Nurofen Pediatric 20 mg/ml oral suspension, orange flavor

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Nurofen Pediatric 20 mg/ml oral suspension, orange-flavoured Ibuprofen

Read the entire leaflet carefully before you start taking this medicine.

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

Contents of the leaflet:

1. What Nurofen Pediatric is and what it is used for
2. What you need to know before giving Nurofen Pediatric
3. How to take Nurofen Pediatric
4. Possible side effects
5. How to store Nurofen Pediatric
6. Contents of the pack and other information

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

Nurofen paediatric contains ibuprofen and belongs to a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs). These medicines work by altering 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,
• mild to moderate occasional pain

2. What you need to know before starting to give Nurofen paediatric to your child

Do not give this medicine to children who:

• Are allergic (hypersensitive) to ibuprofen, to other NSAIDs (e.g., acetylsalicylic acid, naproxen, etc.), or to any of the other ingredients of this medicine (listed in section 6). Allergic reactions may include: difficulty breathing or asthma, runny nose, swelling of the face, lips, tongue or hands, or itchy skin rash after taking acetylsalicylic acid or other similar painkillers (NSAIDs).
• Have had a stomach or duodenal ulcer or bleeding, or have experienced gastrointestinal perforation.
• Have vomited blood.
• Have black stools or diarrhoea with blood.
• Have severe liver or kidney disease.
• Have bleeding or blood coagulation disorders or are taking anticoagulants (medicines used to "thin" the blood), as ibuprofen could increase the duration of bleeding.
• Have severe heart failure.

If you are a woman, you must 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 this medicine to your child:

• If they have oedema (fluid retention).

• If they suffer from asthma or any other respiratory disorder.

• If they have or have had heart problems or high blood pressure.

• If they have kidney or liver disease, are over 60 years old, or need to take the medicine long-term (more than 1–2 weeks), your doctor may need to carry out regular monitoring.

• If they show signs of dehydration, e.g., severe diarrhoea or vomiting, they should drink plenty of fluids and you should contact your doctor immediately, as ibuprofen in such cases could lead to renal failure as a consequence of dehydration. There is a risk of renal failure in dehydrated children and adolescents.

• If they have had or develop a stomach or duodenal ulcer, bleeding, or perforation, which may present as severe or persistent abdominal pain and/or black stools, even without prior warning symptoms. This risk is higher when high doses are used or treatment is prolonged, in patients with a history of peptic ulcer, and in elderly patients.

• If they are taking medicines that affect blood clotting, such as oral anticoagulants (e.g., warfarin) or antiplatelet agents like acetylsalicylic acid. You should also mention the use of other medicines that could increase the risk of such bleeding, such as corticosteroids (e.g., prednisolone) and selective serotonin reuptake inhibitor (SSRI) antidepressants.

• If they have Crohn's disease (a condition in which the immune system attacks the intestine, causing inflammation that usually results in bloody diarrhoea) or ulcerative colitis, as medicines like Nurofen paediatric may worsen these conditions.

• If they have systemic lupus erythematosus (a chronic disease affecting the immune system that can affect vital organs, the nervous system, blood vessels, skin, and joints), as aseptic meningitis may occur.

• If they have acute intermittent porphyria (a metabolic disorder affecting the blood that may cause symptoms such as reddish urine, blood in urine, or liver disease), so that the doctor can assess whether treatment with ibuprofen is appropriate.

• Treatment with ibuprofen may mask fever, an important sign of infection, making diagnosis more difficult.

• If they suffer headaches after prolonged treatment, do not take higher doses of the medicine.

• Allergic reactions to this medicine are possible.

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

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

• The doctor will carry out stricter monitoring if ibuprofen is given after major surgery.

Signs of allergic reaction to ibuprofen, such as breathing difficulties, 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 notice any of these signs.

Cardiovascular precautions

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

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), have had a heart attack, coronary bypass surgery, peripheral arterial disease (circulation problems in legs or feet due to narrowed or blocked arteries), or any type of stroke (including a “mini-stroke” or transient ischaemic attack “TIA”),
• You have high blood pressure, diabetes, high cholesterol, a family history of heart disease or stroke, or if you are a smoker.

In addition, these types of medicines 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

Serious skin reactions, such as exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS syndrome), and acute generalised exanthematous pustulosis (AGEP), have been reported in association with ibuprofen treatment. Stop treatment with Nurofen and seek immediate medical attention if you notice any symptoms related to these serious skin reactions described in section 4.

Infections

Nurofen paediatric may mask signs of infection, such as fever and pain. Therefore, Nurofen paediatric may delay appropriate treatment of the infection, increasing the risk of complications. This has been observed in bacterial pneumonia and bacterial skin infections associated with chickenpox. If you take this medicine while having an infection and infection symptoms persist or worsen, consult a doctor without delay.

When administering this medicine to adults:

Elderly patients

Elderly patients have a higher risk of adverse events when taking NSAIDs, especially gastrointestinal and intestinal problems. See section 4 ‘Possible side effects’ for more information.

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

Pregnancy and fertility precautions

Because administration of medicines like Nurofen paediatric has been associated with an increased risk of congenital abnormalities/abortion, administration during the first and second trimesters of pregnancy is not recommended unless strictly necessary. In such cases, the dose and duration should be limited to the minimum possible.

Administration of ibuprofen during the third trimester is contraindicated. For women of childbearing age, it should be noted that medicines like Nurofen paediatric have been associated with a reduced ability to conceive.

Interference with laboratory tests

Taking ibuprofen may alter the following laboratory tests:

• Bleeding time (may be prolonged for up to 1 day after stopping treatment)
• Blood glucose concentration (may decrease)
• Creatinine clearance (may decrease)
• Haematocrit or haemoglobin (may decrease)
• Blood urea nitrogen and serum creatinine and potassium concentrations (may increase)
• Liver function tests: increased transaminase values.

Inform your doctor if you are scheduled for clinical testing and are taking or have recently taken ibuprofen.

Use of Nurofen paediatric with other medicines

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

Nurofen paediatric may interact with 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 NSAID-type medicines (including COX-2 inhibitors like celecoxib or etoricoxib).

• Anticoagulant medicines (e.g., to treat or prevent blood clotting, e.g., acetylsalicylic acid, warfarin, ticlopidine).

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

• Selective serotonin reuptake inhibitors (used for depression).

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

• Diuretics (medicines used to increase urine output).

• 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-inducing agent): NSAIDs should not be taken within 8–12 days after using mifepristone.

• Hydantoins such as phenytoin (used to treat epilepsy).

• Sulphonamides such as sulfamethoxazole and cotrimoxazole.

• Pentoxifylline (used to treat intermittent claudication).

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

• Zidovudine (a medicine for treating AIDS).

• Sulfonylureas (for diabetes).

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

• Digoxin and other cardiac glycosides (used to treat heart disorders): ibuprofen may increase plasma concentrations of these drugs.

• Thrombolytics (medicines that dissolve blood clots).

• Aminoglycoside antibiotics such as neomycin.

• Quinolone antibiotics such as norfloxacin.

• Herbal extracts (from the Ginkgo biloba tree).

• Cholestyramine (to reduce cholesterol levels), as administering NSAIDs with cholestyramine may delay and reduce NSAID absorption.

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

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

Other medicines may also interact with or be affected by ibuprofen treatment. Therefore, always consult your doctor or pharmacist before using Nurofen paediatric with other medicines.

Taking Nurofen paediatric with food, drinks, and alcohol

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

Alcohol consumption is not recommended during treatment, as it increases the risk of gastrointestinal adverse 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 medicine.

Pregnancy

Do not take ibuprofen during the last 3 months of pregnancy, as it may cause kidney and heart problems in the unborn baby. It may affect your and your baby's tendency to bleed and may delay or prolong labour. Avoid taking ibuprofen during the first 6 months of pregnancy unless advised by your doctor. In such cases, the dose and duration should be limited to the minimum possible. From week 20 of pregnancy, ibuprofen may cause kidney problems in the unborn baby if taken for more than a few days, leading to low levels of amniotic fluid surrounding the baby (oligohydramnios) or narrowing of a blood vessel (ductus arteriosus) in the baby's heart. If treatment for longer than a few days is needed, 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. Usually, 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 upon discontinuation of the medicine. Avoid taking this medicine if you are trying to become pregnant.

Driving and using machines

If you take only a single dose or use the medicine for a short period, no special precautions are necessary.

If you experience dizziness, vertigo, vision disturbances, or other symptoms while taking this medicine, you should not drive or operate dangerous machinery.

Nurofen Paediatric contains maltitol liquid, sodium, and wheat starch.

This medicine contains liquid maltitol (E-965). If your doctor has diagnosed you with an intolerance to certain sugars, consult them before taking this medicine.

It may have a mild laxative effect because it contains 2.226 g of liquid maltitol (E-965) per 5 ml.

Calorific value: 2.3 kcal/g of maltitol.

This medicine contains less than 23 mg of sodium (1 mmol) per ml; this is essentially “sodium-free”.

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

This medicine 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 coeliac disease.

5 ml contain no more than 0.225 micrograms of gluten.

If you have a wheat allergy (different from coeliac disease), you should not take this medicine.

3. How to take Nurofen Pediatric

Follow exactly the dosing instructions for the medicine contained in this leaflet or those indicated by your doctor or pharmacist. If in 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 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. Generally, the recommended daily dose is 20 to 30 mg of ibuprofen per kg of the child's body 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 body weight. The interval between each dose will depend on the course of symptoms, but must never be less than 4 hours.

The recommended dose for pain and fever is:

*The use of this medicine in children under 2 years of age must always be under medical prescription.

Its use is not recommended in children under 3 months of age or weighing less than 5 kg.

Adolescents (over 12 years of age and weighing more than 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 must not exceed 1,200 mg of ibuprofen in 24 hours.

Due to the amount of ibuprofen contained in this medicine, it is recommended to use other formulations more suitable 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 than usual dose. If so, take exactly the dose prescribed by your doctor.

In infants between 3 and 5 months of age weighing more than 5 kg:

Medical advice should be sought if symptoms worsen or if symptoms persist for longer than 24 hours.

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

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

In patients with a sensitive stomach, it is recommended to take the medicine during meals.

Administration method using the syringe

1. Shake the bottle well.
2. Remove the cap by pressing it downwards and turning it counterclockwise.
3. Firmly insert the syringe into the port (opening) located in 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 upright position and remove the syringe from the port by gently twisting it.
6. Place the tip of the syringe into the child's mouth. Press the plunger slowly to gently release the suspension. Replace the cap after use. Wash the syringe with lukewarm water and allow it to dry. Store it out of sight and reach of children.

If you take more Nurofen paediatric than you should:

If you accidentally take or administer more medicine than prescribed, or if a child has accidentally ingested the medicine, consult a doctor immediately or call the Toxicology Information Service at telephone number 915620420, indicating the medicine and the amount used, or go to the nearest hospital to learn about the risks and obtain advice on the measures to be taken. It is recommended to bring the medicine's packaging and leaflet to the healthcare professional.

Symptoms of overdose may include nausea, stomach pain, vomiting (which may contain blood-stained sputum), headache, blurred vision, ringing in the ears, confusion, and involuntary eye movements. At high doses, gastrointestinal bleeding, hypotension, changes in blood composition, drowsiness, chest pain, palpitations, loss of consciousness, seizures (mainly in children), weakness, dizziness, blood in the urine, low blood potassium levels, chills, and breathing difficulties have been reported.

If you forget to take or give your child Nurofen paediatric:

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

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

4. Possible adverse effects

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

Adverse 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 adverse effects of NSAIDs. In such a case, or if you have any concerns, stop taking/administering this medicine and consult your doctor as soon as possible. Elderly patients using this medicine are at greater risk of developing problems associated with adverse effects.

The incidence of adverse effects is lower with short-term treatment and when the daily dose is below the maximum recommended dose.

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

• signs of gastrointestinal bleeding, such as severe abdominal pain, black or tarry stools, vomiting blood or dark particles resembling ground coffee
• signs of a 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, or a drop in blood pressure causing shock. These may occur even with the first use of this medicine
• Non-elevated red skin lesions, target-shaped or circular, on the trunk, often with blisters in the center, skin peeling, mouth, throat, nose, genital or eye ulcers. These serious skin rashes may be preceded by fever and flu-like symptoms (exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis).
• Generalized skin rash, high 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 beginning of treatment (acute generalized exanthematous pustulosis).
• Chest pain, which may be a sign of a potentially serious allergic reaction called Kounis syndrome.

Inform your doctor if you experience the following adverse effects:

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

• stomach problems such as heartburn, stomach pain, nausea, indigestion, diarrhea, vomiting, flatulence (gas), constipation, and minor blood loss in the stomach and/or intestine, which may exceptionally lead to anemia.

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 bowel disease (ulcerative colitis or Crohn's disease), gastritis
• disorders of the central nervous system 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 levels, 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 development of diaphragm-type intestinal strictures
• heart failure, heart attack, and swelling of the face and hands (edema)
• reduced 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) which may lead to acute kidney failure. If you experience any of the symptoms mentioned above, or if you feel sad, stop taking this medicine and consult your doctor immediately, as these may be early signs of kidney damage or failure
• psychotic-type reactions, depression
• high blood pressure, vasculitis
• palpitations
• liver dysfunction, liver damage (early signs may include skin discoloration), especially during long-term treatment, liver failure, acute inflammation of the liver (hepatitis)
• problems with blood cell production, early symptoms being: fever, sore throat, superficial mouth ulcers, flu-like symptoms, excessive tiredness, nosebleeds and skin bleeding, and unexplained bruising. In such cases, treatment must be stopped immediately and your doctor consulted. Do not self-medicate with painkillers or fever-reducing medicines (antipyretics)
• severe skin infections and soft tissue complications during chickenpox infection
• worsening of infections-related inflammation (e.g., necrotizing fasciitis) has been associated with the use of some painkillers (NSAIDs). If signs of infection appear or worsen, seek medical help immediately. Antibiotic therapy should be evaluated
• symptoms of aseptic meningitis such as neck stiffness, headache, nausea, vomiting, fever, or disorientation have been observed during treatment with ibuprofen. This is more likely to affect patients with autoimmune disorders (e.g., SLE, mixed connective tissue disease). If this occurs, contact your doctor immediately
• severe forms of skin reactions such as skin rashes with redness and blisters (e.g., Stevens-Johnson syndrome, erythema multiforme, toxic epidermal necrolysis / Lyell's 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. Symptoms of DRESS syndrome include: skin rash, swollen lymph nodes, and elevated eosinophils (a type of white blood cells)
• widespread red, scaly rash with bumps under the skin and blisters, mainly located in skin folds, trunk, and upper limbs, accompanied by fever at the beginning of treatment (acute generalized exanthematous pustulosis). Stop taking this medicine if you experience these symptoms and seek immediate medical attention. See also section 2
• skin becomes sensitive to light.

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

Reporting of adverse effects

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

5. Storage of Nurofen Pediatric

Keep out of sight and reach of children.

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.

Do not store above 30 °C.

Validity period after opening: 6 months.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused containers and medicines at the SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to properly dispose of unused containers and medicines. This helps protect the environment.

6. Contents of the container and additional information

Composition of Nurofen Paediatric:

The active substance 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, monohydrate citric acid, sodium citrate, sodium chloride, orange flavour (containing wheat starch and potato starch), domiphen bromide, and purified water.

Appearance of the product and contents of the container

White or almost white oral suspension with an orange flavour.

It is presented in amber-coloured PET bottles of 100, 150 or 200 ml, equipped with child-resistant closures.

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

Only some pack sizes may be commercially available.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder:
Reckitt Benckiser Healthcare S.A.
Paseo de Gracia, 9, 08007, Barcelona, Spain

Manufacturer:
RB NL Brands B.V.
Schiphol Blvd 207, 1118 BH Schiphol, Netherlands

Date of the most recent revision of this summary: October 2024

Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS): http://www.aemps.gob.es/