this medication, such as respiratory problems, facial and neck swelling (angioedema), and chest pain, have been reported with ibuprofen. Stop using Ibudol Pediátrico immediately and contact your doctor or emergency medical services if you observe any of these signs.

Consult your doctor or pharmacist before starting 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.
• If you are receiving treatment with this medication, 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 have had or develop a stomach or duodenal ulcer, bleeding, or perforation, which may manifest as intense or persistent abdominal pain and/or black stools, or even without previous warning symptoms.

This risk is higher when using high doses and prolonged treatments, 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 you are taking anticoagulants, antiplatelet agents of the type of acetylsalicylic acid, or 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 condition in which the immune system attacks the intestine, causing inflammation that produces, usually, bloody diarrhea) or ulcerative colitis, as ibuprofen-containing medications may worsen these conditions.
• If you are receiving diuretics (medications to urinate), as your doctor must monitor your kidney function.
• If you have systemic lupus erythematosus (a chronic condition 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 disorder that affects your blood and can cause symptoms such as urine discoloration, blood in urine, or liver disease), so your doctor can assess the advisability of ibuprofen treatment.
• 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 stringent check if you receive ibuprofen after undergoing major surgery.
• It is recommended not to take this medication if you have chickenpox.

- If you have an infection: see the "Infections" section later.

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.

Skin reactions

Be especially careful with Ibudol Pediátrico:

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 exanthema (PEGA), have been reported in association with ibuprofen treatment. Discontinue Ibudol Pediátrico treatment and seek medical attention immediately if you notice any of the symptoms related to these severe skin reactions described in section 4.

CARDIOVASCULAR PRECAUTIONS

Nonsteroidal anti-inflammatory drugs (NSAIDs) like ibuprofen may be associated with a small increase in the risk of heart attack or stroke, especially when used in high doses. Do not exceed the recommended dose or treatment duration.

Inform your doctor or pharmacist before taking ibuprofen if:

• You have heart problems, including heart failure, angina (chest pain), or have had a heart attack, coronary artery bypass surgery, peripheral artery disease, 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 medications may also cause fluid retention, especially in patients with heart failure and/or high blood pressure.

Children and adolescents

There is a risk of kidney damage in dehydrated children and adolescents.

Pregnancy, lactation, and fertility

Due to the association of ibuprofen medication administration with an increased risk of congenital anomalies/abortions, it is not recommended to administer it during the first and second trimesters of pregnancy, except in strictly necessary cases. In these cases, the dose and duration will be limited to the minimum possible.

In the third trimester, administration of this medication is contraindicated.

For women of childbearing age, it should be noted that ibuprofen-containing medications have been associated with a decrease in the ability to conceive.

Infections

Ibudol Pediátrico may mask the signs of an infection, such as fever and pain. Consequently, it is possible that this medication may delay the appropriate treatment of the infection, increasing the risk of complications. This has been observed in pneumonia caused by bacteria and in bacterial skin infections related to chickenpox. If you take this medication while having an infection and the infection symptoms persist or worsen, consult your doctor without delay.

Other medications and Ibudol Pediátrico

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

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

• Other nonsteroidal anti-inflammatory drugs (NSAIDs) such as aspirin, as it may increase the risk of stomach ulcers and bleeding.
• Antiplatelet agents (prevent blood clots) such as ticlopidine.
• Anticoagulants, e.g., for treating blood clotting problems (e.g., acetylsalicylic acid, warfarin, ticlopidine).
• Colestiramine (used to treat high cholesterol).
• Selective serotonin reuptake inhibitors (SSRIs) used in depression.
• Lithium (used to treat depression). Your doctor may adjust the dose of this medication.
• Methotrexate (used to treat cancer and inflammatory diseases). Your doctor may adjust the dose of this medication.
• Mifepristone (induces abortion).
• Digoxin and cardiac glycosides (used to treat heart problems).
• Hydantoins such as phenytoin (used to treat epilepsy).
• Sulfonamides such as sulfamethoxazole and cotrimoxazole (used to treat some bacterial infections).
• Corticosteroids such as cortisone and prednisolone.
• Diuretics (used to increase urine production), as it may increase the risk of kidney toxicity.
• Pentoxifylline (used to treat intermittent claudication).
• Probenecid (used in patients with gout or with penicillin in infections).
• Quinolone antibiotics such as norfloxacin.
• Sulfinpyrazone (used for gout).
• Sulfonylureas such as tolbutamide (used for diabetes), as it may cause hypoglycemia.
• Tacrolimus or cyclosporine (used in organ transplants to prevent rejection).
• Zidovudine (used to treat HIV/AIDS).
• Medications that lower high blood pressure (ACE inhibitors such as captopril, beta-blockers such as atenolol, and angiotensin II receptor antagonists such as losartan).
• Fibrinolytics (medications that dissolve blood clots).
• Aminoglycoside antibiotics such as neomycin.
• Herbal extracts: Ginkgo biloba.
• CYP2C9 inhibitors (responsible for metabolizing many medications in the liver), such as voriconazole and fluconazole (used to treat fungal infections).

