Nurofen for children junior

Nurofen dla dzieci Junior, 100 mg, chewable soft capsules
For use in children weighing from 20 kg (aged 7 years) to 40 kg (up to 12 years of age)
Ibuprofenum
Please read the entire package leaflet carefully before taking this medicine, as it contains
important information for the patient.
This medicine should always be taken exactly as described in this patient information leaflet or as directed by a doctor or pharmacist.

• Keep this leaflet for future reference.
• If you need advice or further information, consult your pharmacist.
• If your child experiences any adverse reactions, consult a doctor or pharmacist, including any adverse reactions not listed in this leaflet. See section 4.
• If there is no improvement after 3 days, or if your child feels worse, consult a doctor.

Table of contents:

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

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

The active substance (responsible for the medicinal effect) is ibuprofen, an analgesic medicine belonging to the group of non-steroidal anti-inflammatory drugs (NSAIDs).
Nurofen dla dzieci Junior is used in children aged 7 to 12 years, weighing 20 to 40 kg, to relieve mild to moderate pain such as sore throat, toothache, earache, headache, minor aches and sprains, as well as symptoms of cold and flu. Nurofen dla dzieci Junior also reduces fever.
If there is no improvement after 3 days, or if your child feels worse, consult a doctor.

2. Important information before using Nurofen dla dzieci Junior

Do not give this medicine to a child:

• if they are allergic to ibuprofen or any of the other ingredients of this medicine (listed in section 6),
• if they have ever had a hypersensitivity reaction (e.g. asthma, rhinitis, rash, swelling of the face, tongue, lips or throat) after taking acetylsalicylic acid or other non-steroidal anti-inflammatory drugs (NSAIDs),
• if they are allergic to peanuts or soya, because the medicine contains soya lecithin,
• if they currently have or have previously had stomach or duodenal ulcers (peptic ulcers) or gastrointestinal bleeding (two or more confirmed episodes of ulceration or bleeding),
• if they have ever experienced gastrointestinal bleeding or perforation related to previous use of NSAIDs,
• if they have severe liver, kidney or heart failure,
• if they have brain haemorrhage (cerebral haemorrhage) or any other active bleeding,
• if they have blood cell production disorders of unknown origin,
• if the child is dehydrated (due to vomiting, diarrhoea or insufficient fluid intake).

Do not use the medicine during the last 3 months of pregnancy.
Warnings and precautions
Before using Nurofen dla dzieci Junior, consult a doctor or pharmacist:

• if the child has an infection – see below, section "Infections".
• if the child has asthma or allergic conditions, as breathing difficulties may occur;
• if the child has hay fever, nasal polyps or chronic obstructive respiratory diseases, as there is an increased risk of allergic reactions. Allergic reactions may manifest as asthma attacks (so-called analgesic-induced asthma), Quincke's oedema (angioedema) or urticaria;
• if the child has or has had intestinal disorders;
• if the child has impaired kidney function;
• if the child has impaired liver function. During prolonged treatment with Nurofen dla dzieci Junior, regular monitoring of liver and kidney function parameters and blood morphology is required; caution is advised if the child is taking 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) or antiplatelet agents (e.g. acetylsalicylic acid). if the child is taking other NSAIDs (including COX-2 inhibitors such as celecoxib or etoricoxib), as such combination should be avoided; if the child has SLE (systemic lupus erythematosus, an autoimmune disease affecting connective tissue, causing joint pain, skin lesions and organ dysfunction) or mixed connective tissue disease;
• if the child has certain inherited blood formation disorders (e.g. acute intermittent porphyria);
• if the child suffers from coagulation disorders;
• if the child has chronic inflammatory bowel disease, such as Crohn's disease or ulcerative colitis;
• if the child is dehydrated, due to the risk of impaired kidney function in dehydrated children;
• if the child has recently undergone major surgery;
• if the child has chickenpox, as use of Nurofen dla dzieci Junior should be avoided during infection.

Infections
Nurofen dla dzieci Junior may mask symptoms of infection such as fever and pain. Therefore,
Nurofen dla dzieci Junior may delay appropriate treatment of infection and consequently increase the risk of complications. This has been observed in bacterial pneumonia and bacterial skin infections associated with chickenpox.
If a patient takes this medicine during an ongoing infection and infection symptoms persist or worsen, medical advice should be sought immediately.
Skin reactions
Serious skin reactions have been reported with the use of ibuprofen, including exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), and acute generalised exanthematous pustulosis (AGEP). If a patient experiences any of the symptoms related to these serious skin reactions described in section 4, Nurofen dla dzieci Junior should be discontinued immediately and medical help should be sought.
Gastrointestinal bleeding, ulceration or perforation, which may be fatal, have been reported with all NSAIDs, at any time during treatment, with or without warning symptoms or serious gastrointestinal events in medical history. 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 peptic ulceration, particularly if complicated by haemorrhage or perforation (see section 2 "When not to use Nurofen dla dzieci Junior") and in elderly patients. In these patients, treatment should be initiated at the lowest available dose. In such patients and in patients requiring concomitant administration of low-dose acetylsalicylic acid or other drugs that may increase the risk of gastrointestinal disorders, the physician may consider concomitant use of gastroprotective agents (e.g. misoprostol or proton pump inhibitors).
Chronic use (of some) analgesics may lead to irreversible severe kidney disorders with risk of kidney failure (analgesic nephropathy).
Anti-inflammatory and analgesic medicines such as ibuprofen may slightly increase the risk of myocardial infarction or stroke, particularly when used in high doses. Do not exceed the recommended dose or duration of treatment.
Before using Nurofen dla dzieci Junior, talk to a doctor or pharmacist:

• if the patient has heart disease, including heart failure, angina pectoris (chest pain), or if the patient has had a myocardial infarction, coronary artery bypass grafting, peripheral arterial disease (poor circulation in legs and feet due to narrowed or blocked arteries), or any type of stroke (including "mini-stroke" or transient ischaemic attack "TIA").
• if the patient has high blood pressure, diabetes, high cholesterol levels, a family history of heart disease or stroke, or if the patient is a smoker.

Allergic reactions to ibuprofen, including breathing difficulties, facial and neck swelling (angioedema), and chest pain, have been reported during ibuprofen use. If the patient experiences any of these symptoms, they should immediately stop using Nurofen dla dzieci Junior and contact a doctor or emergency services.
Elderly patients
Elderly patients have an increased risk of adverse effects when using NSAIDs, particularly those related to the stomach and intestines. For more information, see section 4 "Possible side effects".
Patients with a history of gastrointestinal toxicity, especially elderly patients, should report any unusual abdominal symptoms (particularly gastrointestinal bleeding), especially in the initial stages of treatment.
Long-term use of any type of analgesic for headache treatment may worsen symptoms. If this occurs or is suspected, treatment should be discontinued and medical advice sought. Medication-overuse headache should be suspected in patients who experience frequent or daily headaches despite (or because of) regular use of analgesics.
Other medicines and Nurofen dla dzieci Junior
Tell the doctor or pharmacist about all medicines currently or recently taken by the child, as well as any medicines they may take in the future.
Nurofen dla dzieci Junior may affect the action of certain medicines or other medicines may affect the action of Nurofen dla dzieci Junior, for example:

• anticoagulants (blood thinners or agents preventing blood clotting, e.g. acetylsalicylic acid, warfarin, ticlopidine)
• medicines for high blood pressure (ACE inhibitors, e.g. captopril, beta-blockers, e.g. atenolol, angiotensin II receptor antagonists, e.g. losartan)

Some other medicines may also affect treatment with Nurofen dla dzieci Junior or be affected by it. Always consult a doctor or pharmacist before using Nurofen dla dzieci Junior together with other medicines, especially if the patient is taking any of the medicines listed above:

