Nurofen for children forte strawberry flavored

Package leaflet: Information for the user

Warning! Please keep the leaflet. Information on the immediate packaging in a foreign language.
Nurofen dla dzieci Forte truskawkowy (Nurofen Junior Fieber- und Schmerzsaft Erdbeer)
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 the entire leaflet carefully before using this 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.
• Please keep this leaflet, so that you may read it again if necessary.
• If you need advice or further information, please contact your pharmacist.
• If the patient experiences any adverse reactions, including any possible adverse reactions not listed in this leaflet, inform a doctor, pharmacist, or nurse. See section 4.
• If there is no improvement within 24 hours (infants aged 3–5 months with body weight greater than 5 kg) or 3 days (children aged over 6 months), 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. What you need to know 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 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 within 24 hours (infants aged 3–5 months with body weight greater than 5 kg) or 3 days (children aged over 6 months), 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 hives occurred after taking acetylsalicylic acid or other similar pain-relieving medicines (NSAIDs).
• If gastrointestinal bleeding or perforation occurred previously related to prior use of NSAIDs.
• If there is or has been peptic ulceration of the stomach and (or) duodenum (peptic ulcer disease) or gastrointestinal 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 cerebral haemorrhage (bleeding from cerebral vessels) or any other active bleeding.
• If blood clotting disorders are present, as ibuprofen may prolong bleeding time.
• If there are blood formation 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 treatment with Nurofen dla dzieci Forte truskawkowy, discuss this with your
doctor or pharmacist

• If the child has an infection – see below, section "Infections".
• If the child has certain inherited blood formation 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 their symptoms may worsen.
• If the child has or has previously had high blood pressure and (or) heart failure.
• If the child has kidney function disorders.
• If the child has liver diseases. During prolonged treatment with 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 agents (e.g. acetylsalicylic acid).
• If the child is simultaneously taking other NSAIDs (including COX-2 inhibitors such as celecoxib or etoricoxib), as concomitant use of these medicines should be avoided.
• The occurrence of adverse effects may be reduced by using the lowest effective dose for the shortest possible duration.
• Generally, continuous use of (several types of) painkillers may lead to persistent serious kidney diseases. This risk may increase during physical exertion associated with salt loss and dehydration. This should therefore be avoided.
• Headaches may occur after prolonged use of any type of painkillers, 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 has asthma or allergic diseases 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, and
consequently lead to an increased 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
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 changes, blisters, or other allergic symptoms appear, stop taking
Nurofen dla dzieci Forte truskawkowy immediately and seek urgent medical help, as these may be
the first 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, or in patients with
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 doses of NSAIDs, 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 administration of low-dose acetylsalicylic acid or medicines
increasing 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 medicines such as ibuprofen may be associated with a
slight increase in the 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 diseases such as heart failure, angina pectoris (chest pain), has had a heart attack, coronary artery bypass surgery, peripheral arterial disease (poor blood circulation in the legs due to narrowed or blocked arteries), or has had any stroke (including mini-stroke or transient ischaemic attack - TIA).
• the patient has hypertension, diabetes, high cholesterol levels, a family history of heart disease or stroke, or if the patient smokes.

If any of the above conditions apply to the child, contact a doctor before using Nurofen dla dzieci Forte truskawkowy.
Elderly patients
Elderly patients have an increased risk of adverse effects during treatment with NSAIDs, particularly those 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.
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:

• anticoagulants (i.e. blood-thinning agents/preventing clot formation, such as acetylsalicylic acid, warfarin, ticlopidine)
• blood pressure-lowering medicines (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 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:
Other NSAIDs including COX-2 inhibitors as the risk of adverse effects may increase
Digoxin (a medicine used in heart failure) as the effect of digoxin may be enhanced
Glucocorticoids (medicines containing cortisone or similar substances) as the risk of gastrointestinal ulceration and bleeding may increase
Antiplatelet agents as the risk of bleeding may increase
Acetylsalicylic acid (low doses) as the blood-thinning effect may be weakened
Anticoagulants (e.g. warfarin) as ibuprofen may enhance the effect of these medicines
Phenytoin (a medicine used in epilepsy treatment) as the effect of phenytoin may be enhanced
Selective serotonin reuptake inhibitors (medicines used in depression treatment) as they may increase the risk of gastrointestinal bleeding
Lithium (a medicine used in bipolar disorder and depression treatment) as the effect of lithium may be enhanced
Probenecid and sulfinpyrazone (medicines used in gout treatment) as the excretion of ibuprofen may be delayed
Antihypertensive medicines and diuretics as ibuprofen may weaken the effect of these medicines and the risk of worsening kidney function may increase
Potassium-sparing diuretics such as amiloride, potassium canrenoate, spironolactone, triamterene as hyperkalaemia may occur
Methotrexate (a medicine used in cancer and rheumatism treatment) as the effect of methotrexate may be enhanced
Tacrolimus and cyclosporine (immunosuppressive medicines) as kidney damage may occur
Zidovudine (in HIV/AIDS treatment) as use of Nurofen dla dzieci Forte truskawkowy may increase the risk of intrasternal bleeding or bleeding leading to swelling in HIV(+) patients with haemophilia
Sulfonylurea derivatives (antidiabetic medicines) as they may affect blood glucose levels
Quinolone antibiotics as the risk of seizures may increase
Voriconazole and fluconazole (CYP2C9 inhibitors), used in fungal infections, may enhance the effect of ibuprofen;
consider reducing the dose of ibuprofen, especially when using high doses of ibuprofen together with voriconazole or fluconazole
Baclofen as baclofen toxicity may develop after ibuprofen administration
Ritonavir as ritonavir may increase NSAID plasma concentrations
Aminoglycosides as NSAIDs may increase aminoglycoside excretion
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 central nervous system, may be more likely when alcohol is consumed together 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 3 months of pregnancy. Avoid using this medicine during the first 6 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) that may affect fertility in women. This effect is reversible after discontinuation of the medicine.
Driving and operating machinery
During short-term use, this medicine has no effect or has a negligible effect on the ability to drive or operate machinery.
Important information on some ingredients of 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 contact a doctor before taking this medicine.
• The medicine may have a mild laxative effect.
• Calorific value of maltitol: 2.3 kcal/g
• Nurofen dla dzieci Forte truskawkowy 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 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 symptoms of infection (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.
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 by pressing 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 downward to draw the suspension up to the correct mark on the syringe.
5. Turn the bottle upright again and gently twist to remove the syringe.
6. Place the tip of the syringe into the child's mouth. Slowly and gently push the plunger to administer the suspension. After use, replace the protective cap. Wash the syringe with warm water and allow it to dry. Store in a place inaccessible and out of sight 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.
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 has accidentally ingested the medicine, always contact a doctor or go to the nearest hospital for advice on possible health risks and what actions should be taken.
Symptoms may include nausea, stomach pain, vomiting (possibly with blood), gastrointestinal bleeding, headache, tinnitus, confusion and nystagmus, or less commonly, diarrhea. After a large overdose, symptoms may include disturbances of balance, visual disturbances, low blood pressure, agitation, confusion, 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, convulsions (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 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 regarding 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 they do not occur in everyone. 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 adverse effects occur or if there is any doubt, administration of the medicine should be discontinued 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, blood in vomit, or vomit containing 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, blistering, and shedding of skin sheets.

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 discomfort 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 pre-existing bowel disease (colitis or Crohn's disease), gastric mucosal inflammation
• 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 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, 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 discontinued immediately and medical advice sought urgently, 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 discolouration), particularly during long-term 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 undertaken
• 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 appear or worsen, the patient should seek medical attention 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, 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, mainly 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 taking 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 those not listed in this leaflet, inform a doctor, pharmacist, or nurse. Adverse effects can also be reported directly to the Department of Monitoring Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products: Al. Jerozolimskie 181C, 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 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.
After opening the bottle, the medicine should be used within 6 months.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to
dispose of medicines no longer required. Doing so helps protect the environment.

6. Contents of the packaging and other information

What Nurofen for Children Forte Strawberry 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 for Children Forte Strawberry looks like and contents of the pack
Nurofen for Children Forte Strawberry is a white, syrup-like oral suspension with a characteristic
strawberry odour.
Each bottle contains 100 ml or 150 ml.
The pack contains an oral syringe (5 ml syringe with markings: 1.25 ml, 2.5 ml, 3.75 ml and 5.0 ml).
Outer packaging: cardboard box.

For more detailed information, please contact the responsible party or parallel importer.

Marketing Authorisation 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, Poland

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

German Marketing Authorisation Number (country of export): 76554.00.00
Parallel Import Authorisation Number: 280/22

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