Ibudol Pediatric 200 mg oral suspension: detailed information

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Ibudol Pediatric 200 mg oral suspension

Ibuprofen

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

Follow exactly the administration instructions of 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 adverse effects, consult your doctor, pharmacist, or nurse, even if they are adverse effects not listed in this leaflet. See section 4.
You should consult a doctor if you worsen or do not improve after 3 days.

Contents of the leaflet

What Ibudol Pediatric is and what it is used for
What you need to know before taking Ibudol Pediatric
How to take Ibudol Pediatric
Possible adverse effects
How to store Ibudol Pediatric
Contents of the pack and other information

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

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

It is indicated in children from 7 years of age for the symptomatic relief of mild to moderate occasional pain, as well as febrile conditions.

2. What you need to know before taking Ibudol Pediatric

Do not take Ibudol Pediatric:

If you are allergic 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 this medicine. 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 gastrointestinal tract.
If you are vomiting blood.
If you have black stools or bloody diarrhea.
If you have bleeding disorders or blood coagulation problems, or are taking anticoagulants (medicines used to "thin" the blood). If it is necessary to use anticoagulants at the same time, your doctor will perform blood coagulation 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 to take this medicine.

Allergic reactions to ibuprofen, such as breathing problems, swelling of the face and neck area (angioedema), or chest pain, have been reported. Immediately stop using Ibudol Pediatric and contact your doctor or emergency medical services immediately if you notice any of these signs.

Inform your doctor:

If you have edema (fluid retention).
If you have or have had heart disorders or high blood pressure.
If you have asthma or any other respiratory disorder.
If you have an infection; see the section “Infections” below.
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 perform regular monitoring. Your doctor will advise you on how often these checks should be done.
If you experience symptoms of dehydration, e.g., severe diarrhea or vomiting, drink plenty of fluids and contact your doctor immediately, as ibuprofen in this case could lead to kidney 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 prolonged 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 you are taking medicines that affect blood clotting, such as oral anticoagulants or antiplatelet agents like acetylsalicylic acid. You should also mention the use of other medicines that could increase the risk of such bleeding, such as corticosteroids and selective serotonin reuptake inhibitor (SSRI) antidepressants.
If you have Crohn’s disease (a chronic condition in which the immune system attacks the intestine, causing inflammation that usually results in bloody diarrhea) or ulcerative colitis, as this type of medicine 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 affect vital organs, the nervous system, blood vessels, skin, and joints), as aseptic meningitis 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 to this medicine may occur.
Your doctor will perform more careful monitoring if you receive ibuprofen after major surgery.
It is advisable not to take this medicine if you have chickenpox.

It is important to use the lowest dose that relieves/controls the pain and not to take this medicine longer than necessary to control your symptoms.

Skin reactions

Take special care with Ibudol Pediatric:

Severe 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 in association with ibuprofen treatment. Discontinue treatment with Ibudol Pediatric and seek immediate medical attention if you notice any symptoms related to these severe skin reactions described in section 4.

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 ibuprofen if:

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

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

Infections

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

Children and adolescents

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

Using Ibudol Pediatric with other medicines

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

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

Anticoagulant medicines (e.g., to treat or prevent blood clotting, such as acetylsalicylic acid, warfarin, ticlopidine).
Medicines that lower high blood pressure (ACE inhibitors such as captopril, beta-blockers such as atenolol, angiotensin II receptor antagonists such as losartan).
Baclofen (used to treat involuntary and persistent muscle contractions).
Lithium (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 to treat heart disorders).
Hydantoins such as phenytoin (used to treat epilepsy).
Sulfonamides 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 for infections).
Quinolone antibiotics such as norfloxacin.
Ion-exchange resins such as cholestyramine (used to lower blood cholesterol levels).
Sulfinpyrazone (for gout).
Sulfonylureas such as tolbutamide (for diabetes).
Tacrine (used to treat Alzheimer’s disease).
Tacrolimus or cyclosporine (used in organ transplants to prevent rejection).
Zidovudine (an anti-HIV medication).
Thrombolytics (medicines that dissolve blood clots).
Aminoglycoside antibiotics such as neomycin.
Voriconazole or fluconazole (used for fungal infections).
Herbal extracts: Ginkgo biloba.

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

Interference with laboratory tests

Taking ibuprofen may affect the following laboratory tests:

Bleeding time (may be prolonged for up to 1 day after stopping treatment)
Blood glucose concentration (may decrease)
Creatinine clearance (may decrease)
Hematocrit or hemoglobin (may decrease)
Blood urea nitrogen levels and serum creatinine and potassium levels (may increase)
Liver function tests: increased transaminase values

If you are scheduled for any diagnostic tests (including blood and urine tests, skin tests using allergens, etc.), inform your doctor that you are taking this medicine, as it may affect test results.

Taking Ibudol Pediatric with food and drinks

You may take Ibudol Pediatric directly from the sachet or dissolved in water. You may take it with or without food. It is generally recommended to take it with food to reduce the possibility of stomach discomfort.

Pregnancy, breastfeeding, and fertility

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

Pregnancy:

Precautions during pregnancy and in women of childbearing age

Because administration of this medicine has been associated with an increased risk of congenital abnormalities and miscarriage, it is not recommended during the first and second trimesters of pregnancy unless strictly necessary. In such cases, the dose and duration should be limited to the minimum possible.

Administration is contraindicated during the third trimester. It may cause kidney and heart problems in your fetus. It may affect your and your baby’s tendency to bleed and may delay or prolong labor beyond expected duration. You should 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, you should 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 for longer than a few days is needed, your doctor may recommend additional monitoring.

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

Breastfeeding:

Although drug levels in breast milk are negligible, it is recommended to consult your doctor during long-term treatment or when using high doses while breastfeeding.

Driving and using machines

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

Ibudol Pediatric contains sodium and maltitol syrup

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

Patients on low-sodium diets should be aware that this medicine contains 17 mg of sodium per 200 mg sachet.

3. How to take Ibudol Pediátrico

Follow exactly the instructions for administering this medicine as described in this leaflet or as directed by your doctor, pharmacist, or nurse. If in doubt, consult your doctor, pharmacist, or nurse.

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

The recommended dose is:

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

The following dosage guidelines are recommended as a reference:

Children weighing 25 to 40 kg (approximately 7–12 years of age): The recommended daily dose is 600–800 mg of ibuprofen, divided into 3 or 4 doses (1 sachet 3 or 4 times daily), with a maximum recommended daily dose of 800 mg.
Children weighing over 40 kg and adolescents (over 12 years of age): The recommended daily dose is 800–1,200 mg of ibuprofen per day, divided into 3 or 4 doses (1–2 sachets 3 or 4 times daily), with a maximum recommended daily dose of 1,200 mg.

Other formulations with more appropriate dosages are recommended for use in adolescents and adults.

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

The use of this medicine is not recommended in children weighing less than 25 kg (approximately 7 years of age), as the dose (200 mg of ibuprofen) does not match the recommended dosage for these patients.

Patients with kidney, liver, or heart disease:

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.

Instructions for administration

This medicine is administered orally.

Ibudol Pediátrico is a suspension. It should be homogenized before use by pressing the top and bottom parts of the sachet several times with your fingers. It can be taken directly from the sachet or diluted in water. If gastrointestinal discomfort occurs, it is recommended to take the medicine with food.

Always use the lowest dose that is effective. Administration of the medicine should be based on the presence of pain or fever. As these symptoms subside, the medication should be discontinued. If pain or fever worsen or if these or other symptoms appear, stop treatment and consult your doctor.

If it is necessary to use this medicine for more than 3 days in children and adolescents (from 7 to under 18 years of age), or if symptoms worsen, consult your doctor.

If you take more Ibudol Pediátrico than you should

If you have taken more medicine than you should, or if a child has accidentally ingested the contents of the package, contact your doctor or pharmacist immediately, call the Toxicology Information Service at telephone: 91 562 04 20, or go to the nearest hospital to obtain advice on the risks and necessary measures, indicating the medicine and the amount ingested. It is recommended to bring the medicine’s packaging and leaflet to the healthcare professional. Symptoms of overdose may include: stomach pain, nausea, vomiting (which may contain blood-stained sputum), indifference, drowsiness, headache, involuntary eye movements, tinnitus, confusion, and lack of muscle coordination.

More severe symptoms may occur, such as intestinal bleeding, low blood pressure, decreased body temperature, metabolic acidosis, seizures, impaired kidney function, coma, adult respiratory distress, and transient cessation of breathing in children (after ingestion of large amounts).

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.

In cases of severe poisoning, the doctor will take the necessary measures.

If you forget to take Ibudol Pediátrico

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 the next dose is due soon, skip the missed dose and take the next dose at the 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, Ibudol Pediátrico may cause adverse effects, although not everyone experiences them.

Frequencies are defined as follows: very common (may affect more than 1 in 10 people), common (may affect up to 1 in 10 people), uncommon (may affect up to 1 in 100 people), rare (may affect up to 1 in 1,000 people), very rare (may affect up to 1 in 10,000 people), and not known frequency (cannot be estimated from available data).

The following adverse effects have been observed:

Gastrointestinal:

The most common adverse effects associated with ibuprofen-containing medicines are gastrointestinal: peptic ulcers, gastrointestinal bleeding, perforations (in some cases fatal), especially in elderly patients. Nausea, vomiting, diarrhea, flatulence, constipation, heartburn, abdominal pain, blood in stool, oral ulcers, and worsening of ulcerative colitis and Crohn's disease have also been observed. Less frequently, gastritis has been reported.

