IBUDOL PEDIATRIC 20 mg/mL ORAL SUSPENSION

2. What you need to know before taking Ibudol Pediatric

Do not takeIbudol Pediatric:

• If you are allergic (hypersensitive) to ibuprofen or any of the other ingredients of this medicine (listed in section 6) or to other medicines of the non-steroidal anti-inflammatory drug group (NSAIDs) or to aspirin. Allergic reactions may be: skin rash with itching, swelling of the face, lips, or tongue, 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 have suffered a perforation of the digestive tract.
• If you vomit blood.
• If you have black stools or bloody diarrhea.
• If you have bleeding disorders or blood coagulation disorders, or are taking anticoagulants (medicines used to "thin" the blood). If it is necessary to use anticoagulant medications 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

Ibuprofen has been associated with signs of allergic reaction to this medicine, such as respiratory problems, swelling of the face and neck (angioedema), and chest pain. Stop using Ibudol Pediatric immediately and contact your doctor or medical emergency services immediately if you observe 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 disorders or have high blood pressure.
• If you have asthma or any other respiratory disorder.
• If you are receiving treatment with this medicine, as it may mask fever, which is an important sign of infection, making diagnosis 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 checks. Your doctor will indicate the frequency of these checks.
• If you have had or developed an ulcer, bleeding, or perforation in the stomach or duodenum, which may be manifested by intense or persistent abdominal pain and/or black stools, or even without previous warning symptoms.

This risk is greater when high doses and prolonged treatments are used, in patients with a history of peptic ulcer and in elderly patients. In these cases, your doctor will consider the possibility of associating a stomach protective medicine.

• If you are taking medicines that alter blood coagulation, such as oral anticoagulants, antiplatelet agents of the type of acetylsalicylic acid. You should also discuss the use of other medicines that may increase the risk of such bleeding, such as corticosteroids and selective serotonin reuptake inhibitor antidepressants.
• If you have Crohn's disease (a chronic disease in which the immune system attacks the intestine, causing inflammation that produces, usually, bloody diarrhea) or ulcerative colitis, as ibuprofen medicines can worsen these conditions.
• If you are being treated with diuretics (medicines to urinate) because your doctor should monitor your kidney function.
• If you have systemic lupus erythematosus (a chronic disease 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 acute intermittent porphyria (a metabolic disease that affects your blood and can cause symptoms such as reddish urine color, blood in urine, or liver disease), so that your doctor can assess the convenience or not of treatment with ibuprofen.
• If you suffer from headaches after prolonged treatment, do not take higher doses of the medicine.
• It is possible that allergic reactions may occur with this medicine.
• Your doctor will perform stricter control if you receive ibuprofen after undergoing 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 the pain and do not take this medicine for longer than necessary to control your symptoms.

Skin Reactions

Be especially careful 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), acute generalized exanthematous pustulosis (AGEP), have been reported in association with ibuprofen treatment. Discontinue treatment with Ibudol Pediatric and seek medical attention immediately if you notice any of the symptoms related to these severe skin reactions described in section 4.

Cardiovascular Precautions

Anti-inflammatory/analgesic medicines like ibuprofen may be associated with a small increased risk of heart attack or stroke, especially when used in high doses. Do not exceed the recommended dose or treatment duration.

You should discuss your treatment with your doctor or pharmacist before taking ibuprofen if:

• You have heart problems, including heart failure, angina (chest pain), or if you have had a heart attack, bypass surgery, peripheral arteriopathy (circulation problems in the legs or feet due to narrowing or blockage of the arteries), or any type of stroke (including a "mini-stroke" or transient ischemic attack "TIA").

• You have high blood pressure, diabetes, high cholesterol, have a family history of heart disease or stroke, or are a smoker.

Similarly, this type of medicine 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 administration of ibuprofen has been associated with an increased risk of congenital anomalies/abortions, its administration is not recommended during the first and second trimester of pregnancy, unless it is strictly necessary. In these cases, the dose and duration will be limited to the minimum possible.

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

For women of childbearing age, it should be taken into account that ibuprofen has been associated with a decrease in fertility.

Infections

Ibudol Pediatric may mask the signs of an infection, such as fever and pain. Consequently, this medicine may delay the appropriate treatment of the infection, which may increase the risk of complications. This has been observed in bacterial pneumonia and bacterial skin infections related to chickenpox. If you take this medicine while having an infection and the symptoms of the infection persist or worsen, consult your doctor without delay.

Other Medicines and Ibudol Pediatric

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

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

• Other non-steroidal anti-inflammatory drugs like aspirin, as the risk of stomach ulcers and gastrointestinal bleeding may increase.
• Antiplatelet agents (prevent the formation of blood clots or thrombi in blood vessels) such as ticlopidine.
• Anticoagulant medicines, e.g., to treat coagulation problems/prevent coagulation, (e.g., acetylsalicylic acid, warfarin, ticlopidine).
• Colestyramine (medicine used to treat high cholesterol).
• Selective serotonin reuptake inhibitors (used in depression).
• Lithium (medicine used to treat depression). Your doctor may adjust the dose of this medicine.
• Methotrexate (for cancer and inflammatory diseases). Your doctor may adjust the dose of this medicine.
• Mifepristone (abortion inducer).
• Digoxin and cardiac glycosides (used in the treatment of heart disorders).
• Hydantoins such as phenytoin (used in the treatment of epilepsy).
• Sulfonamides such as sulfamethoxazole and cotrimoxazole (used in the treatment of certain bacterial infections).
• Corticosteroids such as cortisone and prednisolone.
• Diuretics (medicines used to increase urine production), as they may increase the risk of kidney toxicity.
• Pentoxifylline (for intermittent claudication).
• Probenecid (used in patients with gout or with penicillin in infections).
• Quinolone antibiotics such as norfloxacin.
• Sulfinpyrazone (for gout).
• Sulfonylureas such as tolbutamide (for diabetes), as they may cause hypoglycemia.
• Tacrolimus or cyclosporin (used in organ transplants to prevent rejection).
• Zidovudine (medicine against the AIDS virus).
• Medicines that lower high blood pressure (ACE inhibitors such as captopril, beta-blockers such as atenolol, and angiotensin II receptor antagonists such as losartan).
• Thrombolytics (medicines that dissolve blood clots).
• Aminoglycoside antibiotics such as neomycin.
• Herbal extracts: Ginkgo biloba tree.
• CYP2C9 inhibitors (responsible for the metabolism of numerous drugs in the liver), such as voriconazole and fluticonazole (used to treat fungal infections).

Other medicines may also affect or be affected by treatment with ibuprofen. 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 and serum creatinine and potassium concentrations (may increase).
• With liver function tests: increased transaminase values.

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

Taking Ibudol Pediatric with Food, Drinks, and Alcohol

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

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 are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. You should not take this medicine during pregnancy, especially during the third trimester (see section precautions during pregnancy and in women of childbearing age). It may cause kidney and heart problems in your fetus. It may affect your ability and that of your baby to bleed and delay or prolong labor more than expected. You should 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 possible time. From the 20th week of pregnancy, ibuprofen may cause kidney problems in your fetus if taken for more than a few days, which may cause low levels of amniotic fluid surrounding the baby (oligohydramnios) or narrowing of a blood vessel (ductus arteriosus) in the baby's heart. If you need treatment for more than a few days, your doctor may recommend additional checks.

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

Driving and Using Machines

If you experience dizziness, vertigo, vision disturbances, or other symptoms while taking this medicine, do not drive or use hazardous machinery. If you only take one dose of ibuprofen or for a short period, you do not need to take special precautions.

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

This applies to a greater extent to the combination with alcohol.

Ibudol Pediatric Contains Maltitol Liquid (E-965), Propylene Glycol (E-1520), Sodium Benzoate (E-211), Ethanol, and Sodium

This medicine contains maltitol liquid. If your doctor has told you that you have an intolerance to some sugars, consult with them before taking this medicine. It may have a slight 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 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), which corresponds to 1.43 mg per ml of oral suspension.

This medicine contains sodium:

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

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

3. How to take Ibudol Pediatric

Follow the administration instructions for this medication exactly as indicated by your doctor or pharmacist. In case of 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 time 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 intensity of the symptoms, and is divided into three doses.

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

For guidance, the following doses can be followed:

The suspension can also be dosed following a regimen of 4 daily doses. In this case, the maximum daily doses (see last column of the previous table) should not be exceeded in 24 hours. The dose to be administered at each dose, every 6 hours, will be recalculated/reduced proportionally.

The use of this medication is not recommended in children under 3 months or with a weight of less than 5 kg.

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

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

In children aged 3 to 5 months, a doctor should be consulted if symptoms worsen or persist after 24 hours.

Form of administration

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

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

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

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

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

If you take more Ibudol Pediatric than you should

If you have taken more Ibudol Pediatric than you should, or if a child has accidentally ingested the medication, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested, and go to the nearest hospital to find out 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 bloody stools), headache, ringing in the ears, confusion, involuntary eye movement, and lack of muscle coordination. At high doses, symptoms of drowsiness, chest pain, palpitations, loss of consciousness, seizures (mainly in children), weakness, and dizziness, blood in the urine, low potassium levels in the blood, chills, and breathing problems have been reported. There may be cases of increased blood acidity (metabolic acidosis), decreased body temperature, altered kidney function, stomach and intestinal bleeding, coma, transient loss of breathing (apnea), central nervous system depression, and respiratory system. Also, cases of cardiovascular toxicity (low blood pressure, decreased heart rate, and increased heart rate) have been reported.

If a severe overdose has occurred, kidney failure and liver damage may occur. In these cases, the doctor will take the necessary measures.

If you forget to take Ibudol Pediatric

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

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

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

4. Possible side effects

Like all medications, Ibudol Pediatric can cause side effects, although not everyone gets them. The incidence of side effects is lower in short treatments and if the daily dose is below the maximum recommended dose.

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

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

• Reddish spots, not raised, in a target or circular shape on the trunk, often with blisters in the center, skin peeling, mouth ulcers, genital ulcers, and eye ulcers. These serious skin rashes can be preceded by fever and flu-like symptoms [exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis].
• Widespread rash, high body temperature, and swollen lymph nodes (DRESS syndrome).
• Widespread, red, and scaly rash, with bumps under the skin and blisters, accompanied by fever. The symptoms usually appear at the start of treatment (acute generalized exanthematous pustulosis).

The frequencies shown below refer to the short-term use of maximum daily doses of up to 1200 mg of oral ibuprofen:

Common side effects:(may affect up to 1 in 10 people): Gastrointestinal bleeding, especially in elderly patients. Nausea, vomiting, diarrhea, flatulence, dyspepsia (disorder of gastrointestinal secretion or motility), constipation, heartburn, abdominal pain, blood in stool, vomiting blood, headache, dizziness or feeling of instability, fatigue.

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

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 impairment, reversible toxic amblyopia, liver damage, edema (swelling caused by fluid accumulation in tissues), optic neuritis, anaphylactic reaction (in case of severe generalized hypersensitivity reaction, signs may include facial swelling, tongue and larynx swelling, shortness of breath, tachycardia, hypotension, anaphylaxis, or severe shock), aseptic meningitis (inflammation of the meninges, which are the membranes that protect the brain and spinal cord, not caused by bacteria). In most cases where aseptic meningitis 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. The symptoms of aseptic meningitis observed were neck stiffness, headache, nausea, vomiting, fever, or disorientation. Other side effects are decreased platelet count, decreased white blood cell count (may manifest as frequent infections with fever, chills, or sore throat), decreased red blood cell count (may manifest as difficulty breathing and pale skin), neutropenia (decrease in neutrophils), and agranulocytosis (very large decrease in neutrophils), aplastic anemia (insufficiency of the bone marrow to produce different types of cells), hemolytic anemia (premature destruction of red blood cells). The first symptoms are: fever, sore throat, superficial mouth ulcers, pseudo-flu symptoms, extreme fatigue, bleeding, and bruises of unknown cause.

Very rare side effects:(may affect up to 1 in 10,000 people): Pancreatitis, severe blistering reactions including Stevens-Johnson syndrome (widespread erosions affecting the skin and at least two mucous membranes) and toxic epidermal necrolysis (erosions on mucous membranes and painful lesions with necrosis and shedding of the epidermis), erythema multiforme (skin lesion, exceptionally can have serious skin infections and soft tissue complications during chickenpox), liver failure, heart failure, myocardial infarction, hypertension.

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

Frequency not known:(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 produces bloody diarrhea).

A serious skin reaction known as DRESS syndrome (by its English acronym) may occur. The 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, mainly located in skin folds, trunk, and upper limbs, accompanied by fever at the start of treatment (acute generalized exanthematous pustulosis). Stop taking this medication if you experience these symptoms and seek immediate medical attention. See also section 2.

If any of the following side effects occur, interrupt treatment and go to your doctor immediately:

• Allergic reactions such as skin rashes, facial swelling, wheezing in the chest, or difficulty breathing.
• Vomiting blood or coffee grounds-like vomit.
• Blood in stool or bloody diarrhea.
• Severe stomach pain.
• Severe skin peeling or blisters.
• 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 the arms or legs.

Reporting side effects

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

5. Conservation of Ibudol Pediatric

Keep this medication out of sight and reach of children.

No special storage conditions are required.

Validity period after opening: 6 months.

Do not use this medication after the expiration date shown on the packaging after "CAD". The expiration date is the last day of the month indicated.

Medications should not be thrown down the drain or into the trash. Deposit the packaging and medications you no longer need in the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This way, you will help protect the environment.

6. Package contents and additional information

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 package contents

White or almost white suspension with orange odor and flavor.

It comes in a 200 mL amber plastic bottle with a child-resistant cap, including a 5 mL graduated dosing syringe.

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 last revision of this prospectus: July 2024

Detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/.