NUROFEN PEDIATRIC 40 mg/ml ORAL SUSPENSION STRAWBERRY FLAVOR

Introduction

Package Leaflet: Information for the User

Nurofen Pediatric 40 mg/ml Oral Suspension Strawberry Flavor

Ibuprofen

Read the package leaflet carefully before starting to take this medication, as it contains important information for you.

Follow the administration instructions for the medication 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 side effects not listed in this package leaflet. See section 4.
• You should consult a doctor if your symptoms or those of your child 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 Nurofen Pediatric is and what it is 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

Contents of the pack and additional information

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

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

This medication 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

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

Do not administer this medication to children who:

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Warnings and precautions:

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

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Cardiovascular precautions

Anti-inflammatory/analgesic medications 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 medication if:

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

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), and acute generalized exanthematous pustulosis (AGEP), have been reported in association with ibuprofen treatment. Discontinue treatment with Nurofen and seek immediate medical attention if you notice any 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 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 medication while having an infection and the symptoms of the infection persist or worsen, consult your doctor without delay.

In case of administration of this medication to adults:

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 during the early stages of treatment.

Precautions during pregnancy and in women of childbearing age

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

Interference with laboratory tests

Taking ibuprofen may alter the following laboratory tests:

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

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Other medications 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 medications.

Taking Nurofen Pediatric with food, drinks, and alcohol

It is recommended to take this medication 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 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 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 medication 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 medications (NSAIDs) that may affect female fertility. This effect is reversible upon discontinuation of the medication. Avoid taking this medication if you are trying to become pregnant.

Driving and using machines

If you only take one dose of the medication or take it for a short period, it is not necessary to take special precautions.

If you experience dizziness, vertigo, vision changes, 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 have an intolerance to certain sugars, consult with them before taking this medication. It may have 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 less than 4 weeks old, consult your doctor or pharmacist, especially if the baby has been given other medications that contain propylene glycol or alcohol.

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

3. How to take Nurofen Pediatric

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

For oral use.

Use the lowest effective dose for the shortest necessary duration to alleviate symptoms. If you have an infection, consult your doctor without delay if the 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 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 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 this medication in children under 3 months or weighing 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 treatment in adults and adolescents over 12 years.

Patient 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 a weight over 5 kg:

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, consult your 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 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. Return the bottle to its normal position and remove the syringe from the port by gently turning 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 take or accidentally administer more medication than you should, or if a child has ingested the medication accidentally, consult your doctor 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 package 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 forget to take or give Nurofen Pediatric to your child:

Do not take or administer a double dose to make up for forgotten 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 Adverse Effects

Like all medicines, this medicine can cause adverse effects, although not all people suffer from them.

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

The incidence of adverse 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 medical help immediately if you or your child present:

• signs of intestinal bleeding, such as: severe abdominal pain, black or tarry stools, vomiting blood or dark particles that resemble ground coffee beans
• signs of a very rare but severe allergic reaction, such as worsening 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 medicine
• Bull's-eye or circular red patches on the torso, 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 (exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis).
• Widespread rash, elevated body temperature, and swollen lymph nodes (DRESS syndrome).

Widespread, red, scaly rash, with bumps under the skin and blisters, accompanied by fever. Symptoms usually appear at the start of treatment (acute generalized exanthematous pustulosis).

Inform your doctor if you present the following adverse 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 minor stomach and/or intestinal bleeding 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 ulcers, 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 blood urea concentrations, pain in the sides and/or abdomen, blood in the urine, and fever may be signs of kidney damage (papillary necrosis)
• decreased hemoglobin levels.

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

• esophagitis, pancreatitis, and intestinal stenosis formation
• heart failure, heart attack, and swelling of the face and hands (edema)
• decreased urine output and inflammation (especially in patients with hypertension or reduced kidney function), swelling (edema), and cloudy urine (nephrotic syndrome), inflammatory kidney disease (interstitial nephritis) that can lead to acute kidney failure. If you experience any of the above symptoms or have a feeling of sadness, 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 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 bruises of unknown origin. In these cases, you should stop treatment immediately and consult your doctor. You should not self-medicate with pain relievers or antipyretic medications
• severe skin infections and soft tissue complications during chickenpox infection
• worsening of inflammation-related infections (e.g., necrotizing fasciitis) associated with the use of some pain relievers (NSAIDs). If signs of infection appear or worsen, you should see a doctor immediately. It should be evaluated whether antibiotic therapy is necessary
• symptoms of aseptic meningitis, such as stiff neck, 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 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)

• chest pain, which may be a sign of a potentially severe allergic reaction called Kounis syndrome
• 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, lymph node inflammation, and elevated eosinophils (a type of white blood cell)
• widespread, red, scaly rash, with bumps under the skin and blisters, mainly on the skin folds, torso, and upper limbs, accompanied by fever at the start of treatment (acute generalized exanthematous pustulosis). Stop taking this medicine if you present these symptoms and seek medical attention immediately. See also section 2
• skin becomes sensitive to light.

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

Adverse Effect Reporting

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is an adverse effect that does not appear in this leaflet. You can also report them directly through the Spanish Medicines and Healthcare Products Agency (AEMPS) website (https://www.notificaram.es). By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Conservation of Nurofen Pediatric

Keep out of sight and reach of children.

Do not use this medicine after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Do not store above 25 °C.

Validity period after opening the bottle: 6 months.

Medicines should not be thrown away through wastewater or household waste. Deposit the packaging and medicines you no longer need at the pharmacy's SIGRE point. In case of doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This way, you will help protect the environment.

6. Package Contents and Additional Information

Nurofen Pediatric Composition:

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

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

Product Appearance and Package Contents

Almost white oral suspension with strawberry flavor.

It is presented in 150 or 200 ml amber PET bottles, 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 package sizes may be marketed.

Marketing Authorization Holder and Manufacturer

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

Date of the Last Revision of this Leaflet:October 2024

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