Leaflet: information for the user

Nurofen pediatric 40 mg/ml oral suspension strawberry flavor

Ibuprofen

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

Follow exactly the administration instructions contained in this leaflet or those given 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 or your child experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.
• You should consult a doctor if your symptoms or your child's symptoms worsen or do not improve:
• after 24 hours in infants aged 3 to 5 months and weighing more than 5 kg
• after 3 days in children over 6 months of age and adolescents.

Contents of the pack and additional information

Nurofen pediatric contains ibuprofen andbelongs to a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs). These medicines work by modifying the body's response to pain, inflammation, and elevated body temperature.

This medicine is used in children from 3 months of age for the symptomatic treatment of:

• fever,
• occasional mild or moderate pain

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

Do not administer this medication to children who:

?Are allergic (hypersensitive) to ibuprofen, other NSAIDs (e.g., acetylsalicylic acid, naproxen, etc.), or any other components of this medication (listed in section 6). Allergic reactions may include: difficulty breathing or asthma, nasal discharge, facial swelling, lip, tongue, or hand swelling, or skin rash with itching after taking acetylsalicylic acid or other similar analgesics (NSAIDs).

?Have experienced stomach ulcers or bleeding, or have suffered from digestive tract perforation.

?Have vomiting with blood.

?Have black stools or diarrhea with blood.

?Have a severe liver or kidney disease.

?Have bleeding or coagulation disorders or are taking anticoagulants (medications used to "thin" the blood), as ibuprofen may increase the duration of bleeding.

?Have severe heart failure.

?If you are a woman, do not use this medication if you are in the last trimester of pregnancy.

Warnings and precautions:

You should consult your doctor or pharmacist before starting to administer this medication to your child:

?If you have edema (fluid retention).

?If you have asthma or any other respiratory disorder.

?If you have or have had any heart problems or have high blood pressure.

?If you have kidney or liver disease or need to take the medication for a prolonged period (more than 1 to 2 weeks), your doctor may need to perform regular checks.

?If you present symptoms of dehydration, e.g., severe diarrhea or vomiting, you should take plenty of fluid and contact your doctor immediately, as ibuprofen in this case may cause kidney failure as a result of dehydration. There is a risk of kidney failure in dehydrated children and adolescents.

?Have had or develop a stomach or duodenal ulcer, bleeding, or perforation, which may manifest as intense or persistent abdominal pain and/or black stools, even without previous warning symptoms.

?This risk is higher when using high doses and prolonged treatments, in patients with a history of peptic ulcers, and in elderly patients.

?If you are taking anticoagulant medications, such as warfarin or antiplatelet agents like acetylsalicylic acid. You should also inform your doctor about the use of other medications that may increase the risk of bleeding, such as corticosteroids (e.g., prednisolone) and selective serotonin reuptake inhibitors (SSRIs).

?If you have Crohn's disease (a condition in which the immune system attacks the intestine, causing inflammation that usually results in bloody diarrhea) or ulcerative colitis, as ibuprofen pediatric medication may worsen these conditions.

?If you have 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 meningitis.

?If you have intermittent acute porphyria (a metabolic disorder that affects your blood and can cause symptoms such as urine discoloration, blood in urine, or liver disease), so that your doctor can assess the advisability or not of treatment with ibuprofen.

?The treatment with ibuprofen may mask fever, which is an important sign of infection, making diagnosis more difficult.

?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.

?If you have an infection; see the "Infections" heading later.

?During chickenpox, it is recommended not to use this medication.

?Your doctor will perform a more strict control if you receive ibuprofen after undergoing major surgery.

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 consult your doctor or pharmacist before taking this medication if:

-You have heart problems, including heart failure, angina (chest pain), or if you have had a heart attack, coronary artery bypass surgery, peripheral artery disease (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, a family history of heart disease or stroke, or if you are a smoker.

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

Consult your doctor before using this medication if your child has any of the above conditions.

SKIN REACTIONS

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

INFECTIONS

Nurofen pediatric medication may mask the signs of an infection, such as fever and pain. Therefore, it is possible that Nurofen pediatric medication 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 your doctor without delay.

IN CASE OF ADMINISTRATION OF THIS MEDICATION IN ADULTS:

Older patients are at a higher risk of adverse events when taking NSAIDs, especially of the gastrointestinal and intestinal type. See section 4 "Possible side effects" for more information.

Patients with a history of gastrointestinal toxicity, especially older patients, should report any unusual abdominal symptoms (especially gastrointestinal bleeding), especially in the early stages of treatment.

PREGNANCY AND BREASTFEEDING PRECAUTIONS

Due to the association of NSAID administration with an increased risk of congenital anomalies/abortion, 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 will be limited to the minimum possible.

In the third trimester, administration of this medication is contraindicated. For women of childbearing age, it should be noted that NSAIDs have been associated with a decrease in fertility.

