Ibudol Pediatric 20 mg/ml oral suspension

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the user

Ibudol Pediatric 20 mg/ml oral suspension

Ibuprofen

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

Follow exactly the instructions for administration of this medicine as described in this leaflet or as indicated by your doctor or pharmacist.

• 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 reactions, consult your doctor or pharmacist, even if they are adverse reactions not listed in this leaflet. 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 older than 6 months of age.

Contents of the leaflet

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

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

Ibudol Pediatric 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 mild to moderate occasional pain in children from 3 months up to 12 years of age.

2. What you need to know before taking Ibudol Pediátrico

Do not take Ibudol Pediátrico:

• If you are allergic (hypersensitive) to ibuprofen or to any of the other components of this medicine (listed in section 6) or to other medicines in the group of non-steroidal anti-inflammatory drugs (NSAIDs) or to aspirin. Signs of allergy may include: itchy skin rash, swelling of the face, lips or tongue, runny nose, breathing difficulties or asthma.
• If you have severe liver or kidney disease.
• If you have had a stomach or duodenal ulcer or bleeding, or have experienced a perforation of the digestive tract.
• If you are vomiting blood.
• If you have black stools or diarrhea with blood.
• If you have bleeding or blood coagulation disorders, or are taking anticoagulants (medicines used to "thin" the blood). If anticoagulant medicines must be used at the same time, your doctor will perform blood coagulation tests.
• If you have severe dehydration (caused by vomiting, diarrhea, or insufficient fluid intake).
• If you have severe heart failure.
• If you are in the third trimester of pregnancy.

Warnings and precautions

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

Consult your doctor or pharmacist before starting to take this medicine:

• If you have edema (fluid retention).
• If you have or have had heart problems or high blood pressure.
• If you have asthma or any other respiratory disorder.
• If you are being treated with this medicine, as it may mask fever, an important sign of infection, making diagnosis more difficult.
• If you have kidney or liver disease, are over 60 years old, or need to take the medicine for a prolonged period (more than 1 to 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 have had or develop a stomach or duodenal ulcer, bleeding, or perforation, which may present as severe or persistent abdominal pain and/or black stools, or even without prior warning symptoms.

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

• If 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 ibuprofen-containing medicines may worsen these conditions.

• If you are taking diuretics (medicines to increase urine production), 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 (inflammation of the meninges, the membranes protecting the brain and spinal cord, not caused by bacteria) 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 ibuprofen treatment is appropriate.

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

• Allergic reactions may occur with this medicine.

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

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

• If you have an infection: see the “Infections” section below.

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

Skin reactions

Take special care 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 syndrome), and acute generalized exanthematous pustulosis (AGEP) have been reported in association with ibuprofen treatment. Discontinue treatment with Ibudol Pediátrico 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.

You should 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 arterial disease (circulation problems in legs or feet due to narrowed or blocked arteries), or any type of stroke (including a "mini-stroke" or transient 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 types of medicines may cause fluid retention, especially in patients with heart failure and/or high blood pressure (hypertension).

Children and adolescents

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

Precautions during pregnancy and in women of childbearing age

Because the use of ibuprofen-containing medicines has been associated with an increased risk of congenital abnormalities or miscarriage, their use is not recommended during the first and second trimesters of pregnancy, unless strictly necessary. In such cases, the dose and duration of treatment should be limited to the minimum possible.

Administration of this medicine is contraindicated during the third trimester.

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

Infections

Ibudol Pediátrico 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 associated with chickenpox. If you take this medicine while having an infection and infection symptoms persist or worsen, consult your doctor without delay.

Other medicines and Ibudol Pediátrico

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

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

• Other non-steroidal anti-inflammatory drugs such as aspirin, as this may increase the risk of gastrointestinal ulcer and bleeding.
• Antiplatelet agents (which prevent blood clots or thrombi in blood vessels) such as ticlopidine.
• Anticoagulant medicines, e.g., for treating coagulation problems/preventing clotting (e.g., acetylsalicylic acid, warfarin, ticlopidine).
• Cholestyramine (a medicine used to treat high cholesterol).
• Selective serotonin reuptake inhibitors (used for depression).
• Lithium (a medicine used to treat depression). Your doctor may adjust the dose of this medicine.
• Methotrexate (used to treat cancer and inflammatory diseases). Your doctor may adjust the dose of this medicine.
• Mifepristone (an abortion-inducing agent).
• Digoxin and 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), as they may increase the risk of kidney toxicity.
• Pentoxifylline (for treating intermittent claudication).
• Probenecid (used in patients with gout or together with penicillin for infections).
• Quinolone antibiotics such as norfloxacin.
• Sulfinpyrazone (for gout).
• Sulfonylureas such as tolbutamide (for diabetes), which may cause hypoglycemia.
• Tacrolimus or cyclosporine (used in organ transplants to prevent rejection).
• Zidovudine (an anti-HIV medicine).
• Medicines that lower high blood pressure (ACE inhibitors such as captopril, beta-blockers such as atenolol-containing medicines, and angiotensin II receptor antagonists such as losartan).
• Thrombolytics (medicines that dissolve blood clots).
• Aminoglycoside antibiotics such as neomycin.
• Herbal extracts: Ginkgo biloba.
• CYP2C9 inhibitors (responsible for the metabolism of numerous drugs in the liver), such as voriconazole and fluconazole (used to treat fungal infections).

Other medicines may also affect or be affected by ibuprofen treatment. Therefore, you should always consult your doctor or pharmacist before using this medicine with other medicines.

Taking 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).
• Blood urea nitrogen levels and serum creatinine and potassium concentrations (may increase).
• Liver function tests: increased transaminase values.

Inform your doctor if you are undergoing clinical testing and are taking or have recently taken ibuprofen.

Taking Ibudol Pediátrico with food, drinks, and alcohol

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

Pregnancy, breastfeeding, and fertility

The use of this medicine is not recommended in women who are trying to become pregnant.

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine. This medicine should not be taken during pregnancy, especially during the third trimester (see section on precautions during pregnancy and in women of childbearing age). 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 more than expected. You should not take ibuprofen during the first 6 months of pregnancy unless clearly necessary and as directed by your doctor. If treatment is needed during this period or while trying to conceive, 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, which may lead to low levels of amniotic fluid surrounding the baby (oligohydramnios) or narrowing of a blood vessel (ductus arteriosus) in the baby's heart. If treatment is needed for more than a few days, your doctor may recommend additional monitoring.

Although only small amounts of the medicine pass into breast milk, prolonged use of ibuprofen during breastfeeding is not recommended.

Driving and using machines

If you experience dizziness, vertigo, vision disturbances, or other symptoms while taking this medicine, you should not drive or operate dangerous machinery. If you take only a single dose of ibuprofen or use it for a short period, special precautions are not usually necessary.

Ibuprofen may slow your reaction time, which should be considered before engaging in activities requiring high alertness, such as driving or operating machinery.

This is especially important when combined with alcohol.

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

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

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

This medicine contains 2 mg of sodium benzoate in each ml of suspension. Sodium benzoate may increase the risk of jaundice (yellowing of the skin and eyes) in newborns (up to 4 weeks of age).

This medicine contains 0.18% ethanol (alcohol); this small amount corresponds to 1.43 mg per ml of oral suspension.

This medicine contains sodium:

Doses up to 13 ml per single dose (included): This medicine contains less than 23 mg of sodium (1 mmol) per ml of oral suspension; this is essentially "sodium-free."

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

3. How to take Ibudol Pediatric

Follow exactly the administration instructions for this medicine provided by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

For occasional use only and for limited periods.

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

Children from 3 months to 12 years:

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

As a general rule, for children from 3 months to 12 years, the recommended daily dose is 20 to 30 mg per kg of body weight, depending on the severity of symptoms, divided into three doses.

This medicine should always be used in children under 2 years of age only under medical prescription.

As a guide, the following doses may be followed:

The suspension may also be dosed according to a schedule of 4 doses per day. In this case, the maximum daily doses (see last column of the table above) must not be exceeded within 24 hours. The dose to be administered every 6 hours should be recalculated/reduced proportionally.

The use of this medicinal product is not recommended in children under 3 months of age or weighing less than 5 kg.

Patients with kidney, liver, or heart disease: dosage must be reduced and medical advice sought. Ibuprofen should not be used in patients with severe heart, renal, or hepatic failure.

If this medicinal product needs to be used for more than 3 days, or if symptoms worsen in children aged 6 months to 12 years, medical advice must be sought.

In children aged 3 to 5 months, consult a physician if symptoms worsen or persist beyond 24 hours.

Method of administration

Ibudol Pediátrico is an oral suspension. It may be administered directly or diluted in water.

1. Shake the container before use.
2. Insert the syringe into the pierced opening of the cap.
3. Invert the bottle and withdraw the required dose.
4. Administer the contents of the syringe directly into the mouth or onto a spoon.
5. The syringe should be washed after each use and may be sterilized by boiling in water or by immersion in the sterilizing solution used for baby bottles.

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

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

Administration of the medication should only occur when pain or fever is present. As these symptoms subside, the 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, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number: 91 562 04 20, indicating the medication and the amount ingested. Go to the nearest hospital to assess the risk and receive advice on necessary measures.

Symptoms of overdose typically occur 4 to 6 hours after taking ibuprofen.

Symptoms of overdose may include nausea, stomach pain, vomiting (which may contain blood-stained sputum), headache, tinnitus, confusion, involuntary eye movements, and lack of muscle coordination. 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 may be reported. Cases of increased blood plasma acidity (metabolic acidosis), decreased body temperature, impaired kidney function, gastrointestinal bleeding, coma, temporary cessation of breathing (apnea), central nervous system depression, and respiratory depression may also occur. Cardiovascular toxicity (low blood pressure, decreased heart rate, and increased heart rate) has also been reported.

In cases of severe poisoning, renal failure and liver damage may occur. In such cases, the physician will take the necessary measures.

If you forget to take Ibudol Pediátrico

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

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

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

4. Possible adverse effects

Like all medicines, Ibudol Pediátrico may cause adverse effects, although not everyone will experience them. The incidence of adverse effects is lower with short-term treatment and when the daily dose is below the recommended maximum dose.

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

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

• Flat red spots, target-shaped or circular rashes 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 skin rash, high body temperature, and swollen 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).

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

Frequent adverse effects: (may affect up to 1 in 10 people): Gastrointestinal bleeding, especially in elderly patients. Nausea, vomiting, diarrhea, flatulence, dyspepsia (gastrointestinal secretion or motility disorder), constipation, heartburn, abdominal pain, blood in stools, vomiting blood, headache, dizziness or unsteadiness, fatigue have also been observed.

Uncommon adverse effects: (may affect up to 1 in 100 people): Gastritis, duodenal ulcers, gastric ulcers, skin redness, skin itching or tingling, urticaria, purpura (purple skin spots), hypersensitivity, paresthesia (numbness, tingling, "pins and needles" sensation, more frequent in hands, feet, arms or legs), somnolence, insomnia, anxiety, auditory disturbances, vision disturbances, rhinitis (inflammation of the nasal mucosa), inflammation of the oral mucosa with ulcer formation (mouth ulcers), gastrointestinal perforations, hepatitis (liver inflammation), liver function abnormalities and jaundice (yellowing of skin and eyes), asthma, bronchospasm, dyspnea (difficulty breathing). Tubulointerstitial nephritis (kidney disorder), nephrotic syndrome (disorder characterized by protein in urine and body swelling), renal failure (sudden loss of kidney function), acute renal failure and papillary necrosis (especially with prolonged use) associated with increased urea levels have also been observed.

Rare adverse effects: (may affect up to 1 in 1,000 people): Disorientation or confusion, depression, dizziness, tinnitus (ringing or noise in the ear), hearing disturbances, reversible toxic amblyopia, liver injury, edema (swelling due to fluid accumulation in tissues), optic neuritis, anaphylactic reaction (in case of severe generalized hypersensitivity reaction, signs may include swelling of the face, tongue and larynx, dyspnea (shortness of breath), tachycardia, hypotension (anaphylaxis, angioedema or severe shock)), aseptic meningitis (inflammation of the meninges, the membranes protecting the brain and spinal cord, not caused by bacteria). In most reported cases of aseptic meningitis 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 observed in aseptic meningitis included neck stiffness, headache, nausea, vomiting, fever or disorientation. Other adverse effects include 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), neutropenia (decreased neutrophils), agranulocytosis (severe decrease in neutrophils), aplastic anemia (bone marrow failure to produce various types of blood cells), hemolytic anemia (premature destruction of red blood cells). Initial symptoms include: fever, sore throat, superficial mouth ulcers, flu-like symptoms, extreme fatigue, unexplained bleeding and bruising.

Very rare adverse effects: (may affect up to 1 in 10,000 people): Pancreatitis, very severe blistering reactions including Stevens-Johnson syndrome (widespread erosions affecting the skin and two or more mucous membranes and purplish lesions, preferably on the trunk) and toxic epidermal necrolysis (erosions in mucous membranes and painful lesions with necrosis and detachment of the epidermis), erythema multiforme (skin lesion). Rarely, severe skin infections and soft tissue complications may occur during chickenpox. Liver failure (severe liver impairment), heart failure, myocardial infarction, hypertension.

Exacerbation of inflammation related to infections has been observed coinciding with the use of NSAIDs. If signs of infection appear or worsen during ibuprofen use, it is recommended to consult a doctor as soon as possible.

Frequency not known: (cannot be estimated from available data):

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 serious skin reaction known as DRESS syndrome (an acronym in English) may occur. Symptoms of DRESS syndrome include: skin rash, swollen lymph nodes, and elevated eosinophils (a type of white blood cell).

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). Stop taking this medicine if you experience these symptoms and seek immediate medical attention. See also section 2.

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

• Allergic reactions such as skin rashes, swelling of the face, wheezing in the chest or difficulty breathing.
• Vomiting blood or material resembling coffee grounds.
• Blood in stools or diarrhea with blood.
• Severe stomach pain.
• Blisters or significant skin peeling.
• Severe 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 arms or legs.

Reporting of adverse effects

If you experience any adverse effects, consult your doctor or pharmacist, even if they are possible adverse effects not listed in this leaflet. You may 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.

No special storage conditions are required.

Shelf life after opening: 6 months.

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 unused medicines and their containers at the SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the container and other information

Composition of Ibudol Pediatric

• The active substance 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 flavor (containing ethanol and propylene glycol (E-1520)) and purified water.

Appearance of Ibudol Pediatric and contents of the container

White or almost white suspension with an orange odor and flavor.

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

Marketing Authorization Holder

Kern Pharma, S.L.

Venus, 72 - Pol. Ind. Colón II

08228 Terrassa - Barcelona

Spain

Manufacturer

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

Date of the most recent review of this leaflet: July 2024

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