Consult a doctor or pharmacist if any of the above situations apply to the
patient. If in doubt about which type of medicine the child is taking, show this medicine to a
doctor or pharmacist.
Nurofen for Children Junior and alcohol consumption
Do not drink alcohol while taking Nurofen for Children Junior. The risk of certain adverse effects, such as those affecting the gastrointestinal tract or central nervous system, may be increased if alcohol is consumed during treatment with Nurofen for Children Junior.
Pregnancy, breastfeeding and 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. Use may cause kidney and heart problems in the unborn child. It may also affect bleeding tendency in both the mother and the child, and may delay or prolong labour. Avoid using this medicine during the first six months of pregnancy unless otherwise advised by a doctor. Taking ibuprofen for longer than a few days after the start of week 20 of pregnancy may cause kidney problems in the unborn child and lead to reduced levels of amniotic fluid surrounding the baby (oligohydramnios) or narrowing of a blood vessel (ductus arteriosus) in the baby's heart. If longer-term treatment is required, the doctor may recommend additional monitoring tests.
Breastfeeding
Only small amounts of ibuprofen and its metabolites pass into breast milk. Nurofen for Children Junior may be used during breastfeeding if taken at the recommended doses and for the shortest possible duration.
Fertility
Nurofen for Children Junior belongs to a group of medicines (NSAIDs) which may impair female fertility. This effect is reversible upon discontinuation of the medicine.
Driving and operating machinery
During short-term use, this medicine has no effect or has a negligible effect on the ability to drive and operate machinery.
Nurofen for Children Junior contains soya lecithin. If the patient is allergic to peanuts or soya, this medicine should not be used.
Nurofen for Children Junior contains glucose and sucrose. If a doctor has diagnosed the child with an intolerance to certain sugars, consult a doctor before administering this medicine. This medicine may harm teeth.
Nurofen for Children Junior contains less than 1 mmol (23 mg) of sodium per dose, meaning the medicine is considered "sodium-free".

3. How to use Nurofen dla dzieci Junior

This medicine should always be taken exactly as described in the patient leaflet or as directed by a doctor or pharmacist. If in doubt, consult a doctor or pharmacist.
Nurofen dla dzieci Junior is intended for oral use.
The capsules should be chewed and swallowed. There is no need to take with water.
This medicine is intended for short-term use only.
The lowest effective dose should be used for the shortest duration necessary to relieve symptoms. If, during an infection, symptoms (such as fever and pain) persist or worsen, medical advice should be sought immediately (see section 2). Do not give Nurofen dla dzieci Junior to children under 7 years of age or to children weighing less than 20 kg.
Recommended dose:
In children, ibuprofen is dosed according to body weight, usually 5 to 10 mg/kg body weight as a single dose, up to a maximum total daily dose of 20–30 mg/kg body weight.

Use of a higher than recommended dose of Nurofen dla dzieci Junior
If a patient has used a higher than recommended dose of Nurofen dla dzieci Junior or if a child
has accidentally taken the medicine, always consult a doctor or go to the nearest hospital to
obtain advice regarding possible health risks and guidance on actions to be taken in such
a case.
Symptoms of overdose may include nausea, vomiting (blood may be present), blood in
the stool (gastrointestinal bleeding), abdominal pain or, less commonly, diarrhoea. In addition,
after ingestion of a large dose, symptoms such as tinnitus, headache, gastrointestinal bleeding,
confusion, nystagmus, excitation, disorientation, coma, metabolic acidosis, prolonged prothrombin
time (elevated INR), acute kidney failure, liver damage, worsening of asthma in asthmatics, 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
Do not use a double dose to make up for a missed dose.
If you have any further doubts concerning the use of this medicine, consult your
doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
Adverse effects can be minimised by using the lowest effective dose for the shortest duration necessary
to relieve symptoms. Although adverse effects are not very common, known adverse effects typical of
NSAIDs may occur in children. In such cases or if in doubt, administration of the medicine to the child
should be discontinued and a doctor should be consulted as soon as possible. In elderly individuals
taking this medicine, there is an increased risk of disorders associated with adverse effects.
STOP USING the medicine and contact a doctor immediately if the child experiences any of the
following symptoms:

• signs of gastrointestinal bleeding, such as severe stomach pain, black tarry stools, vomiting blood or dark particles resembling coffee grounds.
• signs of a very rare but serious allergic reaction, such as worsening asthma symptoms, unexplained wheezing or shortness of breath, swelling of the face, tongue or throat, difficulty breathing, rapid heartbeat, or drop in blood pressure leading to shock. Such a reaction may occur even after the first dose of the medicine. If any of these symptoms occur, contact a doctor immediately.
• red, flat, target-like or round skin lesions on the trunk, often with blisters in the centre, skin peeling, and mucosal ulcers in the mouth, 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 up to 1 in 10,000 people].
• widespread rash, high body temperature, 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, on the trunk and upper limbs, accompanied by fever. Symptoms usually appear at the beginning of treatment (acute generalised exanthematous pustulosis) [Frequency unknown – cannot be estimated based on available data]. If any of the adverse effects worsen or new adverse effects not listed in this leaflet occur in the child, inform the doctor. Common (may occur in 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 occur in up to 1 in 100 people):

• Gastrointestinal ulceration, perforation or bleeding, oral mucosal inflammation with ulceration, exacerbation of existing bowel disease (ulcerative colitis or Crohn's disease), gastric mucosal inflammation.
• Headache, dizziness, insomnia, restlessness, irritability or fatigue.
• Visual disturbances.
• Various skin rashes.
• Hypersensitivity reactions with urticaria and itching.

Rare (may occur in up to 1 in 1,000 people):

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

Very rare (may occur in up to 1 in 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 normal and oedema (especially in patients with high blood pressure or impaired kidney function), oedema and cloudy urine (nephrotic syndrome), inflammatory kidney disease (interstitial nephritis), which may lead to acute kidney failure. If any of the above symptoms occur, or if the patient feels unwell, treatment with Nurofen dla dzieci Junior should be discontinued immediately and a doctor should be consulted promptly, as these may be early signs of kidney damage or kidney failure.
• Psychotic reactions and depression.
• High blood pressure, vasculitis.
• Palpitations.
• Blood cell production disorders – early symptoms include: fever, sore throat, superficial mouth ulcers, flu-like symptoms, severe fatigue, nosebleeds and skin bleeding, unexplained bruising. In such cases, treatment should be stopped immediately and a doctor should be consulted. Self-treatment with painkillers or antipyretic medicines should not be used.
• Severe skin infections and soft tissue complications during chickenpox infection.
• Worsening of inflammatory conditions related to infection (e.g. necrotising fasciitis) has been reported with the use of certain painkillers (NSAIDs). If signs of infection occur or worsen, the patient should seek immediate medical attention. 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) have a higher risk of these disorders. If such symptoms occur, contact a doctor immediately.
• Hair loss (alopecia).

Frequency unknown (cannot be estimated from available data):

• Chest pain, which may be a sign 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 Nurofen may slightly increase the 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 provide more information on the safety of the medicine.
How to store Nurofen dla dzieci Junior
Store below 25°C.
Keep the medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton. The expiry date refers to the last day of the stated month.
Medicines should not be disposed of via wastewater or household waste. Ask a pharmacist how to dispose of medicines no longer in use. Such measures help protect the environment.

6. Contents of the packaging and other information

What Nurofen dla dzieci Junior contains

• The active substance is ibuprofen. One chewable soft capsule contains 100 mg of ibuprofen.
• Other ingredients are: gelatin, purified water, liquid glucose, sucrose, fumaric acid (E297), sucralose, citric acid (E330), acesulfame K (E950), disodium edetate, glycerol, orange flavour, iron oxide red (E172), iron oxide yellow (E172), titanium dioxide (E171), propylene glycol and HPMC 2910/hypromellose 3cP.

Processing aids: medium-chain triglycerides, soybean lecithin and stearic acid.

What Nurofen dla dzieci Junior looks like and contents of the pack

Nurofen dla dzieci Junior is an orange, square, soft, chewable, gelatin capsule with the marking "N100" in white ink.

Nurofen dla dzieci Junior is available in PVC/PE/PVdC/Al blisters.

Pack sizes contain 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30 or 32 capsules.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Reckitt Benckiser (Poland) S.A.
ul. Okunin 1
05-100 Nowy Dwór Mazowiecki
Poland

Importer
RB NL Brands B.V.
WTC Schiphol Airport,
Schiphol Boulevard 207,
1118 BH Schiphol,
The Netherlands

This medicinal product is authorised for supply in the European Economic Area Member States under the following names: