Nurofen dla dzieci Forte truskavkovi

Leaflet attached to the packaging: information for the user

Warning! The leaflet should be kept. Information on the immediate packaging in a foreign language

Nurofen for Children Forte Strawberry(Nurofen pediatric)

40 mg/ml, oral suspension

Ibuprofen
Nurofen for Children Forte Strawberry and Nurofen pediatric are different trade names for the same medicine.
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.
• This leaflet should be kept so that it can be read again if necessary.
• If advice or additional information is needed, a pharmacist should be consulted.
• If the patient experiences any side effects, including any possible side effects not listed in the leaflet, they should tell their doctor, pharmacist, or nurse. 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 packaging 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 elevated body 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 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 to use Nurofen for Children Forte Strawberry, the patient should discuss it with their 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 intestinal 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 diseases. 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.
• Caution is recommended 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), as concurrent use of these medicines should be avoided.
• Reducing the risk of side effects 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. 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 medicines.
• 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 aspirin-induced asthma), Quincke's edema, or hives.
• 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 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 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, they should immediately consult a doctor.
Skin reactions
Severe skin reactions have been reported with the use of Nurofen for Children Forte Strawberry. If the following occur: any skin rash, changes in mucous membranes, blisters, or other signs of allergy, the use of Nurofen for Children Forte Strawberry should be discontinued and medical help sought immediately, as these may be the first signs of a severe skin reaction. See section 4.
Gastrointestinal bleeding, ulcers, or perforation, which can be fatal, have been reported during treatment with all NSAIDs with or without warning signs 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 the dose of NSAIDs in patients with a history of 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 lowest effective dose. In these patients, as well as in patients requiring concurrent use of low-dose acetylsalicylic acid or medicines that increase the risk of gastrointestinal reactions, consideration should be given to combination therapy with protective agents (e.g., misoprostol or proton pump inhibitors).
Taking anti-inflammatory and pain-relieving medicines, 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 Forte Strawberry, 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 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, has a family history of heart disease or stroke, or smokes.

If any of the above applies 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, 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 early stages of treatment.
Nurofen for Children Forte Strawberry and other medicines

The patient should tell their doctor or pharmacist about all medicines currently being taken or recently taken by the child, as well as any medicines the child may take.
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).

Some other medicines may also be affected or have an effect on treatment with Nurofen for Children Forte Strawberry. Therefore, before using Nurofen for Children Forte Strawberry with other medicines, the patient should always consult a doctor or pharmacist.
In particular, the patient should inform their doctor if they are taking any of 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 gastrointestinal 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 effect 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 (medicines used to treat gout), as the elimination of ibuprofen may be delayed
Blood pressure-lowering medicines and diuretics, as ibuprofen may reduce the effect of these medicines and increase the risk of kidney function deterioration
Potassium-sparing diuretics, e.g., 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 (anti-diabetic medicines), as they may affect blood sugar levels
Quinolone antibiotics, as the risk of seizures may increase
Voriconazole and fluconazole (CYP2C9 inhibitors), as the action of ibuprofen may be enhanced; used in fungal infections
Consideration should be given to reducing the dose of ibuprofen, particularly when using high doses of ibuprofen with voriconazole or fluconazole
Baclofen, as baclofen toxicity may develop after using ibuprofen
Ritonavir, as ritonavir may increase the plasma concentration of NSAIDs

Nurofen for Children Forte Strawberry and alcohol

Alcohol should not be consumed 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 alcohol and Nurofen for Children Forte Strawberry are taken together.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a baby, 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 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 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 arterial duct (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 given in the recommended dose 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 and use 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 in each 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 doubt, the patient should consult a doctor or pharmacist.

Use the smallest effective dose for the shortest duration necessary to relieve symptoms. If the symptoms of infection (such as fever and pain) persist or worsen, the patient 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 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 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 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), the doctor should be consulted if the symptoms do not improve after 24 hours.

If the symptoms worsen, the patient should 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 may include nausea, stomach pain, vomiting (which may contain blood), gastrointestinal bleeding, headache, ringing in the ears, disorientation, or nystagmus, or less frequently, diarrhea. After taking a large dose, there have been reports of balance disorders, vision disorders, low blood pressure, agitation, 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 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 at the recommended interval.

In case of any further doubts about using this medicine, the patient should 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 risk 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, the patient 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 medical help 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, the patient should immediately consult a doctor.
• severe skin reactionssuch as a rash covering the whole body, peeling, blistering, and shedding of the skin.

If the child experiences any of the following side effects or any other side effects not listed in the leaflet, they should tell their doctor.

Frequent(may affect up to 1 in 10 people)

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

Uncommon(may affect up to 1 in 100 people)

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

Rare(may affect up to 1 in 1,000 people)

• Tinnitus (ringing in the ears)
• Increased blood urea levels, side or stomach pain, and fever, which may be signs of kidney damage (renal papillary necrosis)
• Increased blood uric acid levels
• Decreased hemoglobin levels.

Very rare(may affect up to 1 in 10,000 people)

• Esophagitis, pancreatitis, intestinal stricture
• 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, they should stop using Nurofen for Children Forte Strawberry and immediately consult a doctor, as these may be the first signs of kidney damage or failure
• Psychotic reactions and depression
• Hypertension, vasculitis
• Palpitations
• 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, 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

Frequency not known (cannot be estimated from the 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, swollen 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 on the folds of the skin, torso, and upper limbs, with fever at the beginning of treatment (acute generalized exanthematous pustulosis). If such symptoms occur, the use of Nurofen for Children Forte Strawberry should be discontinued and medical help sought immediately. See also section 2.
• 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 the patient experiences any side effects, including any side effects not listed in the leaflet, they should tell their 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:
Jerozolimskie Avenue 181C, 02-222 Warsaw
Phone: 22 49-21-301
Fax: 22 49-21-309
Website: https://smz.ezdrowie.gov.pl
By reporting side effects, more information can be collected on the safety of the medicine.

5. How to store Nurofen for Children Forte Strawberry

Store the medicine out of sight and reach of children.
Do not use Nurofen for Children Forte Strawberry 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. The patient should ask their pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the packaging 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: liquid maltitol (E 965), propylene glycol (E 1520), sodium citrate, sodium chloride, sodium saccharin, citric acid monohydrate, polysorbate 80, bromhexine hydrochloride, glycerol, xanthan gum, strawberry flavor (contains propylene glycol (E 1520)), 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 strawberry flavor and a syrupy consistency.
The packaging contains a brown PET bottle with an HDPE cap with a child-resistant closure and a connector for the syringe, together with an oral syringe with a capacity of 5 ml with graduations of 1.25 ml, 2.5 ml, 3.75 ml, and 5 ml (PP cylinder, PE plunger), in a cardboard box.
For more detailed information, the patient should consult the marketing authorization holder or parallel importer.

Marketing authorization holder in Spain, the country of export:

Reckitt Benckiser Healthcare S.A.
C/Mataró, 28
08403 Granollers (Barcelona)
Spain

Manufacturer:

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

Parallel importer:

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

Repackaged by:

Medezin Sp. z o.o.
Zbąszyńska Street 3
91-342 Łódź
Spanish marketing authorization number: 701428.7

Parallel import authorization number: 286/24

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

Date of leaflet approval: 11.07.2024

[Information about the trademark]