Nurofen for children junior strawberry flavored

Package leaflet: Information for the user

Warning! Keep this leaflet! Information on the immediate packaging in a foreign language
Nurofen dla dzieci Junior truskawkowy
40 mg/ml, oral suspension
Ibuprofenum
For children weighing from 20 kg (6 years) to 40 kg (12 years)
Please read carefully the entire leaflet 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.
• Keep this leaflet, so that you can 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 or pharmacist. See section 4.
• If there is no improvement after 3 days, or if the patient feels worse, consult a doctor.

Contents of the leaflet:

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

1. What Nurofen dla dzieci Junior 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 fever. Nurofen dla dzieci Junior truskawkowy is intended for short-term, symptomatic treatment of:

• fever,
• mild to moderate pain.

If there is no improvement after 3 days, or if the patient feels worse, consult a doctor.

2. Important information before using Nurofen Junior Strawberry

When not to use Nurofen Junior Strawberry

• If the child is allergic to ibuprofen or other similar pain-relieving medicines (NSAIDs) or to any of the other ingredients of this medicine (listed in section 6).
• If the child has ever experienced breathlessness, asthma, nasal congestion, facial and (or) hand swelling, or hives after taking acetylsalicylic acid or other similar pain-relieving medicines (NSAIDs).
• If the child has ever had gastrointestinal bleeding or perforation related to previous use of NSAIDs.
• If the child currently has or has had gastric or duodenal ulcers (peptic 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 bleeding in the brain (cerebral haemorrhage) or any other active bleeding.
• If the child has blood clotting disorders, as ibuprofen may prolong bleeding time.
• If the child has 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 Junior Strawberry, discuss this with a 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 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 treatment with Nurofen Junior Strawberry, 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 ulcers 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).
• If the child is taking other NSAIDs (including COX-2 inhibitors such as celecoxib or etoricoxib), as concurrent use of these medicines should be avoided.
• The 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.
• Headaches may occur as a result of prolonged use of any type of pain-relieving medicine, 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 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 Junior 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 Junior Strawberry may mask symptoms of infection such as fever and pain.
Therefore, Nurofen Junior Strawberry 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 the patient is taking 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 Junior Strawberry have been reported. If any skin rash, changes in mucous membranes, blisters, or other allergy symptoms occur, discontinue use of Nurofen Junior Strawberry immediately and seek medical help without delay, 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 previous serious gastrointestinal disorders. If gastrointestinal bleeding or ulceration occurs, treatment should be stopped immediately. The risk of gastrointestinal bleeding, ulceration, or perforation increases with higher doses of NSAIDs, especially in patients with a history of ulcers, particularly with bleeding or perforation (see section 2 “ When not to use Nurofen Junior Strawberry”) and in elderly patients. These patients should start treatment with the lowest effective dose. In these patients and in patients requiring concomitant use of low-dose acetylsalicylic acid or drugs increasing the risk of gastrointestinal reactions, concomitant treatment with protective agents (e.g. misoprostol or proton pump inhibitors) should be considered.
Use of anti-inflammatory and pain-relieving medicines such as ibuprofen may be associated with a small increased risk of heart attack or stroke, particularly when used at high doses. Do not exceed the recommended dose or duration of treatment.
Before using Nurofen Junior Strawberry, the patient should discuss treatment with a doctor or pharmacist if:

• The patient has heart diseases such as heart failure, angina (chest pain), previous heart attack, bypass surgery, peripheral arterial disease (poor blood circulation in legs due to narrowed or blocked arteries), or has had any stroke (including mini-stroke or transient ischaemic attack (TIA)).
• The patient has high blood pressure, diabetes, elevated 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, consult a doctor before using Nurofen Junior Strawberry.
Elderly patients
Elderly patients have an increased risk of adverse effects during NSAID treatment, 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 Junior Strawberry 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 Junior Strawberry may affect the action of other medicines or other medicines may affect the action of Nurofen Junior Strawberry. 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 those containing atenolol, angiotensin II receptor antagonists such as losartan)

Also, some other medicines may be affected by or may affect treatment with Nurofen Junior Strawberry. Therefore, always consult a doctor or pharmacist before using Nurofen Junior Strawberry 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 (used in heart failure) as the effect of digoxin may be enhanced
Glucocorticoids (medicines containing cortisone or cortisone-like substances) as the risk of gastrointestinal ulcers and bleeding may increase
Antiplatelet medicines 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 (used in epilepsy treatment) as the effect of phenytoin may be enhanced
Selective serotonin reuptake inhibitors (antidepressants) as they may increase the risk of gastrointestinal bleeding
Lithium (used in bipolar disorder and depression treatment) as the effect of lithium may be enhanced
Probenecid and sulfinpyrazone (used in gout treatment) as the excretion of ibuprofen may be delayed
Antihypertensive and diuretic medicines as ibuprofen may reduce the effect of these medicines and increase the risk of worsening kidney function
Potassium-sparing diuretics such as amiloride, potassium canrenoate, spironolactone, triamterene as hyperkalaemia may occur
Methotrexate (used in cancer and rheumatism treatment) as the effect of methotrexate may be enhanced
Tacrolimus and cyclosporine (immunosuppressants) as kidney damage may occur
Zidovudine (in HIV/AIDS treatment) as use of Nurofen Junior Strawberry may increase the risk of intra-articular bleeding or bleeding leading to swelling in HIV(+) patients with haemophilia
Sulfonylurea derivatives (antidiabetic medicines) as they may affect blood sugar levels
Quinolone antibiotics as the risk of seizures may increase
Voriconazole and fluconazole (CYP2C9 inhibitors), used in fungal infections, as the effect of ibuprofen may be enhanced; dose reduction of ibuprofen should be considered, especially when high doses of ibuprofen are used with voriconazole or fluconazole
Baclofen as baclofen toxicity may develop after ibuprofen use
Ritonavir as ritonavir may increase NSAID plasma concentrations
Aminoglycosides as NSAIDs may increase aminoglycoside excretion

Nurofen Junior Strawberry and alcohol
Do not consume alcohol while taking Nurofen Junior Strawberry.
Some adverse effects, such as those related to the gastrointestinal tract or central nervous system, may be more likely when alcohol is taken concurrently with Nurofen Junior Strawberry.
Pregnancy, breastfeeding, and effect 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. Use may cause kidney and heart function disorders in the unborn child. It may also affect bleeding tendency in the mother and her child and may delay or prolong labour. Avoid using this medicine during the first 6 months of pregnancy unless otherwise directed by a doctor. Taking ibuprofen for longer than a few days after the 20th week of pregnancy may cause kidney function disorders in the unborn child and lead to reduced amniotic fluid levels surrounding the child (oligohydramnios) or narrowing of a blood vessel (ductus arteriosus) in the child’s heart. If longer-term treatment is necessary, the doctor may recommend additional monitoring tests.
Breastfeeding
Only small amounts of ibuprofen and its metabolites pass into breast milk. Nurofen Junior Strawberry may be used during breastfeeding if taken at the recommended doses and for the shortest possible duration.
Fertility
Nurofen Junior Strawberry 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 does not affect or has negligible effect on the ability to drive or operate machinery.
Important information about certain ingredients of Nurofen Junior Strawberry

• Nurofen Junior Strawberry 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.
• Calorific value of maltitol: 2.3 kcal/g
• Nurofen Junior Strawberry contains less than 1 mmol of sodium (23 mg) per dose, meaning the medicine is considered “sodium-free”.
• Nurofen Junior Strawberry contains 16.45 mg of propylene glycol in each 5 ml of suspension.

3. How to use Nurofen dla dzieci Junior truskawkowy

Nurofen dla dzieci Junior 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.
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.
Not recommended for use in children under 6 years of age or weighing less than 20 kg.
In patients with sensitive stomach, it is recommended that Nurofen dla dzieci Junior truskawkowy be
taken during a meal.
WARNING: Do not exceed the recommended dose.
For oral use
Administration method using the measuring spoon

1. Shake the bottle well.
2. Use the end of the measuring spoon appropriate for the required dose.
3. Pour the medicine onto the measuring spoon.
4. Place the measuring spoon in the child's mouth and administer the dose.
5. After use, close the bottle tightly. Wash the measuring spoon with warm water and allow it to dry. Store in a place out of sight and reach of children.

Duration of treatment
This medicine is intended for short-term use only. If symptoms persist for more than 3 days or the patient feels worse, consult a doctor.
Overdose of Nurofen dla dzieci Junior truskawkowy
If the patient has taken more than the recommended dose of Nurofen dla dzieci Junior truskawkowy
or if a child has accidentally ingested the medicine, always contact a doctor or go to the nearest hospital to obtain advice on possible health risks and guidance on actions to take in such a case.
Symptoms may include nausea, stomach pain, vomiting (blood traces may be present), gastrointestinal bleeding, headache, tinnitus, confusion and nystagmus, or less frequently diarrhea.
After ingestion of a large dose, disturbances in balance, visual disturbances, low blood pressure, restlessness, confusion, coma, hyperkalemia, metabolic acidosis, prolonged prothrombin time/INR, acute kidney failure, liver damage, respiratory depression, cyanosis, and exacerbation 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 may occur.
Missed dose of Nurofen dla dzieci Junior truskawkowy
Do not take a double dose to make up for a missed dose. If the patient forgets to take or administer a dose, it should be taken or administered as soon as remembered, then the next dose should be taken or administered according to the dosing interval described above.
If you have any further doubts regarding the use of this medicine,
consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, Nurofen dla dzieci Junior truskawkowy may cause adverse effects,
although not everyone will experience them. The risk of adverse effects can be reduced by
using the lowest effective dose for the shortest duration necessary to relieve symptoms.
Your child may experience one of the known adverse effects associated with NSAIDs.
If adverse effects occur or if you have any doubts, discontinue use of the medicine and consult
a doctor as soon as possible. Elderly individuals using this medicine belong to a group at
increased risk of experiencing adverse effects.
DISCONTINUE USE of the medicine and seek immediate medical help if your child
experiences:

• symptoms of intestinal bleeding, such as: severe abdominal pain, black tarry stools, bloody 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 entire body, skin peeling, blistering, and shedding of skin in sheets.

If any of the adverse effects worsen or if any adverse effects not listed in this leaflet occur,
inform your doctor.
Common (may affect up to 1 in 10 people)

• Gastrointestinal disorders 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 affect up to 1 in 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 affect up to 1 in 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 (papillary necrosis)
• Increased blood uric acid levels
• Decreased haemoglobin concentration.

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

• Oesophagitis, pancreatitis, development of diaphragm-like intestinal strictures
• Heart failure, myocardial infarction, facial or hand swelling
• Reduced urine output compared to normal, 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, discontinue use of Nurofen dla dzieci Junior truskawkowy and consult a doctor immediately, 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 long-term treatment, liver failure, acute hepatitis
• Blood cell production disorders – early signs include: fever, sore throat, superficial ulcers of the oral mucosa, flu-like symptoms, severe fatigue, nosebleeds and skin bleeding, unexplained bruising. In such cases, discontinue treatment immediately and consult a doctor. Self-treatment with painkillers or antipyretics (fever-reducing medicines) must not be attempted
• Severe skin infections and soft tissue complications during chickenpox infection
• Worsening of infection-related inflammation (e.g. necrotizing fasciitis) has been reported with certain painkillers (NSAIDs). If signs of infection appear 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. 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).

• Erythematous 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 generalized exanthematous pustulosis). If such symptoms occur, discontinue use of Nurofen dla dzieci Junior 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 your 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 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 Junior truskawkowy

Keep out of the sight and reach of children.
Do not use Nurofen dla dzieci Junior truskawkowy after the expiry date stated on the packaging.
The expiry date refers to the last day of the specified month.
Store below 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 in use. This helps protect the environment.

6. Contents of the pack and other information

What Nurofen for Children Junior 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 Junior Strawberry looks like and contents of the pack
Nurofen for Children Junior Strawberry is a white, syrup-like oral suspension with a characteristic strawberry odour.
Each bottle contains 100 ml of oral suspension.
The pack contains a double-ended dosing spoon (PP) with a capacity of 2.5 ml (marked at 1.25 ml) on one side and 5 ml on the other side, for accurate dose measurement.

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

Responsible party in Bulgaria, the country of export:
Reckitt Benckiser (Romania) S.R.L.
48 lanţ de Hunedoara Boulevard
Building Crystal Tower, 11th floor
District 1, Bucharest, Romania

Manufacturer:
RB NL Brands B.V.
Schiphol Boulevard 207
1118 BH Schiphol
The Netherlands

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

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

Marketing authorisation number in Bulgaria, the country of export: 20150019
Parallel import authorisation number: 131/24

This medicinal product is authorised in the European Economic Area countries under the following names:
Belgium Nurofen voor Kinderen Suikervrij Rood 4% suspensie voor oraal gebruik
Bulgaria Нурофен за Юноши Ягода 200 mg/5 ml перорално суспензия
Croatia Nurofen Forte za djecu 200 mg/5 ml oralna suspenzija s okusom jagode
Cyprus Nurofen για Παιδιά 4% Φράουλα
Czech Republic Nurofen pro děti 4% jahoda
Germany Nurodon Schmerz-und Fiebersaft Erdbeer 40 mg/ml Suspension zum Einnehmen
Greece Nurofen for Children 4% strawberry
Hungary Nurofen eperízű 40 mg/ml belsőleges szuszpenzió gyermekeknek
Ireland Nurofen for Children Six Plus Strawberry 200 mg/5ml Oral Suspension
Luxembourg Nurofen pour Enfants 4% suspension buvable
The Netherlands Nurofen voor Kinderen Aardbei suspensie, suspensie 200 mg/5ml
Poland Nurofen dla dzieci Junior truskawkowy
Portugal Nurofen Morango 40 mg/ml suspensão oral
Romania Nurofen Junior, cu aromă de căpşuni, 200 mg/5 ml, suspensie orală
Slovakia Nurofen pre deti 4% jahoda