Leaflet: information for the user

Ibudol Pediatric 200 mg oral suspension

Ibuprofen

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

Follow exactly the administration instructions for the medicine contained in this leaflet or those 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 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 symptoms worsen or do not improve after 3 days.

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

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

3. How to take Ibudol Pediatric

4. Possible side effects

5. Storage of Ibudol Pediatric

6. Contents of the pack and additional information

The active ingredient, ibuprofen, in this medication works by reducing pain and fever.

It is indicated for children aged 7 years and above for the symptomatic relief of occasional mild to moderate pain, as well as feverish states.

Do not take Ibudol Pediátrico:

• If you have a 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 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

Consult your doctor, pharmacist, or nurse before starting this medication.

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

Inform your doctor:

- 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 have an infection; see the "Infections" section below.

- If you have kidney or liver disease, are over 60 years old, or need to take the medication for an extended period (more than 1-2 weeks), your doctor may need to perform regular checks. Your doctor will indicate the frequency of these checks.

- If you experience dehydration symptoms, such as severe diarrhea or vomiting, drink plenty of fluids and immediately contact your doctor, as ibuprofen in this case may cause kidney failure as a consequence of dehydration.

- If you have had or develop a stomach or duodenal ulcer, bleeding, or perforation, which may manifest as severe abdominal 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 adding a stomach protector medication.

- If you take anticoagulant medications, such as oral anticoagulants, antiplatelet agents like aspirin, 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 intestines, causing inflammation that often results in bloody diarrhea) or ulcerative colitis, as these medications may worsen these conditions.

- If you are taking diuretics (medications to increase urine production), as your doctor will need to 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 meningitis.

- If you have porphyria (a metabolic disorder that affects your blood and can cause symptoms such as red urine, blood in urine, or liver disease), so your doctor can assess the need for 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 more frequent checks if you receive ibuprofen after major surgery.

- It is not recommended to take this medication if you have chickenpox.

Use the smallest dose necessary to alleviate or control pain and do not 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 psoriasis (GAP), have been reported in association with ibuprofen treatment. Discontinue Ibudol Pediátrico treatment and seek medical attention immediately if you notice any 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.

You should 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.

Additionally, this type of medication may cause fluid retention, especially in patients with heart failure and/or high blood pressure (hypertension).

Infections

Ibudol Pediátrico may mask the signs of an infection, such as fever and pain. Therefore, it may delay the appropriate treatment of the infection, increasing 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 infection symptoms persist or worsen, consult a doctor without delay.

Children and Adolescents

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

Use of Ibudol Pediátrico with Other Medications

Inform your doctor or pharmacist if you are using, or have recently used, any other medication, including those purchased without a prescription.

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

• Anticoagulant medications (e.g., for treating blood clotting problems or preventing clotting, such as aspirin, warfarin, ticlopidine).
• Medications that lower high blood pressure (ACE inhibitors like captopril, beta-blockers like atenolol, and angiotensin II receptor antagonists like losartan).
• Baclofen (used to treat involuntary muscle contractions).
• 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 (an abortion inducer).
• Digoxin and other cardiac glycosides (used to treat heart problems).
• Hydantoins like phenytoin (used to treat epilepsy).
• Sulfonamides like sulfamethoxazole and trimethoprim (used to treat certain bacterial infections).
• Corticosteroids like prednisone and prednisolone.
• Diuretics (medications to increase urine production).
• Pentoxifylline (used to treat intermittent claudication).
• Probenecid (used in patients with gout or with penicillin for infections).
• Quinolone antibiotics like norfloxacin.
• Ion exchange resins like cholestyramine (used to lower cholesterol levels in the blood).
• Sulfinpyrazone (used for gout).
• Sulfonylureas like tolbutamide (used for diabetes).
• Tacrine (used to treat Alzheimer's disease).
• Tacrolimus or cyclosporine (used in organ transplants to prevent rejection).
• Zidovudine (used to treat HIV/AIDS).
• Thrombolytics (medications that dissolve blood clots).
• Aminoglycoside antibiotics like neomycin.
• Voriconazole or fluconazole, used for fungal infections.
• Herbal extracts: from the Ginkgo biloba tree.

