Nurofen dla dzieci Iunior

PATIENT INFORMATION LEAFLET: USER INFORMATION

Nurofen for Children Junior, 100 mg, Chewable Capsules, Soft

For use in children with a body weight from 20 kg (from 7 years of age) to 40 kg (up to 12 years of age)
Ibuprofen

You should carefully read the contents of this leaflet before using the medicine, as it contains important information for the patient.

This medicine should always be used exactly as described in the patient information leaflet or as directed by your doctor or pharmacist.

• You should keep this leaflet, so you can read it again if you need to.
• If you need advice or more information, you should speak to your pharmacist.
• If your child experiences any side effects, you should consult your doctor or pharmacist. This also includes side effects not listed in this leaflet. See section 4.
• If after 3 days there is no improvement or your child feels worse, you should contact your doctor.

Table of Contents of the Leaflet:

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

1. What is Nurofen for Children Junior and what is it used for

The active substance (responsible for the medicine's effect) is ibuprofen, a pain-relieving medicine, belonging to nonsteroidal anti-inflammatory drugs (NSAIDs).
Nurofen for Children Junior is used in children aged 7 to 12 years, with a body weight from 20 to 40 kg, to relieve mild to moderate pain, such as sore throat, toothache, earache, headache, minor sprains and strains, and symptoms of colds and flu. Nurofen for Children Junior also reduces fever.
If after 3 days there is no improvement or your child feels worse, you should contact your doctor.

2. Important information before using Nurofen for Children Junior

Do not give this medicine to your 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 an allergic reaction (e.g., asthma, hay fever, hives, facial swelling, tongue, lip, or throat swelling) after taking acetylsalicylic acid or other nonsteroidal anti-inflammatory drugs (NSAIDs),
• if they are allergic to peanuts or soy, as the medicine contains soy lecithin,
• if they currently have or have had stomach or duodenal ulcers (peptic ulcers) or bleeding (two or more confirmed cases of ulcers or bleeding),
• if they have ever had bleeding or perforation of the gastrointestinal tract associated with previous use of NSAIDs,
• if they have severe liver, kidney, or heart failure,
• if they have had bleeding in the brain (cerebral hemorrhage) or other active bleeding,
• if they have blood disorders of unknown origin,
• if your child is dehydrated (due to vomiting, diarrhea, or insufficient fluid intake).

Do not use the medicine in the last 3 months of pregnancy.

Warnings and precautions

Before using Nurofen for Children Junior, you should consult your doctor or pharmacist:

• if your child has an infection - see below, "Infections".
• if your child has asthma or allergic diseases, as they may experience shortness of breath;
• if your child has hay fever, nasal polyps, or chronic obstructive pulmonary disease, as there is an increased risk of allergic reactions. Allergic reactions can occur in the form of asthma attacks (so-called analgesic asthma), Quincke's edema, or urticaria;
• if your child has or has had gastrointestinal diseases;
• if your child has impaired kidney function;
• if your child has liver function disorders. During long-term use of Nurofen for Children Junior, regular monitoring of liver and kidney function parameters, as well as blood morphology, is required; you should exercise caution if your child is taking 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), or antiplatelet agents (e.g., acetylsalicylic acid). if your child is taking other NSAIDs (including COX-2 inhibitors, such as celecoxib or etoricoxib), as you should avoid such a combination; if your child has systemic lupus erythematosus (SLE) or mixed connective tissue disease;
• if your child has certain inherited blood disorders (e.g., acute intermittent porphyria);
• if your child has bleeding disorders;
• if your child has chronic inflammatory bowel disease, such as Crohn's disease or ulcerative colitis;
• if your child is dehydrated, due to the risk of kidney function impairment in dehydrated children;
• if your child has recently undergone major surgery;
• if your child has chickenpox, as you should avoid using Nurofen for Children Junior during the infection.

Infections
Nurofen for Children Junior may mask the symptoms of infection, such as fever and pain. Therefore, Nurofen for Children Junior may delay the use of appropriate infection treatment, which may lead to 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 existing infection, and the symptoms of the infection persist or worsen, they should immediately consult a doctor.
Skin reactions
Severe skin reactions have been reported with ibuprofen use, such as exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), and acute generalized exanthematous pustulosis (AGEP). If the patient experiences any of the symptoms associated with these severe skin reactions described in section 4, they should immediately discontinue Nurofen for Children Junior and seek medical attention.
Bleeding, ulcers, or perforations of the gastrointestinal tract that can be fatal, have been reported with the use of all NSAIDs, at any time during treatment, with or without warning symptoms or a history of serious gastrointestinal events. If gastrointestinal bleeding or ulcers occur, treatment should be discontinued immediately. The risk of bleeding, ulcers, or perforation of the gastrointestinal tract increases with the use of higher NSAID doses, in patients with a history of ulcers, especially if they were complicated by bleeding or perforation (see section 2 "When not to use Nurofen for Children Junior"), and in the elderly. In these patients, treatment should be initiated with the lowest available dose. In such patients, as well as in patients requiring concomitant use of low-dose acetylsalicylic acid or other drugs that may increase the risk of gastrointestinal disorders, the doctor will consider concomitant use of medications with a protective effect on the gastric mucosa (e.g., misoprostol or proton pump inhibitors).
Chronic use of (certain) painkillers may lead to permanent severe kidney damage with a risk of kidney failure (analgesic nephropathy).
Pain-relieving and anti-inflammatory medicines like ibuprofen may slightly increase the risk of heart attack or stroke, especially when used in high doses. Do not exceed the recommended dose or duration of treatment.
Before using Nurofen for Children Junior, you should talk to your doctor or pharmacist:

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

During ibuprofen use, symptoms of an allergic reaction to this medicine have been reported, including breathing difficulties, facial swelling, and chest pain. If the patient notices any of these symptoms, they should immediately stop using Nurofen for Children Junior and contact a doctor or emergency services.
Elderly patients
Elderly patients have an increased risk of experiencing side effects when using NSAIDs, especially those related to the stomach and intestines. For more information, see section 4 "Possible side effects".
Patient with a history of gastrointestinal toxicity, especially the elderly, should report any unusual abdominal symptoms (especially gastrointestinal bleeding), especially during the initial treatment phase.
Long-term use of any type of pain reliever for headache treatment may worsen symptoms. If this situation occurs or the patient suspects it, they should discontinue treatment and consult a doctor. Headache related to pain reliever overuse should be suspected in patients who have frequent or daily headaches, despite (or due to) regular use of pain relievers.

Other medicines and Nurofen for Children Junior

Tell your doctor or pharmacist about all the medicines your child is taking, has recently taken, or might take.
Nurofen for Children Junior may affect the way some other medicines work, or other medicines may affect the way Nurofen for Children Junior works, for example:

• anticoagulants (blood thinners or anti-clotting agents, e.g., acetylsalicylic acid, warfarin, ticlopidine)
• medicines to lower 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 the treatment with Nurofen for Children Junior or be affected by it. You should always consult your doctor or pharmacist before using Nurofen for Children Junior with other medicines, especially if your child is taking any of the following medicines:

You should consult your doctor or pharmacist if any of the above situations apply to your child. If in doubt about the type of medicine your child is taking, you should show the medicine to your doctor or pharmacist.

Nurofen for Children Junior and alcohol consumption

Do not drink alcohol while using Nurofen for Children Junior. Some side effects, such as effects on the gastrointestinal tract or central nervous system, may be more likely if alcohol is consumed while using Nurofen for Children Junior.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a child, you should ask your doctor or pharmacist for advice before using this medicine.
Pregnancy
Do not use this medicine during the last 3 months of pregnancy. Use may cause kidney and heart problems in the unborn child. It may also affect the mother's and child's ability to clot and prolong labor. Avoid using this medicine during the first 6 months of pregnancy, unless your doctor advises otherwise. Taking ibuprofen for more than a few days after the start of the 20th week of pregnancy may cause kidney problems in the unborn child and lead to low levels of amniotic fluid surrounding the child (oligohydramnios) or narrowing of the ductus arteriosus in the child's heart. If longer-term treatment is necessary, your doctor may recommend additional monitoring.
Breastfeeding
Only small amounts of ibuprofen and its breakdown products pass into breast milk. Nurofen for Children Junior can be used during breastfeeding, if used in recommended doses and for the shortest possible duration.
Fertility
Nurofen for Children Junior belongs to a group of medicines (NSAIDs) that may impair female fertility. This effect is reversible after stopping the medicine.

Driving and using machines

During short-term use, the medicine has no or negligible influence on the ability to drive and use machines.
Nurofen for Children Junior contains soy lecithin. If the patient is allergic to peanuts or soy, they should not use this medicine.
Nurofen for Children Junior contains glucose syrup. If the doctor has told your child that they have an intolerance to some sugars, you should consult the doctor before giving this medicine to your child. The medicine may have a harmful effect on teeth.
Nurofen for Children Juniorcontains less than 1 mmol (23 mg) of sodium per dose, which means the medicine is essentially "sodium-free".

3. How to use Nurofen for Children Junior

This medicine should always be used exactly as described in the patient information leaflet or as directed by your doctor or pharmacist.
Nurofen for Children Junior is for oral use.
The capsules should be chewed and swallowed. There is no need to drink water.
The medicine is intended for short-term use only.
You should use the smallest effective dose for the shortest duration necessary to relieve symptoms. If the symptoms of an infection (such as fever and pain) persist or worsen, you should immediately consult a doctor (see section 2). Do not give Nurofen for Children Junior to children under 7 years of age or children with a body weight less than 20 kg.

Recommended dose:

In children, ibuprofen is dosed based on body weight, usually 5 to 10 mg/kg body weight in a single dose, up to a maximum of 20-30 mg/kg body weight as a total daily dose.

Using a higher dose of Nurofen for Children Junior than recommended

If your child has used a higher dose of Nurofen for Children Junior than recommended or has accidentally taken the medicine, you should always consult a doctor or go to the nearest hospital to get an opinion on possible health risks and advice on what to do in such a case.
Symptoms of overdose may include nausea, vomiting (which may contain blood), blood in the stool (gastrointestinal bleeding), abdominal pain, or diarrhea. Additionally, after taking a large dose, there have been reports of ringing in the ears, headaches, gastrointestinal bleeding, confusion, agitation, 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 the urine, low potassium levels in the blood, feeling cold, and breathing difficulties .

Missing a dose of Nurofen for Children Junior

Do not take a double doseto make up for a missed dose.
If you have any further questions about using this medicine, you should ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Side effects can be minimized by using the lowest effective dose for the shortest duration necessary to relieve symptoms. Although side effects are not very common, your child may experience known side effects typical of NSAIDs. In such a case or if in doubt, you should discontinue the medicine and consult a doctor as soon as possible. In elderly patients using this medicine, there is an increased risk of side effects related to the medicine.

You should STOP using the medicine and immediately consult a doctor if your child experiences any of the following symptoms:

• symptoms of gastrointestinal bleeding, such as severe abdominal pain, black stools, vomiting with blood or dark particles that look like coffee grounds.
• symptoms of a very rare but serious allergic reaction, such as worsening of asthma symptoms, unexplained wheezing or shortness of breath, swelling of the face, tongue, or throat, difficulty breathing, rapid heartbeat, drop in blood pressure leading to shock. Such a reaction may occur even after the first dose. If such symptoms occur, you should immediately consult a doctor
• red, non-raised, target-like, or circular patches on the torso, often with blisters in the center, peeling of the skin, ulcers in the mouth, throat, nose, genitals, and eyes. These severe skin reactions may be preceded by fever and flu-like symptoms (exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis) [Very rare - may occur with a frequency of up to 1 in 10,000 people]
• widespread rash, high body temperature, enlarged lymph nodes, and an increased number of eosinophils (a type of white blood cell) (DRESS syndrome) [Frequency not known; cannot be estimated from the available data].
• red, peeling, widespread rash with bumps under the skin and blisters, mainly located in skin folds, on the torso, and upper limbs, with accompanying fever. Symptoms usually appear at the beginning of treatment (acute generalized exanthematous pustulosis) [Frequency not known - cannot be estimated from the available data]. If your child experiences or worsens any of the side effects or experiences any side effects not listed in the leaflet, you should tell your doctor. Frequent(may occur in 1 in 10 people):
• Gastrointestinal disorders, such as heartburn, abdominal pain, nausea, indigestion, diarrhea, vomiting, bloating (gas), constipation, minor gastrointestinal bleeding, which in rare cases may cause anemia.

Uncommon(may occur in 1 in 100 people):

• Ulcers, perforations, or bleeding of the gastrointestinal tract, inflammation of the oral mucosa with ulcers, worsening of existing bowel disease (ulcerative colitis or Crohn's disease), inflammation of the stomach lining.
• Headaches, dizziness, insomnia, restlessness, irritability, or fatigue.
• Visual disturbances.
• Various skin rashes.
• Allergic reactions with hives and itching.

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

• Ringing in the ears (tinnitus).
• Increased blood urea levels, pain in the side and (or) abdominal pain, blood in the urine, and fever may be symptoms of kidney damage (papillary necrosis).
• Increased blood uric acid levels.
• Decreased hemoglobin levels.

Very rare(may occur with a frequency of up to 1 in 10,000 people):

• Esophagitis, pancreatitis, formation of diaphragm-like contractions in the intestine.
• Heart failure, heart attack, and facial or hand swelling.
• Kidney failure, decreased urine output, and swelling (especially in patients with high blood pressure or impaired kidney function), swelling and clouding of the urine (nephrotic syndrome), inflammatory kidney disease (interstitial nephritis), which may lead to acute kidney failure. If any of the above symptoms occur, or if you feel unwell, you should stop using Nurofen for Children Junior and consult a doctor immediately, as they may be the first signs of kidney damage or failure.
• Psychotic reactions and depression.
• High blood pressure, vasculitis.
• Palpitations.
• Liver function disorders, liver damage (the first symptoms may be skin discoloration), especially during long-term treatment, liver failure, acute hepatitis.
• Blood disorders - the first symptoms are: fever, sore throat, mouth ulcers, flu-like symptoms, severe fatigue, nosebleeds, and skin bruising. In such cases, you should immediately stop the treatment and consult a doctor. Do not treat yourself with pain relievers or antipyretics (fever-reducing medicines).
• Severe skin and soft tissue infections during chickenpox.
• Worsening of an infectious condition (e.g., necrotizing fasciitis) due to the use of certain pain relievers (NSAIDs). If symptoms of infection worsen or appear, the patient should immediately consult a doctor. It should be assessed whether there are indications for the use of anti-infective treatment (antibiotic therapy).
• Ibuprofen use has been associated with symptoms of aseptic meningitis, with stiffness of the neck, headache, nausea, vomiting, fever, and changes in consciousness. In patients with autoimmune disorders (lupus, mixed connective tissue disease), there is a higher risk of these disorders. If such symptoms occur, you should immediately consult a doctor.
• Hair loss (alopecia).

Frequency not known(cannot be estimated from the 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 like Nurofen may slightly increase the risk of heart attack (myocardial infarction) or stroke.

Reporting side effects

If you experience any side effects, including any not listed in the leaflet, you should tell your doctor or pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Jerozolimskie Avenue 181C, 02-222 Warsaw, phone: 22 49-21-301, fax: 22 49-21-309,
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, you can help provide more information on the safety of this medicine.

How to store Nurofen for Children Junior

Store in a temperature below 25°C.
Keep the medicine out of the 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 month.
Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Nurofen for Children Junior contains

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

Auxiliary processing agents: medium-chain triglycerides, soy lecithin, and stearic acid.

What Nurofen for Children Junior looks like and what the pack contains

Nurofen for Children Junior is an orange, square, soft, chewable gelatin capsule with "N100" printed in white ink.
Nurofen for Children Junior is available in PVC/PE/PVdC/Al blisters.
The packs 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 authorization holder

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

Importer

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

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Date of approval of the leaflet: 04/2025