LABORATORY TEST INTERFERENCES

The administration of 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)

-Urea nitrogen concentrations, serum creatinine, and potassium concentrations (may increase)

-Liver function tests: increased transaminase values.

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

USE OF Nurofen PEDIATRIC WITH OTHER MEDICATIONS

Inform your doctor or pharmacist if your child is using or has recently used other medications, including those purchased without a prescription.

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

?Corticosteroids (such as cortisone or prednisolone), as they may increase the risk of gastrointestinal bleeding or ulcers.

?Other NSAIDs, such as aspirin and other medications of the NSAID type (including COX-2 inhibitors like celecoxib or etoricoxib).

?Anticoagulant medications (e.g., to treat blood clotting problems or prevent clotting, e.g., acetylsalicylic acid, warfarin, ticlopidine).

?Antiplatelet agents (prevent blood clots from forming in blood vessels) like ticlopidine.

?Selective serotonin reuptake inhibitors (SSRIs) used in depression.

?Blood pressure-lowering medications (ACE inhibitors like captopril, beta-blockers like atenolol, and angiotensin II receptor antagonists like losartan).

?Diuretics (medications used to increase urine production).

?Lithium (a medication for depression), which may require your doctor to adjust the dose of this medication.

?Methotrexate (a medication for cancer and inflammatory diseases), which may require your doctor to adjust the dose of this medication.

?Mifepristone (an abortion inducer): NSAIDs should not be taken in the 8-12 days following mifepristone use.

?Hydantoins like phenytoin (used to treat epilepsy).

?Sulfonamides like sulfamethoxazole and cotrimoxazole.

?Pentoxifylline (used to treat intermittent claudication).

?Ciclosporin and tacrolimus (used in organ transplants to prevent rejection).

?Zidovudine (a medication for HIV/AIDS).

?Sulfonylureas (used for diabetes).

?Probenecid (used for gout or with penicillin in infections) and sulfinpyrazone (used for gout).

?Digoxin and other cardiac glycosides (used to treat heart problems): ibuprofen may increase the plasma concentrations of these medications.

?Thrombolytics (medications that dissolve blood clots).

?Aminoglycoside antibiotics like neomycin.

?Quinolone antibiotics like norfloxacin.

?Herbal extracts (from the Ginkgo biloba tree).

?Colestiramine (used to reduce cholesterol levels), as the administration of NSAIDs with colestiramine may delay and reduce the reabsorption of NSAIDs.

?Baclofen (used to treat involuntary and persistent muscle contractions).

?CYP2C9 inhibitors like voriconazole and fluconazole (used to treat fungal infections), as these medications may increase exposure to NSAIDs.

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

TAKE Nurofen PEDIATRIC WITH FOOD, BEVERAGES, AND ALCOHOL

It is recommended to take this medication with milk or food, or immediately after eating, to reduce the likelihood of stomach discomfort.

Do not take alcohol during treatment, as it increases the risk of gastrointestinal side effects.

PREGNANCY, BREASTFEEDING, AND FERTILITY

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

PREGNANCY

Do not take ibuprofen if you are in the last 3 months of pregnancy, as it may cause kidney and heart problems in the fetus. It may affect your tendency and that of your baby to bleed, and delay or prolong labor more than expected. Avoid taking ibuprofen during the first 6 months of pregnancy, except as directed by your doctor. In these cases, the dose and duration will be limited to the minimum possible. From week 20 of pregnancy, ibuprofen may cause kidney problems in the 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 the baby's heart. If you need treatment for more than a few days, your doctor may recommend additional monitoring.

BREASTFEEDING

Although only small amounts of the medication pass into breast milk, it is recommended not to take ibuprofen for prolonged periods during breastfeeding. Normally, it is not necessary to stop breastfeeding during a short treatment with the recommended dose for pain and fever.

FEMALE FERTILITY

Ibuprofen belongs to a group of medications (NSAIDs) that may affect female fertility. This effect is reversible when the medication is discontinued. Avoid taking this medication if you are trying to become pregnant.

DRIVING AND OPERATING MACHINERY

If you only take one dose of the medication or take it for a short period, no special precautions are necessary.

If you experience dizziness, vertigo, visual disturbances, or other symptoms while taking this medication, you should not drive or operate hazardous machinery.

Nurofen PEDIATRIC CONTAINS MALTITOL LIQUID, PROPYLENE GLYCOL, AND SODIUM.

This medication contains maltitol liquid (E-965). If your doctor has told you that you are intolerant to certain sugars, consult with them before taking this medication. It may cause a mild laxative effect because it contains 2,226 g of maltitol liquid (E-965) per 5 ml.

Caloric value: 2.3 kcal/g of maltitol.

