Nurofen for children forte orange

Package leaflet: Information for the user

Warning! Keep this leaflet! The information on the immediate packaging is in a foreign language.
Nurofen dla dzieci Forte pomarańczowy (Nurofen Junior Fieber- und Schmerzsaft Orange)
40 mg/ml, oral suspension
Ibuprofenum
Nurofen dla dzieci Forte pomarańczowy and Nurofen Junior Fieber- und Schmerzsaft Orange are different
brand names for the same medicine.
For children weighing from 5 kg (from 3 months of age) to 40 kg (12 years of age)
Please read the entire leaflet carefully 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 a doctor or pharmacist.
• Keep this leaflet for future reference.
• If you need advice or further information, consult your pharmacist.
• If any adverse reactions occur, including any possible adverse reactions not listed in this leaflet, inform your doctor, pharmacist or nurse. See section 4.
• If there is no improvement after 24 hours (infants aged 3–5 months, body weight over 5 kg) or 3 days (children aged over 6 months), contact your doctor.

Table of contents:

1. What Nurofen dla dzieci Forte pomarańczowy is and what it is used for
2. What you need to know before using Nurofen dla dzieci Forte pomarańczowy
3. How to use Nurofen dla dzieci Forte pomarańczowy
4. Possible side effects
5. How to store Nurofen dla dzieci Forte pomarańczowy
6. Contents of the pack and other information

1. What Nurofen dla dzieci Forte pomarańczowy 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 and elevated body temperature.
Nurofen dla dzieci Forte pomarańczowy is intended for short-term, symptomatic treatment of:

• fever,
• mild to moderate pain.

If there is no improvement after 24 hours (infants aged 3–5 months, body weight over 5 kg) or 3 days (children aged over 6 months), contact your doctor.

2. Important information before using Nurofen dla dzieci Forte pomarańczowy

When not to use Nurofen dla dzieci Forte pomarańczowy

• If the child is allergic to ibuprofen or other similar pain-relieving medicines (NSAIDs) or to any of the other ingredients of this medicine (listed in section 6).
• If asthma, wheezing, rhinitis, swelling of the face and/or hands, or hives occurred after taking acetylsalicylic acid or other similar pain-relieving medicines (NSAIDs).
• If gastrointestinal bleeding or perforation has ever occurred related to previous use of NSAIDs.
• If there is current or past history of stomach or duodenal ulcer (peptic ulcer disease) or bleeding (two or more confirmed episodes of ulceration or bleeding).
• If severe liver or kidney failure is present.
• If severe heart failure is present.
• If there is bleeding in the brain (cerebral haemorrhage) or any other active bleeding.
• If blood clotting disorders are present, as ibuprofen may prolong bleeding time.
• If there are blood formation disorders of unknown origin.
• In children with severe dehydration (caused by vomiting, diarrhoea, or insufficient fluid intake).

Do not take this medicine during the last 3 months of pregnancy.
Warnings and precautions
Before starting treatment with Nurofen dla dzieci Forte pomarańczowy, discuss this with your
doctor or pharmacist:

• If the child has an infection – see below, section "Infections"
• If the child has certain inherited blood formation 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 or has ever had intestinal diseases (ulcerative colitis or Crohn's disease), as 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 case of long-term treatment with Nurofen dla dzieci Forte pomarańczowy, regular monitoring of liver and kidney function tests and blood counts is required.
• Caution is advised when using other medicines that may increase the risk of gastrointestinal ulceration or bleeding, such as oral corticosteroids (e.g. prednisolone), anticoagulants (e.g. warfarin), selective serotonin reuptake inhibitors (antidepressants), and antiplatelet drugs (e.g. acetylsalicylic acid).
• If the child is simultaneously taking other NSAIDs (including COX-2 inhibitors such as celecoxib or etoricoxib), as concomitant use of these medicines should be avoided.
• The occurrence of adverse effects may be reduced by using the lowest effective dose for the shortest possible duration.
• In general, prolonged use of (multiple types of) pain-relieving medicines may lead to persistent serious kidney disorders. This risk may increase during physical exertion associated with loss of salts and dehydration. Therefore, this should be avoided.
• Prolonged use of any type of pain-relieving medicine may result in headaches, which should not be treated with increased doses of this medicine. In such cases, the medicine should be discontinued and medical advice sought. Medication-overuse headache should be suspected in patients who have frequent or daily headaches despite (or because of) regular use of headache-relieving medicines.
• If the child has had or currently has asthma or allergic conditions that may cause breathing difficulties.
• If the child has hay fever, nasal polyps, or chronic obstructive respiratory diseases, there is an increased risk of allergic reactions. Allergic reactions may present as asthma attacks (so-called drug-induced asthma), Quincke's oedema, or urticaria.
• The use of Nurofen dla dzieci Forte pomarańczowy should be avoided in case of chickenpox (varicella).
• If the child has recently undergone major surgery (medical supervision is required).
• If the child is dehydrated, due to increased risk of kidney failure in dehydrated children.

Infections
Nurofen dla dzieci Forte pomarańczowy may mask symptoms of infection such as fever and pain.
Therefore, Nurofen dla dzieci Forte pomarańczowy may delay appropriate treatment of infection,
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 ongoing infection and infection
symptoms persist or worsen, immediate medical advice should be sought.
Skin reactions
Severe skin reactions, including exfoliative dermatitis, erythema multiforme, Stevens-Johnson
syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms
(DRESS), and acute generalised exanthematous pustulosis (AGEP), have been reported with the use
of ibuprofen. If the patient develops any of the symptoms associated with these severe skin
reactions described in section 4, Nurofen dla dzieci Forte pomarańczowy should be stopped
immediately and medical help sought.
Gastrointestinal bleeding, ulceration, or perforation, which may be fatal, have been reported
during treatment with all NSAIDs, with or without warning symptoms, or in patients with previous
serious gastrointestinal disorders. If gastrointestinal bleeding or ulceration occurs, treatment must
be stopped immediately. The risk of gastrointestinal bleeding, ulceration, or perforation increases
with higher doses of NSAIDs, in patients with a history of ulcers, especially with bleeding or
perforation (see section 2 "When not to use Nurofen dla dzieci Forte pomarańczowy"), and in elderly
patients. These patients should start treatment with the lowest effective dose. In these patients,
and in patients requiring concomitant use of low-dose acetylsalicylic acid or other drugs increasing
the risk of gastrointestinal reactions, concomitant gastroprotective treatment (e.g. misoprostol or
proton pump inhibitors) should be considered.
Taking anti-inflammatory and pain-relieving medicines such as ibuprofen may be associated with
a small increased risk of heart attack or stroke, particularly when used at high doses. Do not exceed
the recommended dose or duration of treatment.
Before using Nurofen dla dzieci Forte pomarańczowy, the patient should discuss treatment with
their doctor or pharmacist if:

• the patient has heart diseases such as heart failure, angina pectoris (chest pain), history of heart attack, coronary artery bypass surgery, peripheral arterial disease (poor blood circulation in legs due to narrowed or blocked arteries), or history of stroke (including mini-stroke or transient ischaemic attack - TIA).
• the patient has hypertension, diabetes, high cholesterol levels, family history of heart disease or stroke, or if the patient smokes.

Allergic reactions to ibuprofen, including breathing difficulties, facial and neck swelling (angioedema), and chest pain, have been reported during ibuprofen use. If the patient experiences any of these symptoms, they should immediately stop taking Nurofen dla dzieci Forte pomarańczowy and contact a doctor or emergency services.
If any of the above conditions apply to the child, consult a doctor before using Nurofen dla dzieci Forte pomarańczowy.
Elderly patients
Elderly patients have an increased risk of adverse effects during NSAID use, particularly affecting the stomach and intestines.
Patients with a history of gastrointestinal disorders, especially elderly patients, should report any unusual abdominal symptoms (particularly gastrointestinal bleeding), especially at the beginning of treatment.
Nurofen dla dzieci Forte pomarańczowy and other medicines
Tell your doctor or pharmacist about all medicines currently or recently taken by the child, as well as any medicines the child may take in the future.
Nurofen dla dzieci Forte pomarańczowy may affect the action of other medicines or other medicines may affect the action of Nurofen dla dzieci Forte pomarańczowy. For example:

• anticoagulant medicines (i.e. blood thinners/preventing blood clots, such as acetylsalicylic acid, warfarin, ticlopidine)
• medicines that lower blood pressure (ACE inhibitors such as captopril, beta-blockers such as those containing atenolol, angiotensin II receptor antagonists such as losartan)

Also, some other medicines may be affected by or may affect treatment with Nurofen dla dzieci Forte pomarańczowy. Therefore, always consult a doctor or pharmacist before using Nurofen dla dzieci Forte pomarańczowy with other medicines.
In particular, inform your doctor if the patient is taking the following medicines:

Nurofen dla dzieci Forte pomarańczowy and alcohol
Alcohol should not be consumed while taking Nurofen dla dzieci Forte pomarańczowy.
The risk of certain adverse effects, particularly those related to the gastrointestinal tract or central
nervous system, may be increased when alcohol is consumed simultaneously with Nurofen dla dzieci Forte pomarańczowy.

Pregnancy, breastfeeding and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult a doctor or pharmacist before using this medicine.

Pregnancy
Do not use this medicine during the last three months of pregnancy. Use may cause kidney and heart problems in the unborn child. It may also affect bleeding tendency in both the mother and the child, and may delay or prolong labour. Avoid using this medicine during the first six months of pregnancy unless otherwise advised by a doctor. Use of ibuprofen for longer than a few days after the start of week 20 of pregnancy may cause impaired kidney function in the unborn child, leading to reduced levels of amniotic fluid surrounding the baby (oligohydramnios) or narrowing of a blood vessel (ductus arteriosus) in the baby's heart.
If prolonged treatment beyond a few days is required, the doctor may recommend additional monitoring tests.

Breastfeeding
Only small amounts of ibuprofen and its metabolites pass into breast milk. Nurofen dla dzieci Forte pomarańczowy may be used during breastfeeding, provided it is administered at the recommended doses and for the shortest possible duration.

Fertility
Nurofen dla dzieci Forte pomarańczowy belongs to a group of medicines (NSAIDs) that may affect female fertility. This effect is reversible upon discontinuation of the medicine.

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

Important information about certain excipients in Nurofen dla dzieci Forte pomarańczowy

• Nurofen dla dzieci Forte pomarańczowy contains liquid maltitol. If a patient has previously been diagnosed with intolerance to certain sugars, the patient should consult a doctor before taking this medicine.
• The medicine may have a mild laxative effect.
• The caloric value of maltitol is: 2.3 kcal/g.
• Nurofen dla dzieci Forte pomarańczowy contains less than 1 mmol of sodium (23 mg) per dose, meaning the medicine is considered "sodium-free".
• This medicine contains very small amounts of gluten (derived from wheat starch) and is classified as "gluten-free". Therefore, it is highly unlikely to cause any problems in patients with coeliac disease.
• One 5 ml dose contains no more than 0.315 micrograms of gluten.
• This medicine should not be used by patients with wheat allergy (other than coeliac disease).

3. How to use Nurofen dla dzieci Forte pomaranczowy

Nurofen dla dzieci Forte pomaranczowy should always be used exactly as described
in the patient leaflet or as advised by a doctor or pharmacist. If in doubt,
consult a 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 a doctor immediately (see section 2).
The recommended dose for pain and fever is:

* Doses should be administered approximately every 6 to 8 hours.
Not recommended for use in children under 3 months of age or weighing less than 5 kg.
In patients with sensitive stomach, it is recommended that Nurofen dla dzieci Forte pomaranczowy be
taken during a meal.
WARNING: Do not exceed the recommended dose.
For oral use
Administration method using the oral syringe

1. Shake the bottle well.
2. Remove the cap by pressing down and turning it to the left.
3. Firmly insert the oral syringe into the neck of the bottle.
4. To fill the syringe, invert the bottle. While holding the syringe in place, gently pull the plunger down to draw the suspension up to the appropriate mark on the syringe.
5. Turn the bottle upright again and remove the syringe by gently twisting it off.
6. Place the tip of the syringe into the child's mouth. Slowly and gently press the plunger to administer the suspension. After use, replace the cap. Rinse the syringe with warm water and allow it to air dry. Store in a place inaccessible and out of sight of children.

Duration of treatment
This medicine is intended for short-term use only. If symptoms in children over 6 months of age persist for more than 3 days or if the patient feels worse, consult a doctor.
For infants aged 3–5 months (weighing 5 kg or more), consult a doctor if symptoms do not improve within 24 hours.
If symptoms worsen, consult a doctor.
Accidental overdose of Nurofen dla dzieci Forte pomaranczowy:
If the patient has taken more than the recommended dose of Nurofen dla dzieci Forte pomaranczowy or if a child has accidentally ingested the medicine, always contact a doctor or go to the nearest hospital for assessment of potential health risks and advice on necessary actions.
Symptoms of overdose may include nausea, stomach pain, vomiting (possibly with blood), gastrointestinal bleeding, headache, tinnitus, disorientation, and nystagmus, or less commonly diarrhea. After ingestion of a large dose, disturbances in balance, visual disturbances, low blood pressure, agitation, disorientation, coma, hyperkalemia, metabolic acidosis, prolonged prothrombin time/INR, acute kidney failure, liver damage, respiratory depression, cyanosis, and exacerbation of asthma in asthmatic patients, drowsiness, chest pain, palpitations, loss of consciousness, convulsions (mainly in children), weakness, dizziness, blood in urine, low blood potassium levels, feeling cold, and breathing difficulties may occur.
Missed dose of Nurofen dla dzieci Forte pomaranczowy:
Do not take a double dose to make up for a missed dose. If the patient forgets to take or administer a dose, take or administer it as soon as remembered, then continue with the next dose according to the dosing interval described above.
If you have any further questions concerning the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, Nurofen dla dzieci Forte pomaranczowy may cause adverse effects, although they do not occur in everyone. The risk of adverse effects can be reduced by using the lowest effective dose for the shortest duration necessary to relieve symptoms. One of the known adverse effects of NSAIDs may occur in a child. If any adverse effects occur or if there is any doubt, administration of the medicine should be discontinued and medical advice should be sought as soon as possible. Elderly individuals taking this medicine belong to a group at increased risk of adverse effects.

DISCONTINUE TREATMENT and seek immediate medical help if the child has:

• symptoms of gastrointestinal bleeding, such as severe abdominal pain, black tarry stools, blood in vomit or vomit containing dark particles resembling coffee grounds.
• symptoms of rare but serious allergic reactions, such as worsening asthma, unexplained wheezing or shortness of breath, swelling of the face, tongue or throat, difficulty breathing, palpitations, drop in blood pressure leading to shock. Symptoms may occur even after the first dose. If any of these symptoms occur, contact a doctor immediately.
• red, flat, target-like or circular skin lesions on the trunk, often with blisters in the center, skin peeling, mouth, throat, nose, genital or eye ulcers. 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 in 1 in 10,000 people].
• widespread rash, high fever, swollen lymph nodes and increased eosinophils (a type of white blood cells) (DRESS syndrome) [Frequency unknown – cannot be estimated from available data].
• red, scaly, widespread rash with nodules under the skin and blisters, mainly located in skin folds, on the trunk and upper limbs, accompanied by fever. Symptoms usually appear at the beginning of treatment (acute generalized exanthematous pustulosis) [Frequency unknown – cannot be estimated from available data]. If any adverse effect worsens or if any adverse effects not listed in this leaflet occur, inform a doctor.

Common (may occur in 1 in 10 people)

• Gastrointestinal disorders such as heartburn, abdominal pain, nausea, indigestion, diarrhoea, vomiting, bloating (gas), constipation, minor blood loss from the stomach and/or intestines, which in rare cases may lead to anaemia.

