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 old)

You should carefully read the contents of the leaflet before using the medicine, as it contains important information for the patient.

• This medicine should always be used exactly as described in the patient leaflet or as directed by a doctor or pharmacist.
• This leaflet should be kept, so that it can be re-read 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 old, weighing over 5 kg) or 3 days (children over 6 months old) 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 old, weighing over 5 kg) or 3 days (children over 6 months old) 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 (from the NSAID group) or any of the other ingredients of this medicine (listed in section 6).
• If the child has ever had difficulty breathing, asthma, hay fever, swelling of the face and/or hands or hives after taking acetylsalicylic acid or other similar painkillers (from the NSAID group).
• 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 treatment with 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 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 bowel 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 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.
• The occurrence of side effects can be reduced by using the smallest effective dose for the shortest duration necessary to relieve symptoms.
• 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 cases, 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 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 can occur as asthma attacks (so-called analgesic-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 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. In this regard, 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 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 medical help sought immediately, as these may be the first signs of a very 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 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 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 concurrent administration of acetylsalicylic acid in small doses or medications that increase the risk of gastrointestinal reactions, concomitant treatment with protective agents (e.g., misoprostol or proton pump inhibitors) should be considered.
Taking anti-inflammatory and pain-relieving medications, such as ibuprofen, may be associated with a slight increase in the risk of heart attack or stroke, particularly when used in high doses. The recommended dose should not be exceeded, and the duration of treatment should be as short as possible.
Before using Nurofen for Children Forte Strawberry, the patient should discuss the 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 artery disease (poor blood circulation in the legs due to narrowing or blockage of arteries), or has had any stroke (including mini-stroke or transient ischemic attack - TIA).
• The patient has high blood pressure, diabetes, high cholesterol levels, has a family history of heart disease or stroke, or smokes.

If any of the above applies to the child, they should consult a doctor before using Nurofen for Children Forte Strawberry.
Elderly patients
Elderly patients using NSAIDs are at increased risk of side effects, particularly those affecting the stomach and intestines.
Patient with a history of gastrointestinal disorders, especially 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:

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

Also, some other medicines may be affected or may affect 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 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 action of digoxin may be enhanced
Corticosteroids (medicines containing cortisone or similar substances)
because the risk of stomach ulcers and bleeding may increase
Antiplatelet agents
because the risk of bleeding may increase
Acetylsalicylic acid (in small doses)
because the blood-thinning action may be weakened
Blood thinners (e.g., warfarin)
because ibuprofen may enhance the action of these medicines
Phenytoin (a medicine used to treat epilepsy)
because the action of phenytoin may be enhanced
Selective serotonin reuptake inhibitors (medicines used to treat depression)
because they may increase the risk of gastrointestinal bleeding
Lithium (a medicine used to treat manic-depressive disorders and depression)
because the action of lithium may be enhanced
Probenecid and sulfinpyrazone (a medicine used to treat gout)
because the excretion of ibuprofen may be delayed
Blood pressure-lowering medicines and diuretics
because ibuprofen may weaken the action of these medicines and may increase the risk of kidney function deterioration
Potassium-sparing diuretics, such as amiloride, potassium canrenoate, spironolactone, triamterene
because hyperkalemia may occur
Methotrexate (a medicine used to treat cancer and rheumatism)
because the action of methotrexate may be enhanced
Tacrolimus and cyclosporin (immunosuppressive medicines)
because kidney damage may occur
Zidovudine (in the treatment of HIV/AIDS)
because the use of Nurofen for Children Forte Strawberry may increase the risk of bleeding or bleeding leading to swelling in HIV-positive patients with hemophilia
Sulfonylurea derivatives (oral hypoglycemic medicines)
because they may affect blood sugar levels
Quinolone antibiotics
because the risk of seizures may increase
Voriconazole and fluconazole (CYP2C9 inhibitors, used in fungal infections)
the action of ibuprofen may be enhanced; it is recommended to reduce the dose of ibuprofen, especially when using high doses of ibuprofen with voriconazole or fluconazole
Baclofen
after using ibuprofen, baclofen toxicity may develop
Ritonavir
ritonavir may increase the plasma concentration of NSAIDs

Nurofen for Children Forte Strawberry and alcohol

Alcohol should not be consumed while using Nurofen for Children Forte Strawberry.
Certain 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 the medicine during the last 3 months of pregnancy. Avoid using this medicine during the first 6 months of pregnancy, unless the doctor recommends otherwise.
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 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.

The smallest effective dose should be used for the shortest duration necessary to relieve symptoms. If the symptoms of an 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.

It is not recommended to use in children under 3 months old or weighing less than 5 kg.

In patients with sensitive stomachs, Nurofen for Children Forte Strawberry should be taken 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 turning 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 a child over 6 months old persist for more than 3 days or the patient feels worse, they should consult a doctor.

In the case of infants 3 - 5 months old (weighing from 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 the possible risk to their health and advice on what to do.
Symptoms may include nausea, stomach pain, vomiting (which may contain blood), gastrointestinal bleeding, headaches, ringing in the ears, disorientation, and 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 asthmatic patients, drowsiness, chest pain, palpitations, loss of consciousness, seizures (mainly in children), weakness, and dizziness, hematuria, feeling cold, and breathing difficulties.

Missing a dose of Nurofen for Children Forte Strawberry:

A double dose should not be taken 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 any 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. In children, one of the known side effects of NSAIDs may occur. 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 patients using this medicine are at increased risk of side effects.

DISCONTINUE USE of 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-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, 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.

Common(may affect up to 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 affect up to 1 in 100 people)

• Ulcers in the gastrointestinal tract, which may bleed or perforate, inflammation of the oral mucosa with ulcers, worsening of existing bowel disease (ulcerative colitis or Crohn's disease), gastritis
• Central nervous system disorders, such as headaches, dizziness, insomnia, excitement, 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 and/or stomach 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 affect up to 1 in 10,000 people)

• Esophagitis, pancreatitis, formation of intestinal strictures
• Heart failure, heart attack, and facial or hand edema
• Decreased urine output and edema (especially in patients with high blood pressure or impaired kidney function), edema 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 the use of 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
• 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 oral mucosa ulcers, flu-like symptoms, severe fatigue, nosebleeds, and unexplained bruising. In such cases, treatment should be discontinued and a doctor consulted. The patient should not self-medicate 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 occur, the patient should immediately consult a doctor. It should be assessed whether there are indications for the use of anti-infective treatment (antibiotic therapy)
• During the use of ibuprofen, symptoms of aseptic meningitis with neck stiffness, headache, nausea, vomiting, fever, and altered consciousness have been observed. In patients with autoimmune disorders (lupus, mixed connective tissue disease), there is a higher risk of such symptoms. If such symptoms occur, a doctor should be consulted immediately
• Severe skin reactions, such as a rash with redness and blistering (e.g., Stevens-Johnson syndrome, erythema multiforme, and toxic epidermal necrolysis/Lyell's syndrome), hair loss (alopecia).

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 may occur. 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 located in skin folds, on the trunk, 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.
• The skin becomes sensitive to light.

Medicines like this one may be associated with a slight increase in the 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 told. 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:
Aleje Jerozolimskie 181C, 02-222 Warsaw, tel.: 22 49-21-301, fax: 22 49-21-309, website:
https://smz.ezdrowie.gov.pl
By reporting side effects, more information can be collected on the safety of the medicine.

5. How to store Nurofen for Children Forte Strawberry

The medicine should be stored out of sight and reach of children.
Do not use this medicine 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 that are no longer needed. 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 (containing propylene glycol), and purified water.

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

Nurofen for Children Forte Strawberry is a white suspension with a syrupy consistency and a characteristic strawberry flavor.
Each bottle contains 100 ml, 150 ml.
The packaging includes an oral syringe (5 ml syringe with a scale: 1.25 ml, 2.5 ml, 3.75 ml, and 5.0 ml).
The outer packaging: a 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:

Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź

Repackaged by:

Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź
Marketing authorization number in Germany, the country of export: 76554.00.00

Parallel import authorization number: 280/22

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

Approval date of the leaflet: 15.07.2022

[Information about the trademark]