Nurofen dla dzieci forte truskavkovi

Leaflet attached to the packaging: information for the user

Nurofen for Children Forte Strawberry

40 mg/ml, oral suspension
Ibuprofen
For children weighing from 5 kg (from 3 months of age) 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 a 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 a pharmacist.
• If the patient experiences any side effects, including any possible side effects not listed in the leaflet, they should tell their 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, they should contact a doctor.

Table of contents of the leaflet:

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

1. What is Nurofen for Children Forte Strawberry 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 temperature. Nurofen for Children Forte Strawberry 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, they should contact a doctor.

2. Important information before using Nurofen for Children Forte Strawberry

When not to use Nurofen for Children Forte Strawberry

• 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 Strawberry, 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 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 or has had high blood pressure and/or heart failure.
• If the child has kidney function disorders.
• If the child has liver disease. In the case of long-term use of Nurofen for Children Forte Strawberry, 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 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), they should avoid taking them at the same time.
• The occurrence of side effects can be reduced by using the smallest effective dose for the shortest possible time.
• 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. The 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 or has 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 can occur as asthma attacks (so-called analgesic-induced asthma), Quincke's edema, or urticaria.
• It is recommended to avoid using Nurofen for Children Forte Strawberry in case of chickenpox (varicella).
• If the child has recently undergone major surgery (medical supervision is required).
• If the child is dehydrated, due to the increased risk of kidney failure in dehydrated children.

Infections
Nurofen for Children Forte Strawberry may mask the symptoms of infection, such as fever and pain. Therefore, Nurofen for Children Forte Strawberry may delay the use of appropriate infection treatment, and consequently, lead to an increased risk of complications. This has been observed in the course of bacterial pneumonia and bacterial skin infections associated with chickenpox. If the patient takes this medicine during an existing infection, and the symptoms of the infection persist or worsen, they 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, they should immediately discontinue Nurofen for Children Forte Strawberry and seek medical attention.
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, treatment should be discontinued immediately. The risk of bleeding, ulcers, or perforation of the gastrointestinal tract increases with the increase in the dose of NSAIDs in patients who have had ulcers, especially with bleeding or perforation (see section 2 "When not to use Nurofen for Children Forte Strawberry") and in the elderly. These patients should start treatment with the smallest effective dose. For these patients and patients requiring concomitant use of low-dose acetylsalicylic acid or drugs that increase the risk of gastrointestinal reactions, concomitant use of 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 Strawberry, 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 an 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 immediately discontinue Nurofen for Children Forte Strawberry and contact a doctor or emergency services.
If any of the above cases apply to the child, they should consult a doctor before using Nurofen for Children Forte Strawberry.
Elderly patients
Elderly patients using this medicine are at increased risk of side effects, especially those related to the stomach and intestines.
Patients 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 Strawberry and other medicines

Tell your doctor or pharmacist about all medicines your child is taking or has recently taken, as well as any medicines your child may be taking.
Nurofen for Children Forte Strawberry may affect the action of other medicines or other medicines may affect the action of Nurofen for Children Forte Strawberry. 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 Strawberry treatment. Therefore, before using Nurofen for Children Forte Strawberry with other medicines, you should always consult a doctor or pharmacist.
In particular, you should inform your doctor if your child 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 action 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 reduced
Blood thinners (e.g., warfarin), as ibuprofen may enhance the action of these medicines
Phenytoin (a medicine used to treat epilepsy), as the action 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 action 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 medicines and diuretics, as ibuprofen may reduce the action 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 action 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 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 action of ibuprofen may be enhanced; the dose of ibuprofen should be reduced, 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

Nurofen for Children Forte Strawberry with alcohol

Do not consume alcohol while using Nurofen for Children Forte Strawberry. 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 Strawberry at the same time.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, you 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 mother's and child's ability to clot and prolong labor. Avoid using this medicine during the first 6 months of pregnancy unless the doctor recommends it. 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.
Breastfeeding
Only small amounts of ibuprofen and its breakdown products pass into breast milk. Nurofen for Children Forte Strawberry can be used during breastfeeding if administered in the recommended doses and for the shortest possible time.
Fertility
Nurofen for Children Forte Strawberry 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 vehicles and operate machines.

• Nurofen for Children Forte Strawberry 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 Strawberry contains less than 1 mmol of sodium (23 mg) per dose, so the medicine is considered "sodium-free".
• Nurofen for Children Forte Strawberry contains 16.45 mg of propylene glycol per 5 ml of suspension.

3. How to use Nurofen for Children Forte Strawberry

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

Use the smallest effective dose for the shortest possible time necessary to relieve symptoms.
If the symptoms of 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 given 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 Strawberry 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. The oral syringe should be firmly inserted 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 to 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 (over 6 months) persist for more than 3 days or the patient feels worse, they should 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 Strawberry than recommended:

If the patient has taken a higher dose of Nurofen for Children Forte Strawberry than recommended or if the child has accidentally taken the medicine, they 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, dizziness, or nystagmus, or less commonly, 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 worsening of asthma in asthma patients, drowsiness, chest pain, palpitations, loss of consciousness, seizures (mainly in children), weakness, and dizziness, hematuria, hypokalemia, feeling cold, and breathing difficulties.

Missing a dose of Nurofen for Children Forte Strawberry:

Do not take a double dose to make up for a missed dose. If the patient forgets to take or give a dose, they should take or give it as soon as they remember, and then take or give the next dose of the medicine according to the dosing interval described above.

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

4. Possible side effects

Like all medicines, Nurofen for Children Forte Strawberry 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 necessary to relieve symptoms. The child may experience one of the known side effects of NSAIDs. If side effects occur or in case of doubts, discontinue the medicine and talk to a doctor as soon as possible. Elderly patients using this medicine are at 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 grounds, or dark-colored 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 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.
• red, non-raised, target-like, or circular patches on the torso, often with blisters in the center, peeling 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 fever, and enlarged lymph nodes, and an increase in 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, tell your doctor.

Frequent(may occur in 1 in 10 people)

• Gastrointestinal disorders, such as heartburn, stomach 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 mouth with ulcers, worsening of existing bowel disease (ulcerative colitis or Crohn's disease), stomach inflammation
• Central nervous system disorders, such as headaches, dizziness, insomnia, restlessness, or fatigue
• Visual disturbances
• Various skin rashes
• Allergic reactions with hives and itching.

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

• Tinnitus (ringing in the ears)
• Increased urea levels in the blood, 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 uric acid levels in the blood
• 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
• Decreased urine output and swelling (especially in patients with high blood pressure or impaired kidney function), swelling and clouding of 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, they should discontinue Nurofen for Children Forte Strawberry and consult a doctor immediately, as they may be the first symptoms of kidney damage or failure

Psychotic reactions and depression

High blood pressure, vasculitis

Palpitations

Liver function disorders, liver damage (the first symptoms may be skin discoloration), especially during long-term treatment, liver failure, acute hepatitis

Disorders of blood cell production - the first symptoms are: fever, sore throat, superficial mouth ulcers, flu-like symptoms, severe fatigue, nosebleeds, and unexplained bruising. In such cases, treatment should be discontinued immediately and a doctor consulted. Do not self-medicate with painkillers or antipyretics

Severe skin and soft tissue infections during chickenpox

Aseptic meningitis symptoms, such as stiff neck, headache, nausea, vomiting, fever, and impaired consciousness, have been reported with ibuprofen use. In patients with autoimmune disorders (lupus, mixed connective tissue disease), there is a higher risk of such symptoms. If such symptoms occur, seek medical attention immediately

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 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, phone: 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.
Reporting side effects will help gather more information on the safety of this medicine.

5. How to store Nurofen for Children Forte Strawberry

Store out of sight and reach of children.
Do not use Nurofen for Children Forte Strawberry after the expiration date stated on the carton and bottle. The expiration 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 Strawberry 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, strawberry flavor 500244E (propylene glycol, ascorbic acid (E 300) natural and identical to natural flavoring substances) and purified water.

What Nurofen for Children Forte Strawberry looks like and what the pack contains

Nurofen for Children Forte Strawberry is a white oral suspension with a syrupy consistency and a characteristic strawberry smell.
Each bottle contains 100 ml, 150 ml, or 200 ml.
The pack includes an oral syringe (5 ml syringe with a scale: 1.25 ml, 2.5 ml, 3.75 ml, and 5 ml).
The outer packaging is a 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
Phone: (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