Nurofen dla dzieci Forte truskavkovi

Leaflet attached to the packaging: information for the user

Warning! Keep the leaflet! Information on the immediate packaging in a foreign language.

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 that you can read it again if you need to.
• If you need advice or additional information, you should consult 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 taking Nurofen for Children Forte Strawberry
• 3. How to take 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 taking Nurofen for Children Forte Strawberry

When not to take 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 bleeding disorders, as ibuprofen may prolong bleeding time.
• If the child has blood 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 taking Nurofen for Children Forte Strawberry, you should discuss this with your doctor or pharmacist

• If the child has an infection - see below, "Infections" section.
• If the child has certain inherited blood disorders (e.g., acute intermittent porphyria).
• If the child has bleeding disorders.
• If the child has certain skin diseases (systemic lupus erythematosus (SLE) or mixed connective tissue disease).
• If the child has 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. With long-term use of Nurofen for Children Forte Strawberry, regular monitoring of liver and kidney function parameters and blood morphology is required.
• Caution is advised 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), they should be avoided as concurrent use of these medicines is not recommended.
• The occurrence of side effects may be reduced by using the smallest effective dose for the shortest duration necessary.
• Generally, continuous use of (various) painkillers may lead to persistent serious kidney disease. This risk may increase during physical exertion associated with salt loss and dehydration. Therefore, this 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. 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 may occur as asthma attacks (so-called analgesic-induced asthma), Quincke's edema, or hives.
• 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. In
connection with this, 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
while an infection is present, 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.
Bleeding, ulcers, or perforation of the gastrointestinal tract, 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 bleeding or ulcers occur, treatment should be discontinued immediately. The risk of bleeding, ulcers, or
perforation of the gastrointestinal tract increases with the dose of NSAIDs in patients who have had ulcers,
especially with bleeding or perforation (see section 2 "When not to take Nurofen for Children Forte
Strawberry") and in the elderly. These patients should start treatment with the lowest effective dose.
Patients with a history of gastrointestinal disorders, especially in the elderly, should report any unusual
symptoms in the abdominal cavity (mainly gastrointestinal bleeding), especially in the initial stages of
treatment.

Nurofen for Children Forte Strawberry and other medicines

Tell your doctor or pharmacist about all medicines your child is currently 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).

Some other medicines may also be affected or have an effect on treatment with Nurofen for Children Forte
Strawberry. Therefore, before taking 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 any of the following medicines:

Nurofen for Children Forte Strawberry and alcohol

Do not consume alcohol while taking 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 taking alcohol and Nurofen for Children Forte Strawberry.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a child, you should
consult a doctor or pharmacist before taking this medicine.
Pregnancy
Do not take 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
taking this medicine during the first 6 months of pregnancy unless your doctor advises 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 blood vessel (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 taken 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 of maltitol is: 2.3 kcal/g
• This medicine contains less than 1 mmol of sodium (23 mg) per dose, so it 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 take 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, 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, 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 syringe should be firmly pressed 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. 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, they should consult a doctor.

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

If the 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 assess the potential risk to their health and for advice on what to do.
Symptoms may include nausea, stomach pain, vomiting (which may contain blood), gastrointestinal bleeding,
headache, ringing in the ears, disorientation, 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 asthmatic patients, drowsiness, chest pain,
palpitations, loss of consciousness, seizures (mainly in children), weakness, and dizziness, blood in urine, and
feeling cold and breathing problems.

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 administer a dose,
they should take or administer it as soon as they remember, and then take or administer the next dose of
the medicine according to the dosing interval described above.

If you have any further doubts about the use of 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
duration necessary to relieve symptoms. In children, one of the known side effects of NSAIDs may occur.
If side effects occur or if you are unsure, stop taking the medicine and consult a doctor as soon as possible.
The elderly using this medicine are at increased risk of side effects.

STOP TAKING the medicine and seek medical help immediately if your 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 help immediately.
• severe skin reactionssuch as a rash covering the whole body, peeling, blistering, or shedding of the skin.

If any of the side effects get worse or if your child experiences any side effects not listed in the leaflet, tell their doctor.

Common(may affect up to 1 in 10 people)

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

Uncommon(may affect up to 1 in 100 people)

• Ulcers in the gastrointestinal tract that may bleed or perforate, mouth ulcers, worsening of existing intestinal diseases (ulcerative colitis or Crohn's disease), stomach inflammation
• 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)

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

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

• Esophageal inflammation, pancreatitis, formation of 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 these symptoms occur, stop taking Nurofen for Children Forte Strawberry and consult a doctor immediately, as they may be the first signs of kidney damage or failure
• Psychotic reactions and depression
• High blood pressure, vasculitis
• Rapid heartbeat
• Liver function disorders, liver damage (the first symptoms may be skin discoloration), especially during long-term treatment, liver failure, acute hepatitis
• Blood 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 and a doctor consulted. Do not self-medicate with painkillers or antipyretics
• Severe skin infections and soft tissue complications during chickenpox
• A rare but serious skin condition with a red, scaly rash, 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, stop taking Nurofen for Children Forte Strawberry and seek medical help immediately. See also section 2
• Skin sensitivity to light.

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. Symptoms of DRESS syndrome include: skin rash, fever, swollen lymph nodes, and an increased number of eosinophils (a type of white blood cell)

(a type of white blood cell)

• A red, scaly rash with thickening of the skin and blisters, usually on the skin folds, torso, and upper limbs, with fever at the beginning of treatment (acute generalized exanthematous pustulosis). If such symptoms occur, stop taking Nurofen for Children Forte Strawberry and seek medical help 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 you experience any side effects, including any side effects not listed in the leaflet, you should tell your doctor
or pharmacist. 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, Al. Jerozolimskie 181 C,
02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Nurofen for Children Forte Strawberry

Keep the medicine 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 stated.
Do not store above 25°C.
Shelf life after first opening: 6 months.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose
of medicines no longer required. These measures 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, domiphen bromide, liquid maltitol, glycerol, xanthan gum, strawberry flavor (contains
propylene glycol), and purified water.

What Nurofen for Children Forte Strawberry looks like and contents of the pack

Nurofen for Children Forte Strawberry is a white suspension with a syrupy consistency and a characteristic
strawberry flavor.
Each bottle contains 150 ml of suspension.
The packaging includes an oral syringe with a capacity of 5 ml with markings for 1.25 ml; 2.5 ml; 3.75 ml,
and 5.0 ml.
The outer packaging is a cardboard box.
For more detailed information, please contact 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:

InPharm Sp. z o.o.
ul. Strumykowa 28/11, 03-138 Warsaw

Repackaged by:

InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249, 04-458 Warsaw
Spanish marketing authorization number:701428.7

Parallel import authorization number: 307/24

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

Date of leaflet approval: 26.07.2024

[Information about the trademark]