Nurofen dla dzieci Iunior truskavkovi

Leaflet attached to the packaging: information for the user

Warning! Keep the leaflet! Information on the immediate packaging in a foreign language

Nurofen for Children Junior Strawberry

40 mg/ml, oral suspension

Ibuprofen
For children weighing from 20 kg (6 years) to 40 kg (12 years)

Table of contents of the leaflet:

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

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

Ibuprofen belongs to a group of medicines called Non-Steroidal Anti-Inflammatory Drugs (NSAIDs).
The action of these medicines is based on changing the body's response to pain and elevated body temperature.
Nurofen for Children Junior Strawberry is intended for short-term, symptomatic treatment of:

• fever,
• pain of mild to moderate severity.

If after 3 days there is no improvement or the patient feels worse, a doctor should be consulted.

2. Important information before taking Nurofen for Children Junior Strawberry

When not to take Nurofen for Children Junior Strawberry

• If the child is allergic to ibuprofen or other similar painkillers (from the NSAID group) or

It is necessary to carefully read the contents of the leaflet before taking the medicine, as it contains important information for the patient.

• This medicine should always be taken exactly as described in the patient leaflet or as directed by a doctor or pharmacist.
• This leaflet should be kept, so that it can be re-read if necessary.
• If advice or additional information is needed, a pharmacist should be consulted.
• If the patient experiences any side effects, including any possible side effects not listed in the leaflet, they should tell their doctor or pharmacist. See section 4.
• If after 3 days there is no improvement or the patient feels worse, a doctor should be consulted.

any of the other ingredients of this medicine (listed in section 6).

• If the child has ever had difficulty breathing, asthma, hay fever, swelling of the face and/or hands or hives after taking acetylsalicylic acid or other similar painkillers (from the NSAID group).
• If the child has ever had bleeding or perforation of the gastrointestinal tract associated with previous use of NSAIDs.
• If the child currently has or has had stomach and/or duodenal ulcers (ulcer disease) or bleeding (two or more confirmed cases of ulcers or bleeding).
• If the child has severe liver and kidney failure.
• If the child has severe heart failure.
• If the child has had bleeding in the brain (cerebral hemorrhage) or other active bleeding.
• If the child has blood clotting disorders, as ibuprofen may prolong bleeding time.
• If the child has blood production disorders of unknown origin.
• In children with severe dehydration (caused by vomiting, diarrhea, or insufficient fluid intake).

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

Warnings and precautions

Before taking Nurofen for Children Junior Strawberry, the patient should discuss the treatment with a doctor or pharmacist

• If the child has an infection - see below, "Infections".
• If the child has certain inherited blood 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 intestinal diseases (ulcerative colitis or Crohn's disease), as their symptoms may worsen.
• If the child has ever had or currently has high blood pressure and/or heart failure.
• If the child has kidney function disorders.
• If the child has liver diseases. In the case of long-term use of Nurofen for Children Junior Strawberry, regular monitoring of liver function, kidney function, and blood morphology parameters is required.
• Caution is recommended when using other medicines that may increase the risk of stomach or intestinal ulcers, such as oral corticosteroids (e.g., prednisolone), blood thinners (e.g., warfarin), selective serotonin reuptake inhibitors (antidepressants), and antiplatelet agents (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 occurrence of side effects can be reduced by using the smallest effective dose for the shortest possible time.
• Generally, continuous use (of several types) of painkillers can lead to persistent serious kidney disease. This risk may increase during physical exertion associated with salt loss and dehydration. Therefore, this should be avoided.
• As a result of long-term use of any type of painkillers, headaches may occur, which should not be treated with increased doses of this medicine. In such a case, the medicine should be discontinued and a doctor consulted. The diagnosis of headache caused by drug abuse should be suspected in patients who have frequent or daily headaches despite (or due to) regular use of headache-relieving medications.
• If the child has ever had asthma or allergic diseases that can cause shortness of breath.
• If the child has hay fever, nasal polyps, chronic obstructive pulmonary disease, there is an increased risk of allergic reactions. Allergic reactions can occur as asthma attacks (so-called analgesic-induced asthma), Quincke's edema, or hives.
• It is recommended to avoid taking Nurofen for Children 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 the increased risk of kidney failure in dehydrated children.

Infections
Nurofen for Children Junior Strawberry may mask the symptoms of infection, such as fever and pain.
Therefore, Nurofen for Children Junior Strawberry may delay the application of appropriate infection treatment 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 infection and the symptoms of the infection persist or worsen, a doctor should be consulted immediately.
Skin reactions
Severe skin reactions have been reported with the use of Nurofen for Children Junior Strawberry. If any skin rash, mucosal lesions, blisters, or other signs of allergy occur, the use of Nurofen for Children Junior Strawberry should be discontinued and medical help sought immediately, as these may be the first signs of a very severe skin reaction. See section 4.
Bleeding, ulcers, or perforation of the gastrointestinal tract, which can be fatal, have been reported during treatment with all NSAIDs with warning signs or without, or in patients who have had serious gastrointestinal diseases. In case of gastrointestinal bleeding or ulcers, treatment should be discontinued immediately. The risk of bleeding, ulcers, or perforation of the gastrointestinal tract increases with the increase in the dose of NSAIDs in patients who have had ulcers, especially with bleeding or perforation (see section 2 "When not to take Nurofen for Children Junior Strawberry") and in the elderly. These patients should start treatment with the smallest effective dose. In these patients, as well as in patients who require concurrent administration of acetylsalicylic acid in small doses or medications that increase the risk of gastrointestinal reactions, concomitant treatment with protective agents (e.g., misoprostol or proton pump inhibitors) should be considered.
Taking anti-inflammatory and pain-relieving medications, such as ibuprofen, may be associated with a small increase in the risk of heart attack or stroke, particularly when used in high doses. The recommended dose should not be exceeded, and the duration of treatment should not be prolonged.

• If the patient has heart diseases, such as heart failure, angina pectoris (chest pain), the patient has had a heart attack, bypass surgery, has peripheral arterial disease (poor blood circulation in the legs due to narrowing or blockage of arteries), or if the patient has had any stroke (including mini-stroke or transient ischemic attack (TIA)).
• If the patient has high blood pressure, diabetes, has high cholesterol levels, has a family history of heart disease or stroke, or if the patient smokes.

If any of the above cases apply to the child, a doctor should be consulted before taking Nurofen for Children Junior Strawberry.
Elderly patients
Elderly patients have an increased risk of side effects when taking NSAIDs, particularly those related to the stomach and intestines.
Patients with a history of gastrointestinal diseases, especially in the elderly, should report any unusual symptoms in the abdominal cavity (mainly gastrointestinal bleeding), especially in the initial stage of treatment.

Nurofen for Children Junior Strawberry and other medicines

The doctor or pharmacist should be informed about all medicines currently or recently taken by the child, as well as any medicines that the child may take.
Nurofen for Children Junior Strawberry may affect the action of other medicines or other medicines may affect the action of Nurofen for Children Junior Strawberry. For example:

• medicines with anticoagulant action (i.e., blood thinners/anti-clotting agents, such as aspirin/acetylsalicylic acid, warfarin, ticlopidine)
• medicines that lower blood pressure (ACE inhibitors, such as captopril, beta-adrenergic blockers, such as atenolol, angiotensin II receptor antagonists, such as losartan).

Also, some other medicines may be affected or may affect the treatment with Nurofen for Children Junior Strawberry. Therefore, before taking Nurofen for Children Junior Strawberry with other medicines, a doctor or pharmacist should always be consulted.
In particular, the doctor should be informed if the patient is taking the following medicines:
Other NSAIDs, including COX-2 inhibitors
because the risk of side effects may increase
Digoxin (a medicine used in heart failure)
because the action of digoxin may be enhanced
Corticosteroids (medicines containing cortisone or similar substances)
because the risk of stomach ulcers and bleeding may increase
Antiplatelet agents
because the risk of bleeding may increase
Acetylsalicylic acid (in small doses)
because the blood-thinning action may be weakened
Blood thinners (e.g., warfarin)
because ibuprofen may enhance the action of these medicines
Phenytoin (a medicine used in the treatment of epilepsy)
because the action of phenytoin may be enhanced
Selective serotonin reuptake inhibitors (medicines used in the treatment of depression)
because they may increase the risk of gastrointestinal bleeding
Lithium (a medicine used in the treatment of manic-depressive disorders and depression)
because the action of lithium may be enhanced
Probenecid and sulfinpyrazone (a medicine used in the treatment of gout)
because the excretion of ibuprofen may be delayed
Blood pressure-lowering medicines and diuretics
because ibuprofen may weaken the action of these medicines and may increase the risk of kidney function deterioration
Diuretics that spare potassium, such as amiloride, potassium canrenoate, spironolactone, triamterene
because hyperkalemia may occur
Methotrexate (a medicine used in the treatment of cancer and rheumatism)
because the action of methotrexate may be enhanced
Tacrolimus and cyclosporin (immunosuppressive medicines)
because kidney damage may occur
Zidovudine (in the treatment of HIV/AIDS)
because the use of Nurofen for Children Junior Strawberry may increase the risk of intracranial bleeding or bleeding leading to swelling in HIV-positive patients with hemophilia
Sulfonylurea derivatives (oral hypoglycemic medicines)
because they may affect blood sugar levels
Quinolone antibiotics
because the risk of seizures may increase
Voriconazole and fluconazole (CYP2C9 inhibitors), used in fungal infections
because the action of ibuprofen may be enhanced; it is recommended to consider reducing the dose of ibuprofen, especially when using high doses of ibuprofen with voriconazole or fluconazole
Baclofen
after taking ibuprofen, baclofen toxicity may develop
Ritonavir
ritonavir may increase the plasma concentration of NSAIDs

Nurofen for Children Junior Strawberry and alcohol

Alcohol should not be consumed while taking Nurofen for Children Junior Strawberry.
Some side effects, such as those related to the gastrointestinal tract or central nervous system, may be more likely when taking alcohol and Nurofen for Children Junior Strawberry.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult a doctor or pharmacist before taking this medicine.
Pregnancy
This medicine should not be taken during the last 3 months of pregnancy. Its use may cause kidney and heart problems in the unborn child. It may also affect the patient's and their child's tendency to bleed and prolong or prolong labor. This medicine should be avoided during the first 6 months of pregnancy, unless a doctor advises otherwise. Taking ibuprofen for a period longer than a few days after the start of the 20th week of pregnancy may cause kidney problems in the unborn child and lead to a low level of amniotic fluid surrounding the child (oligohydramnios) or narrowing of the arterial duct (ductal constriction) in the child's heart. If necessary, the doctor may prescribe additional monitoring.

How to take Nurofen for Children Junior Strawberry

The recommended dose for pain and fever is:

* Doses should be administered every 6 to 8 hours.

It is not recommended to take this medicine in children under 6 years of age or weighing less than 20 kg.

In patients with sensitive stomachs, it is recommended to take Nurofen for Children Junior Strawberry with food.
WARNING: do not exceed the established dose.

For oral use

Method of administration using a measuring spoon

• 1. Shake the bottle well.
• 2. Use the end of the measuring spoon suitable for the required dose.
• 3. Pour the medicine into the measuring spoon.
• 4. Place the measuring spoon in the child's mouth and administer the dose.
• 5. After use, screw the bottle cap back on. Wash the measuring spoon with warm water and let it dry. Store it out of sight and reach of children.

Duration of treatment

This medicine is intended for short-term use only.If the child's symptoms persist for more than 3 days or the patient feels worse, a doctor should be consulted.

Taking a higher dose of Nurofen for Children Junior Strawberry than recommended

If the patient has taken a higher dose of Nurofen for Children Junior Strawberry than recommended or if the child has accidentally taken the medicine, a doctor or the nearest hospital should always be consulted to assess the potential risk to health and for advice on what actions to take.
Symptoms may include nausea, stomach pain, vomiting (which may contain blood), gastrointestinal bleeding, headache, ringing in the ears, disorientation, or nystagmus, or less frequently, diarrhea.
After taking a large dose, balance disorders, vision disorders, low blood pressure, excitement, disorientation, coma, hyperkalemia, metabolic acidosis, increased 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, feeling cold, and breathing difficulties have been reported.

Missing a dose of Nurofen for Children Junior Strawberry

A double dose should not be taken to make up for a missed dose. If a dose is missed or not given, it should be taken or given as soon as remembered, and the next dose should be taken or given at the scheduled time interval as described above.

In case of any further doubts about the use of this medicine, a doctor or pharmacist should be consulted.

4. Possible side effects

Like all medicines, Nurofen for Children Junior Strawberry can cause side effects, although not everybody gets them. The occurrence of side effects can be reduced by using the smallest effective dose for the shortest possible time. In children, one of the known side effects of NSAIDs may occur. If side effects occur or in case of doubts, the use of the medicine should be discontinued and a doctor consulted as soon as possible. Elderly patients taking this medicine belong to a group with an increased risk of side effects.

DISCONTINUE USE of the medicine and seek medical help immediately if the child experiences:

• symptoms of gastrointestinal bleeding, such as severe abdominal pain, black tarry stools, vomiting blood or coffee ground-like vomit.
• symptoms of rare but serious allergic reactions, such as worsening of asthma, unexplained wheezing or shortness of breath, swelling of the face, tongue, or throat, difficulty breathing, rapid heartbeat, and low blood pressure leading to shock. Symptoms may occur even after the first use of the medicine. If any of these symptoms occur, a doctor should be consulted immediately.
• severe skin reactionssuch as a rash covering the whole body, peeling, blistering, or other signs of allergy.

If any of the side effects worsen or any side effects not listed in the leaflet occur, a doctor should be informed.

Frequent(may occur in 1 in 10 people)

• Gastrointestinal disorders, such as heartburn, abdominal pain, nausea, indigestion, diarrhea, vomiting, bloating (gas), constipation, and minor gastrointestinal bleeding, which in rare cases may cause anemia.

Uncommon(may occur in 1 in 100 people)

• Ulcers in the gastrointestinal tract, which may bleed or perforate, inflammation of the oral mucosa with ulcers, worsening of existing intestinal diseases (ulcerative colitis or Crohn's disease), inflammation of the stomach lining.
• Central nervous system disorders, such as headaches, dizziness, insomnia, excitement, irritability, or fatigue.
• Visual disturbances.
• Various skin rashes.
• Allergic reactions with hives and itching.

Rare(may occur in 1 in 1000 people)

• Tinnitus (ringing in the ears).
• Increased blood urea levels, side or abdominal pain, and blood in urine, which may be signs of kidney damage (renal papillary necrosis).
• Increased blood uric acid levels.
• Decreased hemoglobin levels.

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

• Esophageal inflammation, pancreatitis, formation of intestinal strictures.
• Heart failure, heart attack, and facial or hand swelling.
• Decreased urine output and swelling (especially in patients with high blood pressure or impaired kidney function), kidney syndrome, and interstitial kidney disease, which may lead to acute kidney failure. If any of these symptoms occur or if the patient feels unwell, the use of Nurofen for Children Junior Strawberry should be discontinued and a doctor consulted immediately, as these may be the first signs of kidney damage or failure.
• Psychotic reactions and depression.
• High blood pressure, vasculitis.
• Rapid heartbeat.
• Liver function disorders, liver damage (the first signs may be skin discoloration), especially during long-term treatment, liver failure, acute hepatitis.
• Blood production disorders - the first signs are fever, sore throat, superficial oral mucosa ulcers, flu-like symptoms, severe fatigue, nosebleeds, and unexplained bruising. In such cases, treatment should be discontinued immediately and a doctor consulted. Self-medication with painkillers or antipyretics should not be used.
• Severe skin and soft tissue infections during chickenpox.
• Worsening of inflammatory conditions (e.g., necrotizing fasciitis) due to the use of certain painkillers (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).
• Severe skin reactions, such as rash covering the whole body, peeling, blistering, and shedding of skin.

Frequency not known(cannot be estimated from the available data)

• Respiratory tract reactions, including asthma, bronchospasm, shortness of breath.
• They may occur severe skin reactions known as DRESS syndrome. The symptoms of DRESS syndrome include skin rash, fever, swelling of lymph nodes, and an increased number of eosinophils (a type of white blood cell).

(a type of white blood cell).

• A red scaly rash with thickening under the skin and blisters, usually located in skin folds, on the torso, and upper limbs, with fever at the beginning of treatment (acute generalized exanthematous pustulosis). If such symptoms occur, the use of Nurofen for Children Junior Strawberry should be discontinued and medical help sought immediately. See also section 2.
• The skin becomes sensitive to light.

Medicines like this one may be associated with a small increased risk of heart attack (myocardial infarction) or stroke.

Reporting side effects

If side effects occur, including any side effects not listed in the leaflet, a doctor or pharmacist should be informed. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, phone: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl.
By reporting side effects, more information can be collected on the safety of the medicine.

5. How to store Nurofen for Children Junior Strawberry

Store out of sight and reach of children.
Nurofen for Children Junior Strawberry should not be taken after the expiry date stated on the packaging. The expiry date refers to the last day of the specified month.
Store at a temperature below 25°C.
After opening the bottle, the medicine should be used within 6 months.

Medicines should not be disposed of via wastewater or household waste. A pharmacist should be asked how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Nurofen for Children Junior Strawberry contains

The active substance of the medicine 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, strawberry flavor (containing propylene glycol), and purified water.

What Nurofen for Children Junior Strawberry looks like and what the packaging contains

Nurofen for Children Junior Strawberry is a white, syrupy oral suspension with a characteristic strawberry smell.
Each bottle contains 100 ml of oral suspension.
The packaging includes a double-ended measuring spoon (PP) with a capacity of 2.5 ml (with a 1.25 ml graduation) on one side and 5 ml on the other side for accurate dosing.

Marketing authorization holder in Bulgaria, the country of export:

Reckitt Benckiser (Romania) S.R.L.
48 lancu de Hunedoara Boulevard
Building Crystal Tower, 11th floor
District 1, Bucharest, Romania

Manufacturer:

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

Parallel importer:

InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw

Repackaged by:

InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Marketing authorization number in Bulgaria, the country of export:20150019

Parallel import authorization number: 131/24

This medicine is authorized for marketing in the Member States of the European Economic Area 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 dĕti 4% jahoda
Germany
Nurodon Schmerz-und Fiebersaft Erdbeer 40 mg/ml Suspension zum Einnehmen
Greece
Nurofen for Children 4% strawberry
Hungary
Nurofen eperízû 40 mg/ml belsõleges szuszpenzió gyermekeknek
Ireland
Nurofen for Children Six Plus Strawberry 200 mg/5ml Oral Suspension
Luxembourg
Nurofen pour Enfants 4% suspension buvable
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

Date of leaflet approval: 25.03.2024

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