Nurofen for children forte strawberry flavored

Patient Information Leaflet

Warning! Keep this leaflet! Information on the outer packaging in a foreign language.
Nurofen dla dzieci Forte truskawkowy
40 mg/ml oral suspension
Ibuprofenum
For children weighing from 5 kg (from 3 months of age) to 40 kg (12 years of age)
Please read this leaflet carefully before using the medicine, as it contains
important information for the patient.

• This medicine should always be used exactly as described in this patient leaflet or as directed by a doctor or pharmacist.
• Keep this leaflet for future reference.
• If you need advice or further information, please consult a pharmacist.
• If the patient experiences any adverse reactions, including any possible adverse reactions not listed in this leaflet, inform a doctor or pharmacist. See section 4.
• If there is no improvement within 24 hours (infants aged 3–5 months with body weight above 5 kg) or 3 days (children over 6 months of age), or if the patient feels worse, consult a doctor.

Contents of the leaflet:

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

1. What Nurofen dla dzieci Forte truskawkowy is and what it is used for

Ibuprofen belongs to a group of medicines known as Non-Steroidal Anti-Inflammatory Drugs (NSAIDs).
These medicines work by altering the body's response to pain and fever. Nurofen dla dzieci Forte truskawkowy is intended for short-term, symptomatic treatment of:

• fever,
• mild to moderate pain.

If there is no improvement within 24 hours (infants aged 3–5 months with body weight above 5 kg) or 3 days (children over 6 months of age), or if the patient feels worse, consult a doctor.

2. Important information before using Nurofen dla dzieci Forte truskawkowy

When not to use Nurofen dla dzieci Forte truskawkowy

• If the child is allergic to ibuprofen or other similar pain-relieving medicines (NSAIDs) or any of the other ingredients of this medicine (listed in section 6).
• If breathlessness, asthma, rhinitis, facial and (or) hand swelling, or urticaria occurred after taking acetylsalicylic acid or other similar pain-relieving medicines (NSAIDs) in the past.
• If gastrointestinal bleeding or perforation has occurred in the past due to previous use of NSAIDs.
• If there is current or previous peptic ulceration of the stomach and (or) duodenum (peptic ulcer disease) or gastrointestinal bleeding (two or more confirmed episodes of ulceration or bleeding).
• If severe liver or kidney failure is present.
• If severe heart failure is present.
• If there is cerebral hemorrhage (bleeding from brain blood vessels) or any other active bleeding.
• If blood clotting disorders are present, as ibuprofen may prolong bleeding time.
• If unexplained blood cell production disorders are present.
• In children with severe dehydration (caused by vomiting, diarrhea, or insufficient fluid intake).

Do not take this medicine during the last 3 months of pregnancy.
Warnings and precautions
Before starting treatment with Nurofen dla dzieci Forte truskawkowy, consult a
doctor or pharmacist

• If the child has an infection – see below, section "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 or has previously had intestinal diseases (ulcerative colitis or Crohn's disease), as symptoms may worsen.
• If the child has or has ever had high blood pressure and (or) heart failure.
• If the child has kidney function disorders.
• If the child has liver diseases. With long-term use of Nurofen dla dzieci Forte truskawkowy, regular monitoring of liver function tests, kidney function, and blood counts is required.
• Caution is advised when using other medicines that may increase the risk of gastrointestinal ulceration or bleeding, such as oral corticosteroids (e.g. prednisolone), anticoagulants (e.g. warfarin), selective serotonin reuptake inhibitors (antidepressants), and antiplatelet medicines (e.g. acetylsalicylic acid). Avoid concomitant use of other NSAIDs (including COX-2 inhibitors such as celecoxib or etoricoxib).
• The risk of adverse effects may be reduced by using the lowest effective dose for the shortest possible duration.
• Generally, prolonged use of (multiple types of) painkillers may lead to persistent serious kidney diseases. This risk may increase during physical exertion associated with salt loss and dehydration. Therefore, this should be avoided.
• Prolonged use of any type of painkillers may lead to headaches, which should not be treated with increased doses of this medicine. In such cases, the medicine should be discontinued and medical advice sought. Medication-overuse headache should be suspected in patients who have frequent or daily headaches despite (or because of) regular use of headache-relieving medicines.
• If the child has had or currently has asthma or allergic conditions causing breathlessness.
• If the child has hay fever, nasal polyps, or chronic obstructive pulmonary disease, there is an increased risk of allergic reactions. Allergic reactions may manifest as asthma attacks (so-called drug-induced asthma), Quincke's edema, or urticaria.
• Avoid using Nurofen dla dzieci Forte truskawkowy in case of chickenpox (varicella).
• If the child has recently undergone major surgery (medical supervision required).
• If the child is dehydrated, due to increased risk of kidney failure in dehydrated children.

Infections
Nurofen dla dzieci Forte truskawkowy may mask symptoms of infection such as fever and pain.
Therefore, Nurofen dla dzieci Forte truskawkowy may delay appropriate treatment of infection,
potentially increasing the risk of complications. This has been observed in bacterial pneumonia and
bacterial skin infections associated with chickenpox. If a patient takes this medicine during an
ongoing infection and infection symptoms persist or worsen, immediate medical advice must be
sought.
Skin reactions
Severe skin reactions associated with the use of Nurofen dla dzieci Forte truskawkowy have been
reported. If any skin rash, mucosal lesions, blisters, or other allergic symptoms appear, stop taking
Nurofen dla dzieci Forte truskawkowy immediately and seek urgent medical help, as these may be
early signs of a very serious skin reaction. See section 4.
Bleeding, ulceration, or perforation of the gastrointestinal tract, which may be fatal, have been
reported during treatment with all NSAIDs, with or without warning signs, particularly in patients
with previous serious gastrointestinal disorders. If gastrointestinal bleeding or ulceration occurs,
treatment must be stopped immediately. The risk of gastrointestinal bleeding, ulceration, or
perforation increases with higher NSAID doses, especially in patients with a history of peptic ulcer,
particularly with bleeding or perforation (see section 2 " When not to use Nurofen dla dzieci Forte
truskawkowy") and in elderly patients. These patients should start treatment with the lowest
effective dose. In these patients and in patients requiring concomitant low-dose acetylsalicylic acid or
other drugs increasing gastrointestinal risk, consider concomitant use of protective agents (e.g.
misoprostol or proton pump inhibitors).
Use of anti-inflammatory and pain-relieving medicines such as ibuprofen may be associated with a
small increased risk of heart attack or stroke, especially when used at high doses. Do not exceed the
recommended dose or duration of treatment.
Before using Nurofen dla dzieci Forte truskawkowy, the patient should discuss treatment with a
doctor or pharmacist if:

• the patient has heart conditions such as heart failure, angina (chest pain), history of heart attack, coronary artery bypass surgery, peripheral arterial disease (poor blood circulation in legs due to narrowed or blocked arteries), or history of stroke (including mini-stroke or transient ischemic attack - TIA).
• the patient has hypertension, diabetes, high cholesterol levels, family history of heart disease or stroke, or is a smoker.

If any of the above conditions apply to the child, consult a doctor before using Nurofen dla dzieci Forte truskawkowy.
Elderly patients
Elderly patients have an increased risk of adverse effects during NSAID use, particularly affecting the stomach and intestines.
Patients with a history of gastrointestinal disorders, especially elderly patients, should report any unusual abdominal symptoms (particularly gastrointestinal bleeding), especially at the beginning of treatment.
Nurofen dla dzieci Forte truskawkowy and other medicines
Inform the doctor or pharmacist about all medicines currently or recently taken by the child, as well as any medicines the child may take in the future.
Nurofen dla dzieci Forte truskawkowy may affect the action of other medicines or other medicines may affect the action of Nurofen dla dzieci Forte truskawkowy. For example:

• anticoagulant medicines (i.e. blood thinners/preventing clot formation, such as acetylsalicylic acid, warfarin, ticlopidine)
• blood pressure-lowering medicines (ACE inhibitors, such as captopril, beta-blockers, such as medicines containing atenolol, angiotensin II receptor antagonists, such as losartan).

Also, some other medicines may be affected by or may affect treatment with Nurofen dla dzieci Forte truskawkowy. Therefore, always consult a doctor or pharmacist before using Nurofen dla dzieci Forte truskawkowy with other medicines.
In particular, inform the doctor if the patient is taking the following medicines:

Nurofen dla dzieci Forte truskawkowy and alcohol
Do not consume alcohol while taking Nurofen dla dzieci Forte truskawkowy.
Some adverse effects, such as those related to the gastrointestinal tract or the central nervous system, may be more likely when alcohol and Nurofen dla dzieci Forte truskawkowy are taken together.

Pregnancy, breastfeeding and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a baby, she should consult a doctor or pharmacist before using this medicine.

Pregnancy
Do not use this medicine during the last three months of pregnancy. Use during this period may cause kidney and heart problems in the unborn child. It may also affect bleeding tendency in both the mother and her child and may delay or prolong labour. Avoid using this medicine during the first six months of pregnancy unless advised otherwise by a doctor. Taking ibuprofen for longer than a few days after the start of week 20 of pregnancy may cause kidney problems in the unborn child and lead to reduced levels of amniotic fluid surrounding the child (oligohydramnios) or narrowing of a blood vessel (ductus arteriosus) in the child's heart. If longer-term treatment is required, the doctor may recommend additional monitoring tests.

Breastfeeding
Only small amounts of ibuprofen and its metabolites pass into breast milk. Nurofen dla dzieci Forte truskawkowy may be used during breastfeeding if taken at the recommended doses and for the shortest possible duration.

Fertility
Nurofen dla dzieci Forte truskawkowy belongs to a group of medicines (NSAIDs) which may affect female fertility. This effect is reversible upon discontinuation of the medicine.

Driving and operating machinery
During short-term use, this medicine has no effect or negligible effect on the ability to drive and operate machinery.

Important information about some of the ingredients of Nurofen dla dzieci Forte truskawkowy

• Nurofen dla dzieci Forte truskawkowy contains liquid maltitol. If the patient has been previously diagnosed with intolerance to certain sugars, the patient should consult a doctor before taking this medicine.
• The medicine may have a mild laxative effect.
• Calorific value of maltitol: 2.3 kcal/g
• This medicine contains less than 1 mmol sodium (23 mg) per dose, meaning the medicine is considered "sodium-free".
• Nurofen dla dzieci Forte truskawkowy contains 16.45 mg of propylene glycol in each 5 ml of suspension.

3. How to use Nurofen dla dzieci Forte truskawkowy

Nurofen dla dzieci Forte truskawkowy should always be used exactly as described
in the patient leaflet or as advised by a doctor or pharmacist. If in doubt, consult a
doctor or pharmacist.
Use the lowest effective dose for the shortest duration necessary to relieve symptoms.
If, during an infection, its symptoms (such as fever and pain) persist or worsen, consult a doctor immediately (see section 2).
The recommended dose for pain and fever is:

* Doses should be administered approximately every 6 to 8 hours.
Not recommended for use in children under 3 months of age or weighing less than 5 kg.
In patients with sensitive stomach, it is recommended that Nurofen dla dzieci Forte truskawkowy be
taken during a meal.
WARNING: Do not exceed the recommended dose.
For oral use
Administration method using the oral syringe

1. Shake the bottle vigorously.
2. Remove the cap from the bottle by pressing it down and turning it to the left.
3. Firmly insert the oral syringe into the neck of the bottle.
4. To fill the syringe, invert the bottle. While holding the syringe in place, gently pull the plunger down to draw the suspension up to the appropriate mark on the syringe.
5. Turn the bottle upright again and remove the syringe by gently twisting it.
6. Place the tip of the syringe into the child's mouth. Slowly and gently press the plunger to administer the suspension. Rinse the syringe with warm water and allow it to dry. Store out of sight and reach of children.

Duration of treatment
This medicine is intended for short-term use only. If symptoms in children over 6 months of age
persist for more than 3 days or if the patient feels worse, consult a doctor.
In infants aged 3–5 months (weighing 5 kg or more), consult a doctor if symptoms do not improve
within 24 hours.
If symptoms worsen, consult a doctor.
Overdose of Nurofen dla dzieci Forte truskawkowy
If a patient has taken more than the recommended dose of Nurofen dla dzieci Forte truskawkowy or
if a child has accidentally ingested the medicine, seek immediate advice from a doctor or go to the
nearest hospital for assessment of potential health risks and guidance on necessary actions.
Symptoms may include nausea, stomach pain, vomiting (possibly with blood), gastrointestinal
bleeding, headache, tinnitus, disorientation, and nystagmus, or less commonly, diarrhea.
After ingestion of a large dose, symptoms may include loss of balance, visual disturbances, low blood
pressure, agitation, disorientation, coma, hyperkalemia, metabolic acidosis, prolonged 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, feeling cold, and breathing difficulties.
Missed dose of Nurofen dla dzieci Forte truskawkowy
Do not take a double dose to make up for a missed dose. If a patient forgets to take or administer a
dose, it should be taken or administered as soon as remembered, and then the next dose should be
taken or administered according to the dosing interval described above.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, Nurofen dla dzieci Forte truskawkowy may cause adverse effects, although not everyone experiences them. The risk of adverse effects can be reduced by using the lowest effective dose for the shortest duration necessary to relieve symptoms. Children may experience any of the known adverse effects associated with NSAIDs. If any adverse effects occur or if there is any uncertainty, administration of the medicine should be stopped and medical advice should be sought as soon as possible. Elderly individuals using this medicine belong to a group at increased risk of adverse effects.

DISCONTINUE USE of the medicine and seek immediate medical attention if the child experiences:

• Symptoms of gastrointestinal bleeding, such as severe abdominal pain, black tarry stools, vomiting blood, or vomiting material resembling dark granules or coffee grounds.
• Symptoms of rare but serious allergic reactions, such as worsening asthma, unexplained wheezing or shortness of breath, swelling of the face, tongue or throat, difficulty breathing, palpitations, or drop in blood pressure leading to shock. These symptoms may occur even after the first dose. If any of these symptoms occur, contact a doctor immediately.
• Severe skin reactions, such as rash affecting the whole body, skin peeling, blistering, or shedding of skin in layers.

If any of the adverse effects worsen or if any adverse effects not listed in this leaflet occur, inform a doctor.

Common (may occur in 1 out of 10 people)

• Gastrointestinal disturbances such as heartburn, abdominal pain, nausea, indigestion, diarrhoea, vomiting, bloating (gas), constipation, minor gastrointestinal bleeding which, in rare cases, may lead to anaemia.

Uncommon (may occur in 1 out of 100 people)

• Gastrointestinal ulcers which may bleed or perforate, inflammation of the oral mucosa with ulceration, exacerbation of existing bowel disease (colitis or Crohn's disease), inflammation of the gastric mucosa
• Central nervous system disorders such as headache, dizziness, insomnia, restlessness, irritability or fatigue
• Visual disturbances
• Various skin rashes
• Hypersensitivity reactions with urticaria and itching.

Rare (may occur in 1 out of 1000 people)

• Tinnitus (ringing in the ears)
• Increased blood urea levels, flank pain and/or abdominal pain, blood in urine, and fever which may indicate kidney damage (papillary necrosis)
• Increased blood uric acid levels
• Decreased haemoglobin concentration.

Very rare (may occur in 1 out of 10,000 people)

• Oesophagitis, pancreatitis, formation of diaphragm-like intestinal strictures
• Heart failure, myocardial infarction, and facial or hand swelling
• Reduced urine output compared to usual, and oedema (especially in patients with high blood pressure or impaired kidney function), oedema and cloudy 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, treatment with Nurofen dla dzieci Forte truskawkowy should be stopped immediately and medical advice should be sought without delay, as these may be early signs of kidney damage or kidney failure
• Psychotic reactions and depression
• High blood pressure, vasculitis
• Palpitations
• Liver function disorders, liver damage (early signs may include skin discoloration), particularly during prolonged treatment, liver failure, acute hepatitis
• Blood cell production disorders – early signs include: fever, sore throat, superficial ulceration of the oral mucosa, flu-like symptoms, severe fatigue, nosebleeds and skin bleeding, unexplained bruising. In such cases, treatment should be stopped immediately and medical advice sought. Self-treatment with painkillers or antipyretics should not be continued
• Severe skin infections and soft tissue complications during chickenpox infection
• Worsening of inflammatory conditions related to infection (e.g. necrotizing fasciitis) has been reported with certain painkillers (NSAIDs). If signs of infection occur or worsen, the patient should seek medical advice immediately. The need for anti-infective treatment (antibiotic therapy) should be assessed
• Aseptic meningitis symptoms such as neck stiffness, headache, nausea, vomiting, fever, and altered consciousness have been observed during ibuprofen use. Patients with autoimmune disorders (lupus, mixed connective tissue disease) are at higher risk of such symptoms. If such symptoms occur, contact a doctor immediately
• Severe skin reactions such as 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 available data)

• Respiratory tract reactivity, including asthma, bronchospasm, shortness of breath
• Severe skin reactions known as DRESS syndrome may occur. Symptoms of DRESS syndrome include: skin rash, fever, lymph node swelling, and increased eosinophil count (a type of white blood cell)
• Erythematous scaly rash with subcutaneous nodules and blisters, predominantly located in skin folds, trunk, and upper limbs, accompanied by fever at the beginning of treatment (acute generalised exanthematous pustulosis). If such symptoms occur, discontinue use of Nurofen dla dzieci Forte truskawkowy and seek immediate medical help. See also section 2
• Skin becomes sensitive to light.

Medicines such as this one may be associated with a small increased risk of heart attack (myocardial infarction) or stroke.

Reporting of adverse effects

If any adverse effects occur, including any not listed in this leaflet, inform a doctor or pharmacist. Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions, 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.

Reporting adverse effects helps to provide more information on the safety of the medicine.

5. How to store Nurofen dla dzieci Forte truskawkowy

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 stated month.
Do not store above 25°C.
Usable period after first opening: 6 months.
Do not dispose of medicines via the sewage system or household waste. Ask your pharmacist what to do with medicines no longer in use. This will help protect the environment.

6. Contents of the packaging and other information

What Nurofen dla dzieci Forte truskawkowy contains
The active substance is ibuprofen. Each 1 ml of oral suspension contains 40 mg of ibuprofen.
Other ingredients are: citric acid monohydrate, sodium citrate, sodium chloride, sodium saccharin,
polysorbate 80, domiphen bromide, liquid maltitol, glycerol, xanthan gum, strawberry flavour
(containing propylene glycol), and purified water.

What Nurofen dla dzieci Forte truskawkowy looks like and contents of the pack
Nurofen dla dzieci Forte truskawkowy is a white, syrup-like oral suspension with a characteristic
strawberry odour.
Each bottle contains 150 ml of suspension.
The pack contains an oral syringe with a capacity of 5 ml, marked at 1.25 ml, 2.5 ml, 3.75 ml,
and 5.0 ml.
Outer packaging: cardboard box.

For more detailed information, please contact the marketing authorisation holder or the parallel importer.

Marketing authorisation 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
The Netherlands

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

Repackaged in:
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249, 04-458 Warsaw

Marketing authorisation number in Spain, the country of export: 701428.7
Parallel import authorisation number: 307/24

This medicinal product is authorised in the European Economic Area countries under the following names: