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 Junior Fieber-und Schmerzsaft Erdbeer)

40 mg/ml, oral suspension

Ibuprofen
Nurofen for Children Forte Strawberry and Nurofen Junior Fieber-und Schmerzsaft Erdbeer 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 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 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 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.
• 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 also taking other NSAIDs (including COX-2 inhibitors such as celecoxib or etoricoxib), they should be avoided.
• Taking painkillers and anti-inflammatory 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.
• Generally, continuous use (of several types) of 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.
• Nurofen for Children Forte Strawberry should be avoided 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 the mucous membranes, blisters, or other signs of allergy, the use of Nurofen for Children Forte Strawberry should be discontinued and immediate medical attention should be sought, as these may be the first signs of a very 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 symptoms or in patients with a history of serious gastrointestinal disorders. If gastrointestinal bleeding or ulcers occur, treatment should be discontinued immediately. The risk of 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 lowest effective dose. In these patients and in patients requiring concomitant use of low-dose acetylsalicylic acid or drugs that increase the risk of gastrointestinal reactions, concomitant treatment with protective agents (e.g., misoprostol or proton pump inhibitors) should be considered.

Taking painkillers and anti-inflammatory 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.

Nurofen for Children Forte Strawberry and other medicines

The doctor or pharmacist should be informed about all medicines currently being taken or recently taken by the child, as well as any medicines that 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).

Also, some other medicines may 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, a doctor or pharmacist should always be consulted.
In particular, the doctor should be informed 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 for heart failure)
because the effect of digoxin may be enhanced
Corticosteroids (medicines containing cortisone or similar substances)
because the risk of ulcers and bleeding from the gastrointestinal tract may increase
Antiplatelet agents
because the risk of bleeding may increase
Acetylsalicylic acid (low doses)
because the blood-thinning effect may be weakened
Blood thinners (e.g., warfarin)
because ibuprofen may enhance the effect of these medicines
Phenytoin (a medicine used to treat epilepsy)
because the effect of phenytoin may be enhanced
Selective serotonin reuptake inhibitors (medicines used to treat depression)
because they may increase the risk of bleeding from the gastrointestinal tract
Lithium (a medicine used to treat manic-depressive disorders and depression)
because the effect 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 effect of these medicines and may increase the risk of worsening kidney function
Potassium-sparing diuretics (e.g., amiloride, potassium canrenoate, spironolactone, triamterene)
because hyperkalemia may occur
Methotrexate (a medicine used to treat cancer and rheumatism)
because the effect 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 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 effect 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 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 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 may prolong or delay labor. Avoid using this medicine during the first 6 months of pregnancy, unless the doctor recommends otherwise. Taking ibuprofen for more than a few days after the start of the 20th week of pregnancy may cause kidney problems in the unborn child and lead to 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 Strawberry can be used during breastfeeding if it is given 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 and use machines.

Important information about some ingredients of Nurofen for Children Forte Strawberry

• 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, a doctor or pharmacist should be consulted.

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, a doctor should be consulted 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. Insert the syringe firmly 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 symptoms in children over 6 months persist for more than 3 days or the patient feels worse, a doctor should be consulted.

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

If the symptoms worsen, a doctor should be consulted.

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, 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 have occurred. Drowsiness, chest pain, palpitations, loss of consciousness, seizures (mainly in children), weakness, and dizziness, blood in the urine, feeling cold, and breathing problems.

Missing a dose of Nurofen for Children Forte Strawberry:

A double dose should not be taken to make up for a missed dose. If a dose is missed or not given, it should be taken or given as soon as remembered, and the next dose should be taken or given as scheduled.

In case of further doubts about the use of this medicine, a doctor or pharmacist should be consulted.

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 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 use of the medicine should be discontinued and a doctor consulted as soon as possible. Elderly people using this medicine belong to a group with an increased risk of side effects.

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

• symptoms of gastrointestinal bleeding, such as severe abdominal 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 a drop in blood pressure leading to shock. Symptoms may occur even after the first use of the medicine. If any of these symptoms occur, a doctor should be consulted immediately.
• severe skin reactionssuch as a rash covering the whole body, peeling, blistering, and shedding of the skin.

If any of the side effects worsen or any side effects not listed in the leaflet occur, a doctor should be told.

Frequent(may occur in 1 in 10 people)

• Gastrointestinal disorders such as heartburn, abdominal pain, nausea, indigestion, diarrhea, vomiting, bloating (gas), constipation, or 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 intestinal diseases (ulcerative colitis or Crohn's disease), inflammation of the stomach lining
• 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 occur in 1 in 1000 people)

• Tinnitus (ringing in the ears)
• Increased blood urea levels, pain in the side 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)

• Esophagitis, pancreatitis, formation of diaphragm-like strictures in the intestine
• 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 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 consult a doctor immediately, as these may be the first signs 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
• Blood production disorders - the first symptoms are: fever, sore throat, superficial ulcers of the mucous membrane of the mouth, 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 infections and soft tissue complications during chickenpox

Frequency not known(cannot be estimated from available data)

• Respiratory tract reactions, including asthma, bronchospasm, shortness of breath
• They may occur 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 on the folds of the skin, on the 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 immediate medical attention should be sought. 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, a doctor, pharmacist, or nurse should be informed. 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 out of sight and reach of children.
Do not use Nurofen for Children Forte Strawberry 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. A pharmacist should be asked 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: citric acid monohydrate, sodium citrate, sodium chloride, sodium saccharin, polysorbate 80, bromhexine hydrochloride, liquid maltitol, glycerol, xanthan gum, strawberry flavor (contains propylene glycol), and purified water.

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

Nurofen for Children Forte Strawberry is a white suspension with a syrupy consistency and a characteristic strawberry smell.
Each bottle contains 100 ml or 150 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, the marketing authorization holder or parallel importer should be contacted.

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.
Zbąszyńska Street 3
91-342 Łódź

Repackaged by:

Medezin Sp. z o.o.
Zbąszyńska Street 3
91-342 Łódź
Marketing authorization number in Germany, the country of export: 76554.00.00

Parallel import authorization number: 83/25

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]