Nurofen dla dzieci

Leaflet accompanying the packaging: information for the user

Nurofen for children, 60 mg, suppositories

(Ibuprofen)

You should carefully read the contents of the 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 leaflet or as directed by a 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 consult a pharmacist.
• 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.
• You should contact a doctor if there is no improvement or the patient feels worse:
• after 24 hours in children aged 3-5 months or
• after 3 days in children over 6 months old.

Table of contents of the leaflet:

• 1. What is Nurofen for children and what is it used for
• 2. Important information before using Nurofen for children
• 3. How to use Nurofen for children
• 4. Possible side effects
• 5. How to store Nurofen for children
• 6. Package contents and other information

1. What is Nurofen for children and what is it used for

Ibuprofen belongs to a group of medicines called nonsteroidal anti-inflammatory drugs (NSAIDs). The action of these medicines is to change the body's response to pain, swelling, and elevated body temperature. Nurofen for children is intended for symptomatic treatment of:

• fever
• pain of mild to moderate severity.

Nurofen for children is used when oral administration of the medicine is not recommended, e.g., when vomiting occurs.
If after 24 hours (infants aged 3-5 months, with a body weight over 5 kg) or 3 days (children over 6 months old) there is no improvement or the patient feels worse, you should contact a doctor.

2. Important information before using Nurofen for children

When not to use Nurofen for children

• if the patient is hypersensitive (allergic) to ibuprofen or other similar painkillers (NSAIDs) or any of the other ingredients of Nurofen for children (listed in section 6);
• if the patient has ever had difficulty breathing, asthma, hay fever, facial swelling, and/or hives after taking ibuprofen, acetylsalicylic acid, or other similar painkillers (NSAIDs);
• if the patient has ever had bleeding or perforation of the gastrointestinal tract associated with previous NSAID treatment;
• if the patient has had two or more episodes of stomach or duodenal ulcers or bleeding;
• in patients with bleeding from blood vessels in the brain or other active bleeding;
• in patients with unexplained blood clotting disorders;
• in patients with severe dehydration (caused by vomiting, diarrhea, or insufficient fluid intake);
• if there is severe liver, kidney, or heart failure;
• if the patient is in the last three months of pregnancy;
• in infants weighing less than 6.0 kg (under 3 months old).

Warnings and precautions

Before using the suppositories, you should consult a doctor or pharmacist:

• If the patient has an infection - see below, "Infections".
• If the patient has certain skin diseases (systemic lupus erythematosus - SLE or mixed connective tissue disease).
• If the patient has certain congenital blood disorders (e.g., acute intermittent porphyria).
• If the patient has bleeding disorders.
• If the patient has intestinal diseases (ulcerative colitis or Crohn's disease).
• If the patient has rectal or anal diseases.
• If the patient has ever had high blood pressure and/or heart failure.
• If the patient has impaired kidney function.
• If the patient has liver disease.
• If the patient has or has had allergic diseases or asthma, as shortness of breath may occur.
• If the patient has hay fever, nasal polyps, or chronic obstructive pulmonary disease, there is an increased risk of allergic reactions; allergic reactions may occur in the form of asthma attacks (so-called analgesic asthma), angioedema, or hives.
• If the patient has heart disease, has had a stroke, or thinks they may be at increased risk of these diseases (e.g., if they have high blood pressure, diabetes, high cholesterol, or smoke). In such cases, they should discuss treatment with their doctor or pharmacist.
• During ibuprofen use, symptoms of an allergic reaction to this medicine have been reported, including breathing problems, facial swelling, and chest pain. If the patient notices any of these symptoms, they should stop using Nurofen for children immediately and contact their doctor or emergency services.
• Medicines like Nurofen for children may slightly increase the risk of heart attack (myocardial infarction) or stroke. This risk is higher with high doses and long-term treatment. Do not exceed the recommended dose or treatment duration, which is 24 hours for infants aged 3-5 months and 3 days for children over 6 months old.
• During long-term use of Nurofen for children, regular monitoring of liver and kidney function parameters, as well as blood morphology, is required.
• Side effects can be minimized by using the smallest effective dose for the shortest necessary time to control symptoms.
• In elderly patients, there is an increased risk of side effects.
• Chronic use of (some) painkillers may lead to severe kidney disorders. This risk may increase with physical exertion associated with salt loss and dehydration. Therefore, this should be avoided.
• Long-term use of painkillers for headaches may exacerbate these conditions. If suspected or confirmed, medical advice should be sought, and treatment should be discontinued. Medication-overuse headaches should be expected in patients who frequently or daily experience headaches, despite (or due to) regular use of painkillers.
• There is a risk of gastrointestinal bleeding, ulcers, or perforation, which can be fatal and may not be preceded by warning signs; they can also

occur in patients who have had warning signs. In case of gastrointestinal bleeding or ulcers, the medicine should be discontinued immediately.

• Caution should be exercised in patients taking medicines that may increase the risk of 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).
• Concomitant use with NSAIDs, including selective cyclooxygenase-2 (COX-2) inhibitors, such as celecoxib or etoricoxib, increases the risk of side effects (see "Nurofen for children and other medicines" below), so this should be avoided.
• If the patient has chickenpox (varicella), they should avoid using Nurofen for children.
• There is a risk of kidney function disorders in dehydrated children and adolescents.
• Medical supervision is particularly required immediately after major surgery.

Infections
Nurofen for children may mask the symptoms of infection, such as fever and pain. Therefore, Nurofen for children may delay the use of appropriate infection treatment and consequently 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 infection, and the infection symptoms persist or worsen, they should consult their doctor immediately.
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 discontinue Nurofen for children immediately and seek medical attention.

Nurofen for children and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.

Which medicines should be avoided during Nurofen for children use?

Nurofen for children may affect or be affected by other medicines, for example:

• anticoagulant medicines (i.e., blood thinners/preventing blood clots, e.g., acetylsalicylic acid, warfarin, ticlopidine);
• antihypertensive medicines (ACE inhibitors, e.g., captopril, beta-adrenergic blockers such as atenolol, angiotensin II antagonists such as losartan); Some other medicines may affect treatment with Nurofen for children or be affected by it.

The patient should always consult their doctor before using Nurofen for children with other medicines.
In particular, they should inform their doctor about taking the following medicines:
Acetylsalicylic acid or other NSAIDs (anti-inflammatory and pain-relieving medicines)
because the risk of ulcers and gastrointestinal bleeding may increase
Digoxin (a medicine used for heart failure)
because the effect of digoxin may be enhanced
Corticosteroids (medicines containing cortisone or substances similar to cortisone)
because the risk of ulcers and gastrointestinal bleeding may increase
Antiplatelet agents
because the risk of bleeding may increase
Acetylsalicylic acid (low doses)
because the blood-thinning effect may be reduced
Anticoagulant medicines (e.g., warfarin)
because ibuprofen may enhance the effect of these medicines
Phenytoin (a medicine used to treat epilepsy)
because the effect of phenytoin may be enhanced
Selective serotonin reuptake inhibitors (used to treat depression)
because they may increase the risk of gastrointestinal bleeding
Lithium (a medicine used to treat manic-depressive disorders and depression)
because the effect of lithium may be enhanced
Probenecid and sulfinpyrazone (used to treat gout)
because ibuprofen excretion may be delayed
Antihypertensive medicines and diuretics
because ibuprofen may reduce the effect of these medicines and may increase the risk of nephrotoxicity
Potassium-sparing diuretics
because hyperkalemia may occur
Methotrexate (used to treat cancer and rheumatism)
because the effect of methotrexate may be enhanced
Tacrolimus and cyclosporin (immunosuppressive medicines)
because kidney damage may occur
Zidovudine (used to treat HIV/AIDS)
because Nurofen use may increase the risk of intracranial bleeding or bleeding leading to swelling in HIV-positive patients with hemophilia.
Sulfonylurea derivatives (antidiabetic medicines)
because interactions are possible
Quinolone antibiotics
because the risk of seizures may increase
Voriconazole and fluconazole (CYP2C9 inhibitors), used in fungal infections
The effect of ibuprofen may be enhanced; it is recommended to consider reducing the ibuprofen dose, especially when using high doses of ibuprofen with voriconazole or fluconazole.

Using Nurofen for children with alcohol

The patient should not drink alcohol while using Nurofen for children. Alcohol may enhance certain side effects, such as those affecting the gastrointestinal tract or central nervous system.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, or thinks they may be pregnant or plan to have a child, they should consult their doctor or pharmacist before taking the medicine.
Pregnancy
The patient should inform their doctor if they become pregnant while using Nurofen for children. The medicine should not be used during the last three months of pregnancy. Use may cause kidney and heart disorders in the unborn child. It may also affect the patient's and their child's tendency to bleed and may prolong or delay labor. The medicine should be avoided during the first six months of pregnancy, unless the doctor recommends otherwise. Taking ibuprofen for more than a few days after the start of the 20th week of pregnancy may cause kidney disorders in the unborn child and lead to a low level of amniotic fluid surrounding the child (oligohydramnios) or narrowing of the arterial duct in the child's heart. If necessary, the doctor may recommend additional monitoring.
Breastfeeding
The medicine passes into breast milk, but it can be used during breastfeeding if taken in the recommended dose and for the shortest possible period.
Fertility
The medicine belongs to a group of medicines (NSAIDs) that may adversely affect female fertility. This effect is temporary after discontinuing 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.

3. How to use Nurofen for children

Nurofen for children should always be used exactly as described in the leaflet or as directed by a doctor or pharmacist. In case of doubt, the patient should consult their doctor or pharmacist.
The patient should use the smallest effective dose for the shortest period necessary to relieve symptoms. If the infection symptoms (such as fever and pain) persist or worsen, the patient should consult their doctor immediately (see section 2).
Nurofen for children should only be used in children over 3 months old, with a body weight of at least 6.0 kg. The maximum single dose is 10 mg per kilogram of body weight. The interval between doses should not be less than 6 hours. The maximum total daily dose of ibuprofen is 20-30 mg per kilogram of body weight, divided into 3-4 single doses. For Nurofen for children, the following guidelines can be used (the child's body weight is more important than their age):

Suppositories are intended for rectal use. Before using the suppositories, they can be warmed in the hands.
For short-term use only.
In the case of infants aged 3-5 months, the patient should consult their doctor if symptoms worsen or do not improve after 24 hours.
In the case of children over 6 months old, the patient should consult their doctor if the medicine needs to be given for more than 3 days or if symptoms worsen.

Using a higher dose of Nurofen for children than recommended

If the patient has used a higher dose of Nurofen for children than recommended or if a child has accidentally taken the medicine, they should always consult their doctor or go to the nearest hospital to get an opinion on possible health risks and advice on what to do.
Symptoms of overdose may include nausea, stomach pain, vomiting (which may contain blood or dark particles resembling coffee grounds), gastrointestinal bleeding, headache, ringing in the ears, disorientation, or nystagmus (eye movement disorder). After taking a large dose, disturbances of balance, chest pain, palpitations, loss of consciousness, seizures (mainly in children), weakness, and dizziness have occurred. The patient may also experience blood in the urine, low potassium levels in the blood, feeling cold, vision disturbances, low blood pressure, excitement, disorientation, coma, hyperkalemia (elevated potassium levels in the blood), metabolic acidosis, increased prothrombin time/INR, acute kidney failure, liver damage, respiratory depression, cyanosis, and worsening of asthma in asthma patients, drowsiness, and breathing difficulties.
In case of any further doubts about using the medicine, the patient should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Nurofen for children can cause side effects, although not everybody gets them.
The patient may experience known side effects typical of NSAIDs (see below). If in doubt, the patient should stop using the medicine and consult their doctor as soon as possible. In elderly patients using this medicine, there is an increased risk of side effects related to the medicine's action.

The patient should STOP using the medicine and contact their doctor immediately if they experience any of the following symptoms:

• symptoms of gastrointestinal bleeding, such as severe stomach pain, black stools, vomiting with blood or dark particles resembling coffee grounds;
• symptoms 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, and a drop in blood pressure leading to shock. Such a reaction may occur even after the first dose;
• red, non-raised, target-like, or circular patches on the torso, often with blisters in the center, peeling 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, swollen lymph nodes, and an increased number of eosinophils (a type of white blood cell) (DRESS syndrome) [Frequency not known - cannot be estimated from available data].
• red, peeling, widespread rash with bumps under the skin and blisters, mainly 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 available data].

The patient should inform their doctor if they experience any other possible side effects.
Frequent: (may occur in 1 in 10 people)

• stomach problems, such as heartburn, stomach pain, nausea, indigestion, diarrhea, vomiting, bloating (gas), constipation, minor blood loss in the stomach and/or intestines, which in rare cases may cause anemia.

Uncommon: (may occur in 1 in 100 people)

• ulcers, perforation, or bleeding in the gastrointestinal tract, inflammation of the mouth mucosa with ulcers, worsening of existing intestinal diseases (ulcerative colitis or Crohn's disease), stomach mucosa inflammation, localized rectal irritation
• central nervous system disorders, such as headache, dizziness, insomnia, agitation, irritability, or fatigue
• vision 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 uric acid levels in the blood, side and/or stomach pain, blood in the urine, and fever may be symptoms of kidney damage (papillary necrosis)
• decreased hemoglobin levels

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

• esophagitis, pancreatitis, formation of intestinal strictures
• heart failure, heart attack, and facial or hand swelling
• kidney failure, and fluid retention (especially in patients with high blood pressure or kidney function disorders), swelling, and clouding of the urine (nephrotic syndrome), inflammatory kidney disease (interstitial nephritis), which may lead to acute kidney failure. If any of these symptoms occur, the patient should stop using Nurofen for children and consult their 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), particularly during long-term treatment, liver failure, acute hepatitis
• blood production disorders - the first symptoms are: fever, sore throat, superficial mouth ulcers, flu-like symptoms, severe fatigue, nosebleeds, and unexplained bruising. In such cases, the patient should stop treatment and consult their doctor immediately. They should not treat themselves with painkillers or antipyretics.
• severe skin and soft tissue infections during chickenpox
• worsening of inflammatory conditions associated with infections (e.g., necrotizing fasciitis) due to the use of certain painkillers (NSAIDs). If infection symptoms occur or worsen, the patient should immediately consult their doctor. It should be assessed whether there are indications for antimicrobial treatment (antibiotic therapy).
• aseptic meningitis symptoms, such as stiff neck, headache, nausea, vomiting, fever, and consciousness disorders, have been observed with ibuprofen use. In patients with autoimmune disorders (lupus, mixed connective tissue disease), there is a higher risk of such symptoms. If such symptoms occur, the patient should immediately consult their doctor.
• hair loss (alopecia).

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

Reporting side effects

If the patient experiences any side effects, including any possible side effects not listed in the leaflet, they should tell their doctor or pharmacist or nurse. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, Medical Devices, and Biocides
Al. Jerozolimskie 181C
02-222 Warsaw
tel: 22 49-21-301, fax: 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

The medicine should be stored out of sight and reach of children.
The medicine should not be used after the expiration date stated on the carton and blister pack.
The expiration date refers to the last day of the month.
Store at a temperature below 25°C.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Package contents and other information

What Nurofen for children contains

The active substance of the medicine is ibuprofen. Each suppository contains 60 mg of ibuprofen. The medicine also contains:
Hard fat (Witepsol H15)
Hard fat (Witepsol W45).

What Nurofen for children looks like and what the package contains

Suppositories are almost white or white and have a cylindrical shape.
The package contains 10 or 20 suppositories.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

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

Manufacturer

Famar A.V.E
Avlon Plant
49th KM National Road
Athens - Lamia
19011 Avlona Attiki
Greece
To obtain more detailed information, the patient should contact the representative of the marketing authorization holder:
Reckitt Benckiser (Poland) S.A.
ul. Okunin 1
05-100 Nowy Dwór Mazowiecki
tel: (22) 211 26 92

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

Austria: Nureflex 60 mg Zäpfchen für Kinder
Belgium: Nurofen voor Kinderen suppo 60 mg
Czech Republic: Nurofen pro děti čípky 60 mg
Germany: Nurofen Junior 60 mg Zäpfchen
Luxembourg: Nurofen pour Enfants suppo 60 mg
Poland: Nurofen dla dzieci, 60 mg, czopki
Slovakia: Nurofen pre deti čapíky 60mg

Date of last revision of the leaflet: 04/2025