Nurofen dla dzieci

Leaflet accompanying the packaging: information for the user

Nurofen for children, 125 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 this patient 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 ask your pharmacist.
• If you experience any side effects, including those not listed in this leaflet, you should tell your doctor or pharmacist. See section 4.
• You should contact your doctor if your symptoms worsen or do not improve after 3 days.

Table of contents of the leaflet

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

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

Nurofen for children is a pain-relieving, antipyretic, and anti-inflammatory medicine, belonging to the group of nonsteroidal anti-inflammatory drugs (NSAIDs).
Clinical trials have shown the effectiveness of ibuprofen in treating mild to moderate pain, such as pain during teething and toothache, headache, earache, sore throat, post-operative pain, pain due to soft tissue injury, fever, including post-vaccination fever, as well as pain and fever in colds and flu.
Nurofen for children in suppositories is used when oral administration is not possible or causes vomiting.

2. Important information before taking Nurofen for children

When not to take Nurofen for children

• If the patient is allergic to ibuprofen and other nonsteroidal anti-inflammatory drugs (NSAIDs) or any of the other ingredients listed in section 6.1.
• If the patient has had hypersensitivity reactions (e.g., bronchospasm, asthma, rhinitis, or urticaria) after taking ibuprofen, acetylsalicylic acid, or other nonsteroidal anti-inflammatory drugs.
• If the patient has or has had stomach or duodenal ulcer or gastrointestinal bleeding (two or more distinct episodes of confirmed ulceration or bleeding).
• If the patient has severe liver or kidney failure, as well as uncontrolled heart failure.
• If the patient is in the last 3 months of pregnancy (see section 4.6).

Warnings and precautions

Important information before taking Nurofen for children:
During treatment with ibuprofen, symptoms of allergic reactions to this medicine have occurred, including difficulty breathing, swelling of the face and neck (angioedema), and chest pain.
If you notice any of these symptoms, you should stop taking Nurofen for children and contact your doctor or emergency services immediately.
When taking Nurofen for children, you should be particularly careful:
Due to the use of ibuprofen, severe skin reactions have occurred, such as exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, and drug reaction with eosinophilia and systemic symptoms (DRESS) and acute generalized exanthematous pustulosis (AGEP). If you experience any symptoms related to severe skin reactions described in section 4, you should stop taking Nurofen for children and seek medical attention.
Taking this medicine in the smallest effective dose for the shortest necessary period reduces the risk of side effects (see gastrointestinal and cardiovascular effects below).
The elderly are more likely to experience side effects.
You should be particularly careful when taking Nurofen for children if you have:

• infection - see below, section "Infections",
• connective tissue diseases (systemic lupus erythematosus), taking other NSAIDs,
• gastrointestinal disorders, including chronic non-specific enteritis, ulcerative enteritis, Crohn's disease, anal diseases,
• hypertension and (or) heart failure,
• kidney failure - in dehydrated children, there is a risk of kidney function disorder,
• liver function disorders

There is a risk of gastrointestinal bleeding or ulceration/perforation, which does not necessarily have to be preceded by warning symptoms or occur in patients who have had such warning symptoms. If gastrointestinal bleeding or ulceration occurs, you should stop taking the medicine and contact your doctor immediately.
Bronchospasm may occur in patients with asthma, chronic rhinitis, sinusitis, nasal polyps, or current or past allergies.
Taking such medicines as Nurofen for children may be associated with a small increased risk of heart attack (myocardial infarction) or stroke. This risk increases with long-term use of high doses of the medicine. You should not take higher doses or use the medicine for longer than recommended (3 days).
In case of heart problems, a history of stroke, or suspected risk of these disorders (e.g., high blood pressure, diabetes, high cholesterol, smoking), you should discuss your treatment with your doctor or pharmacist.
This medicine belongs to a group of medicines (nonsteroidal anti-inflammatory drugs) that may adversely affect fertility in women. The effect is temporary and reverses after stopping treatment.
Very rarely, after taking NSAIDs, severe, sometimes fatal, skin reactions have been reported, including exfoliative dermatitis, Stevens-Johnson syndrome, and toxic epidermal necrolysis. It appears that patients are more likely to experience such reactions in the early stages of treatment, with most reactions occurring within the first month of treatment. You should stop taking ibuprofen after the first symptoms appear, such as skin rash, mucosal lesions, or other symptoms of hypersensitivity.
Particular caution should be exercised in patients who have recently undergone 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 lead to increased risk of complications. This has been observed in bacterial pneumonia and bacterial skin infections associated with chickenpox. If you are taking this medicine while an infection is present.
In patients with heart, kidney, or liver failure, or those taking diuretics or with significant fluid loss due to major surgery, your doctor may consider monitoring kidney function.
It is recommended to avoid taking ibuprofen in patients with chickenpox. Chickenpox can lead to severe skin infections and soft tissue complications.

Nurofen for children and other medicines

You should inform your doctor about all medicines you have taken recently, even those that are available without a prescription.
You should avoid taking ibuprofen at the same time as the following medicines:

• with acetylsalicylic acid, except for acetylsalicylic acid in low doses (no more than 75 mg per day) as prescribed by your doctor, due to the possible increased risk of side effects;
• with other NSAIDs, including selective cyclooxygenase-2 inhibitors.

When taking ibuprofen at the same time as the following medicines, caution is advised:

• Anticoagulants - there is limited data on the intensity of action and increased risk of bleeding.
• Blood pressure-lowering medicines and diuretics - NSAIDs may reduce their effectiveness. There is an increased risk of side effects related to kidney function disorders, such as hyperkalemia. In patients who have experienced such disorders, your doctor will recommend drinking plenty of fluids.
• Corticosteroids - increased risk of stomach or duodenal ulcer or bleeding.
• Antiplatelet agents and selective serotonin reuptake inhibitors (SSRIs) - increased risk of gastrointestinal bleeding.
• Cardiac glycosides - NSAIDs may exacerbate heart failure, reduce GFR, and increase glycoside levels in the blood.
• Lithium - NSAIDs may cause increased lithium levels in the blood.
• Methotrexate - NSAIDs may cause increased methotrexate levels in the blood.
• Tacrolimus - there is an increased risk of kidney damage.
• Cyclosporin - NSAIDs may cause increased risk of kidney damage.
• Mifepristone - NSAIDs should not be taken within 8-12 days after mifepristone administration, as they may reduce its effect.
• Zidovudine - NSAIDs may cause increased risk of bleeding time prolongation.
• Quinolone antibiotics - data from animal studies indicate that NSAIDs may increase the risk of seizures associated with quinolone antibiotics. Patients taking NSAIDs and quinolones may be at increased risk of seizures.

Pregnancy, breastfeeding, and fertility

The medicine is intended for children. The data presented below concerns the action of the active substance ibuprofen.
Pregnancy
You should not take Nurofen for children in the last 3 months of pregnancy, as it may harm the unborn child or cause complications during delivery. Taking Nurofen for children may cause kidney or heart function disorders in the unborn child. It may also affect the mother's and child's bleeding tendency and prolong or prolong labor. You should not take Nurofen for children during the first 6 months of pregnancy, unless it is clearly necessary and recommended by your doctor. If treatment is necessary during this period or when trying to conceive, you should use the smallest dose for the shortest possible time.
Taking Nurofen for children for more than a few days after the start of the 20th week of pregnancy may cause kidney function disorders in the unborn child and lead to decreased amniotic fluid levels (oligohydramnios) or narrowing of the arterial duct (ductal constriction) in the child's heart. If long-term treatment is necessary, your doctor may recommend additional monitoring.
Inhibition of prostaglandin synthesis may have a negative effect on pregnancy and (or) fetal development. Data from epidemiological studies suggest an increased risk of miscarriage and congenital heart defects and gastroschisis due to the use of prostaglandin synthesis inhibitors in early pregnancy. The absolute risk of cardiovascular defects increases from less than 1% to approximately 1.5%. It is considered that the risk increases with the dose and duration of treatment.
Animal studies have shown that the administration of prostaglandin synthesis inhibitors causes an increased frequency of pre- and post-implantation losses, as well as embryonic and fetal death. Additionally, in animals receiving prostaglandin synthesis inhibitors during organogenesis, an increased frequency of various developmental abnormalities, including cardiovascular defects, has been reported.
Breastfeeding
You should consult your doctor before taking the medicine. Ibuprofen may pass into breast milk in small amounts. So far, no adverse effects on the breastfed infant have been reported, so during short-term use of ibuprofen in the recommended dose, it is usually not necessary to interrupt breastfeeding.
Fertility
Ibuprofen may affect fertility in women. This effect is temporary and reverses after stopping treatment.

Driving and using machines

During short-term use, Nurofen for children does not affect the ability to drive vehicles or operate machinery.

3. How to take Nurofen for children

You should use the smallest effective dose for the shortest necessary period to relieve symptoms. If the symptoms of infection (such as fever and pain) persist or worsen, you should contact your doctor immediately (see section 2).
In case of doubts about taking Nurofen for children, you should contact your doctor.
Method of administration: Take rectally.
The suppository should be removed from the aluminum blister pack and inserted into the anus, preferably after the child has had a bowel movement. To make the suppository more moist, you can warm it in your hand or dip it in warm water for a moment.
Nurofen for children in suppositories is used in a dose of 20 mg to 30 mg per kilogram of body weight in 3 to 4 divided doses according to the following dosage schedule:
For children weighing 12.5 kg to 17 kg (aged 2 to 4 years):the initial dose is 1 suppository. If necessary, 1 suppository after 6 to 8 hours. Do not take more than 3 suppositories (375 mg of ibuprofen) in 24 hours.
For children weighing 17 kg to 20.5 kg (aged 4 to 6 years):the initial dose is 1 suppository. If necessary, 1 suppository after 6 hours. Do not take more than 4 suppositories (500 mg of ibuprofen) in 24 hours.
The medicine should not be taken in children weighing less than 12.5 kg, as products containing lower amounts of ibuprofen are recommended for these children.
Patients with kidney or liver function disorders should consult their doctor before taking Nurofen for children.
If, despite taking the medicine, fever and pain do not improve or worsen, you should contact your doctor.

Overdose of Nurofen for children

If you have taken more than the recommended dose of Nurofen for children or if a child has accidentally taken the medicine, you should always contact your 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.
Overdose symptoms may include nausea, stomach pain, vomiting (which may contain blood), headache, ringing in the ears, and confusion. After taking a large dose, 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 may occur. Additionally, dizziness, vision disturbances, kidney failure, and decreased hemoglobin levels may occur.
There is no specific antidote.

Missed dose of Nurofen for children

You should not take a double dose to make up for a missed dose.

4. Possible side effects

Like all medicines, Nurofen for children in suppositories can cause side effects.
The following side effects have been observed in patients taking ibuprofen for short-term treatment of pain or fever of mild to moderate severity. When taking ibuprofen for other indications or long-term, other side effects may also occur.
Side effects are ranked according to frequency of occurrence using the following terms:

Uncommon: occurs in less than 1 in 100, but more than 1 in 1,000 patients.

• Hypersensitivity with urticaria and itching.
• Headache.
• Abdominal pain, nausea, and indigestion.
• Skin rash.

Rare: occurs in less than 1 in 1,000, but more than 1 in 10,000 patients.

• Diarrhea, bloating, constipation, vomiting.

Very rare: occurs in less than 1 in 10,000 patients.

• Skin infection.
• Blood system disorders.
• Severe hypersensitivity reactions, including face, tongue, and throat edema, dyspnea, tachycardia, and hypotension (anaphylaxis, angioedema, or severe shock).
• Aseptic meningitis.
• Blistering reactions, including Stevens-Johnson syndrome, erythema multiforme, and toxic epidermal necrolysis.
• Acute kidney failure.
• Decreased hemoglobin levels, decreased urea clearance.
• Liver function disorders.
• Peptic ulcer, perforation, or gastrointestinal bleeding, melena, and hematemesis, oral and mucosal ulceration.

Frequency not known: frequency cannot be estimated from available data.

• Heart failure and edema.
• Hypertension.
• Respiratory tract reactivity, including asthma, bronchospasm, or dyspnea.
• Exacerbation of ulcerative colitis and Crohn's disease.
• Skin becomes sensitive to light.

If you experience any of the following symptoms, you should stop taking ibuprofen and seek medical attention:

• red, non-raised, target-like, or circular patches on the torso, often with blisters in the center, skin peeling, ulcers in the mouth, throat, nose, genitals, 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).
• widespread rash, high body temperature, and enlarged lymph nodes (DRESS syndrome).
• red, scaly rash with nodules under the skin and blisters, usually located in skin folds, on the torso, and upper limbs, with fever occurring at the beginning of treatment (acute generalized exanthematous pustulosis).
• chest pain, which may be a symptom of a potentially severe allergic reaction called Kounis syndrome.

In some people, while taking Nurofen for children in suppositories, other side effects may occur. If you experience other side effects not listed in this leaflet, you should inform your doctor or pharmacist.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, you should tell your doctor or pharmacist or nurse. 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
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.

5. How to store Nurofen for children

The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging.
Do not store above 25°C.
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 packaging and other information

What Nurofen for children contains

1 suppository contains
active substance: 125 mg ibuprofen
excipient: solid fat.

What Nurofen for children looks like and contents of the pack

The suppositories are white or yellowish-white and have a cylindrical shape.
The packaging contains 10 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 about this medicine, you should contact the representative of the marketing authorization holder:
Reckitt Benckiser (Poland) S.A.
ul. Okunin 1
05-100 Nowy Dwór Mazowiecki
phone: (22) 211 26 92

Date of last revision of the leaflet: