Nurofen dla dzieci Iunior pomaranihovi

Leaflet attached to the packaging: information for the user

Nurofen for Children Junior Orange

40 mg/ml, oral suspension
Ibuprofen
For children weighing from 20 kg (6 years) to 40 kg (12 years)

You should carefully read the contents of the leaflet before using the medicine, as it contains important information for the patient.

• This medicine should always be used exactly as described in the patient leaflet or as directed by your doctor or pharmacist.
• You should keep this leaflet, so you can read it again if you need to.
• If you need advice or more information, you should talk to your pharmacist.
• If the patient experiences any side effects, including any possible side effects not listed in the leaflet, you should tell your doctor or pharmacist. See section 4.
• If after 3 days there is no improvement or the patient feels worse, you should contact your doctor.

Table of contents of the leaflet:

• 1. What is Nurofen for Children Junior Orange and what is it used for
• 2. Important information before using Nurofen for Children Junior Orange
• 3. How to use Nurofen for Children Junior Orange
• 4. Possible side effects
• 5. How to store Nurofen for Children Junior Orange
• 6. Contents of the packaging and other information

1. What is Nurofen for Children Junior Orange and what is it used for

Ibuprofen belongs to a group of medicines called Non-Steroidal Anti-Inflammatory Drugs (NSAIDs). The action of these medicines is to change the body's response to pain and high body temperature. Nurofen for Children Junior Orange is intended for short-term, symptomatic treatment of:

• fever,
• pain of mild to moderate severity.

If after 3 days there is no improvement or the patient feels worse, you should contact your doctor.

2. Important information before using Nurofen for Children Junior Orange

When not to use Nurofen for Children Junior Orange

• If the child is allergic to ibuprofen or other similar painkillers (NSAIDs) or any of the other ingredients of this medicine (listed in section 6).
• If the child has ever had breathing difficulties, asthma, hay fever, swelling of the face and/or hands or hives after taking acetylsalicylic acid or other similar painkillers (NSAIDs).
• If the child has ever had bleeding or perforation of the gastrointestinal tract associated with previous use of NSAIDs.
• If the child currently has or has had stomach or duodenal ulcers (ulcer disease) or bleeding (two or more confirmed cases of ulcers or bleeding).
• If the child has severe liver or kidney failure.
• If the child has severe heart failure.
• If the child has had bleeding in the brain (cerebral hemorrhage) or other active bleeding.
• If the child has blood clotting disorders, as ibuprofen may prolong bleeding time.
• If the child has blood production disorders of unknown origin.
• In children with severe dehydration (caused by vomiting, diarrhea, or insufficient fluid intake).

Do not take the medicine in the last 3 months of pregnancy.

Warnings and precautions

Before starting treatment with Nurofen for Children Junior Orange, you should discuss it with your doctor or pharmacist.

• If the child has an infection - see below, "Infections".
• If the child has certain inherited blood disorders (e.g., acute intermittent porphyria).
• If the child has blood clotting disorders.
• If the child has certain skin diseases (systemic lupus erythematosus (SLE) or mixed connective tissue disease).
• If the child has intestinal diseases (ulcerative colitis or Crohn's disease), as their symptoms may worsen.
• If the child has had or currently has high blood pressure and/or heart failure.
• If the child has kidney function disorders.
• If the child has liver diseases. With long-term use of Nurofen for Children Junior Orange, regular monitoring of liver function, kidney function, and blood morphology parameters is required.
• It is recommended to exercise caution when using other medicines that may increase the risk of gastrointestinal ulcers or bleeding, such as oral corticosteroids (e.g., prednisolone), blood thinners (e.g., warfarin), selective serotonin reuptake inhibitors (antidepressants), and antiplatelet agents (e.g., acetylsalicylic acid). If the child is taking other NSAIDs (including COX-2 inhibitors such as celecoxib or etoricoxib), you should avoid concurrent use of these medicines.
• The occurrence of side effects can be reduced by using the smallest effective dose for the shortest duration necessary to relieve symptoms.
• Generally, continuous use of (various) painkillers can lead to persistent serious kidney disease. This risk may increase during physical exertion associated with salt loss and dehydration. Therefore, you should avoid this.
• As a result of long-term use of any type of painkillers, headaches may occur, which should not be treated with increased doses of this medicine. In such a case, the medicine should be discontinued and a doctor consulted. The diagnosis of a headache caused by drug abuse should be suspected in patients who have frequent or daily headaches despite (or due to) regular use of pain-relieving medications.
• If the child has had or currently has asthma or allergic diseases that can cause shortness of breath.
• If the child has hay fever, nasal polyps, chronic obstructive pulmonary disease, there is an increased risk of allergic reactions. Allergic reactions can occur as asthma attacks (so-called aspirin-induced asthma), Quincke's edema, or hives.
• You should avoid using Nurofen for Children Junior Orange in case of chickenpox (varicella).
• If the child has recently undergone major surgery (medical supervision is required).
• If the child is dehydrated, due to increased risk of kidney failure in dehydrated children.

Infections
Nurofen for Children Junior Orange may mask the symptoms of infection, such as fever and pain. Therefore, Nurofen for Children Junior Orange may delay the use of appropriate infection treatment and consequently lead to increased risk of complications. This has been observed in bacterial pneumonia and bacterial skin infections associated with chickenpox. If the patient is taking this medicine during an infection and the symptoms of the infection persist or worsen, you should immediately consult a doctor.
Skin reactions
Severe skin reactions have been reported with ibuprofen use, 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). If the patient experiences any of the symptoms associated with these severe skin reactions described in section 4, you should immediately discontinue Nurofen for Children Junior Orange and seek medical attention.
Gastrointestinal bleeding, ulcers, or perforation, which can be fatal, have been reported during treatment with all NSAIDs with or without warning symptoms or in patients with a history of serious gastrointestinal disorders. If gastrointestinal bleeding or ulcers occur, treatment should be discontinued immediately. The risk of gastrointestinal bleeding, ulcers, or perforation increases with increasing doses of NSAIDs in patients with a history of ulcers, especially with bleeding or perforation (see section 2 "When not to use Nurofen for Children Junior Orange") and in the elderly. These patients should start treatment with the lowest effective dose. For these patients and patients requiring concurrent use of low-dose acetylsalicylic acid or medications that increase the risk of gastrointestinal reactions, consideration should be given to concomitant use with protective agents (e.g., misoprostol or proton pump inhibitors).
Taking anti-inflammatory and pain-relieving medications, such as ibuprofen, may be associated with a small increased risk of heart attack or stroke, particularly when used in high doses.
Do not exceed the recommended dose and duration of treatment.
Before using Nurofen for Children Junior Orange, the patient should discuss treatment with their doctor or pharmacist if:

• the patient has heart disease, such as heart failure, angina pectoris (chest pain), has had a heart attack, coronary artery bypass grafting, has peripheral arterial disease (poor circulation in the legs due to narrowing or blockage of arteries), or has had any stroke (including mini-stroke or transient ischemic attack - TIA). The patient has high blood pressure, diabetes, high cholesterol levels, has a family history of heart disease or stroke, or smokes.

Also, some other medicines may be affected or have an effect on Nurofen for Children Junior Orange treatment. Therefore, before using Nurofen for Children Junior Orange with other medicines, you should always consult your doctor or pharmacist.
In particular, you should inform your doctor if the patient is taking the following medicines:
Other NSAIDs, including COX-2 inhibitors, as the risk of side effects may increase.
Digoxin (a medicine used for heart failure), as the effect of digoxin may be enhanced.
Corticosteroids (medicines containing cortisone or similar substances), as the risk of stomach ulcers and bleeding may increase.
Antiplatelet agents, as the risk of bleeding may increase.
Acetylsalicylic acid (low doses), as the blood-thinning effect may be weakened.
Blood thinners (e.g., warfarin), as ibuprofen may enhance the effect of these medicines.
Phenytoin (a medicine used to treat epilepsy), as the effect of phenytoin may be enhanced.
Selective serotonin reuptake inhibitors (antidepressants), as they may increase the risk of gastrointestinal bleeding.
Lithium (a medicine used to treat manic-depressive disorders and depression), as the effect of lithium may be enhanced.
Probenecid and sulfinpyrazone (a medicine used to treat gout), as the excretion of ibuprofen may be delayed.
Blood pressure-lowering medicines and diuretics, as ibuprofen may weaken the effect of these medicines and may increase the risk of kidney function deterioration.
Potassium-sparing diuretics, such as amiloride, potassium canrenoate, spironolactone, and triamterene, as hyperkalemia may occur.
Methotrexate (a medicine used to treat cancer and rheumatism), as the effect of methotrexate may be enhanced.
Tacrolimus and cyclosporin (immunosuppressive agents), as kidney damage may occur.
Zidovudine (in HIV/AIDS treatment), as the use of Nurofen may increase the risk of intracranial bleeding or bleeding leading to edema in HIV-positive patients with hemophilia.
Sulfonylurea derivatives (oral antidiabetic medicines), as they may affect blood sugar levels.
Quinolone antibiotics, as the risk of seizures may increase.
Voriconazole and fluconazole (CYP2C9 inhibitors, used in fungal infections), as the effect of ibuprofen may be enhanced; consideration should be given to reducing the ibuprofen dose, especially when using high doses of ibuprofen with voriconazole or fluconazole.
Baclofen, as baclofen toxicity may develop after ibuprofen administration.
Ritonavir, as ritonavir may increase the plasma concentration of NSAIDs.
Aminoglycosides, as NSAIDs may increase the excretion of aminoglycosides.

Nurofen for Children Junior Orange and alcohol

Do not consume alcohol while using Nurofen for Children Junior Orange. Some side effects, such as those related to the gastrointestinal tract or central nervous system, may be more likely when taking alcohol and Nurofen for Children Junior Orange concurrently.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before using this medicine.
Pregnancy
Do not use this medicine during the last 3 months of pregnancy. Use may cause kidney and heart problems in the unborn child. It may also affect the patient's and their child's tendency to bleed and may prolong or delay labor. Avoid using this medicine during the first 6 months of pregnancy, unless the doctor recommends otherwise. Taking ibuprofen for more than a few days after the start of the 20th week of pregnancy may cause kidney problems in the unborn child and lead to low levels of amniotic fluid surrounding the child (oligohydramnios) or narrowing of the ductus arteriosus in the child's heart. If necessary, the doctor may recommend additional monitoring during longer treatment.
Breastfeeding
Only small amounts of ibuprofen and its breakdown products pass into breast milk. Nurofen for Children Junior Orange can be used during breastfeeding if administered in recommended doses and for the shortest possible duration.
Fertility
Nurofen for Children Junior Orange belongs to a group of medicines (NSAIDs) that may affect fertility in women. This effect is temporary after stopping the medicine.

Driving and using machines

During short-term use, the medicine does not affect or has a negligible effect on the ability to drive and use machines.

• Nurofen for Children Junior Orange contains liquid maltitol. If the patient has previously been diagnosed with intolerance to some sugars, they should consult their doctor before taking the medicine.
• The medicine may have a mild laxative effect.
• The caloric value for maltitol is: 2.3 kcal/g. Nurofen for Children Junior Orange contains less than 1 mmol of sodium (23 mg) per dose, so the medicine is considered "sodium-free".
• This medicine contains very small amounts of gluten (from wheat starch) and is considered "gluten-free". Therefore, it is very unlikely to cause problems in patients with celiac disease.
• One 5 ml dose contains no more than 0.315 micrograms of gluten.
• Patient with a wheat allergy (other than celiac disease) should not use this medicine.

3. How to use Nurofen for Children Junior Orange

Nurofen for Children Junior Orange should always be used exactly as described in the patient leaflet or as directed by your doctor or pharmacist. In case of doubt, you should consult your doctor or pharmacist.

Use the smallest effective dose for the shortest duration necessary to relieve symptoms.
If the child's symptoms (such as fever and pain) persist or worsen during an infection, you should immediately consult a doctor (see section 2).

Recommended dose for pain and fever:

*Doses should be given every 6 to 8 hours.

Do not recommend for children under 6 years of age or weighing less than 20 kg.

In patients with sensitive stomachs, it is recommended to take Nurofen for Children Junior Orange with food.
WARNING: do not exceed the recommended dose.

For oral use

Method of administration using a measuring spoon

• 1. Shake the bottle well.
• 2. Use the end of the measuring spoon suitable for the required dose.
• 3. Pour the medicine into the measuring spoon.
• 4. Place the measuring spoon in the child's mouth and administer the dose.
• 5. After use, close the bottle. Wash the measuring spoon in warm water and let it dry. Store it out of reach and sight of children.

Duration of treatment

This medicine is intended for short-term use only.If the child's symptoms persist for more than 3 days or the patient feels worse, you should consult a doctor.

If you have taken more than the recommended dose of Nurofen for Children Junior Orange:

If the patient has taken a larger dose than recommended of Nurofen for Children Junior Orange or if the child has accidentally taken the medicine, you should always consult a doctor or go to the nearest hospital to get an opinion on possible health risks and advice on what to do in such a case.
Symptoms of overdose may include nausea, stomach pain, vomiting (which may contain blood), gastrointestinal bleeding, headache, ringing in the ears, disorientation, and nystagmus or, less commonly, balance disorders, vision disorders, low blood pressure, excitement, disorientation, coma, hyperkalemia, metabolic acidosis, increased prothrombin time/INR, acute kidney failure, liver damage, respiratory depression, cyanosis, and worsening of asthma in asthmatic patients, drowsiness, chest pain, palpitations, loss of consciousness, seizures (mainly in children), weakness, and dizziness, blood in the urine, low potassium levels in the blood, feeling cold, and breathing difficulties.

Missed dose of Nurofen for Children Junior Orange:

Do not take a double dose to make up for a missed dose. If the patient forgets to take or administer a dose, it should be taken or administered after remembering, and then the next dose should be taken or administered according to the dosing interval described above.

In case of further doubts about using this medicine, you should consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, Nurofen for Children Junior Orange can cause side effects, although not everybody gets them. The occurrence of side effects can be reduced by using the smallest effective dose for the shortest duration necessary to relieve symptoms. The child may experience one of the known side effects of NSAIDs. If side effects occur or in case of doubt, you should stop using the medicine and talk to your doctor as soon as possible. Elderly people using this medicine belong to a group with an increased risk of side effects.

STOP USING the medicine and seek medical attention immediately if the child experiences:

• symptoms of gastrointestinal bleeding, such as severe stomach pain, black tarry stools, vomiting blood or coffee ground-like vomit.
• symptoms of rare but serious allergic reactions, such as worsening of asthma, unexplained wheezing or shortness of breath, swelling of the face, tongue, or throat, difficulty breathing, rapid heartbeat, or a drop in blood pressure leading to shock. Symptoms may occur even after the first use of the medicine. If any of these symptoms occur, you should immediately contact a doctor.
• red, non-raised, target-like, or circular patches on the torso, often with blisters in the center, peeling of the skin, ulcers in the mouth, throat, nose, genitals, and eyes. These severe skin rashes may be preceded by fever and flu-like symptoms (exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis). [Very rare - may occur in 1 in 10,000 people].
• widespread rash, high body temperature, swollen lymph nodes, and an increase in the number of eosinophils (a type of white blood cell) (DRESS syndrome) [Frequency not known - cannot be estimated from available data].
• red, peeling, widespread rash with bumps under the skin and blisters, mainly in skin folds, on the torso, and upper limbs, with accompanying fever. Symptoms usually appear at the beginning of treatment (acute generalized exanthematous pustulosis) [Frequency not known - cannot be estimated from available data].

If any side effects worsen or any side effects not listed in the leaflet occur, you should tell your doctor.
Common(may occur in 1 in 10 people)

• Gastrointestinal disorders, such as heartburn, stomach pain, nausea, indigestion, diarrhea, vomiting, bloating (gas), constipation, and minor stomach or intestinal bleeding, which in rare cases may cause anemia.

Uncommon(may occur in 1 in 100 people)

• Ulcers in the gastrointestinal tract, which may bleed or perforate, inflammation of the mouth with ulcers, worsening of existing intestinal diseases (ulcerative colitis or Crohn's disease), and stomach inflammation.
• Central nervous system disorders, such as headaches, dizziness, insomnia, excitement, irritability, or fatigue.
• Vision disorders.
• Various skin rashes.
• Allergic reactions with hives and itching.

Rare(may occur in 1 in 1,000 people)

• Ringing in the ears (tinnitus).
• Increased blood urea levels, pain in the side and/or stomach pain, blood in the urine, and fever, which may be symptoms of kidney damage (renal papillary necrosis).
• Increased blood uric acid levels.
• Decreased hemoglobin levels.

Very rare(may occur in 1 in 10,000 people)

• Esophageal inflammation, pancreatitis, and intestinal narrowing.
• Heart failure, heart attack, and facial or hand swelling.
• Kidney failure, and kidney problems, which may lead to acute kidney failure. If any of these symptoms occur or if the patient feels unwell, you should stop using Nurofen for Children Junior Orange and immediately consult a doctor, as they may be the first signs of kidney damage or failure.
• Psychotic reactions and depression.
• High blood pressure, blood vessel inflammation.
• Rapid heartbeat.
• Liver function disorders, liver damage (the first symptoms may be skin discoloration), especially during long-term treatment, liver failure, acute liver inflammation.
• Blood production disorders - the first symptoms are fever, sore throat, mouth ulcers, flu-like symptoms, severe fatigue, nosebleeds, and unexplained bruising. In such cases, you should immediately stop treatment and consult a doctor. Do not treat yourself with pain-relieving or antipyretic medicines.
• Severe skin infections and soft tissue complications during chickenpox.
• Aseptic meningitis symptoms, such as stiff neck, headache, nausea, vomiting, and altered consciousness, have been observed with ibuprofen use. Patients with autoimmune disorders (lupus, mixed connective tissue disease) are at higher risk of such symptoms. If such symptoms occur, you should immediately consult a doctor.
• Severe skin reactions, such as rash with redness and blistering (e.g., Stevens-Johnson syndrome, erythema multiforme, and toxic epidermal necrolysis), hair loss (alopecia).

Frequency not known(cannot be estimated from available data)

• Chest pain, which may be a symptom of a potentially serious allergic reaction called Kounis syndrome.
• Respiratory tract reactivity, including asthma, bronchospasm, shortness of breath.
• Skin becomes sensitive to light.

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

Reporting side effects

If side effects occur, including any side effects not listed in the leaflet, you should tell your doctor or pharmacist or nurse. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: 22 49-21-301, fax: 22 49-21-309, website:
https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Nurofen for Children Junior Orange

Keep out of sight and reach of children.
Do not use Nurofen for Children Junior Orange after the expiry date stated on the carton and bottle. The expiry date refers to the last day of the month.
Do not store above 25°C.
After opening the bottle, the medicine should be used within 6 months.

Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Nurofen for Children Junior Orange contains

The active substance of the medicine is ibuprofen. Each 1 ml of oral suspension contains 40 mg of ibuprofen.
The other ingredients are citric acid monohydrate, sodium citrate, sodium chloride, sodium saccharin, polysorbate 80, bromhexine hydrochloride, liquid maltitol, glycerol, xanthan gum, orange flavor 2M16014 (modified starch, gum arabic, maltodextrin, natural and identical to natural flavoring substances), and purified water.

What Nurofen for Children Junior Orange looks like and contents of the pack

Nurofen for Children Junior Orange is a white oral suspension with a characteristic orange odor.
Each bottle contains 100 ml, 150 ml, or 200 ml.
The packaging includes a double-ended measuring spoon (with a 2.5 ml measure with an inner mark of 1.25 ml on one end and a 5 ml measure on the other end) for accurate dosing.
Not all pack sizes may be marketed.

Marketing authorization holder and importer

Marketing authorization holder:

Reckitt Benckiser (Poland) S.A.
ul. Okunin 1
05-100 Nowy Dwór Mazowiecki

Importer:

RB NL Brands B.V.
WTC Schiphol Airport,
Schiphol Boulevard 207,
1118 BH Schiphol,
Netherlands
To obtain more detailed information, you should contact the local representative of the marketing authorization holder:
Reckitt Benckiser (Poland) S.A.
ul. Okunin 1
05-100 Nowy Dwór Mazowiecki
Tel.: (22) 211 26 92

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Date of last revision of the leaflet: 04/2025