Nurofen for children

Package leaflet: Information for the user

Nurofen for Children, 60 mg, suppositories
(Ibuprofenum)
Please read all of this leaflet carefully before using this medicine because it contains important information for you.
This medicine should always be used exactly as described in this patient leaflet or as directed by your doctor or pharmacist.

• Keep this leaflet so that you can read it again if necessary.
• If you need advice or further information, please contact your pharmacist.
• If you experience any adverse reactions, including any possible adverse reactions not listed in this leaflet, inform your doctor or pharmacist. See section 4.
• Contact your doctor if there is no improvement or if you feel worse:
  • after 24 hours in children aged 3–5 months, or
  • after 3 days in children over 6 months of age.

Table of contents:

1. What Nurofen for Children is and what it is 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. Contents of the pack and other information

1. What Nurofen for Children is and what it is used for
Ibuprofen belongs to a group of medicines called Non-Steroidal Anti-Inflammatory Drugs (NSAIDs). These medicines work by altering the body's response to pain, swelling, and elevated body temperature. Nurofen for Children is intended for symptomatic treatment of:

• fever
• mild to moderate pain.

Nurofen for Children may be used when oral administration is not suitable, for example, when vomiting occurs.
If there is no improvement after 24 hours (infants aged 3–5 months, weighing more than 5 kg) or 3 days (children over 6 months of age), or if the patient feels worse, contact your doctor.

2. Important information before using Nurofen for Children
When not to use Nurofen for Children

• if the patient is allergic (hypersensitive) to ibuprofen or other similar pain-relieving medicines (NSAIDs) or to any of the other ingredients of Nurofen for Children (listed in section 6);
• if asthma, rhinitis, facial and/or hand swelling, or urticaria occurred after taking ibuprofen, acetylsalicylic acid, or other similar pain-relieving medicines (NSAIDs);
• if gastrointestinal bleeding or perforation occurred during previous treatment with NSAIDs;
• if the patient has or has had two or more episodes of peptic ulcers or gastrointestinal bleeding;
• in patients with cerebral hemorrhage or any other active bleeding;
• in patients with unexplained blood disorders;
• in patients with severe dehydration (caused by vomiting, diarrhea, or insufficient fluid intake);
• in patients with severe liver, kidney, or heart failure;
• if the patient is in the last 3 months of pregnancy;
• in infants weighing less than 6.0 kg (under 3 months of age).

Warnings and precautions
Before using the suppositories, consult your doctor or pharmacist if:

• the patient has an infection – see below, section "Infections".

  • The patient has certain skin diseases (systemic lupus erythematosus – SLE or mixed connective tissue disease).
  • The patient has certain inherited blood formation disorders (e.g., acute intermittent porphyria).
  • The patient has blood clotting disorders.
  • The patient has or has had intestinal diseases (ulcerative colitis or Crohn’s disease).
  • The patient has diseases of the rectum or anus.
  • The patient has ever had high blood pressure and/or heart failure.
  • The patient has impaired kidney function.
  • The patient has liver disease.
  • The patient has allergic diseases or asthma, as breathing difficulties may occur.
  • The patient has hay fever, nasal polyps, or chronic obstructive respiratory disease, as the risk of allergic reactions is increased; allergic reactions may manifest as asthma attacks (so-called analgesic-induced asthma), angioedema, or urticaria.
  • The patient has heart disease, has had a stroke, or believes they may be at increased risk of these conditions (e.g., due to high blood pressure, diabetes, high cholesterol, or smoking). In such cases, discuss treatment with your doctor or pharmacist.
  • Allergic reactions to ibuprofen, including breathing difficulties, facial and neck swelling (angioedema), or chest pain, have been reported. If the patient experiences any of these symptoms, they should immediately stop using Nurofen for Children and contact a doctor or emergency services.
  • Medicines such as Nurofen for Children may slightly increase the risk of heart attack (myocardial infarction) or stroke. This risk is greater with higher doses and prolonged use. Do not exceed the recommended dose or duration of treatment: 24 hours for infants aged 3–5 months and 3 days for children over 6 months of age.
  • During prolonged use of Nurofen for Children, regular monitoring of liver and kidney function and blood morphology is required.
  • Adverse effects can be minimized by using the lowest effective dose for the shortest duration necessary to control symptoms.
  • Elderly patients have an increased risk of adverse effects.
  • Chronic use of (certain) painkillers may lead to serious kidney disorders. This risk may increase during physical exertion associated with salt loss and dehydration. Avoid such situations.
  • Prolonged use of painkillers for headache may worsen the condition. If this is suspected or confirmed, seek medical advice and discontinue treatment. Medication-overuse headache should be expected in patients who experience frequent or daily headaches despite (or due to) regular use of painkillers.
  • There is a risk of gastrointestinal bleeding, ulceration, or perforation, which may be fatal and may occur without warning symptoms; they may also occur in patients who have experienced warning symptoms. If gastrointestinal bleeding or ulceration occurs, discontinue the medicine immediately.

• Exercise caution in patients taking medicines that may increase the risk of 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).

• Concomitant use with NSAIDs, including selective cyclooxygenase-2 (COX-2) inhibitors such as celecoxib or etoricoxib, increases the risk of adverse effects (see section "Nurofen for Children and other medicines" below); therefore, such combination should be avoided.

• If the patient has chickenpox (varicella), avoid using Nurofen for Children.

• There is a risk of impaired kidney function in dehydrated children and adolescents.

• Medical supervision is particularly required after major surgical procedures.

Infections
Nurofen for Children may mask symptoms of infection, such as fever and pain. Therefore, Nurofen for Children 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 the patient takes this medicine during an infection and infection symptoms persist or worsen, seek immediate medical advice.

Skin reactions
Severe skin reactions, 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), have been reported with ibuprofen use. If the patient experiences any of the symptoms associated with these severe skin reactions described in section 4, discontinue Nurofen for Children immediately and seek medical help.

Nurofen for Children and other medicines
Inform your doctor or pharmacist about all medicines currently or recently taken, as well as any medicines planned for future use.

Which medicines should be avoided during treatment with Nurofen for Children?
Nurofen for Children may affect or be affected by other medicines, for example:

• anticoagulants (blood thinners/preventing clot formation, e.g., acetylsalicylic acid, warfarin, ticlopidine);
• antihypertensive medicines (ACE inhibitors, e.g., captopril, beta-blockers such as atenolol, angiotensin II antagonists such as losartan). Other medicines may affect treatment with Nurofen for Children or be affected by it.

Always consult your doctor before using Nurofen for Children together with other medicines.
In particular, inform your doctor if you are taking the following medicines:

| Medicine | Reason | |--------|--------| | Acetylsalicylic acid or other NSAIDs (anti-inflammatory and pain-relieving medicines) | Risk of gastrointestinal ulceration and bleeding may increase | | Digoxin (used in heart failure) | Digoxin effect may be enhanced | | Glucocorticosteroids (containing cortisone or cortisone-like substances) | Risk of gastrointestinal ulceration and bleeding may increase | | Antiplatelet agents | Risk of bleeding may increase | | Acetylsalicylic acid (low doses) | Blood-thinning effect may be reduced | | Anticoagulants (e.g., warfarin) | Ibuprofen may enhance the effect of these medicines | | Phenytoin (used in epilepsy treatment) | Phenytoin effect may be enhanced | | Selective serotonin reuptake inhibitors (used in depression treatment) | Risk of gastrointestinal bleeding may increase | | Lithium (used in bipolar disorder and depression treatment) | Lithium effect may be enhanced | | Probenecid and sulfinpyrazone (used in gout treatment) | Excretion of ibuprofen may be delayed | | Antihypertensive and diuretic medicines | Ibuprofen may weaken their effect and increase the risk of nephrotoxicity | | Potassium-sparing diuretics | Hyperkalemia may occur | | Methotrexate (used in cancer and rheumatism treatment) | Methotrexate effect may be enhanced | | Tacrolimus and cyclosporine (immunosuppressants) | Kidney damage may occur | | Zidovudine (used in HIV/AIDS treatment) | Use of Nurofen may increase the risk of intrastromal bleeding or bleeding leading to swelling in HIV(+) patients with hemophilia | | Sulfonylurea derivatives (antidiabetic medicines) | Possible interactions | | Quinolone antibiotics | Risk of seizures may increase | | Voriconazole and fluconazole (CYP2C9 inhibitors), used in fungal infections | Ibuprofen effect may be enhanced; consider reducing the ibuprofen dose, especially when using high doses of ibuprofen with voriconazole or fluconazole. |

Using Nurofen for Children with alcohol
Do not drink alcohol while using Nurofen for Children. Alcohol may worsen certain adverse effects, such as those affecting the gastrointestinal tract or the central nervous system.

Pregnancy, breastfeeding, and fertility
If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before taking this medicine.

Pregnancy
Inform your doctor if you become pregnant while using Nurofen for Children. Do not use this medicine during the last 3 months of pregnancy. Its use may cause kidney and heart problems in the unborn child. It may also affect bleeding tendency in both mother and child and may delay or prolong labor. Avoid using this medicine during the first 6 months of pregnancy unless otherwise advised by your doctor. Taking ibuprofen for more than a few days after the 20th week of pregnancy may cause kidney problems in the unborn child, lead to reduced amniotic fluid levels (oligohydramnios), or cause narrowing of a blood vessel (ductus arteriosus) in the child's heart. If prolonged treatment is necessary, your doctor may recommend additional monitoring tests.

Breastfeeding
The medicine passes into breast milk but may be used during breastfeeding if taken at the recommended dose and for the shortest possible duration.

Fertility
This medicine belongs to a group of medicines (NSAIDs) that may adversely affect fertility in women. This effect is reversible after discontinuation of the medicine.

Driving and operating machinery
During short-term use, this medicine has no effect or a negligible effect on the ability to drive or operate machinery.

3. How to use Nurofen for Children
Always use Nurofen for Children exactly as described in this leaflet or as directed by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
Use the lowest effective dose for the shortest duration necessary to relieve symptoms. If, during an infection, symptoms (such as fever and pain) persist or worsen, consult your doctor immediately (see section 2).
Nurofen for Children should only be used in children over 3 months of age weighing at least 6.0 kg. The maximum single dose is 10 mg per kg 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 kg of body weight, divided into 3 to 4 single doses. For Nurofen for Children, the following guidelines may be applied (the child's body weight is more important than age):

Suppositories are intended for rectal use. Before administration, the suppository may be warmed in the hands.
For short-term use only.
In infants aged 3–5 months, consult a doctor if symptoms worsen or do not improve within 24 hours.
In children older than 6 months, consult a doctor if the medicine needs to be administered for more than 3 days or if symptoms worsen.

Use of a higher than recommended dose of Nurofen for Children
If a patient has used a higher than recommended dose of Nurofen for Children or if a child has accidentally ingested the medicine, always contact a doctor or go to the nearest hospital to assess possible health risks and receive advice on necessary actions.

Symptoms of overdose may include nausea, stomach pain, vomiting (possibly with blood or dark particles resembling coffee grounds), gastrointestinal bleeding, headache, tinnitus (ringing in the ears), dizziness, nystagmus, or less frequently, diarrhea. After ingestion of a large dose, symptoms such as loss of balance, chest pain, palpitations, loss of consciousness, seizures (especially in children), weakness, dizziness, blood in urine, low blood potassium levels, feeling cold, visual disturbances, low blood pressure, restlessness, disorientation, coma, hyperkalemia (increased blood potassium levels), metabolic acidosis, prolonged prothrombin time/INR, acute kidney failure, liver damage, respiratory depression, cyanosis, worsening of asthma in asthmatic patients, drowsiness, and breathing difficulties may occur.

If you have any further doubts regarding the use of the medicine, consult a doctor or pharmacist.

4. Possible adverse effects
Like all medicines, Nurofen for Children can cause adverse effects, although not everyone experiences them.
Patients may experience known adverse effects typical of NSAIDs (see below). If in doubt, discontinue use and consult a doctor as soon as possible. Elderly patients using this medicine are at increased risk of adverse effects.

DISCONTINUE use and contact a doctor immediately if any of the following symptoms occur:

• Symptoms of gastrointestinal bleeding, such as severe abdominal pain, black tarry stools, vomiting 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, or low blood pressure leading to shock. Such a reaction may occur even after the first dose of the medicine;
• Red, flat, target-like or circular skin lesions on the trunk, often with blisters in the center, skin peeling, and ulcers in the mouth, throat, nose, genital organs, or eyes. These severe skin reactions may be preceded by fever and flu-like symptoms (toxic epidermal necrolysis, erythema multiforme, Stevens-Johnson syndrome). [Very rare – may occur in up to 1 in 10,000 people].
• Widespread rash, high fever, swollen lymph nodes, and increased eosinophils (a type of white blood cell) (DRESS syndrome) [Frequency unknown – cannot be estimated based on available data].
• Red, scaly, widespread rash with subcutaneous nodules and blisters, mainly affecting skin folds, trunk, and upper limbs, accompanied by fever. Symptoms usually appear at the beginning of treatment (acute generalized exanthematous pustulosis). [Frequency unknown – cannot be estimated based on available data].

Inform your doctor if any other adverse effects occur.

Common (may affect up to 1 in 10 people):

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

Uncommon (may affect 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 mucositis, localized rectal irritation.
• Central nervous system disorders such as headache, dizziness, insomnia, restlessness, irritability, or fatigue.
• Visual disturbances.
• Various skin rashes.
• Hypersensitivity reactions with urticaria and itching.

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

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

Very rare (may affect up to 1 in 10,000 people):

• Esophagitis, pancreatitis, formation of diaphragm-like intestinal strictures.
• Heart failure, myocardial infarction, facial or hand edema.
• Reduced urine output and swelling (especially in patients with high blood pressure or kidney dysfunction), edema and cloudy urine (nephrotic syndrome), inflammatory kidney disease (interstitial nephritis), which may lead to acute kidney failure. If any of these symptoms occur, or if the patient feels unwell, discontinue Nurofen for Children and consult a doctor immediately, as these may be early signs of kidney damage or failure.
• Psychotic reactions and depression.
• High blood pressure, vasculitis.
• Palpitations.
• Liver function disorders, liver damage (early signs may include skin discoloration), particularly during prolonged treatment, liver failure, acute hepatitis.
• Blood cell production disorders – early signs include: fever, sore throat, superficial mouth ulcers, flu-like symptoms, severe fatigue, nosebleeds and skin bleeding, unexplained bruising. In such cases, discontinue treatment immediately and consult a doctor. Do not self-medicate with painkillers or antipyretics.
• Severe skin infections and soft tissue complications during chickenpox infection.
• Worsening of inflammatory conditions related to infection (e.g., necrotizing fasciitis) has been reported with certain painkillers (NSAIDs). If signs of infection appear or worsen, the patient should seek medical advice immediately. The need for anti-infective treatment (antibiotic therapy) should be evaluated.
• 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) are at higher risk. Seek medical advice immediately if such symptoms occur.
• Hair loss (alopecia).

Frequency unknown: cannot be estimated from available data

• Chest pain, which may indicate 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 for Children 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 your doctor, pharmacist, or nurse. Adverse effects can also be reported directly to the Department of Monitoring Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: 22 49-21-301, Fax: 22 49-21-309, Website: https://smz.ezdrowie.gov.pl
Reporting adverse effects helps to provide more information on the safety of the medicine.

5. How to store Nurofen for Children
Keep the medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister pack. The expiry date refers to the last day of the stated month.
Store below 25°C.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This helps protect the environment.

6. Contents of the pack and other information

What Nurofen for Children contains
The active substance is ibuprofen. Each suppository contains 60 mg of ibuprofen. The other ingredients are:
Hard fat (Witepsol H15)
Hard fat (Witepsol W45).

What Nurofen for Children looks like and contents of the pack
The suppositories are almost white or white and cylindrical in shape.
Pack 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

For further information, 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

This medicinal product is authorized in the European Economic Area member states 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, suppositories
Slovakia: Nurofen pre deti čapíky 60mg