Nurofen dla dzieci

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

5 ml of Nurofen for children suspension contains 100 mg of ibuprofen, which belongs to a group of non-steroidal anti-inflammatory drugs (NSAIDs). The medicine relieves symptoms such as pain and fever.
The medicine is intended for use in infants and children in the following cases:

• fever of various origins (also in the course of viral infections, in the course of post-vaccination reaction),
• pains of various origins of mild to moderate severity: headaches, throat and muscle pains, e.g. in the course of viral infections; muscle, joint and bone pains, as a result of injuries to the musculoskeletal system (strains, sprains); pains due to soft tissue injuries, post-operative pains; toothaches, pains after dental procedures, pains due to teething; headaches; ear pains occurring in inflammatory conditions of the middle ear.

2. Important information before taking Nurofen for children

When not to take Nurofen for children

Nurofen for children should not be taken by patients:

• with hypersensitivity to ibuprofen or any of the other ingredients of this medicine (listed in section 6) and to other non-steroidal anti-inflammatory drugs (NSAIDs),
• who have ever had symptoms of allergy (e.g. hives, rhinitis, angioedema or bronchial asthma) after taking acetylsalicylic acid or other non-steroidal anti-inflammatory drugs,

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• with active or recurrent stomach and/or duodenal ulcer, perforation or bleeding, also those that occurred after taking NSAIDs,
• with severe liver, kidney or heart failure,
• in the third trimester of pregnancy,
• with hemorrhagic diathesis.

Warnings and precautions

Severe skin reactions have been reported with the use of Nurofen for children. If the following occur: any skin rash, changes in the mucous membranes, blisters or other symptoms of hypersensitivity, the use of Nurofen for children should be discontinued and medical help sought immediately, as these may be the first symptoms of a very severe skin reaction. See section 4.
Before starting to take Nurofen for children, the doctor or pharmacist should be consulted if the child has:

• infection - see below, section entitled "Infections".
• systemic lupus erythematosus and mixed connective tissue disease,
• symptoms of allergic reactions after taking acetylsalicylic acid,
• gastrointestinal diseases and chronic inflammatory bowel diseases (ulcerative colitis, Crohn's disease),
• hypertension and/or heart failure,
• renal impairment,
• liver dysfunction,
• blood coagulation disorders,
• active or a history of bronchial asthma or symptoms of allergic reactions in the past; after taking the medicine, bronchospasm may occur,
• taking other medicines (especially anticoagulants, diuretics, cardiac glycosides, corticosteroids),
• hereditary fructose intolerance (due to the possibility of maltitol, one of the excipients, being converted to fructose),

Dehydrated children are at risk of renal impairment.
In the case of chickenpox, it is recommended to avoid taking the medicine.
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 an increased risk of complications. This has been observed in the course of 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, medical help should be sought immediately.
There is a risk of gastrointestinal bleeding, ulceration or perforation, which can be fatal and does not necessarily have to be preceded by warning signs or may occur in patients who have had such warning signs. In case of gastrointestinal bleeding or ulceration, the medicine should be discontinued immediately. Patients with a history of gastrointestinal diseases, especially the elderly (Nurofen for children may also be used by adults), should inform their doctor about any unusual gastrointestinal symptoms (especially bleeding), especially during the initial treatment period.
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Concomitant, long-term use of different painkillers may lead to kidney damage with a risk of kidney failure (analgesic nephropathy).
Taking medicines such as ibuprofen 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. Higher doses and longer treatment periods than recommended should not be used. If symptoms persist, worsen or do not improve after 3 days, or if new symptoms occur, a doctor should be consulted.
In case of heart problems, a history of stroke, or suspected risk of these disorders (e.g. high blood pressure, diabetes, high cholesterol, smoking), the treatment method should be discussed with a doctor or pharmacist.
This medicine belongs to a group of medicines (non-steroidal anti-inflammatory drugs) that may adversely affect female fertility. This effect is temporary and disappears after the end of treatment.
A doctor should be consulted even if the above warnings refer to situations that occurred in the past.

Nurofen for children and other medicines

The doctor or pharmacist should be informed about all medicines currently or recently taken by the child, as well as about medicines that the child may take.
Nurofen for children should be avoided when taking other medicines from the group of non-steroidal anti-inflammatory drugs (including cyclooxygenase-2 inhibitors, such as celecoxib or etoricoxib), acetylsalicylic acid, other painkillers.
Nurofen for children should be used with caution with the following medicines:

• antihypertensive drugs, ACE inhibitors, such as captopril, beta-adrenergic blockers, such as atenolol, angiotensin II receptor antagonists, such as losartan, diuretics,
• anticoagulant medicines, such as aspirin/acetylsalicylic acid, warfarin, ticlopidine,
• zydovudine,
• lithium and methotrexate,
• corticosteroids,
• antiplatelet agents and selective serotonin reuptake inhibitors (SSRIs),
• cyclosporine,
• mifepristone,
• tacrolimus,
• quinolone antibiotics

Pregnancy and breastfeeding and fertility

If the patient is pregnant or breastfeeding, suspects that she may be pregnant or plans to have a child, she should consult a doctor or pharmacist before taking this medicine.
In the first 6 months of pregnancy, the use of the medicine is not recommended. During the last three months of pregnancy, the use of the medicine is contraindicated, as it may increase the risk of complications in the mother and child during the perinatal period.
Ibuprofen may pass into breast milk in small amounts. Nurofen for children can be used during breastfeeding if it is administered in the recommended doses and for the shortest possible time.
Nurofen for children belongs to a group of medicines (NSAIDs) that may affect female fertility. This effect is temporary and disappears after the end of treatment.

Driving and using machines

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During short-term use, the medicine does not affect or has a negligible effect on the ability to drive vehicles and operate machinery.

Nurofen for children contains liquid maltitol

If the patient has previously been diagnosed with intolerance to some sugars, the patient should consult a doctor before taking the medicine, due to the possibility of maltitol, one of the excipients, being converted to fructose.

3. How to take Nurofen for children

Nurofen for children should always be used exactly as described in the patient leaflet or as directed by a doctor or pharmacist. In case of doubt, a doctor or pharmacist should be consulted.
The smallest effective dose should be used for the shortest period necessary to relieve the symptoms. If the symptoms of the infection (such as fever and pain) persist or worsen, a doctor should be consulted immediately (see section 2).
The recommended daily dose is 20-30 mg/kg body weight, divided into equal doses administered at 6-8 hour intervals. A higher dose of the medicine than recommended should not be used.

Children under 6 months of age can be given the medicinal product only after consulting a doctor.
The medicine should not be used in children with a body weight of less than 5 kg.
In the case of children aged 3-5 months, a doctor's advice should be sought if the symptoms worsen or do not improve after 24 hours.
In the case of children over 6 months of age, a doctor's advice should be sought if the administration of the medicine is necessary for more than 3 days or if the symptoms worsen.

Special patient groups

Post-vaccination fever (children aged 3-6 months): The recommended daily dose of the medicine is 1 x 50 mg; if necessary, a second dose of 1 x 50 mg can be taken after 6 hours. The dose should not exceed 2 x 50 mg in 24 hours. If the fever does not decrease, a doctor should be consulted.

Method of administration

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For oral use.
A measuring spoon with a capacity of 2.5 ml/5 ml is attached to the packaging to facilitate dosing.
The bottle should be shaken before use.
or
A dosing device in the form of a syringe with a scale facilitating dosing is attached to the packaging.

Instructions for use

• 1. The bottle cap should be unscrewed (press down and turn in the opposite direction to the arrow).
• 2. The dosing device should be firmly pressed into the opening in the neck of the bottle.
• 3. The bottle should be shaken vigorously.
• 4. To fill the dosing device, the bottle should be turned upside down and then the plunger of the dosing device should be slowly moved down, drawing the suspension to the desired mark on the scale.
• 5. The bottle should be turned back to its original position and the dosing device should be carefully unscrewed and removed from the bottle.
• 6. The tip of the dosing device should be placed in the child's mouth and then, slowly pressing the plunger, the contents of the dosing device should be carefully emptied.
• 7. After use, the bottle should be closed by screwing the cap back on, and the dosing device should be washed and dried.

Using a higher than recommended dose of Nurofen for children

If the patient has used a higher dose of Nurofen for children than recommended or if the child has accidentally taken the medicine, a doctor or the nearest hospital should always be consulted to obtain an opinion on the possible health risk and advice on what actions to take in such a case.
Symptoms may include nausea, stomach pain, vomiting (which may contain blood), headaches, ringing in the ears, disorientation and nystagmus. After taking a large dose, drowsiness, chest pain, palpitations, loss of consciousness, seizures (mainly in children), weakness and dizziness, blood in the urine, feeling cold and breathing difficulties may occur.
The following may also occur: abdominal pain or, less frequently, diarrhea, gastrointestinal bleeding, excitement or coma, metabolic acidosis, increased prothrombin time (INR), acute kidney failure or liver damage, and in patients with asthma - worsening of asthma symptoms.
Treatment of overdose: there is no specific antidote. The treatment is symptomatic and supportive, based on the removal of the medicine from the body. The doctor will monitor the heart function and control the symptoms of vital functions, if they are stable. The doctor will consider administering activated charcoal orally within 1 hour of overdose. In case of frequent or prolonged seizures, the doctor will administer diazepam or lorazepam intravenously. In case of patients with asthma, the doctor will administer bronchodilators.

Missing a dose of Nurofen for children

A double dose should not be used to make up for a missed dose.
In case of any further doubts related to the use of this medicine, a doctor or pharmacist should be consulted.
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4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The following side effects have been observed during short-term use of the medicine in doses available without a prescription. When using the medicine for other indications and long-term, other side effects may occur.
Side effects are ranked according to frequency of occurrence using the following terms:
Very common: more than 1 in 10 treated patients.
Common: less than 1 in 10 but more than 1 in 100 patients.
Uncommon: less than 1 in 100 but more than 1 in 1000 patients.
Rare: less than 1 in 1000 but more than 1 in 10,000 patients.
Very rare: less than 1 in 10,000 patients and in individual cases.
Frequency not known: cannot be estimated from the available data.

Uncommon:

hypersensitivity with urticaria and itching
headaches
abdominal pain, nausea and indigestion
skin rash

Rare:

dizziness, insomnia, agitation, irritability or feeling tired. In individual cases, depression, psychotic reactions and tinnitus have been reported.
diarrhea, bloating, constipation, vomiting and gastritis
edema

Very rare:

hematological disorders
severe hypersensitivity reactions, including face, tongue and throat edema, dyspnea, tachycardia and hypotension (anaphylaxis, angioedema or shock)
aseptic meningitis
heart failure and edema
hypertension
respiratory tract reactivity, including asthma, bronchospasm or dyspnea
peptic ulcer, perforation or gastrointestinal bleeding, melena and hematemesis, oral ulceration, exacerbation of ulcerative colitis and Crohn's disease
liver disorders
bullous reactions, including Stevens-Johnson syndrome, erythema multiforme and toxic epidermal necrolysis
acute kidney failure
decreased hemoglobin level
serious skin and soft tissue infections in the course of chickenpox (varicella). Worsening of inflammatory conditions associated with infection (e.g. necrotizing fasciitis) has been reported, occurring during the use of some painkillers (NSAIDs).

Frequency not known

severe skin reactions known as DRESS syndrome may occur. The symptoms of DRESS syndrome include: skin rash, fever, lymph node swelling and increased eosinophil count (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 occurring at the beginning of treatment (acute generalized exanthematous pustulosis). If such symptoms occur, the use of Nurofen for children should be discontinued and medical help sought immediately. See also section 2.
The skin becomes sensitive to light
In some people, during the use of the medicine, other side effects may occur. In case of observation of the above symptoms, as well as other, unlisted in this leaflet, the medicine should be discontinued and a doctor consulted.

Reporting side effects

If any side effects occur, including any possible side effects not listed in the leaflet, the doctor or pharmacist or nurse should be informed. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
tel.: 22 49-21-301, fax: 22 49-21-309
Website: https://smz.ezdrowie.gov.
Side effects can be reported directly to the marketing authorization holder
By reporting side effects, more information can be collected on the safety of the use of the medicine.

5. How to store Nurofen for children

The medicine should be stored in a place invisible and inaccessible to children.
Store at a temperature below 25°C.
The opened packaging should be used within 6 months.
The medicine should not be used after the expiry date stated on the packaging.
Medicines should not be disposed of via wastewater or household waste. A pharmacist should be asked what to do with unused medicines. This will help protect the environment.

6. Contents of the packaging and other information

What Nurofen for children contains

5 ml of Nurofen for children contains:
Active substance: ibuprofen 100 mg
Excipients: polysorbate 80, glycerol, liquid maltitol, sodium saccharin, citric acid monohydrate, sodium citrate, xanthan gum, sodium chloride, orange flavor 2M16014 Quest (orange oil, lemon oil in powder, modified starch, gum arabic, maltodextrin, colloidal silica (Sylox 15)), bromhexine hydrochloride, purified water.

What Nurofen for children looks like and what the packaging contains

A bottle containing 100 ml or 150 ml of oral suspension 100 mg/5 ml.
A dosing device in the form of a syringe with a scale facilitating dosing is attached to the packaging.
CE 0543 - the mark applies only to the dosing device.
or
A bottle containing 100 ml or 150 ml of oral suspension 100 mg/5 ml.
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A measuring spoon with a capacity of 2.5 ml/5 ml is attached to the packaging to facilitate dosing.
or
16 sachets of 5 ml of oral suspension 100 mg/5 ml.
A measuring spoon with a capacity of 2.5 ml/5 ml is attached to the packaging to facilitate dosing.

Marketing authorization holder and importer

Marketing authorization holder

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

Importer

RB NL Brands B.V.
WTC Schiphol Airport,
Schiphol Boulevard 207,
1118 BH Schiphol,
Netherlands
To obtain more detailed information, the local representative of the marketing authorization holder should be contacted:
Reckitt Benckiser (Poland) S.A.
ul. Okunin 1
05-100 Nowy Dwór Mazowiecki
Helpline number: 801 88 88 07
Date of last update of the leaflet: 03/2021