Other medications may also affect or be affected by Ibudol Pediátrico treatment. Always consult your doctor or pharmacist before using Ibudol Pediátrico with other medications.

Interference with Laboratory Tests

Ibuprofen 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)
• Serum concentrations of urea nitrogen, creatinine, and potassium (may increase)
• Liver function tests: increased values of transaminases

If you are to undergo any diagnostic tests (including blood, urine, skin tests using allergens, etc.), inform your doctor that you are taking this medication, as it may affect the test results.

Taking Ibudol Pediátrico with Food and Drinks

You can take Ibudol Pediátrico directly from the package or dissolved in water. You can take it with or without food. Generally, it is recommended to take it with meals to reduce the risk of stomach upset.

Pregnancy, Breastfeeding, and Fertility

If you are pregnant, breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medication.

Pregnancy:

Precautions during Pregnancy and in Women of Childbearing Age

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

In the third trimester, administration is contraindicated. 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 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 time possible. From week 20 of pregnancy, ibuprofen may cause kidney problems in your fetus if taken for more than a few days, which may result in low amniotic fluid levels (oligohydramnios) or narrowing of a blood vessel (ductus arteriosus) in your baby's heart. If you need treatment for a period longer than a few days, your doctor may recommend additional monitoring.

For women of childbearing age, it is essential to consider that medications like ibuprofen have been associated with a decrease in fertility.

Breastfeeding:

Although the levels of medication in breast milk are negligible, it is recommended to consult your doctor in cases of prolonged treatment or high doses during breastfeeding.

Driving and Operating Machines

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

Ibudol Pediátrico contains sodium and maltitol syrup

This medication contains maltitol syrup. If your doctor has indicated that you have an intolerance to certain sugars, consult with them before taking this medication.

Patients on low-sodium diets should note that this medication contains 17 mg of sodium per 200 mg sachet.

Follow exactly the medication administration instructions contained in this leaflet or those indicated by your doctor, pharmacist, or nurse. If in doubt, ask your doctor, pharmacist, or nurse.

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

The recommended dose is:

Children:The dose of ibuprofen to be administered depends on the child's age and weight. Generally, the recommended daily dose is 20 to 30 mg/kg of body weight, divided into three or four individual doses.

Approximately, the following dosage regimen is recommended:

-Children weighing 25 to 40 kg (approximately 7-12 years old): The recommended daily dose is 600 – 800 mg of ibuprofen divided into 3 or 4 doses (1 tablet 3 or 4 times a day), with a maximum daily dose of 800 mg.

-Children weighing more than 40 kg and adolescents (over 12 years old):The recommended daily dose is 800 – 1,200 mg of ibuprofen per day, divided into 3 or 4 doses (1-2 tablets 3 or 4 times a day), with a maximum daily dose of 1,200 mg.

Other presentations with more suitable doses for treatment in adolescents and adults are recommended.

The interval between doses will depend on the evolution of symptoms, but will never be less than 4 hours.

This medication is not recommended for use in children weighing less than 25 kg (approximately 7 years old) since the dose (200 mg of ibuprofen) does not adapt to the recommended dosage in these patients.

Patients with kidney, liver, or heart diseases:

In patients with mild or moderate disease, the initial dose should be reduced. Ibuprofen should not be used in patients with severe renal, hepatic, or cardiac insufficiency.

Administration form

This medication is administered orally.

Ibudol Pediátrico is a suspension. It should be homogenized before taking by pressing the top and bottom of the package several times with your fingers. It can be taken directly from the package or diluted in water. In case of gastrointestinal discomfort, it is recommended to take the medication with meals.

Always use the lowest effective dose. Medication administration is subject to the appearance of pain or fever. As these symptoms disappear, medication should be discontinued. If pain or fever worsen or other symptoms appear, interrupt treatment and consult a doctor.

If this medication needs to be used for more than 3 days in children and adolescents (from 7 years to less than 18 years), or if symptoms worsen, consult a doctor.

If you take more Ibudol Pediátrico than you should

If you have taken more medication than you should, or if a child has accidentally ingested the contents of the package, consult your doctor or pharmacist immediately, the Toxicological Information Service, phone: 91 562 04 20, or go to the nearest hospital to inform yourself about the risk and ask for advice on the measures to be taken, indicating the medication and the amount ingested. It is recommended to bring the package and the medication leaflet to the healthcare professional. Symptoms of overdose may include: stomach pain, nausea, vomiting (which may contain blood-stained mucus), indifference, sleepiness, headache, involuntary eye movements, buzzing in the ears, confusion, and muscle coordination disorders.

More severe symptoms may appear, such as intestinal hemorrhage, low blood pressure, low body temperature, metabolic acidosis, convulsions, kidney function disorders, coma, respiratory distress in adults, and transient respiratory arrest in children (after ingesting large amounts).

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 intoxication has occurred, the doctor will take the necessary measures.

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

Like all medications, Ibudol Pediátrico may cause side effects, although not everyone will experience them.

The frequencies have been defined as follows: very common (may affect more than 1 in 10 patients), common (may affect up to 1 in 10 patients), uncommon (may affect up to 1 in 100 patients), rare (may affect up to 1 in 1,000 patients), very rare (may affect up to 1 in 10,000 patients), and unknown frequency (cannot be estimated from available data).

The following side effects have been observed:

Gastrointestinal:

The most common side effects that occur with ibuprofen-containing medications are gastrointestinal: peptic ulcers, gastrointestinal bleeding, perforations (in some cases fatal), especially in elderly patients. Nausea, vomiting, diarrhea, flatulence, constipation, stomach pain, bloody stools, mouth ulcers, worsening of ulcerative colitis, and Crohn's disease have also been observed. Less frequently, gastritis has been observed.

Other side effects are:

Uncommon: mucosal inflammation in the mouth with ulcer formation.

Rare: esophageal inflammation, esophageal stricture (esophageal stenosis), exacerbation of intestinal diverticulum disease, non-specific hemorrhagic colitis (gastroenteritis with bloody diarrhea).

Very rare: pancreatitis.

Cardiovascular:

Ibuprofen-containing medications may be associated with a moderate increase in the risk of suffering a heart attack ("myocardial infarction") or stroke.

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

Edema (fluid retention), hypertension, and heart failure have also been observed in association with ibuprofen-containing treatments.

Dermatological:

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

• Flat, red, circular, or target-shaped patches 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 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).

Ibuprofen-containing medications may be associated with very rare, severe blistering reactions such as Stevens-Johnson syndrome (widespread erosions affecting the skin and two or more mucous membranes and purpuric lesions, preferably on the trunk) and toxic epidermal necrolysis (erosions in mucous membranes and painful, necrotic lesions with epidermal detachment).

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

Other side effects are:

Common: skin rash.

Uncommon: skin redness, itching, or swelling, purpura (purple spots on the skin).

Very rare: hair loss, erythema multiforme (skin lesion), light-sensitive skin reactions, inflammation of skin blood vessels.

Exceedingly rare skin infections and soft tissue complications may occur during chickenpox.

Unknown frequency: generalized, red, scaly rash with bumps under the skin and blisters, primarily located in skin folds, trunk, and upper limbs, accompanied by fever at the beginning of treatment (acute generalized pustular psoriasis). Stop taking Ibudol Pediátrico if you experience these symptoms and seek immediate medical attention. See section 2.

Immune system:

Uncommon: transient edema in skin, mucous membranes, or sometimes in internal organs (angioedema), nasal mucosa inflammation, bronchospasm (bronchi constriction preventing air passage to the lungs).

Rare: severe allergic reactions (anaphylactic shock). In case of severe generalized hypersensitivity reaction, facial swelling, tongue, and laryngeal swelling, bronchospasm, asthma, tachycardia, hypotension, and shock may occur.

Very rare: joint pain and fever (lupus erythematosus).

Central nervous system:

Common: fatigue or drowsiness, headache, dizziness, or feeling unstable.

Rare: paresthesia (numbness, tingling, or prickling sensations, more common in hands, feet, arms, or legs).

Very rare: aseptic meningitis. In most cases where aseptic meningitis has been reported with ibuprofen, the patient had some form of autoimmune disease (such as systemic lupus erythematosus or other collagen diseases), which was a risk factor. Symptoms of aseptic meningitis observed were neck stiffness, headache, nausea, vomiting, fever, or disorientation.

Psychiatric:

Uncommon: insomnia, anxiety, restlessness.

Rare: disorientation or confusion, nervousness, irritability, depression, psychotic reaction.

Auditory:

Common: vertigo. Uncommon: tinnitus or ringing in the ears.

Rare: hearing difficulty.

Ocular:

Uncommon: vision alteration.

Rare: abnormal or blurred vision.

Haematological:

Rare: decreased platelets, decreased white blood cells (may manifest as frequent infections with fever, chills, or sore throat), decreased red blood cells (may manifest as difficulty breathing and pale skin), decreased granulocytes (a type of white blood cell that may predispose to infections), pancytopenia (deficiency of red and white blood cells and platelets in the blood), agranulocytosis (severe decrease in granulocytes), aplastic anemia (bone marrow insufficiency to produce different types of cells), or hemolytic anemia (premature destruction of red blood cells). The first symptoms are: fever, sore throat, superficial mouth ulcers, flu-like symptoms, extreme fatigue, nasal bleeding, and skin bleeding.

Very rare: prolonged bleeding time.

Renal:

Based on the experience with NSAIDs in general, cases of interstitial nephritis (kidney disorder), nephrotic syndrome (characterized by protein in the urine and body swelling), and renal insufficiency (sudden loss of kidney function) cannot be ruled out.

Hepatic:

Ibuprofen-containing medications may be associated, in rare cases, with liver damage.

Other rare side effects are: hepatitis (inflammation of the liver), liver function abnormalities, and jaundice (yellowing of the skin and eyes).

Unknown frequency: liver insufficiency (severe liver deterioration).

General:

Exacerbation of inflammatory processes during infectious diseases.

Until now, no severe allergic reactions have been reported with ibuprofen, although they cannot be ruled out. Manifestations of this type of reaction may include fever, skin rash, abdominal pain, severe headache, nausea, vomiting, facial swelling, tongue, and throat swelling, difficulty breathing, asthma, palpitations, hypotension, or shock.

Stop treatment and seek immediate medical attention if any of the following side effects occur:

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 not listed in this prospectus. You can also report them directly through the Spanish System for the Pharmacovigilance 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.

Store in the original packaging.

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 trash. Dispose of 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 packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Ibudol Pediatric

• The active ingredient is ibuprofen. Each sachet contains 200 mg of ibuprofen.
• The other components (excipients) are: Sodium benzoate (E-211), anhydrous citric acid (E-330), sodium citrate (E-331), sodium saccharin (E-954), microcrystalline cellulose (E-460i), xanthan gum (E-415), maltitol syrup (E-965), orange flavor, glycerol (E-422), polysorbate 80, and purified water.

Appearance ofIbudol Pediatricand contents of the packaging

White oral suspension with orange flavor packaged in thermosealed sachets consisting of a complex of aluminum (polyester, aluminum, polyethylene, polyester, and polyethylene).

Each package contains 20 sachets.

Holder of the marketing authorization and responsible for manufacturing

Kern Pharma, S.L.

Venus, 72 – Pol. Ind. Colón II

08228 Terrassa - Barcelona

Spain

Last review date of this leaflet:August 2024.

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/