This medication contains 3.29 mg of propylene glycol (E-1520) per ml.

If the baby is under 4 weeks old, consult your doctor or pharmacist, especially if the baby has been given other medications containing propylene glycol or alcohol.

This medication contains less than 23 mg of sodium (1 mmol) per ml, which is essentially "sodium-free."

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

For oral use.

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

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 of ibuprofen per kg of the child's weight, divided into three or four individual doses every 6-8 hours. It is recommended not to exceed the maximum daily dose of 40 mg of ibuprofen per kg of weight. The interval between each dose will depend on the evolution of symptoms, but it will never be less than 4 hours.

The recommended dose for pain and fever is:

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

It is not recommended to use in children under 3 months or with a weight less than 5 kg.

Adolescents (over 12 years and over 40 kg):

Take a dose of 5-10 ml (equivalent to 200-400 mg of ibuprofen) every 4 or 6 hours, if necessary. The maximum daily dose for adolescents should not exceed 1200 mg of ibuprofen in 24 hours.

Due to the amount of ibuprofen contained in this medication, it is recommended to use other presentations more suitable for the treatment in adults and adolescents over 12 years.

Patients with kidney and/or liver diseases:

If you have a kidney and/or liver disease, your doctor may prescribe a lower dose than usual. If so, take the exact dose that they have prescribed.

In infants between 3 and 5 months with more than 5 kg of weight:

In infants of 3 to 5 months, medical attention should be sought if symptoms worsen or within 24 hours if symptoms persist.

In children between 6 months and 12 years and in adolescents (under 18 years):

In children from 6 months and in adolescents, consult a doctor if it is necessary to administer the medication for more than 3 days or if symptoms worsen.

In patients with sensitive stomachs, it is recommended to take the medication during meals.

Method of administration with the syringe:

1. Shake the bottle well.
2. Remove the cap from the bottle by pressing it down and turning it counterclockwise.
3. Insert the syringe firmly into the port (hole) located at the neck of the bottle.
4. To fill the syringe, invert the bottle. While holding the syringe, pull the plunger down slowly until the suspension reaches the appropriate mark on the syringe.
5. Return the bottle to its normal position and remove the syringe from the port by turning it gently.
6. Place the tip of the syringe in the child's mouth. Press the plunger slowly to release the suspension gently. Replace the cap after use. Wash the syringe with warm water and let it dry. Store it out of sight and reach of children.

If you take more Nurofen pediatric than you should:

If you take or accidentally administer more medication than you should, or if a child has ingested the medication accidentally, consult a doctor immediately or call the toxicology information service, phone 915620420 indicating the medication and the amount used, or go to the nearest hospital to inform yourself about the risk and ask for advice on the measures to be taken. It is recommended to bring the packaging and the leaflet to the healthcare professional. The symptoms of overdose may include nausea, stomach pain, vomiting (which may contain blood), headache, blurred vision, ringing in the ears, confusion, and involuntary eye movement. At high doses, gastrointestinal bleeding, hypotension, changes in blood composition, 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.

If you forgot to take or give your child Nurofen pediatric:

Do not take or administer a double dose to compensate for the missed doses. If you forget to take or administer a dose, take it as soon as you remember and then take the next dose according to the previous administration interval.

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

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

Side effects can be minimized by taking the lowest dose for the shortest time necessary to relieve symptoms. You or your child may experience one of the known side effects of NSAIDs. In this case, or if you have any concerns, stop administering/taking this medicine and consult your doctor as soon as possible. Elderly patients using this product are at a higher risk of developing problems associated with side effects.

The incidence of side effects is lower in short-term treatments and if the daily dose is below the maximum recommended dose.

STOP administering or taking this medicine and seek immediate medical help if you or your child experience:

• signs of intestinal bleeding, such as: severe abdominal pain, black or tarry stools, vomiting with blood or dark particles that resemble ground coffee
• signs of a very rare but severe allergic reaction, such as worsening asthma, wheezing, or unknown respiratory problems, facial, tongue, or throat swelling, difficulty breathing, rapid heartbeat, decreased blood pressure leading to shock. These can occur even with the first use of this medicine
• Flat, circular, or circular-shaped red spots on the trunk, often with blisters in the center, skin peeling, mouth, throat, nose, genital, and eye ulcers. These severe skin eruptions can 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).

Inform your doctor if you experience the following side effects:

Frequent: (can affect up to 1 in 10 people)

• Stomach problems, such as heartburn, stomach pain, and nausea, indigestion, diarrhea, vomiting, flatulence (gas), and mild bleeding in the stomach and/or intestines that can cause anemia in exceptional cases.

