NUROFEN 40 mg /Ml Suspension

Contents of the leaflet

1. Leaflet attached to the packaging: information for the user
2. Nurofen for Children Forte Orange
   1. Read the leaflet carefully before using the medicine, as it contains important information for the patient.
   2. Table of contents of the leaflet:
3. What is Nurofen for Children Forte Orange and what is it used for
4. Important information before using Nurofen for Children Forte Orange
   1. When not to use Nurofen for Children Forte Orange
   2. Warnings and precautions
   3. Nurofen for Children Forte Orange and other medicines
   4. Pregnancy, breastfeeding, and fertility
   5. Driving and using machines
5. How to use Nurofen for Children Forte Orange
   1. 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, consult a doctor or pharmacist.
   2. Recommended dose for pain and fever:
   3. Do not recommend for children under 3 months or weighing less than 5 kg.
   4. For oral use
   5. Method of administration using an oral syringe
   6. Duration of treatment
   7. 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, consult a doctor.
   8. In the case of infants 3-5 months (weighing over 5 kg), consult a doctor if symptoms do not improve after 24 hours.
   9. If symptoms worsen, consult a doctor.
   10. Taking a higher dose of Nurofen for Children Forte Orange than recommended:
   11. Missing a dose of Nurofen for Children Forte Orange:
   12. In case of any further doubts about using this medicine, consult a doctor or pharmacist.
6. Possible side effects
   1. DISCONTINUE USE of the medicine and seek medical attention immediately if the child experiences:
   2. Reporting side effects
7. How to store Nurofen for Children Forte Orange
   1. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.
8. Contents of the pack and other information
   1. What Nurofen for Children Forte Orange contains
   2. What Nurofen for Children Forte Orange looks like and contents of the pack
   3. Marketing authorization holder and importer
   4. Marketing authorization holder:
   5. Importer:
   6. This medicinal product is authorized in the Member States of the European Economic Area under the following names:
   7. Date of last revision of the leaflet: 04/2025

Leaflet attached to the packaging: information for the user

Nurofen for Children Forte Orange

40 mg/ml, oral suspension
Ibuprofen
For children weighing from 5 kg (from 3 months of age) to 40 kg (12 years)

Read the leaflet carefully 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.
• Keep this leaflet, you may need to read it again.
• If you need advice or additional information, consult a pharmacist.
• If the patient experiences any side effects, including any possible side effects not listed in the leaflet, tell your doctor or pharmacist. See section 4.
• If after 24 hours (infants 3-5 months, weighing over 5 kg) or 3 days (children over 6 months) there is no improvement or the patient feels worse, consult 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 pack 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, weighing over 5 kg) or 3 days (children over 6 months) there is no improvement or the patient feels worse, consult 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.
• 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 Forte Orange, discuss it with your 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 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 disease. With long-term use of Nurofen for Children Forte Orange, regular monitoring of liver and kidney function parameters and blood morphology is required.
• Caution is recommended when using other medicines that may increase the risk of stomach or intestinal ulcers, such as oral corticosteroids (such as prednisolone), blood thinners (such as warfarin), selective serotonin reuptake inhibitors (antidepressants), and antiplatelet agents (such as 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 for the shortest possible duration.
• 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, 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 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 may occur as asthma attacks (so-called analgesic-induced asthma), Quincke's edema, or urticaria.
• 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. Therefore, 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, consult a doctor immediately.
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 with ibuprofen use. If the patient experiences any of the symptoms associated with these severe skin reactions described in section 4, discontinue Nurofen for Children Forte Orange and seek medical attention immediately.
Bleeding, ulcers, or perforation of the gastrointestinal tract, which can be fatal, have been reported during treatment with all NSAIDs, with or without warning symptoms, or in patients with serious gastrointestinal disorders. If bleeding or ulcers occur, discontinue treatment 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 lowest effective dose. For these patients and patients requiring concurrent administration of acetylsalicylic acid in low doses or medications that increase the risk of gastrointestinal reactions, consider combination therapy 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, 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, coronary artery bypass grafting, 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. During ibuprofen use, symptoms of allergic reaction to this medicine have been reported, including breathing difficulties, face and neck swelling (angioedema), chest pain. If the patient notices any of these symptoms, they should discontinue Nurofen for Children Forte Orange and consult a doctor or emergency services immediately.

If any of the above cases apply to the child, consult a doctor before using Nurofen for Children Forte Orange.
Elderly patients
Elderly patients are at increased risk of adverse reactions during NSAID use, 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 the child is currently taking or has recently taken, as well as any medicines the child may take.
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:

• blood-thinning medicines (e.g. acetylsalicylic acid, warfarin, ticlopidine)
• blood pressure-lowering medicines (e.g. 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 Nurofen for Children Forte Orange treatment. Therefore, before using Nurofen for Children Forte Orange with other medicines, always consult a doctor or pharmacist.
In particular, inform your doctor if the patient is taking:

• 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 or intestinal ulcers may increase
• Antiplatelet agents, as the risk of bleeding may increase
• Acetylsalicylic acid (in low doses), as the blood-thinning effect may be reduced
• 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 (medicines used to treat depression), 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 elimination of ibuprofen may be delayed
• Blood pressure-lowering and diuretic medicines, as ibuprofen may reduce the effect of these medicines and increase the risk of kidney function deterioration
• Diuretics that spare potassium, such as amiloride, potassium canrenoate, spironolactone, 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 medicines), as kidney damage may occur
• Zidovudine (used in HIV/AIDS treatment), as 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), 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; consider 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 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 they may be pregnant or plans to have a child, they 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 their child's tendency to bleed and prolong or prolong 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 from 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 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 female fertility. 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 Forte Orange contains liquid maltitol. If the patient has previously been diagnosed with intolerance to some sugars, they 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 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, consult a doctor or pharmacist.

Use the smallest effective dose for the shortest possible duration to relieve symptoms.
If the symptoms of the infection (such as fever and pain) persist or worsen, consult a doctor immediately (see section 2).

Recommended dose for pain and fever:

*Doses should be administered every 6 to 8 hours.

Do not recommend for children under 3 months or weighing less than 5 kg.

In patients with sensitive stomachs, it is recommended to take Nurofen for Children Forte Orange with food.
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. Insert the syringe firmly into the bottle opening.
• 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 twisting 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, consult a doctor.

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

If symptoms worsen, 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, 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 often, diarrhea. After taking a large dose, 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 exacerbation of asthma in asthmatic patients, drowsiness, chest pain, palpitations, loss of consciousness, seizures (mainly in children), weakness, and dizziness, hematuria, low potassium levels in the blood, 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 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 any further doubts about using this medicine, 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 duration to relieve symptoms. The child may experience one of the known side effects of NSAIDs. If side effects occur or in case of doubt, discontinue the medicine and consult a doctor as soon as possible. Elderly patients using this medicine are at increased risk of side effects.

DISCONTINUE USE of the medicine and seek medical attention immediately if the child experiences:

• symptoms of gastrointestinal bleeding, such as severe abdominal 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, low blood pressure leading to shock. Symptoms may occur even after the first use of the medicine. If any of these symptoms occur, seek medical attention immediately.

Frequent(may occur in 1 in 10 people)

• Gastrointestinal disorders such as heartburn, abdominal pain, nausea, indigestion, diarrhea, vomiting, bloating (gas), constipation, 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 mouth with ulcers, worsening of existing intestinal disease (ulcerative colitis or Crohn's disease), stomach inflammation
• Central nervous system disorders, such as headache, dizziness, insomnia, restlessness, irritability, or fatigue
• Vision disorders
• Various skin rashes
• Allergic reactions with urticaria and itching.

Rare(may occur in 1 in 1000 people)

• Tinnitus (ringing in the ears)
• Increased blood urea levels, side pain and/or abdominal pain, blood in 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)

• Esophagitis, pancreatitis, formation of diaphragm-like intestinal strictures
• Heart failure, heart attack, and facial or hand swelling
• Kidney failure, and swelling (especially in patients with high blood pressure or impaired kidney function), swelling and clouding of urine (nephrotic syndrome), which may lead to acute kidney failure. If any of the above symptoms occur or if the patient feels unwell, discontinue Nurofen for Children Forte Orange and consult a doctor immediately.
• 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, discontinue treatment and consult a doctor. Do not treat yourself with painkillers or antipyretics.
• Severe skin and soft tissue infections during chickenpox
• Worsening of inflammatory conditions (e.g. necrotizing fasciitis) due to the use of certain painkillers (NSAIDs). If symptoms of infection worsen or appear, the patient should immediately consult a doctor. It should be assessed whether there are indications for the use of anti-infective treatment (antibiotic therapy)
• Ibuprofen use has been associated with symptoms of aseptic meningitis, with neck stiffness, headache, nausea, vomiting, fever, and altered consciousness. In patients with autoimmune disorders (lupus, mixed connective tissue disease), there is a higher risk of such symptoms. If such symptoms occur, consult a doctor immediately
• Hair loss (alopecia).

Frequency not known(cannot be estimated from the 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 sensitivity 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, 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:
Jerozolimskie Avenue 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 Forte Orange

Keep out of sight and reach of children.
Do not use Nurofen for Children Forte 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. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack 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, bromhexine, 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 contents of the pack

Nurofen for Children Forte Orange is a white oral suspension with a syrupy consistency and a characteristic orange odor.
Each bottle contains 30 ml, 50 ml, 100 ml, 150 ml, or 200 ml.
The pack 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.
Not all pack sizes may be marketed.

Marketing authorization holder and importer

Marketing authorization holder:

Reckitt Benckiser (Poland) S.A.
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, contact the local representative of the marketing authorization holder:
Reckitt Benckiser (Poland) S.A.
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