Nurofen for children forte strawberry flavour

Package leaflet: Information for the user

Warning! Keep this leaflet! Information on the immediate packaging in a foreign language.
Nurofen dla dzieci Forte truskawkowy (Nurofen Junior Fever and Pain Syrup Strawberry)
40 mg/ml, oral suspension
Ibuprofenum
Nurofen dla dzieci Forte truskawkowy and Nurofen Junior Fieber- und Schmerzsaft Erdbeer are different
brand names of the same medicine.
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 your pharmacist.
• If any adverse reactions occur in the patient, including any possible adverse reactions not listed in this leaflet, inform a doctor or pharmacist immediately. See section 4.
• If there is no improvement after 24 hours (infants aged 3–5 months, body weight above 5 kg) or 3 days (children over 6 months of age), or if the patient feels worse, consult a doctor.

Table of contents of the leaflet:

1. What Nurofen dla dzieci Forte truskawkowy is and what it is used for
2. Important information before taking Nurofen dla dzieci Forte truskawkowy
3. How to take 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 called Non-Steroidal Anti-Inflammatory Drugs (NSAIDs).
These medicines work by altering the body's response to pain and elevated body temperature.
Nurofen dla dzieci Forte truskawkowy is intended for short-term, symptomatic treatment of:

• fever,
• mild to moderate pain.

If there is no improvement after 24 hours (infants aged 3–5 months, 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).
• If gastrointestinal bleeding or perforation has ever occurred related to previous use of NSAIDs.
• If there is or has been gastric or duodenal ulceration (peptic ulcer disease) or bleeding (two or more confirmed episodes of ulceration or bleeding).
• If there is severe liver or kidney failure.
• If there is severe heart failure.
• If there is intracranial bleeding (cerebral haemorrhage) or any other active bleeding.
• If there are blood coagulation disorders, as ibuprofen may prolong bleeding time.
• If there are blood cell production disorders of unknown origin.
• In children with severe dehydration (caused by vomiting, diarrhoea, or insufficient fluid intake).

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

• If the child has an infection – see below, section "Infections".
• If the child has certain inherited blood cell production disorders (e.g. acute intermittent porphyria).
• If the child has blood coagulation disorders.
• If the child has certain skin diseases (systemic lupus erythematosus (SLE) or mixed connective tissue disease).
• If the child has or has ever 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. In case of long-term use of Nurofen dla dzieci Forte truskawkowy, regular monitoring of liver and kidney function tests and blood morphology 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 drugs (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) pain-relieving medicines 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 pain-relieving medicine may lead to headaches that should not be treated with increased doses of this medicine. In such cases, discontinue the medicine and consult a doctor. Medication-overuse headache should be suspected in patients who have frequent or daily headaches despite (or because of) regular use of pain-relieving medicines.
• If the child has had or has asthma or allergic conditions that may cause breathlessness.
• If the child has hay fever, nasal polyps, or chronic obstructive respiratory diseases, there is an increased risk of allergic reactions. Allergic reactions may manifest as asthma attacks (so-called drug-induced asthma), Quincke's oedema, or urticaria.
• Avoid using Nurofen dla dzieci Forte truskawkowy 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 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, thereby 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 symptoms persist or worsen, immediate medical advice should 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 allergy symptoms appear, discontinue taking Nurofen dla dzieci Forte truskawkowy immediately and seek medical help promptly, 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 symptoms, particularly in patients with a history of 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, in patients with a history of ulceration, especially 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 combination therapy with 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 myocardial infarction 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 diseases such as heart failure, angina pectoris (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 ischaemic attack - TIA).
• The patient has hypertension, diabetes, high cholesterol levels, family history of heart disease or stroke, or is a tobacco 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 blood clots, such as aspirin/acetylsalicylic acid, warfarin, ticlopidine)
• Medicines that lower blood pressure (ACE inhibitors such as captopril, beta-blockers such as atenolol-containing medicines, 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 with alcohol
Alcohol should not be consumed during treatment with Nurofen dla dzieci Forte truskawkowy.
The risk of certain adverse effects, such as those related to the gastrointestinal tract or central nervous system, may be increased when alcohol is consumed concurrently with Nurofen dla dzieci Forte truskawkowy.

Pregnancy, breastfeeding and effects on fertility

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

Pregnancy
Do not use this medicine during the last three months of pregnancy. Avoid using this medicine during the first six months of pregnancy unless otherwise advised by a doctor.

Breastfeeding
Only small amounts of ibuprofen and its metabolites pass into breast milk. Nurofen dla dzieci Forte truskawkowy may be used during breastfeeding if administered 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 impair fertility in women. This effect is reversible upon discontinuation of the medicine.

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

Important information about certain ingredients in Nurofen dla dzieci Forte truskawkowy

• Nurofen dla dzieci Forte truskawkowy contains liquid maltitol. If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult a doctor before taking this 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, 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 information leaflet or as recommended by the doctor or pharmacist. If in doubt, consult the
doctor or pharmacist.
The lowest effective dose for the shortest duration necessary to relieve symptoms should be used.
If, during an infection, its symptoms (such as fever and pain) persist or worsen, medical advice should be sought immediately (see section 2).
The recommended dose for pain and fever is:

* Doses should be administered approximately every 6 to 8 hours.
Do not 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 syringe into the opening in the neck of the bottle.
4. To fill the syringe, turn the bottle upside down. While holding the syringe in place, gently pull the plunger downward 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 push 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 the patient feels worse, consult a doctor.
For 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.
Accidental overdose of Nurofen dla dzieci Forte truskawkowy
If the patient has taken more than the recommended dose of Nurofen dla dzieci Forte truskawkowy or
if a child accidentally ingests the medicine, always contact a doctor or go to the nearest hospital
to assess possible health risks and receive advice on appropriate actions.
Symptoms may include nausea, stomach pain, vomiting (possibly with blood), gastrointestinal
bleeding, headache, tinnitus, confusion, and nystagmus, or less commonly diarrhea.
After ingestion of a large dose, disturbances in balance, visual disturbances, low blood pressure,
excitation, confusion, coma, hyperkalemia, metabolic acidosis, prolonged prothrombin time/INR,
acute kidney failure, liver damage, respiratory depression, cyanosis, and asthma exacerbation in
asthmatic patients have occurred, as well as drowsiness, chest pain, palpitations, loss of consciousness,
seizures (mainly in children), weakness, 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 the patient forgets to take or administer
a dose, take or administer it as soon as remembered, then continue with the next dose according
to the dosing interval described above.
If you have any further questions concerning the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, Nurofen dla dzieci Forte truskawkowy may cause side effects,
although not everyone experiences them. The risk of side effects can be reduced by using the
lowest effective dose for the shortest duration necessary to relieve symptoms. In children,
any of the known side effects associated with NSAIDs (non-steroidal anti-inflammatory drugs)
may occur. If side effects occur or if there is any uncertainty, administration of the medicine
should be stopped and a doctor should be consulted as soon as possible. Elderly individuals
taking this medicine belong to a group at increased risk of adverse reactions.

STOP USING THE MEDICINE and seek immediate medical help if the child experiences:

• Symptoms of gastrointestinal bleeding, such as severe abdominal pain, black tarry stools, vomiting blood, or vomiting dark particles resembling 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, formation of blisters, and shedding of skin layers.

If any of the side effects worsen or if any unlisted side effects occur, inform a doctor immediately.

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 (from stomach and/or intestines), which in rare cases may lead to anaemia.

Uncommon (may occur in 1 out of 00 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 1,000 people)

• Tinnitus (ringing in the ears)
• Increased blood urea levels, flank and/or abdominal pain, blood in urine, and fever, which may indicate kidney damage (renal 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 these symptoms occur, or if the patient feels unwell, treatment with Nurofen dla dzieci Forte truskawkowy should be stopped immediately and medical advice sought, 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 symptoms 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 must be stopped immediately and a doctor consulted. Self-treatment with painkillers or antipyretics must not be continued
• Severe skin infections and soft tissue complications during chickenpox infection
• Worsening of inflammatory conditions associated with 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 (e.g. lupus, mixed connective tissue disease) are at higher risk. If such symptoms occur, contact a doctor immediately
• Severe skin reactions such as rash with redness and blister formation (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)
• Red, 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 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 side effects

If any side effects occur, including those not listed in this leaflet, inform a doctor or pharmacist. Side 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 side effects helps to provide more information on the safety of the medicine.

5. How to store Nurofen dla dzieci Forte truskawkowy

Keep this 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.
Shelf-life after first opening: 6 months.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack 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.
The 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 suspension with a characteristic
strawberry odour.
Each bottle contains 100 ml.
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 ml.
Outer packaging: cardboard box.
For more detailed information, please contact the marketing authorisation holder or the parallel importer.
Marketing Authorisation Holder in Germany, the country of export:
Reckitt Benckiser Deutschland GmbH
Darwinstrasse 2-4, 69115 Heidelberg, Germany
Manufacturer:
Reckitt Benckiser Healthcare (UK) Limited
Dansom Lane
HU8 7DS Hull
United Kingdom
RB NL Brands B.V.
Schiphol Boulevard 207, 1118 BH Schiphol, Netherlands
Parallel Importer:
InPharm Sp. z o.o.
ul. Strumykowa 28/11, 03-138 Warsaw, Poland
Repackaged in:
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249, 04-458 Warsaw, Poland
German Marketing Authorisation Number (country of export): 76554.00.00
Parallel Import Authorisation Number: 113/22
This medicinal product is authorised for sale in the European Economic Area countries under the following names: