Leaflet: information for the user

Nurofen paediatric 20 mg/ml oral suspensionflavourorange
Ibuprofen

Read this leaflet carefully before you start taking the medicine.

Follow exactly the administration instructions of the medicine contained in this leaflet or those 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.
-Ifyouoryourchildexperienceadverse effects,,consultyourdoctororpharmacist, even if it is about adverse effects that do not appear in this leaflet. See section 4.

-Youshouldconsultadoctorifthesymptomsofyourchildworsenordo not improve:
-after24hoursininfantsof3to5monthsandmorethan5kgofweight.

-after3daysinchildrenolderthan6monthsofage and adolescents.

1.What is Nurofen paediatric and for what it is used.
2.What you need to know before starting to take Nurofen paediatric.
3.HowtotakeNurofen paediatric.
4.Possible adverse effects.
5.Storage of Nurofen paediatric.
6.Contents of the package 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

Do not administer this medication to children who:

• Are allergic (hypersensitive) to ibuprofen, other NSAIDs (e.g., acetylsalicylic acid, naproxen, etc.), or any other component 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 had a stomach ulcer or bleeding, or have suffered from perforation of the digestive tract.
• Have vomiting with blood.
• Have black stools or diarrhea with blood.
• Have a severe liver or kidney disease.
• Have bleeding or clotting 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 they have edema (fluid retention).

• If they have asthma or any other respiratory disorder.

• If they have or have had any heart disorder or have high blood pressure.

• If they have kidney or liver disease, are over 60 years old, 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 they present symptoms of dehydration, such as severe diarrhea or vomiting, they should take plenty of fluid and immediately contact their doctor, as ibuprofen in this case may cause kidney failure as a consequence of dehydration. There is a risk of kidney failure in dehydrated children and adolescents.

• Have had or develop a stomach 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 treatment, in patients with a history of peptic ulcer disease, and in elderly patients.

• If they are taking medications that alter blood clotting, such as oral anticoagulants (e.g., warfarin) or antiplatelet agents (e.g., acetylsalicylic acid). They should also inform their 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 they have Crohn's disease (a disease in which the immune system attacks the intestine, causing inflammation that usually results in bloody diarrhea) or ulcerative colitis, as ibuprofen may worsen these conditions.

• If they 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 aseptic meningitis.

• If they have intermittent acute porphyria (a metabolic disorder that affects the blood and can cause symptoms such as red urine, blood in urine, or liver disease), so their doctor can assess the convenience 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 they experience headaches after prolonged treatment, they should not take higher doses of the medication.

• There may be allergic reactions to this medication.

• If they have an infection; see the "Infections" heading later.

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

• The doctor will perform a more stringent check if ibuprofen is received after major surgery.

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

Cardiovascular precautions:

Nonsteroidal anti-inflammatory drugs (NSAIDs) like ibuprofen may be associated with a small increase in the risk of heart attack or stroke, especially when used in high doses. Do not exceed the recommended dose or treatment duration.

You should inform your doctor or pharmacist before taking this medication if:

• You have heart problems, including heart failure, angina (chest pain), or have had a heart attack, coronary artery bypass surgery, peripheral artery disease (problems with circulation 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 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 may mask the signs of an infection, such as fever and pain. Consequently, Nurofen pediatric may delay or prolong the appropriate treatment of the infection, which may increase the risk of complications. This has been observed in pneumonia caused by bacteria and bacterial skin infections related to chickenpox. If you take this medication while having an infection and the infection symptoms persist or worsen, consult a doctor without delay.

In case of administration of this medication in adults:

Older patients

Older patients have 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.

Precautions during pregnancy and in fertile women:

Due to the association of ibuprofen with an increased risk of congenital anomalies/abortion, it is not recommended to administer it during the first and second trimesters of pregnancy unless strictly necessary. In these cases, the dose and duration will be limited to the minimum possible.

In the third trimester, the administration of ibuprofen is contraindicated. For fertile women, it should be noted that ibuprofen has been associated with a decrease in the ability to conceive.

Interference with laboratory tests:

The use of ibuprofen may alter the following laboratory tests:

• Bleeding time (may be prolonged for 1 day after discontinuing treatment)
• Blood glucose concentration (may decrease)
• Creatinine clearance (may decrease)
• Hematocrit or hemoglobin (may decrease)
• Blood concentrations of urea nitrogen and serum concentrations of creatinine and potassium (may increase)
• With liver function tests: increased values of transaminases.

Inform your doctor if you are to undergo a clinical analysis 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, even those purchased without a prescription.

Nurofen pediatric 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 NSAID-type medications (including COX-2 inhibitors such as celecoxib or etoricoxib).

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

• Antiplatelet agents (prevent blood clots in blood vessels) such as ticlopidine.

• Selective serotonin reuptake inhibitors (used in depression).

• Medications that lower blood pressure (ACE inhibitors, such as captopril, beta-blockers, such as atenolol, and angiotensin II receptor antagonists, such as losartan).

• Diuretics (medications used to increase urine elimination).

• Lithium (a medication for depression), possibly your doctor will adjust the dose of this medication.

• Methotrexate (a medication for cancer and inflammatory diseases), possibly your doctor will adjust the dose of this medication.

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

• Hydantoins such as phenytoin (used in the treatment of epilepsy).

• Sulfonamides such as sulfamethoxazole and cotrimoxazole.

• Pentoxifylline (for intermittent claudication).

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

• Zidovudine (a medication for HIV/AIDS).

• Sulfonylureas (for diabetes).

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

• Digoxin and other cardiac glycosides (used in heart disease treatment): ibuprofen may increase the plasma concentrations of these medications.

• Fibrinolytics (medications that dissolve blood clots).

• Aminoglycoside antibiotics such as neomycin.

• Quinolone antibiotics such as norfloxacin.

• Herbal extracts (from the Ginkgo biloba tree).

• Colestiramine (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 such as voriconazole and fluconazole (for fungal infections), as these medications may increase exposure to NSAIDs.

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

Taking Nurofen pediatric with food, drinks, 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 recommend taking alcohol during treatment as it increases the risk of gastrointestinal side effects.

Pregnancy, breastfeeding, and fertility:

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become 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 unless your doctor advises it. 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 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 a period longer than a few days, your doctor may recommend additional checks.

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, sodium, and wheat starch.

This medication contains maltitol liquid (E-965). If your doctor has told you that you have an intolerance 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 less than 23 mg of sodium (1 mmol) per ml; it is essentially "sodium-free".

For patients over 9 years/30 kg, this medication contains 27.24 mg of sodium (main component of table salt/for cooking) in each 15 ml. This is equivalent to 1.36% of the recommended daily maximum sodium intake for an adult.

This medication contains very low levels of gluten (from wheat starch). It is considered "gluten-free", and it is very unlikely to cause problems if you have celiac disease.

5 ml do not contain more than 0.225 micrograms of gluten.

If you are allergic to wheat (other than celiac disease), do not take this medication.

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 lowest effective dose should be used for the shortest duration necessary to relieve symptoms. If you have an infection, consult a doctor promptly 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 10-20 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 he has prescribed.

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

In infants from 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 of the medication 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 doubts 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. Patients of advanced age who use this medicine are at a higher risk of developing problems associated with side effects.

The incidence of side effects is lower in short 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: intense abdominal pain, black or tar-like stools, vomiting with blood or dark particles that resemble ground coffee
• signs of a very rare but severe allergic reaction, such as worsening of asthma, wheezing or unknown respiratory impairment, swelling of the face, tongue or throat, difficulty breathing, rapid heartbeat, decreased blood pressure leading to shock. These can occur even with the first use of this medicine
• Flat red spots, in the shape of a target or circles 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 eruption, elevated body temperature, and swollen lymph nodes (DRESS syndrome)
• Generalized red and scaly eruption, with protuberances under the skin and blisters, accompanied by fever. Symptoms usually appear at the beginning of treatment (acute generalized pustular psoriasis)
• Chest pain, which can be a sign of a potentially severe allergic reaction called Kounis syndrome

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 headache, 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, which can 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 intestinal stenosis of the diaphragm type
• Heart failure, myocardial infarction, and swelling of the face and hands (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 signs of kidney damage or failure
• Psychotic reactions, depression
• High blood pressure, vasculitis
• Palpitations
• Liver dysfunction, liver damage (the first signs may be skin discoloration), especially during long-term treatment, liver insufficiency, acute inflammation of the liver (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 analgesics 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 signs of infection appear or 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 treatment with ibuprofen. 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)

• Respiratory tract reactivity, including asthma, bronchospasm, or dyspnea
• A severe skin reaction known as DRESS syndrome can occur. DRESS syndrome symptoms include: skin eruption, lymph node inflammation, and elevated eosinophils (a type of white blood cell)
• Generalized red and scaly eruption, with bumps under the skin and blisters, mainly located 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 of side effects

If you experiencenany type of side effect, consult your doctor, pharmacist, or nurse, even if it is not listed in this prospectus. 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 expiration date that appears on the box after CAD. The expiration date is the last day of the month indicated.

Do not store above 86°F (30°C).

Shelf life after opening: 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 of the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and medicines you no longer need. By doing so, you will help protect the environment.

Composition of Nurofen pediatric:

The active ingredient is ibuprofen.Each milliliter of oral suspension contains 20 mg of ibuprofen.

The other components(excipients)are;polysorbate 80, glycerol, maltitolliquid (E-965), xanthan gum, sodium saccharin, citric acid monohydrate, sodium citrate, sodium chloride,orange aromacontaining wheat starch and potato starch, domifen bromideandpurified water.

Appearance of the product and contents of the packaging

White oral suspension with orange flavor.

It is presented in amber PET bottles of 100, 150 or 200 ml, provided with a child-resistant closure.

The packaging contains a 5 ml dosing syringe, graduated in1,2,2.5,3,4and 5 ml.

Only some sizes of packaging may be commercially available.

Marketing authorization holder and responsible manufacturer

Title:
Reckitt Benckiser Healthcare S.A.
Mater 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/