Uncommon (may occur in 1 in 100 people)

• Ulcers in the gastrointestinal tract which may bleed or perforate, inflammation of the oral mucosa with ulceration, exacerbation of existing bowel disease (colitis or Crohn's disease), inflammation of the stomach lining (gastritis)
• 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 occur in 1 in 1,000 people)

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

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

• Oesophagitis, pancreatitis, formation of diaphragm-like intestinal strictures
• Heart failure, myocardial infarction and facial or hand swelling
• Passing less urine than usual and oedema (especially in patients with high blood pressure or impaired kidney function), oedema and cloudy urine (nephrotic syndrome), inflammatory kidney disease (interstitial nephritis), which may lead to acute kidney failure. If any of the above symptoms occur or if the patient feels unwell, treatment with Nurofen dla dzieci Forte pomaranczowy should be discontinued immediately and medical advice sought, as these may be the first signs of kidney damage or kidney failure
• Psychotic reactions and depression
• High blood pressure, vasculitis
• Palpitations
• Liver function disorders, liver damage (first signs may include skin discolouration), particularly during long-term treatment, liver failure, acute hepatitis
• Blood cell production disorders – first signs include: fever, sore throat, superficial ulcers of the oral mucosa, flu-like symptoms, severe fatigue, nosebleeds and skin bleeding, unexplained bruising. In such cases, treatment should be stopped immediately and medical advice sought. Self-treatment with painkillers or antipyretics should not be continued
• 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 the use of certain painkillers (NSAIDs). If signs of infection occur or worsen, the patient should seek medical advice immediately. The need for anti-infective treatment (antibiotic therapy) should be assessed
• Aseptic meningitis with neck stiffness, headache, nausea, vomiting, fever and altered consciousness has been observed during ibuprofen use. Patients with autoimmune disorders (lupus, mixed connective tissue disease) are at higher risk of such symptoms. If such symptoms occur, contact a doctor immediately
• Hair loss (alopecia).

Frequency unknown (cannot be estimated from available data)

• Chest pain, which may be a sign of 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 this one may be associated with a small increased 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 a 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, tel.: +48 22 49 21 301, fax: +48 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 dla dzieci Forte pomaranczowy

Keep the medicine out of sight and reach of children.
Do not use Nurofen dla dzieci Forte pomaranczowy after the expiry date stated on the packaging.
The expiry date refers to the last day of the stated month.
Do not store above 25°C.
After opening the bottle, the medicine should be used within 6 months.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist
how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Nurofen dla dzieci Forte pomarańczowy contains
The active substance 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, orange flavour
2M16014 (modified starch, gum arabic, maltodextrin, natural and nature-identical flavouring substances) and purified water.
What Nurofen dla dzieci Forte pomarańczowy looks like and contents of the pack
Nurofen dla dzieci Forte pomarańczowy is a whiteish syrup-like suspension with a characteristic orange odour.
Each bottle contains 100 ml, 150 ml or 200 ml.
The pack contains an oral syringe (5 ml syringe with scale: 1.25 ml, 2.5 ml, 3.75 ml and 5 ml).
Outer packaging: cardboard box.
For more detailed information, please contact the Marketing Authorisation Holder or Parallel Importer.
Marketing Authorisation Holder in Germany, the country of export:
Reckitt Benckiser Deutschland GmbH
Darwinstrasse 2-4, 69115 Heidelberg, Germany
Manufacturer:
RB NL Brands B.V.
Schiphol Boulevard 207, 1118 BH Schiphol, The Netherlands
Parallel Importer:
InPharm Sp. z o.o.
ul. Strumykowa 28/11, 03-138 Warsaw, Poland
Repackaged in:
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249, 04-458 Warsaw, Poland
Marketing Authorisation Number in Germany, the country of export: 76553.00.00
Parallel Import Licence Number: 102/26
This medicinal product is authorised in the European Economic Area member states under the following names: