Nurofen for children junior orange

Package leaflet: Information for the user

Nurofen dla dzieci Junior pomarańczowy
40 mg/ml, oral suspension
Ibuprofenum
For children weighing from 20 kg (6 years) to 40 kg (12 years)
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 the doctor or pharmacist.
• Keep this leaflet, so you can read it again if necessary.
• If you need advice or further information, please consult your pharmacist.
• If the patient experiences any adverse reactions, including any possible adverse reactions not listed in this leaflet, inform the doctor or pharmacist. See section 4.
• If there is no improvement after 3 days, or if the patient feels worse, contact a doctor.

Contents of the leaflet:

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

1. What Nurofen dla dzieci Junior pomarańczowy 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 Junior pomarańczowy 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, contact a doctor.

2. Important information before using Nurofen dla dzieci Junior pomarańczowy

When not to use Nurofen dla dzieci Junior pomarańczowy

• 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 there has ever been breathlessness, asthma, rhinitis, facial and (or) hand swelling, or urticaria after taking acetylsalicylic acid or other similar pain-relieving medicines (NSAIDs).
• If there has ever been gastrointestinal bleeding or perforation related to previous use of NSAIDs.
• If there is currently or has previously been peptic ulceration of the stomach and (or) duodenum 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 bleeding in the brain (cerebral haemorrhage) or any other active bleeding.
• If there are blood clotting disorders, 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 Junior pomarańczowy, 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 disorders (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 use of Nurofen dla dzieci Junior pomarańczowy, regular monitoring of liver and kidney function parameters and blood morphology is required.
• Caution is advised when using other medicines that may increase the risk of gastrointestinal 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). If the child is simultaneously taking other NSAIDs (including COX-2 inhibitors such as celecoxib or etoricoxib), simultaneous 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, 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. This should therefore be avoided.
• Headaches may occur as a result of long-term 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 a doctor consulted. 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 currently 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 present as asthma attacks (so-called drug-induced asthma), Quincke's oedema, or urticaria.
• Avoid using Nurofen dla dzieci Junior pomarańczowy 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 Junior pomarańczowy may mask symptoms of infection, such as fever and pain. Therefore, Nurofen dla dzieci Junior pomarańczowy 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 infection symptoms persist or worsen, medical advice should be sought immediately.
Skin reactions
Severe skin reactions such as exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), and acute generalised exanthematous pustulosis (AGEP) have been reported with the use of ibuprofen. If the patient develops any of the symptoms associated with these severe skin reactions described in section 4, Nurofen dla dzieci Junior pomarańczowy should be discontinued immediately and medical help sought.
Gastrointestinal bleeding, ulceration, or perforation, which may be fatal, have been reported during treatment with all NSAIDs, with or without warning signs, or in patients with previous serious gastrointestinal disorders. If gastrointestinal bleeding or ulceration occurs, treatment should be discontinued immediately. The risk of gastrointestinal bleeding, ulceration, or perforation increases with higher doses of NSAIDs, in patients with previous ulceration, especially with bleeding or perforation (see section 2 "When not to use Nurofen dla dzieci Junior pomarańczowy") 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 drugs increasing the risk of gastrointestinal reactions, co-therapy 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 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 dla dzieci Junior pomarańczowy, 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 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 hypertension, diabetes, elevated cholesterol levels, a family history of heart disease or stroke, or if the patient smokes.
  Allergic reactions to ibuprofen, including breathing difficulties, facial and neck swelling (angioedema), and chest pain, have been reported during ibuprofen use. If the patient notices any of these symptoms, they should immediately stop taking Nurofen dla dzieci Junior pomarańczowy and contact a doctor or emergency services.

If any of the above cases apply to the child, consult a doctor before using Nurofen dla dzieci Junior pomarańczowy.
Elderly patients
In elderly patients, there is an increased risk of adverse effects during NSAID use, 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 Junior pomarańczowy 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 Junior pomarańczowy may affect the action of other medicines or other medicines may affect the action of Nurofen dla dzieci Junior pomarańczowy. For example:

• Anticoagulant medicines (i.e. blood thinners/preventing clot formation, such as acetylsalicylic acid, warfarin, ticlopidine)
• Medicines lowering 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 affect treatment with Nurofen dla dzieci Junior pomarańczowy. Therefore, always consult a doctor or pharmacist before using Nurofen dla dzieci Junior pomarańczowy 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 digoxin's effect may be enhanced
Glucocorticoids (medicines containing cortisone or cortisone-like substances) as the risk of gastrointestinal ulceration 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
Anticoagulant medicines (e.g. warfarin) as ibuprofen may enhance the effect of these medicines
Phenytoin (a medicine used in epilepsy treatment) as phenytoin's effect 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 lithium's effect may be enhanced
Probenecid and sulfinpyrazone (medicines used in gout treatment) as ibuprofen excretion 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, e.g. amiloride, potassium canrenoate, spironolactone, triamterene as hyperkalaemia may occur
Methotrexate (a medicine used in cancer and rheumatism treatment) as methotrexate's effect may be enhanced
Tacrolimus and cyclosporine (immunosuppressive medicines) as kidney damage may occur
Zidovudine (in HIV/AIDS treatment) as using Nurofen 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 – ibuprofen's effect may be enhanced; dose reduction of ibuprofen should be considered, especially when using high doses of ibuprofen with voriconazole or fluconazole
Baclofen – after ibuprofen use, baclofen toxicity may develop
Ritonavir – ritonavir may increase NSAID plasma concentration
Aminoglycosides – NSAIDs may increase aminoglycoside excretion

Nurofen dla dzieci Junior pomarańczowy and alcohol
Do not consume alcohol while taking Nurofen dla dzieci Junior pomarańczowy. Some adverse effects, such as those related to the gastrointestinal tract or central nervous system, may be more likely when alcohol and Nurofen dla dzieci Junior pomarańczowy are taken together.
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 patient and her child and delay or prolong labour. Avoid using this medicine during the first 6 months of pregnancy unless otherwise advised 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 the 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 dla dzieci Junior pomarańczowy may be used during breastfeeding if administered at recommended doses and for the shortest possible duration.
Fertility
Nurofen dla dzieci Junior pomarańczowy 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 negligible effect on the ability to drive and operate machinery.

• Nurofen dla dzieci Junior pomarańczowy 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. Nurofen dla dzieci Junior pomarańczowy contains less than 1 mmol of sodium (23 mg) per dose, meaning the medicine is considered "sodium-free".
• This medicine contains very small amounts of gluten (derived from wheat starch) and is classified as "gluten-free". Therefore, it is very unlikely to cause any problems in patients with coeliac disease.
• One 5 ml dose contains no more than 0.315 micrograms of gluten.
• This medicine should not be used by patients allergic to wheat (other than coeliac disease).

3. How to use Nurofen dla dzieci Junior pomarańczowy

Nurofen dla dzieci Junior pomarańczowy should always be used exactly as described in
the patient information 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.
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 pomaranczowy 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 leave 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 the child persist for more than 3 days or if the patient feels worse, consult a doctor.
Administration of a higher than recommended dose of Nurofen dla dzieci Junior pomaranczowy:
If the patient has taken a higher than recommended dose of Nurofen dla dzieci Junior pomaranczowy 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 of overdose may include nausea, stomach pain, vomiting (blood traces may occur), gastrointestinal bleeding, headache, tinnitus, disorientation, and nystagmus, or less frequently diarrhea. After ingestion of a large dose, disturbances in 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, low blood potassium levels, feeling cold, and breathing difficulties may occur.
Missed dose of Nurofen dla dzieci Junior pomaranczowy:
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 pomarańczowy may cause adverse effects, although
they do not occur in everyone. The risk of adverse effects can be reduced by using the
lowest dose for the shortest duration necessary to relieve symptoms. In children, one of the known
adverse effects associated with NSAIDs may occur. If any adverse effects occur or if there is any
doubt, administration of the medicine should be discontinued and medical advice should be sought as
quickly as possible. Elderly individuals taking this medicine belong to a group at increased risk of
adverse effects.
DISCONTINUE USE of 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 material with 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, rapid heartbeat, drop in blood pressure leading to shock. Symptoms may occur even after the first dose. If any of these symptoms occur, contact a doctor immediately.
• red, flat, non-elevated, target-like or circular skin lesions on the trunk, often with blisters in the center, skin peeling, mouth ulcers, or ulcers in the throat, nose, genital organs and eyes. These severe skin rashes may be preceded by fever and flu-like symptoms (exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis). [Very rare - may occur in 1 out of 10,000 people].
• widespread rash, high fever, swollen lymph nodes and increased eosinophil count (a type of white blood cells) (DRESS syndrome) [Frequency unknown - cannot be estimated based on available data].
• red, scaly, widespread rash with subcutaneous nodules and blisters, mainly located in skin folds, trunk and upper limbs, accompanied by fever. Symptoms usually appear at the beginning of treatment (acute generalized exanthematous pustulosis) [Frequency unknown - cannot be estimated based on available data].

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 disorders such as heartburn, abdominal pain, nausea, indigestion, diarrhoea, vomiting, flatulence (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 (renal papillary necrosis)
• Increased blood uric acid levels
• Decreased haemoglobin concentration.

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

• Oesophagitis, pancreatitis, development 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, Nurofen dla dzieci Junior pomarańczowy 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 discoloration), particularly during prolonged 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, treatment should be discontinued immediately and medical advice sought. Self-medication with painkillers or antipyretics should not be used
• 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 the use of 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 evaluated
• During ibuprofen use, symptoms of aseptic meningitis with neck stiffness, headache, nausea, vomiting, fever and altered consciousness have been observed. 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 blister formation (e.g. Stevens-Johnson syndrome, erythema multiforme, toxic epidermal necrolysis/Lyell's syndrome), hair loss (alopecia).

Frequency unknown (cannot be estimated based on available data)

• Chest pain, which may be a symptom of a potentially serious allergic reaction called Kounis syndrome.
• Respiratory tract reactivity, including asthma, bronchospasm, shortness of breath.
• 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 be reported directly to the Department of Monitoring Adverse Drug Reactions
of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: 22 49-21-301, fax: 22 49-21-309, website:
https://smz.ezdrowie.gov.pl
Adverse effects can also be reported to the marketing authorisation holder.
Reporting adverse effects helps to provide more information on the safety of the medicine.

5. How to store Nurofen dla dzieci Junior orange

Keep out of the sight and reach of children.
Do not use Nurofen dla dzieci Junior orange after the expiry date stated on the carton and bottle. 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.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist
how to dispose of medicines no longer required. These measures will help protect the
environment.

6. Contents of the pack and other information

What Nurofen dla dzieci Junior pomarańczowy 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, orange flavour
2M16014 (modified starch, gum arabic, maltodextrin, natural and nature-identical flavouring substances) and purified water.
What Nurofen dla dzieci Junior pomarańczowy looks like and contents of the pack
Nurofen dla dzieci Junior pomarańczowy is a white, syrup-like oral suspension with a characteristic
orange odour.
Each bottle contains 100 ml, 150 ml or 200 ml.
The pack contains a double-ended measuring spoon (with a 2.5 ml measure having an internal mark
at 1.25 ml on one end and a 5 ml measure on the other end) for accurate dose measurement.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Importer
Marketing Authorisation Holder:
Reckitt Benckiser (Poland) S.A.
ul. Okunin 1
05-100 Nowy Dwór Mazowiecki
Importer:
RB NL Brands B.V.
WTC Schiphol Airport,
Schiphol Boulevard 207,
1118 BH Schiphol,
The Netherlands
For further information, please contact the local representative of the Marketing Authorisation Holder:
Reckitt Benckiser (Poland) S.A.
ul. Okunin 1
05-100 Nowy Dwór Mazowiecki
Tel.: (22) 211 26 92
This medicinal product is authorised in the European Economic Area countries under the following names: