Nurofen for children forte orange

Package leaflet: Information for the user

Warning! Keep this leaflet. Information on the immediate packaging 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 of the same medicine.
For children weighing from 5 kg (from 3 months of age) to 40 kg (12 years of age)
Please read this 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 so that you can read it again if necessary.
• If you need advice or further information, consult a 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 within 24 hours (infants aged 3–5 months with body weight greater than 5 kg) or 3 days (children aged over 6 months), or if the patient feels worse, contact your doctor.

Contents of the leaflet:

1. What Nurofen dla dzieci Forte pomarańczowy is and what it is used for
2. Important information before taking Nurofen dla dzieci Forte pomarańczowy
3. How to take 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 fever. Nurofen dla dzieci Forte pomarańczowy is intended for short-term, symptomatic treatment of:

• fever,
• mild to moderate pain.

If there is no improvement within 24 hours (infants aged 3–5 months with body weight greater than 5 kg) or 3 days (children aged over 6 months), or if the patient feels worse, contact your doctor.

2. Important information before using Nurofen for Children Forte Orange

When not to use Nurofen for Children Forte Orange

• 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 breathlessness, asthma, rhinitis, facial and (or) hand swelling, or urticaria have ever occurred after taking acetylsalicylic acid or other similar pain-relieving medicines (NSAIDs). Page 1 of 11
• If gastrointestinal bleeding or perforation has ever occurred related to previous use of NSAIDs.
• If there is or has been gastric and (or) duodenal ulceration (peptic ulcer disease) or bleeding (two or more confirmed cases of ulceration or bleeding).
• If there is severe liver or kidney failure.
• If there is severe heart failure.
• If there is bleeding in the brain (cerebral haemorrhage) or any other active bleeding.
• If there are blood clotting disorders, 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 for Children Forte Orange, discuss this with a
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 bowel diseases (ulcerative colitis or Crohn's disease), as symptoms may worsen.
• If the child has or has ever had high blood pressure and (or) heart failure.
• If the child has kidney function disorders.
• If the child has liver diseases. With prolonged use of Nurofen for Children Forte Orange, regular monitoring of liver function tests, kidney parameters, and blood morphology 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.
• Generally, prolonged use (of several types) of pain-relieving medicines may lead to persistent serious kidney diseases. This risk may increase during physical exertion associated with salt loss and dehydration. Therefore, this should be avoided.
• Headaches may occur as a result of prolonged use of any type of pain-relieving medicine, 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 has asthma or allergic diseases that may cause breathlessness.
• If the child has hay fever, nasal polyps, or chronic obstructive respiratory diseases, there is an increased risk of allergic reactions. Allergic reactions may manifest as asthma attacks (so-called drug-induced asthma), Quincke's oedema, or urticaria. Page 2 of 11
• Avoid using Nurofen for Children Forte Orange if chickenpox occurs.
• 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 for Children Forte Orange may mask symptoms of infection, such as fever and pain.
Therefore, Nurofen for Children Forte Orange may delay appropriate treatment of infection, thereby
increasing the risk of complications. This has been observed in bacterial pneumonia and bacterial
skin infections associated with chickenpox. If a patient takes this medicine during an ongoing
infection and symptoms persist or worsen, immediate medical advice should be sought.
Skin reactions
Severe skin reactions associated with the use of Nurofen for Children Forte Orange have been
reported. If any skin rash, mucosal changes, blisters, or other signs of allergy appear, stop taking
Nurofen for Children Forte Orange immediately and seek medical help without delay, as these may
be early signs of a very serious skin reaction. See section 4.
Bleeding, ulceration, or perforation of the gastrointestinal tract, which may be fatal, have been
reported during treatment with all NSAIDs, with or without warning signs, or in patients with
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 for Children Forte Orange") and in elderly
patients. These patients should start treatment with the lowest effective dose. In these patients and
in patients requiring concomitant administration of low-dose acetylsalicylic acid or medicines
increasing the risk of gastrointestinal reactions, consider concomitant treatment with protective
agents (e.g. misoprostol or proton pump inhibitors).
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 for Children Forte Orange, the patient should discuss treatment with a
doctor or pharmacist if:

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

If any of the above conditions apply to the child, contact a doctor before using Nurofen for Children Forte Orange.
Elderly patients
Elderly patients have an increased risk of adverse effects during NSAID use, particularly those affecting the stomach and intestines.
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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 for Children Forte Orange and other medicines
Inform the doctor or pharmacist about all medicines currently or recently taken by the child, as well as any medicines the child may take.
Nurofen for Children Forte Orange may affect the action of other medicines or other medicines may affect the action of Nurofen for Children Forte Orange. For example:

• anticoagulant medicines (i.e. blood thinners/preventing blood clots, such as acetylsalicylic acid, warfarin, ticlopidine)
• blood pressure-lowering medicines (ACE inhibitors, such as captopril, beta-blockers, such as medicines containing atenolol, angiotensin II receptor antagonists, such as losartan). Also, some other medicines may be affected by or affect treatment with Nurofen for Children Forte Orange. Therefore, always consult a doctor or pharmacist before using Nurofen for Children Forte Orange with other medicines.

In particular, inform the doctor if the patient is taking the following medicines:
Other NSAIDs, including COX-2 inhibitors, as the risk of adverse effects may increase
Digoxin (a medicine used in heart failure) as the effect of digoxin may be enhanced
Glucocorticoids (medicines containing cortisone or similar substances) as the risk of gastrointestinal ulceration and bleeding may increase
Antiplatelet medicines as the risk of bleeding may increase
Acetylsalicylic acid (low doses) as the blood-thinning effect may be weakened
Anticoagulant medicines (e.g. warfarin) as ibuprofen may enhance the effect of these medicines
Phenytoin (a medicine used in epilepsy treatment) as the effect of phenytoin may be enhanced
Selective serotonin reuptake inhibitors (medicines used in depression treatment) as they may increase the risk of gastrointestinal bleeding
Lithium (a medicine used in the treatment of manic-depressive disorders and depression) as the effect of lithium may be enhanced
Probenecid and sulfinpyrazone (medicines used in gout treatment) as the excretion of ibuprofen may be delayed
Antihypertensive medicines and diuretics as ibuprofen may weaken the effect of these medicines and the risk of worsening kidney function may increase
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Potassium-sparing diuretics, e.g. amiloride, potassium canrenoate, spironolactone, triamterene as hyperkalaemia may occur
Methotrexate (a medicine used in cancer and rheumatoid arthritis treatment) as the effect of methotrexate may be enhanced
Tacrolimus and cyclosporine (immunosuppressive medicines) as kidney damage may occur
Zidovudine (in HIV/AIDS treatment) as using Nurofen for Children Forte Orange may increase the risk of intrastromal bleeding or bleeding leading to swelling in HIV(+) patients with haemophilia
Sulfonylurea derivatives (antidiabetic medicines) as they may affect blood sugar levels
Quinolone antibiotics as the risk of seizures may increase
Voriconazole and fluconazole (CYP2C9 inhibitors), used in fungal infections, as the effect of ibuprofen may be enhanced; consider reducing the dose of ibuprofen, especially when using high doses of ibuprofen with voriconazole or fluconazole
Baclofen after ibuprofen use, baclofen toxicity may develop
Ritonavir ritonavir may increase NSAID plasma concentrations
Aminoglycosides NSAIDs may increase aminoglycoside excretion
Nurofen for Children Forte Orange and alcohol
Do not consume alcohol while using Nurofen for Children Forte Orange.
Some adverse effects, such as those related to the gastrointestinal tract or central nervous system, may be more likely when alcohol and Nurofen for Children Forte Orange are taken together.
Pregnancy, breastfeeding and effects on fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult a doctor or pharmacist before using this medicine.
Pregnancy
Do not use this medicine during the last 3 months of pregnancy. Use may cause kidney and heart disorders in the unborn child. It may also affect the bleeding tendency of the patient and her child and may delay or prolong labour. Avoid using this medicine during the first 6 months of pregnancy unless otherwise advised by a doctor. Taking ibuprofen for longer than a few days after the 20th week of pregnancy may cause kidney dysfunction in the unborn child and lead to reduced amniotic fluid levels surrounding the child (oligohydramnios) or narrowing of a blood vessel (ductus arteriosus) in the child's heart. If longer-term treatment is necessary, the doctor may recommend additional monitoring tests.
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Breastfeeding
Only small amounts of ibuprofen and its metabolites pass into breast milk. Nurofen for Children Forte Orange may be used during breastfeeding if administered at the recommended doses and for the shortest possible duration.
Fertility
Nurofen for Children Forte Orange belongs to a group of medicines (NSAIDs) that may affect fertility in women. This effect is reversible after discontinuation of the medicine.
Driving and operating machinery
For short-term use, the medicine does not affect or has a negligible effect on the ability to drive and operate machinery.
Important information about some ingredients of Nurofen for Children Forte Orange

• Nurofen for Children Forte Orange contains liquid maltitol. If the patient has previously been diagnosed with intolerance to certain sugars, the patient should contact a doctor before taking the medicine.
• The medicine may have a mild laxative effect.
• The caloric value for maltitol is: 2.3 kcal/g.
• Nurofen for Children Forte Orange contains less than 1 mmol 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 very unlikely to cause any problems in patients with coeliac disease.
• One 5 ml dose contains no more than 0.315 micrograms of gluten.
• Patients with wheat allergy (other than coeliac disease) should not use this medicine.

3. How to use Nurofen dla dzieci Forte orange

Nurofen dla dzieci Forte orange should always be used exactly as described
in the patient information leaflet or as advised by a doctor or pharmacist. If in doubt,
consult a doctor or pharmacist.
The lowest effective dose should be used for the shortest possible duration necessary to relieve symptoms.
If, during an infection, its symptoms (such as fever and pain) persist or worsen, medical advice should be sought immediately (see section 2).
The recommended dose for pain and fever is:

*Doses should be administered approximately every 6 to 8 hours.
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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 pomarańczowy 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 vigorously.
2. Remove the cap by pressing down and turning it to the left.
3. Firmly insert the syringe into the opening in the neck of the bottle.
4. To fill the syringe, turn the bottle upside down. 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 back upright and remove the syringe by gently twisting it.
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 leave it to 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 a child over 6 months of age persist for more than 3 days or if the patient feels worse, consult a doctor.
In 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 pomarańczowy:
If a patient has taken more than the recommended dose of Nurofen dla dzieci Forte pomarańczowy or if a child has accidentally ingested the medicine, always contact a doctor or go to the nearest hospital for advice on possible health risks and what actions should be taken.
Symptoms may include nausea, stomach pain, vomiting (possibly with blood), gastrointestinal bleeding, headache, tinnitus, dizziness and nystagmus, or less commonly, diarrhea. After ingestion of a large dose, symptoms may include balance disturbances, visual disturbances, low blood pressure, agitation, disorientation, coma, hyperkalemia, metabolic acidosis, prolonged prothrombin time/INR, acute kidney failure, liver damage, respiratory depression, cyanosis, and worsening of asthma in asthmatic patients, drowsiness, chest pain, palpitations, loss of consciousness, convulsions (mainly in children), weakness and dizziness, blood in urine, feeling cold, and breathing difficulties.
Missed dose of Nurofen dla dzieci Forte pomarańczowy:
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 at the recommended interval as stated above.
If you have any further questions regarding the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

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Like all medicines, Nurofen dla dzieci Forte pomarańczowy can cause side effects, although not everyone gets them. The risk of side effects can be reduced by using the lowest effective dose for the shortest duration necessary to relieve symptoms. Your child may experience one of the known side effects associated with NSAIDs. If any side effects occur or if you have any doubts, stop giving the medicine and consult a doctor as soon as possible. Elderly patients using this medicine belong to a group at increased risk of adverse effects.
STOP USING the medicine and seek immediate medical help if your child experiences:

• symptoms of gastrointestinal bleeding, such as: severe abdominal pain, black tarry stools, vomiting blood or vomiting material resembling dark granules like 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.
• severe skin reactions such as rash affecting the whole body, skin peeling, formation of blisters and shedding of skin sheets.

If any of the side effects worsen or if any unlisted side effects occur, inform your doctor.
Common (may occur in 1 out of 10 people)

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

Uncommon (may occur in 1 out of 100 people)

• Gastrointestinal ulcers 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 gastric mucosa
• 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 out of 1,000 people)
• Tinnitus (ringing in the ears)
• Increased blood urea levels, flank pain and/or abdominal pain, blood in urine and fever which may indicate kidney damage (papillary necrosis)
• Increased blood uric acid levels
• Decreased haemoglobin concentration. Very rare (may occur in 1 out of 10,000 people)
• Oesophagitis, pancreatitis, formation of web-like intestinal strictures
• Heart failure, myocardial infarction and facial or hand swelling
• Reduced urine output compared to 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, stop using Nurofen dla dzieci Forte pomarańczowy immediately and consult a doctor without delay, as these may be the first signs of kidney damage or kidney failure
• Psychotic reactions and depression
• High blood pressure, vasculitis Page 8 of 11
• 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 ulceration of the oral mucosa, flu-like symptoms, severe fatigue, nosebleeds and skin bleeding, unexplained bruising. In such cases, treatment must be stopped immediately and medical advice sought. Self-treatment with painkillers or antipyretics must 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 appear or worsen, the patient should seek medical advice immediately. The need for anti-infective treatment (antibiotic therapy) should be evaluated
• Aseptic meningitis with symptoms such as 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. In case of such symptoms, contact a doctor immediately
• Severe skin reactions, such as rash with redness and blister formation (e.g. Stevens-Johnson syndrome, erythema multiforme and toxic epidermal necrolysis/Lyell's syndrome), hair loss (alopecia). Frequency not known (cannot be estimated from available data)
• Respiratory tract reactivity, including asthma, bronchospasm, dyspnoea
• Severe skin reactions known as DRESS syndrome may occur. Symptoms of DRESS syndrome include: skin rash, fever, lymph node swelling and increased eosinophil count (a type of white blood cell)
• Red scaly rash with subcutaneous nodules and blisters, mainly located in skin folds, trunk and upper limbs, accompanied by fever at the beginning of treatment (acute generalised exanthematous pustulosis). If such symptoms occur, discontinue use of Nurofen dla dzieci Forte pomarańczowy immediately and seek medical help without delay. See also section 2
• 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 side effects
If any side effects occur, including those not listed in this leaflet, inform your doctor, pharmacist or nurse. Side effects can also be reported directly to the Department of Monitoring Adverse Drug Reactions at 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.pl
Reporting side effects helps provide more information on the safety of the medicine.

5. How to store Nurofen dla dzieci Forte pomarańczowy

Keep the medicine out of sight and reach of children.
Do not use Nurofen dla dzieci Forte pomarańczowy after the expiry date stated on the packaging. The expiry date refers to the last day of the stated month.
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Do not store above 25°C.
After opening the bottle, the medicine should be used within 6 months.
Do not dispose of medicines via the sewage system 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 white, syrup-like oral suspension with a characteristic orange odour.
Each bottle contains 100 ml.
The pack contains an oral syringe (5 ml syringe with markings: 1.25 ml, 2.5 ml, 3.75 ml and 5 ml).
Outer packaging: cardboard box.
For further information, please contact the responsible party or the 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, Netherlands
Parallel importer:
Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź
Repackaged in:
Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź
German Marketing Authorisation Number (country of export): 76553.00.00
Parallel Import Authorisation Number: 157/25
This medicinal product is authorised in the European Economic Area countries under the following names:

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