Other adverse effects include:

Uncommon: inflammation of the oral mucosa with ulcer formation.

Rare: esophagitis, esophageal narrowing (esophageal stenosis), exacerbation of intestinal diverticular disease, nonspecific hemorrhagic colitis (gastroenteritis with bloody diarrhea).

Very rare: pancreatitis.

Cardiovascular:

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

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

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

Dermatological:

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

Flat red spots on the trunk, often with blisters in the center, skin peeling, mouth, throat, nose, genital or eye ulcers. These serious skin rashes may be preceded by fever and flu-like symptoms [exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis].
Generalized rash, high body temperature, and enlarged lymph nodes (DRESS syndrome).
Widespread, 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).

Ibuprofen-containing medicines may, very rarely, be associated with severe blistering reactions such as Stevens-Johnson syndrome (widespread erosions affecting the skin and two or more mucous membranes, and purplish lesions, mainly on the trunk) and toxic epidermal necrolysis (erosions of mucous membranes and painful lesions with necrosis and detachment of the epidermis).

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

Other adverse effects include:

Common: skin rash.

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

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

Severe skin infections and soft tissue complications may exceptionally occur during chickenpox.

Not known frequency: widespread 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). Discontinue Ibudol Pediátrico if you experience these symptoms and seek immediate medical attention. See also section 2.

Immune system:

Uncommon: transient swelling of the skin, mucous membranes, or sometimes internal organs (angioedema), inflammation of nasal mucosa, bronchospasm (spasm of the airways preventing airflow to the lungs).

Rare: severe allergic reactions (anaphylactic shock). In case of severe generalized hypersensitivity reaction, swelling of the face, tongue, and larynx, 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 sensation of instability.

Rare: paresthesia (numbness, tingling, "pins and needles," more frequent in hands, feet, arms, or legs).

Very rare: aseptic meningitis. In most reported cases of aseptic meningitis 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 observed included neck stiffness, headache, nausea, vomiting, fever, or disorientation.

Psychiatric:

Uncommon: insomnia, anxiety, restlessness.

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

Auditory:

Common: dizziness. Uncommon: tinnitus (ringing or buzzing in the ears).

Rare: hearing impairment.

Ocular:

Uncommon: visual disturbances.

Rare: abnormal or blurred vision.

Blood-related:

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 shortness of breath and pale skin), decreased granulocytes (a type of white blood cell that may predispose to infections), pancytopenia (deficiency of red blood cells, white blood cells, and platelets in the blood), agranulocytosis (severe decrease in granulocytes), aplastic anemia (bone marrow failure to produce various blood cells), or hemolytic anemia (premature destruction of red blood cells). Initial symptoms include: fever, sore throat, superficial mouth ulcers, flu-like symptoms, extreme fatigue, nosebleeds, and skin bleeding.

Very rare: prolonged bleeding time.

Renal:

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

Hepatic:

Ibuprofen-containing medicines may, in rare cases, be associated with liver injury.

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

Unknown frequency: liver failure (severe liver damage).

General:

Worsening of inflammation during infectious processes.

To date, no severe allergic reactions have been reported with ibuprofen, although they cannot be ruled out. Manifestations of such reactions could include fever, skin rash, abdominal pain, severe and persistent headache, nausea, vomiting, swelling of the face, tongue, and throat, breathing difficulties, asthma, palpitations, hypotension (lower than usual blood pressure), or shock.

If you experience any of the following adverse effects, stop treatment immediately and consult your doctor:

Allergic reactions such as skin rashes, facial swelling, wheezing, or breathing difficulties.
Vomiting blood or material resembling coffee grounds.
Blood in stool or bloody diarrhea.
Severe stomach pain.
Blisters or significant skin peeling.
Severe or persistent headache.
Yellowing of the skin (jaundice).
Signs of severe hypersensitivity (allergy) (see above in this section).
Swelling of the limbs or fluid accumulation in arms or legs.

Reporting of adverse effects

If you experience any adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect 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 Ibudol Pediatric

Keep this medicine out of sight and reach of children.

Store in the original packaging.

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

Medicines must not be disposed of via wastewater or household waste. Dispose of containers and unused medicines at the SIGRE Point at your pharmacy. If you have any doubts, ask your pharmacist how to properly dispose of containers and unused medicines. This will help protect the environment.

6. Contents of the pack and other information

Composition of Ibudol Pediátrico

The active substance 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 of Ibudol Pediátrico and contents of the pack

White, orange-flavored oral suspension packed in heat-sealed sachets made from an aluminum composite (polyester, aluminum, polyethylene, polyester, and polyethylene).

Each pack contains 20 sachets.

Marketing Authorization Holder and Manufacturer

Kern Pharma, S.L.

Venus, 72 – Pol. Ind. Colón II

08228 Terrassa - Barcelona

Spain

Date of the most recent review of this leaflet: August 2024.

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