NUROFEN PEDIATRIC 20 mg/ml ORAL SUSPENSION ORANGE FLAVOR

Introduction

Package Leaflet: Information for the User

Nurofen Pediatric 20 mg/ml Oral SuspensionOrange FlavorIbuprofen

Read the entire package leaflet carefully before starting to take the medicine.

Follow the administration instructions for the medicine contained in this package leaflet or as indicated by your doctor or pharmacist.

• Keep this package 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 side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. See section 4.
• You should consult a doctor if your child's symptoms worsen or do not improve: - after 24 hours in infants from 3 to 5 months and over 5 kg in weight.
• after 3 days in children over 6 months of age and adolescents.

Contents of the Package Leaflet:

1. What is Nurofen Pediatric and what is it used for.2. What you need to know before taking Nurofen Pediatric.3. How to take Nurofen Pediatric.4. Possible side effects.5. Storage of Nurofen Pediatric.6. Package contents and additional information.

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

Nurofen Pediatric contains ibuprofen and belongs 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 high temperature.

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

• fever,
• mild or moderate occasional pain

2. What you need to know before taking Nurofen Pediatric

Do not give this medicine to children who:

• Are allergic (hypersensitive) to ibuprofen, other NSAIDs (e.g., acetylsalicylic acid, naproxen, etc.), or any of the other components of this medicine (listed in section 6). Allergic reactions can be: difficulty breathing or asthma, nasal discharge, swelling of the face, lips, tongue, or hands, or itchy skin rash after taking acetylsalicylic acid or other similar analgesics (NSAIDs).
• Have had a stomach or duodenal ulcer, or have suffered a perforation of the digestive tract.
• Have vomited blood.
• Have black stools or bloody diarrhea.
• Suffer from severe liver or kidney disease.
• Suffer from bleeding disorders or blood coagulation disorders or are taking anticoagulants (medicines used to "thin" the blood), as ibuprofen may increase the duration of bleeding.
• Suffer from severe heart failure.

If you are a woman, you should not use this medicine if you are in the last trimester of pregnancy.

Warnings and Precautions:

You should consult your doctor or pharmacist before starting to give your child this medicine:

• If they have edema (fluid retention).

• If they have asthma or any other respiratory disorder.

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

• If they 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), their doctor may need to perform regular checks.

• If they show symptoms of dehydration, e.g., severe diarrhea or vomiting, they should drink plenty of fluids and contact their doctor immediately, as ibuprofen may cause kidney failure in this case due to dehydration. There is a risk of kidney failure in dehydrated children and adolescents.

• If they have had an ulcer, bleeding, or perforation in the stomach or duodenum, which may be manifested by intense or persistent abdominal pain and/or black stools, even without previous warning symptoms. This risk is higher when high doses are used and when treatment is prolonged, in patients with a history of peptic ulcer, and in elderly patients.

• If they are taking medicines that alter blood coagulation, such as oral anticoagulants (e.g., warfarin) or antiplatelet agents of the acetylsalicylic acid type. They should also discuss the use of other medicines that may increase the risk of such bleeding, such as corticosteroids (e.g., prednisolone) and selective serotonin reuptake inhibitors.

• If they have Crohn's disease (a disease in which the immune system attacks the intestine, causing inflammation that usually produces diarrhea with blood) or ulcerative colitis, as medicines like Nurofen Pediatric may worsen these conditions.

• If they 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.

• If they have acute intermittent porphyria (a metabolic disease that affects the blood and can cause symptoms such as reddish urine color, blood in urine, or liver disease), so that the doctor can assess the convenience or not of treatment with ibuprofen.

• 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 medicine.

• It is possible that allergic reactions may occur with this medicine.

• If they have an infection; see the "Infections" section below.

• During chickenpox, it is advised not to use this medicine.

• The doctor will perform stricter monitoring if they receive ibuprofen after undergoing major surgery.

With ibuprofen, signs of allergic reaction to this medicine have been reported, such as respiratory problems, swelling of the face and neck area (angioedema), and chest pain. Stop using ibuprofen immediately and contact your doctor or the emergency medical service immediately if you observe any of these signs.

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 this medicine 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, a family history of heart disease or stroke, or if you are a smoker.

Similarly, this type of medicine may cause fluid retention, especially in patients with heart failure and/or high blood pressure (hypertension).

Consult your doctor before using this medicine 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 syndrome), acute generalized exanthematous pustulosis (AGEP), have been reported in association with ibuprofen treatment. Discontinue Nurofen treatment 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 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 a doctor without delay.

In case of administration of this medicine to adults:

Elderly Patients

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

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

Precautions during Pregnancy and in Women of Childbearing Age

Because the administration of medicines like Nurofen Pediatric has been associated with an increased risk of congenital anomalies/abortion, it is not recommended to administer it 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 ibuprofen is contraindicated. For women of childbearing age, it should be taken into account that medicines like Nurofen Pediatric have been associated with a decrease in fertility.

Interference with Laboratory Tests

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.

Use of Nurofen Pediatric with Other Medicines

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

Nurofen Pediatric may affect or be affected by other medicines. For example:

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

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

• Anticoagulant medicines (e.g., to treat coagulation problems/prevent coagulation, e.g., acetylsalicylic acid, warfarin, ticlopidine).

• Antiplatelet agents (prevent the formation of blood clots or thrombi in blood vessels) such as ticlopidine.

• Selective serotonin reuptake inhibitors (used in depression).

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

• Diuretics (medicines used to increase urine elimination).

• Lithium (a medicine for depression), your doctor may adjust the dose of this medicine.

• Methotrexate (a medicine for cancer and inflammatory diseases), your doctor may adjust the dose of this medicine.

• Mifepristone (abortion inducer): 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 (to treat intermittent claudication).

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

• Zidovudine (a medicine for AIDS).

• Sulfonylureas (for diabetes).

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

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

• Thrombolytics (medicines that dissolve blood clots).

• Aminoglycoside antibiotics, such as neomycin.

• Quinolone antibiotics, such as norfloxacin.

• Ginkgo biloba tree extracts.

• Colestyramine (to reduce cholesterol levels), as the administration of NSAIDs with colestyramine may delay and reduce the absorption of NSAIDs.

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

• CYP2C9 inhibitors, such as voriconazole and fluconazole (for fungal infections), as these medicines may increase the exposure to NSAIDs.

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

Taking Nurofen 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 upset.

It is not recommended to drink 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 are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

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 and your baby's tendency to bleed and may delay or prolong labor more than expected. Avoid taking ibuprofen during the first 6 months of pregnancy unless your doctor advises you to do so. In these cases, the dose and duration will be limited to the minimum possible. From the 20th week of pregnancy, ibuprofen may cause kidney problems in the 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 you need treatment for more than a few days, your doctor may recommend additional monitoring.

Breastfeeding

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

Female Fertility

Ibuprofen belongs to a group of medicines (NSAIDs) that may affect female fertility. This effect is reversible when the medicine is stopped. Avoid taking this medicine if you are trying to get pregnant.

Driving and Using Machines

If you only take one dose of the medicine or take it for a short period, you do not need to take special precautions.

If you experience dizziness, vertigo, vision changes, or other symptoms while taking this medicine, you should not drive or use hazardous machinery.

Nurofen Pediatric Contains Maltitol Liquid, Sodium, and Wheat Starch.

This medicine 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 medicine.

It may have a slight 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 medicine contains less than 23 mg of sodium (1 mmol) per ml; that is, it is essentially "sodium-free".

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

This medicine contains very low levels of gluten (from wheat starch). It is considered "gluten-free" and 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 have a wheat allergy (different from celiac disease), you should not take this medicine.

3. How to take Nurofen pediatric

Follow the administration instructions of the medication contained in this prospectus or as 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 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:

The dose of ibuprofen to be administered depends on the child's age and weight. As a general rule, the recommended daily dose is 20 to 30 mg of ibuprofen per kg of 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 the symptoms, but it will never be less than 4 hours.

The recommended dose in case of pain and fever is:

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

It is not recommended to use in children under 3 months or with a weight of 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 more suitable presentations for treatment in adults and adolescents over 12 years of age.

Patients with kidney and/or liver disease:

If you have kidney and/or liver disease, your doctor may prescribe a lower dose than usual. If so, take the exact dose that your doctor 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 a period not exceeding 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, a doctor should be consulted 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.

Administration method with the syringe

1. Shake the bottle well.
2. Remove the cap from the bottle by pressing it down and twisting it counterclockwise.
3. Insert the syringe firmly into the port (hole) located on the neck of the bottle.
4. To fill the syringe, invert the bottle. While holding the syringe, gently pull the plunger down until the suspension reaches the appropriate mark on the syringe.
5. Put the bottle back in its normal position and remove the syringe from the port by gently twisting it.
6. Place the end 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. Keep it out of sight and reach of children.

If you take more Nurofen pediatric than you should:

If you or a child accidentally takes 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 find out about the risk and ask for advice on the measures to be taken. It is recommended to take the package and the prospectus of the medication to the healthcare professional.

Symptoms of overdose may include nausea, stomach pain, vomiting (which may contain bloody stools), 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, convulsions (mainly in children), weakness, and dizziness, blood in the urine, low potassium levels in the blood, chills, and breathing difficulties have been reported.

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

Do not take or administer a double dose to make up for missed doses. If you forget to take or administer a dose, do so as soon as you remember and then take the next dose according to the previously indicated administration interval.

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

4. Possible side effects

Like all medications, this medication 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 such a case, or if you have any concerns about this, stop administering/taking this medication and consult your doctor as soon as possible. Elderly patients who use this medication 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 medication and seek medical help immediately if you or your child experience:

• signs of intestinal bleeding, such as: severe abdominal pain, black or tarry stools, vomiting blood or dark particles that look like coffee grounds
• signs of a very rare but severe allergic reaction, such as worsening of asthma, wheezing or unexplained breathing difficulties, swelling of the face, tongue, or throat, difficulty breathing, rapid heartbeat, decreased blood pressure that causes shock. These can occur even with the first use of this medication
• Reddish patches, not elevated, in the form of a target or circular on the trunk, often with blisters in the center, peeling of the skin, mouth ulcers, throat, nose, genitals, and eyes. These severe skin reactions can be preceded by fever and flu-like symptoms (exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis / Lyell syndrome).
• Widespread skin rash, elevated 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).
• Chest pain, which can be a sign of a potentially severe allergic reaction called Kounis syndrome.

Tell your doctor if you experience the following side effects:

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

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

Uncommon: (may 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
• various skin rashes
• hypersensitivity reactions with hives and itching.

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

• tinnitus (ringing in the ears)
• increased urea concentrations in the blood, pain in the sides and/or abdomen, blood in the urine, and fever may be signs of kidney damage (papillary necrosis)
• decrease in hemoglobin levels.

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

• esophagitis, pancreatitis, and formation of intestinal strictures of the diaphragm type
• heart failure, heart attack, 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 above symptoms or if you feel sad, stop taking this medication 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 failure, acute liver inflammation (hepatitis)
• problems with blood cell production, the first symptoms are: fever, sore throat, superficial mouth ulcers, flu-like symptoms, excessive fatigue, nosebleeds, and skin bleeding, and unexplained bruising. In these cases, treatment should be stopped immediately and a doctor should be consulted. Do not self-medicate with pain relievers or antipyretic medications
• severe skin infections and soft tissue complications during chickenpox
• it has been described that the worsening of inflammation related to an infection (e.g., necrotizing fasciitis) is associated with the use of some pain relievers (NSAIDs). If signs of infection or worsening appear, a doctor should be consulted immediately. It should be evaluated if antibiotic therapy is necessary
• symptoms of aseptic meningitis, such as stiff neck, headache, nausea, vomiting, fever, or disorientation, have been observed during ibuprofen treatment. It is more likely to affect patients with autoimmune disorders (e.g., SLE, mixed connective tissue disease). If this happens, contact your doctor immediately
• severe skin reactions, such as skin rashes with redness and blisters (e.g., Stevens-Johnson syndrome, erythema multiforme, toxic epidermal necrolysis / Lyell syndrome), or hair loss (alopecia).

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

• respiratory tract reactivity, including asthma, bronchospasm, or dyspnea
• a severe skin reaction known as DRESS syndrome may occur. The 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 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 medical attention immediately. See also section 2
• the skin becomes sensitive to light.

Medications of this type may be associated with a small increased risk of suffering a heart attack ("myocardial infarction") or a stroke.

Reporting of side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a side effect that does not appear 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 Nurofen pediatric

Keep out of sight and reach of children.

Do not use this medication 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 at a temperature above 30 °C.

Validity period after opening: 6 months.

Medications should not be thrown down the drain or into the trash. Deposit the packages and medications that are no longer needed in the SIGRE point of the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packages and medications that are no longer needed. In this way, you will help protect the environment.

6. Package contents and additional information

Composition of Nurofen pediatric

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

The other components (excipients) are: polysorbate 80, glycerol, liquid maltitol (E-965), xanthan gum, sodium saccharin, citric acid monohydrate, sodium citrate, sodium chloride, orange flavor (which contains wheat starch and potato starch), bromide domiphen and purified water.

Appearance of the product and package contents

Almost white oral suspension with orange flavor.

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

The package contains a 5 ml dosing syringe, graduated in 1, 2, 2.5, 3, 4, and 5 ml.

Only some package sizes may be marketed.

Marketing authorization holder and manufacturer

Holder: Reckitt Benckiser Healthcare S.A. Mataró 2808403 Granollers (Barcelona), Spain

Manufacturer:

RB NL Brands B.V.

Schiphol Blvd 207, 1118 BH Schiphol, Netherlands

Date of the last revision of this prospectus:October 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/