Nurofen dla dzieci Forte pomaranihovi

Leaflet attached to the packaging: information for the user

Warning! Keep the leaflet, information on the immediate packaging in a foreign language!

Nurofen for Children Forte Orange(Nurofen Junior Fieber-und Schmerzsaft Orange)

40 mg/ml, oral suspension

Ibuprofen
Nurofen for Children Forte Orange and Nurofen Junior Fieber-und Schmerzsaft Orange are different trade names for the same medicine.
For children weighing from 5 kg (from 3 months of age) to 40 kg (12 years old)

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 a doctor or pharmacist.
• You should keep this leaflet, so you can read it again if you need to.
• If you need advice or additional information, you should consult a pharmacist.
• If the patient experiences any side effects, including any possible side effects not listed in the leaflet, you should tell the doctor, pharmacist, or nurse. See section 4.
• If after 24 hours (infants 3-5 months old, weighing over 5 kg) or 3 days (children over 6 months old) there is no improvement or the patient feels worse, you should contact a doctor.

Table of contents of the leaflet:

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

1. What is Nurofen for Children Forte 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 elevated body temperature. Nurofen for Children Forte Orange is intended for short-term, symptomatic treatment of:

• fever,
• pain of mild to moderate severity.

If after 24 hours (infants 3-5 months old, weighing over 5 kg) or 3 days (children over 6 months old) there is no improvement or the patient feels worse, you should contact a doctor.

2. Important information before using Nurofen for Children Forte Orange

When not to use Nurofen for Children Forte 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.

with previous use of NSAIDs.

• If the child currently has or has had stomach and/or duodenal ulcers (ulcer disease) or bleeding (two or more confirmed cases of ulcers or bleeding).
• If the child has severe liver and 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 Forte Orange, you should discuss it with a doctor or pharmacist:

• If the child has an infection - see below, "Infections"
• If the child has certain inherited blood production 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 certain bowel diseases (ulcerative colitis or Crohn's disease), as their symptoms may worsen.
• If the child has ever had or currently has high blood pressure and/or heart failure.
• If the child has kidney function disorders.
• If the child has liver diseases. In the case of long-term use of Nurofen for Children Forte Orange, regular monitoring of liver function, kidney function, and blood morphology parameters is required.
• Caution is recommended when using other medicines that may increase the risk of stomach or intestinal ulcers, 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), as concurrent use of these medicines should be avoided.
• The occurrence of side effects may be reduced by using the smallest effective dose of the medicine for the shortest possible time.
• Generally, continuous use (of several types) of painkillers may lead to persistent serious kidney disease. This risk may increase during physical exertion associated with salt loss and dehydration. Therefore, it should be avoided.
• 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. Diagnosis of 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 ever had 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 may occur as asthma attacks (so-called analgesic-induced asthma), Quincke's edema, or hives.
• Avoid using Nurofen for Children Forte 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 Forte Orange may mask the symptoms of infection, such as fever and pain. In this regard, Nurofen for Children Forte 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 the use of Nurofen for Children Forte Orange. If the following occur: any skin rash, changes in the mucous membranes, blisters, or other signs of allergy, you should stop taking Nurofen for Children Forte Orange and seek immediate medical attention, as these may be the first signs of a severe skin reaction. See section 4.
Bleeding, ulcers, or perforation of the gastrointestinal tract, which can be fatal, have been reported during treatment with all NSAIDs with or without warning signs or in patients with serious gastrointestinal disorders. If bleeding or ulcers occur, treatment should be stopped immediately. The risk of bleeding, ulcers, or perforation of the gastrointestinal tract increases with increasing doses of NSAIDs in patients who have had ulcers, especially with bleeding or perforation (see section 2 "When not to use Nurofen for Children Forte Orange") and in the elderly. These patients should start treatment with the smallest effective dose. In these patients and in patients requiring concurrent administration of acetylsalicylic acid in low doses or medications that increase the risk of gastrointestinal reactions, concomitant treatment with protective agents (e.g., misoprostol or proton pump inhibitors) should be considered.
Taking anti-inflammatory and pain-relieving medicines, such as 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 and duration of treatment.
Before using Nurofen for Children Forte Orange, the patient should discuss treatment with a doctor or pharmacist if:

• the patient has heart disease, such as heart failure, angina pectoris (chest pain), has had a heart attack, bypass surgery, has peripheral arterial disease (poor blood 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.

If any of the above applies to the child, you should consult a doctor before using Nurofen for Children Forte Orange.
Elderly patients
Elderly patients are at increased risk of side effects when using NSAIDs, particularly those affecting the stomach and intestines.
Patient with a history of gastrointestinal disorders, especially in the elderly, should report any unusual abdominal symptoms (mainly gastrointestinal bleeding), especially in the initial treatment phase.

Nurofen for Children Forte Orange and other medicines

Tell your doctor or pharmacist about all medicines your child is currently taking or has recently taken, as well as any medicines your child may be taking.
Nurofen for Children Forte Orange may affect the action of other medicines or other medicines may affect the action of Nurofen for Children Forte Orange. For example:

• medicines with anticoagulant action (i.e., blood thinners/preventing blood clots, such as acetylsalicylic acid, warfarin, ticlopidine)
• medicines that lower blood pressure (ACE inhibitors, such as captopril, beta-blockers, such as atenolol, angiotensin II receptor antagonists, such as losartan).

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

Nurofen for Children Forte Orange and alcohol

Do not consume alcohol while using Nurofen for Children Forte 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 Forte Orange.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding or thinks she may be pregnant or is planning to have a child, she should consult a 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 her 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 a period longer than a few days after the start of the 20th week of pregnancy may cause kidney problems in the unborn child and lead to a low level of amniotic fluid surrounding the child (oligohydramnios) or narrowing of the arterial duct (ductal constriction) in the child's heart. If necessary, the doctor may recommend additional monitoring.
Breastfeeding
Only small amounts of ibuprofen and its breakdown products pass into breast milk. Nurofen for Children Forte Orange can be used during breastfeeding, if administered in recommended doses and for the shortest possible time.
Fertility
Nurofen for Children Forte 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.

Important information about some ingredients of Nurofen for Children Forte Orange

• Nurofen for Children Forte Orange contains liquid maltitol. If the patient has previously been diagnosed with intolerance to some sugars, the patient should consult a 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 Forte 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 any 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 Forte Orange

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

Use the smallest effective dose for the shortest possible time.
If the symptoms of infection (such as fever and pain) persist or worsen, 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 3 months old or weighing less than 5 kg.

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

For oral use

Method of administration using an oral syringe

• 1. Shake the bottle well.
• 2. Remove the cap from the bottle by pressing it down and turning it to the left.

• 3. The syringe should be firmly inserted into the opening in the neck of the bottle.
• 4. To fill the syringe, turn the bottle upside down. Holding the syringe in place, gently pull the plunger down, drawing the suspension to the correct mark on the syringe.
• 5. Turn the bottle back over and remove the syringe by gently turning it.
• 6. Place the end of the syringe in the child's mouth. Press the plunger slowly and gently administer the suspension. After use, replace the cap. Rinse the syringe with 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.

In the case of infants 3-5 months old (weighing over 5 kg), you should consult a doctor if symptoms do not improve after 24 hours.

If symptoms worsen, you should consult a doctor.

Taking a higher dose of Nurofen for Children Forte Orange than recommended:

If the patient has taken a higher dose of Nurofen for Children Forte Orange than recommended 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 may include nausea, stomach pain, vomiting (which may contain blood), gastrointestinal bleeding, headache, ringing in the ears, disorientation, and nystagmus or, less commonly, diarrhea. After taking a large dose, balance disorders, vision disturbances, 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, feeling cold, and breathing difficulties.

Missing a dose of Nurofen for Children Forte Orange:

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

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

4. Possible side effects

Like all medicines, Nurofen for Children Forte 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 possible time. The child may experience one of the known side effects of NSAIDs. If side effects occur or in case of doubt, you should stop taking the medicine and consult a doctor as soon as possible. Elderly patients using this medicine are at increased risk of side effects.