Rare: (can affect up to 1 in 100 people)

• Gastrointestinal ulcers, perforation, or bleeding, inflammation of the mucous membrane of the mouth with ulceration, worsening of existing intestinal disease (ulcerative colitis or Crohn's disease), gastritis
• Central nervous system disorders, such as headaches, dizziness, insomnia, agitation, irritability, and fatigue
• Visual disturbances
• Diverse skin eruptions
• Hypersensitivity reactions with urticaria and itching.

Rare: (can affect up to 1 in 1,000 people)

• Tinnitus (ringing in the ears)
• Increased urea concentrations in the blood, side pain and/or abdomen, blood in the urine, and fever may be signs of kidney damage (papillary necrosis)
• Decreased hemoglobin levels.

Very rare: (can affect up to 1 in 10,000 people)

• Esophagitis, pancreatitis, and formation of diaphragmatic intestinal stenosis
• Heart failure, heart attack, and facial and hand swelling (edema)
• Decreased urine output and inflammation (especially in patients with hypertension or reduced renal function), swelling (edema), and cloudy urine (nephrotic syndrome), inflammatory kidney disease (interstitial nephritis) that can lead to acute renal failure. If you experience any of the mentioned symptoms or feel sad, stop taking this medicine and consult your doctor immediately, as it may be the first sign of kidney damage or failure
• Psychotic reactions, depression
• Elevated blood pressure, vasculitis
• Palpitations
• Liver dysfunction, liver damage (the first signs may be skin discoloration), especially during long-term treatment, liver insufficiency, acute liver inflammation (hepatitis)
• Blood cell production problems. The first symptoms are: fever, sore throat, superficial ulcers in the mouth, flu-like symptoms, excessive fatigue, nasal and skin bleeding, and unknown hematomas. In these cases, stop treatment immediately and consult your doctor. Do not self-medicate with painkillers or antipyretics
• Severe skin infections and complications of soft tissue during varicella infection
• There has been a description of the worsening of inflammatory conditions related to an infection (e.g., necrotizing fasciitis) associated with the use of some analgesics (NSAIDs). If you experience signs of infection or these worsen, seek medical attention immediately. Antibiotic therapy may be necessary
• There have been reports of symptoms of aseptic meningitis, such as neck stiffness, headache, nausea, vomiting, fever, or disorientation during ibuprofen treatment. It is more likely to affect patients with autoimmune disorders (e.g., SLE, mixed connective tissue disease). If this occurs, contact your doctor immediately
• Severe skin reactions, such as skin eruptions with redness and blisters (e.g., Stevens-Johnson syndrome, erythema multiforme, toxic epidermal necrolysis / Lyell syndrome) or hair loss (alopecia).

Frequency unknown: (cannot be estimated from available data)

• Chest pain, which can be a sign of a potentially severe allergic reaction called Kounis syndrome
• Respiratory tract reactivity, including asthma, bronchospasm, or shortness of breath
• A severe skin reaction known as DRESS syndrome can occur. DRESS syndrome symptoms include: skin rash, lymph node inflammation, and elevated eosinophils (a type of white blood cell)
• Generalized, red, scaly rash with bumps under the skin and blisters, located mainly in skin folds, the trunk, and upper limbs, accompanied by fever at the beginning of treatment (acute generalized pustular psoriasis). Stop taking this medicine if you experience these symptoms and seek immediate medical attention. See section 2
• The skin becomes sensitive to light.

This type of medication may be associated with a small increase in the risk of experiencing a heart attack ("myocardial infarction") or stroke.

Reporting side effects

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

Keep out of sight and reach of children.

Do not use this medicine after the expiry date shown on the packaging after CAD. The expiry date is the last day of the month indicated.

Do not store above 25 °C.

Shelf life after opening the bottle: 6 months.

Medicines should not be disposed of through drains or in the trash. Dispose of packaging and medicines you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medicines. By doing so, you will help protect the environment.

Nurofen pediatric composition:

The active ingredient is ibuprofen. Each milliliter of oral suspension contains 40 mg of ibuprofen.

The other components (excipients) are: citric acid monohydrate, sodium citrate, sodium chloride, sodium saccharin, polisorbate 80, domifen bromide, liquid maltitol, glycerol, xanthan gum, strawberry flavor (which contains propylene glycol) and purified water.

Product appearance and packaging contents

White oral suspension with a strawberry flavor.

It is presented in amber PET bottles of 150 or 200 ml, equipped with a child-resistant closure. The packaging includes a 5 ml dosing syringe, graduated in 1.25, 2.5, 3.75, and 5.0 ml.

Only some packaging sizes may be commercially available.

Marketing authorization holder and manufacturer

Marketing authorization holder:

Reckitt Benckiser Healthcare S.A.

C/ Mataró 28, 08403 Granollers (Barcelona) Spain

Manufacturer:

RB NL Brands B.V.

Schiphol Blvd 207, 1118 BH Schiphol, Netherlands

Last review date of this leaflet:October2024

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/