Other medications may also affect or be affected by ibuprofen treatment. Therefore, always consult your doctor or pharmacist before using this medication with other medications.

This medication may alter the following laboratory tests:

• Bleeding time (may be prolonged for 1 day after stopping treatment).
• Blood glucose concentration (may decrease).
• Creatinine clearance (may decrease)
• Hematocrit or hemoglobin (may decrease)
• Urea nitrogen concentrations and serum creatinine and potassium concentrations (may increase).
• With liver function tests: increased values of transaminases.

Inform your doctor if you are to undergo a clinical analysis and are taking or have taken ibuprofen recently.

Taking Ibudol Pediátrico with food, drinks, and alcohol

It is recommended to take this medication with milk or with food, or immediately after eating, to reduce the possibility of stomach discomfort. Do not take alcohol, as it may increase gastrointestinal adverse reactions.

Pregnancy, lactation, and fertility

The use of this medication is not recommended in women trying to conceive.

If you are pregnant or breastfeeding, believe you may be pregnant, or intend to become pregnant, consult your doctor or pharmacist before using this medication. Do not take this medication during pregnancy, especially during the third trimester (see section on precautions during pregnancy and in women of childbearing age).This medication 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 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 conceive, 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.

Although only small amounts of the medication pass into breast milk, it is recommended not to take ibuprofen for prolonged periods during lactation.

Driving and operating machinery

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 single dose of ibuprofen or for a short period, no special precautions are necessary.

Ibuprofen may delay your reaction time, which should be taken into account before performing activities that require greater vigilance, such as driving and operating machinery.

This applies to a greater extent when combined with alcohol.

Ibudol Pediátrico contains maltitol liquid (E-965), propylene glycol (E-1520), sodium benzoate (E-211), ethanol, and sodium

This medication contains maltitol liquid. If your doctor has indicated that you have an intolerance to certain sugars, consult with them before taking this medication.This medication may produce a mild laxative effect because it contains 250 mg of maltitol liquid per ml of oral suspension.Caloric value: 2.3 kcal/g of maltitol/isomalt.

This medication contains 4.77 mg of propylene glycol (E-1520) in each ml of oral suspension.

This medication contains 2 mg of sodium benzoate in each ml of oral suspension. Sodium benzoate may increase the risk of jaundice (yellow discoloration of the skin and eyes) in newborns (up to 4 weeks old).

This medication contains 0.18% ethanol (alcohol), which corresponds to 1.43 mg per ml of oral suspension.

This medication contains sodium:

Up to 13 ml per individual dose (included): This medication contains less than 23 mg of sodium (1 mmol) per ml of oral suspension; it is essentially "sodium-free"

From 13 ml per individual dose: This medication contains 1.71 mg of sodium (main component of table salt/for cooking) in each ml of oral suspension. This corresponds to 0.1% of the recommended daily maximum sodium intake for an adult.

Follow exactly the administration instructions of this medication indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

Only for occasional use and for limited periods.

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

Children 3 months to 12 years:

The recommended dose of ibuprofen depends on the age and weight of the child.

Generally, for children 3 months to 12 years, the recommended daily dose is 20 to 30 mg per kg of body weight depending on the intensity of symptoms and is divided into three doses.

The use of this medication in children under 2 years will always be by medical prescription.

As a guide, the following doses can be followed:

The suspension can also be dosed following a 4-dose daily regimen. In this case, the maximum daily doses (see the last column of the previous table) should not be exceeded. The dose to be administered in each dose, every 6 hours, will be recalculated/reduced proportionally.

This medication should not be used in children under 3 months or with a weight less than 5 kg.

Patients with kidney, liver, or heart diseases:should reduce the dose and consult a doctor. Ibuprofen should not be used in patients with severe cardiac, renal, or hepatic insufficiency.

If this medication needs to be used for more than 3 days or if symptoms worsen in children from 6 months to 12 years, consult a doctor.

Consult a doctor in children aged 3 to 5 months if symptoms worsen or persist after 24 hours.

Administration Form

Ibudol Pediátrico is an oral suspension for administration. It can be administered directly or diluted in water.

1. Shake the container before use.
2. Insert the syringe into the perforated cap.
3. Invert the bottle and withdraw the required dose.
4. Administer the syringe contents directly into the mouth or on a spoon.
5. The syringe should be washed after each dose and can be sterilized by boiling or soaking in a sterilizing solution used for bottles.

A burning sensation in the mouth or throat may occur when taking the oral suspension of ibuprofen; ensure that the bottle has been shaken well before administering the medication.

Patients with stomach discomfort should take the medication with milk and/or during meals.

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

If you take more Ibudol Pediátrico than you should

If you have taken more Ibudol Pediátrico than you should, or if a child has accidentally ingested the medication, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone: 91 562 04 20 indicating the medication and the amount ingested, and go to the nearest hospital to inform yourself about the risk and ask for advice on the measures to be taken.

Normally, symptoms of overdose occur 4 to 6 hours after taking ibuprofen.

Symptoms of an overdose may include nausea, stomach pain, vomiting (which may contain blood), headache, ringing in the ears, confusion, involuntary eye movement, and muscle coordination loss. At high doses, symptoms of drowsiness, chest pain, palpitations, loss of consciousness, seizures (mainly in children), weakness, and dizziness have been reported. Cases of elevated plasma acidity (metabolic acidosis), decreased body temperature, kidney function impairment, stomach and intestinal bleeding, coma, transient loss of breathing (apnea), depression of the central nervous system and respiratory system have also been reported. Cases of cardiovascular toxicity (low blood pressure, decreased heart rate, and increased heart rate) have also been reported.

If a severe intoxication has occurred, renal insufficiency and liver damage may occur. In these cases, the doctor will take the necessary measures.

If you forget to take Ibudol Pediátrico

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

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 use of this medication, ask your doctor or pharmacist.

Like all medications, Ibudol Pediatric may cause side effects, although not everyone will experience them. The incidence of side effects is lower in short-term treatments and when the daily dose is below the maximum recommended dose.

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

Stop treatment with Ibudol Pediatric and seek medical attention immediately if you notice any of the following symptoms:

• Flat, red spots, often with blisters in the center, skin peeling, mouth ulcers, throat ulcers, nasal ulcers, genital ulcers, 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 rash, elevated 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 pustular psoriasis).

The frequencies shown below refer to the use of short-term maximum daily doses of up to 1,200 mg of oral ibuprofen:

Common side effects:(may affect up to 1 in 10 people): Gastrointestinal bleeding, especially in older patients. Nausea, vomiting, diarrhea, flatulence, dyspepsia (gastrointestinal secretion or motility disorder), constipation, stomach pain, abdominal pain, bloody stools, vomiting blood, headache, dizziness, or feeling unsteady, fatigue.

Rare side effects::(may affect up to 1 in 100 people): Gastritis, duodenal ulcers, gastric ulcers, skin redness, itching, urticaria, purpura (purple spots on the skin), hypersensitivity, paresthesia (numbness, tingling, or prickling sensations, often in the hands, feet, arms, or legs), drowsiness, insomnia, anxiety, auditory disturbances, visual disturbances, rhinitis (inflammation of the nasal mucosa), oral mucosa inflammation with ulcer formation (oral aphthae), gastrointestinal perforations, hepatitis (liver inflammation), liver function abnormalities, jaundice (yellowing of the skin and eyes), asthma, bronchospasm, dyspnea (difficulty breathing). Tubulointerstitial nephritis (kidney disorder), nephrotic syndrome (kidney disorder characterized by proteinuria and edema), acute renal failure, and papillary necrosis (especially with prolonged use) associated with increased urea.