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

• symptoms of gastrointestinal bleeding, such as severe abdominal pain, black tarry stools, vomiting blood or coffee grounds-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, low 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.
• severe skin reactionssuch as a rash covering the whole body, peeling, blistering, and shedding of the skin.

If the child's side effects worsen or any side effects not listed in the leaflet occur, you should tell the doctor.

Frequent(may occur in 1 in 10 people)

• Gastrointestinal disorders such as heartburn, abdominal pain, nausea, indigestion, diarrhea, vomiting, bloating (gas), constipation, and minor gastrointestinal 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 mucous membrane of the mouth with ulcers, worsening of existing bowel disease (ulcerative colitis or Crohn's disease), inflammation of the stomach lining
• Central nervous system disorders, such as headaches, dizziness, insomnia, agitation, irritability, or fatigue
• Visual disturbances
• 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, side pain and/or abdominal pain, blood in the urine, and fever, which may be signs 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, formation of diaphragm-like intestinal strictures
• Heart failure, heart attack, and facial or hand swelling
• Reduced urine output and swelling (especially in patients with high blood pressure or impaired kidney function), swelling and clouding of the urine (nephrotic syndrome), inflammatory kidney disease (interstitial nephritis), which may lead to acute kidney failure. If any of the above symptoms occur or if the patient feels unwell, you should stop using Nurofen for Children Forte Orange and immediately consult a doctor, as these may be the first signs of kidney damage or failure
• Psychotic reactions and depression
• High blood pressure, vasculitis
• Rapid heartbeat
• Liver function disorders, liver damage (the first symptoms may be skin discoloration), especially during long-term treatment, liver failure, acute hepatitis
• Blood production disorders - the first symptoms are: fever, sore throat, superficial 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 painkillers or antipyretics
• Severe skin infections and soft tissue complications during chickenpox
• Worsening of inflammatory conditions (e.g., necrotizing fasciitis) due to the use of certain painkillers (NSAIDs). If symptoms of infection occur or worsen, the patient should immediately consult a doctor. It should be assessed whether there are indications for the use of anti-infective treatment (antibiotic therapy)
• During the use of ibuprofen, symptoms of aseptic meningitis have been observed, with stiffness of the neck, headache, nausea, vomiting, fever, and impaired consciousness. In patients with autoimmune disorders (lupus, mixed connective tissue disease), there is a higher risk of such symptoms. If such symptoms occur, you should immediately consult a doctor
• Severe skin reactions, such as a 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)

• Respiratory tract reactions, including asthma, bronchospasm, shortness of breath.
• Severe skin reactions known as DRESS syndrome. The symptoms of DRESS syndrome include: skin rash, fever, swelling of the lymph nodes, and an increased number of eosinophils (a type of white blood cell).
• A red scaly rash with thickening of the skin and blisters, usually located in skin folds, on the torso, and upper limbs, with fever occurring at the beginning of treatment (acute generalized exanthematous pustulosis). If such symptoms occur, you should stop taking Nurofen for Children Forte Orange and seek immediate medical attention. See also section 2.
• The 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 the doctor, 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
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Nurofen for Children Forte Orange

Store out of sight and reach of children.
Do not use Nurofen for Children Forte Orange after the expiry date stated on the packaging. 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 Forte 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, domiphen bromide, 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 Forte Orange looks like and what the packaging contains

Nurofen for Children Forte Orange is a white oral suspension with a characteristic orange odor.
Each bottle contains 100 ml.
The packaging includes an oral syringe (5 ml syringe with scale: 1.25 ml, 2.5 ml, 3.75 ml, and 5 ml).
Outer packaging: cardboard box.
For more detailed information, you should contact the marketing authorization holder or parallel importer.

Marketing authorization holder in Germany, the country of export:

Reckitt Benckiser Deutschland GmbH
Darwinstrasse 2-4
69115 Heidelberg
Germany

Manufacturer:

RB NL Brands B.V.
Schiphol Boulevard 207
1118 BH Schiphol
Netherlands

Parallel importer:

Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź

Repackaged by:

Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Marketing authorization number in Germany, the country of export: 76553.00.00

Parallel import authorization number: 82/25

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

Date of leaflet approval: 05.03.2025

[Information about the trademark]