Very rare side effects:(may affect up to 1 in 1,000 people): Disorientation or confusion, depression, vertigo, tinnitus (ringing or buzzing in the ears), hearing loss, reversible toxic amblyopia, liver damage, edema (swelling caused by fluid accumulation in tissues), optic neuritis, anaphylactic reaction (in case of severe generalized hypersensitivity reaction, symptoms may include facial swelling, tongue swelling, laryngeal edema, dyspnea, tachycardia, hypotension, anaphylaxis, angioedema, or severe shock). Asymptomatic meningitis (inflammation of the meninges, which are the membranes that protect the brain and spinal cord, not caused by bacteria). In most cases where meningitis aséptica has been reported with ibuprofen, the patient had some form of autoimmune disease (such as systemic lupus erythematosus and other collagen diseases), which was a risk factor. Symptoms of meningitis aséptica observed were neck stiffness, headache, nausea, vomiting, fever, or disorientation. Other side effects include thrombocytopenia, leukopenia (decreased white blood cells, which may manifest as frequent infections with fever, chills, or sore throat), anemia (decreased red blood cells, which may manifest as difficulty breathing and pale skin), neutropenia (decreased neutrophils), agranulocytosis (severe decrease in neutrophils), aplastic anemia (bone marrow insufficiency to produce different types of cells), and hemolytic anemia (premature destruction of red blood cells). The first symptoms are fever, sore throat, superficial ulcers in the mouth, flu-like symptoms, extreme fatigue, unexplained bleeding, and hematomas.

Effects very rare:(may affect up to 1 in 10,000 people):Pancreatitis, severe blistering reactions, including Stevens-Johnson syndrome (widespread skin and mucous membrane erosions and purple lesions, preferably on the trunk) and toxic epidermal necrolysis (mucous membrane and painful skin lesions with necrosis and epidermal detachment), erythema multiforme (skin lesions). Exceptionally, severe skin infections and soft tissue complications may occur during varicella. Liver failure, heart failure, myocardial infarction, hypertension.

Exacerbation of inflammatory reactions related to infections coinciding with the use of NSAIDs has been observed. If signs of infection or worsening of these symptoms occur during ibuprofen use, it is recommended to consult a doctor as soon as possible.

Unknown frequency:(cannot be estimated from available data):

The skin becomes sensitive to light, exacerbation of colitis and Crohn's disease (chronic disease in which the immune system attacks the intestine, causing inflammation that usually results in bloody diarrhea).

A severe skin reaction known as DRESS syndrome (Drug Reaction with Eosinophilia and Systemic Symptoms) may occur. 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, located mainly in skin folds, trunk, and upper limbs, accompanied by fever at the beginning of treatment (acute generalized pustular psoriasis). Stop taking this medication if you experience these symptoms and seek medical attention immediately. See section 2.

If any of the following side effects appear, stop treatment and seek medical attention immediately:

• Allergic reactions such as skin eruptions, facial swelling, chest tightness, or difficulty breathing.
• Vomiting blood or coffee ground-like vomit.
• Bloody stools or diarrhea with blood.
• Severe stomach pain.
• Significant blisters or skin peeling.
• Severe headache or persistent headache.
• Yellowing of the skin (jaundice).
• Signs of severe hypersensitivity (see above in this section).
• Swelling of the limbs or fluid accumulation in the arms or legs.

Reporting of side effects

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

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

No special storage conditions are required.

Expiration period after opening: 6 months.

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.

Do not dispose of medications through drains or in the trash. Dispose of packaging and unused medications at the SIGRE collection pointat the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and unused medications. This will help protect the environment.

Composition of Ibudol Pediatric

• The active ingredient is ibuprofen. Each ml of oral suspension contains 20 mg of ibuprofen.
• The other components (excipients) are: liquid maltitol (E-965), glycerol (E-422), microcrystalline cellulose, sodium citrate (E-331), xanthan gum, anhydrous citric acid, sodium benzoate (E-211), sodium saccharin (E-954), polysorbate 80, orange essence (contains ethanol and propylene glycol (E-1520)), and purified water.

Appearance of Ibudol Pediatric and content of the container

White or almost white suspension with orange odor and taste.

It is presented in an amber plastic bottle with a child-resistant safety cap that contains 200 ml of oral suspension. It includes a 5 ml graduated dosing syringe.

Marketing Authorization Holder

Kern Pharma, S.L.

Venus, 72 - Pol. Ind.Colón II

08228 Terrassa - Barcelona

Spain

Responsible for Manufacturing

Kern Pharma, S.L.

Venus, 72 - Pol. Ind.Colón II

08228 Terrassa - Barcelona

Spain

or

SAG MANUFACTURING, S.L.U

Crta.N-I, Km 36, San Agustín de Guadalix

28750 Madrid

Spain

Last review date of this leaflet: July 2024

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