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 for 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 for future reference.
• If you need advice or further information, consult your pharmacist.
• If the patient experiences any adverse effects, including any possible adverse effects not listed in this leaflet, inform a doctor, pharmacist, or nurse. See section 4.
• If there is no improvement after 24 hours (infants aged 3–5 months with body weight above 5 kg) or 3 days (children over 6 months of age), or if the patient feels worse, consult a doctor.

Contents of the leaflet:

1. What Nurofen dla dzieci Forte pomarańczowy is and what it is used for
2. What you need to know 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 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 with body weight above 5 kg) or 3 days (children over 6 months of age), or if the patient feels worse, consult a doctor.

2. 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 painkillers (NSAIDs) or any of the other ingredients of this medicine (listed in section 6).
• If the child has ever experienced breathlessness, asthma, rhinitis, facial and (or) hand swelling, or urticaria after taking acetylsalicylic acid or other similar painkillers (NSAIDs).
• If gastrointestinal bleeding or perforation has ever occurred related to previous use of NSAIDs.
• If peptic ulceration of the stomach and (or) duodenum (peptic ulcer disease) or bleeding is currently present or has occurred previously (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 cerebral haemorrhage (bleeding from brain vessels) 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 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 previously 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. During prolonged treatment with Nurofen dla dzieci Forte pomarańczowy, regular monitoring of liver and kidney function 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 agents (e.g. acetylsalicylic acid).
• If the child is taking other NSAIDs simultaneously (including COX-2 inhibitors such as celecoxib or etoricoxib), as concomitant use of these medicines should be avoided.
• The risk of adverse effects may be reduced by using the lowest effective dose for the shortest possible duration.
• Generally, continuous use of (several types of) painkillers may lead to persistent serious kidney diseases. This risk may increase during physical exertion associated with salt loss and dehydration. This should therefore be avoided.
• Prolonged use of any type of painkillers 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 due to) regular use of headache-relieving medicines.
• If the child has had or currently has asthma or allergic conditions 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.
• Avoid using Nurofen dla dzieci Forte pomarańczowy 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 a patient takes this medicine during an ongoing infection and infection symptoms persist or worsen, immediate medical consultation is required.
Skin reactions
Severe skin reactions associated with the use of Nurofen dla dzieci Forte pomarańczowy have been reported. If any skin rash, mucosal changes, blisters, or other allergy symptoms appear, discontinue taking Nurofen dla dzieci Forte pomarańczowy immediately and seek medical help without delay, as these may be the first 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 symptoms, or in patients with serious gastrointestinal disorders. If gastrointestinal bleeding or ulceration occurs, treatment should be discontinued immediately. The risk of gastrointestinal bleeding, ulceration, or perforation increases with higher doses of NSAIDs, in patients with a history of ulcers, particularly 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 administration of low-dose acetylsalicylic acid or drugs increasing the risk of gastrointestinal reactions, consider combination therapy with protective agents (e.g. misoprostol or proton pump inhibitors).
Use of anti-inflammatory and pain-relieving medicines such as ibuprofen may be associated with a small increased risk of myocardial infarction or stroke, especially 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 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, has 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, has a family history of heart disease or stroke, or is a smoker.

If any of the above conditions apply to the child, contact 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
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 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:

• anticoagulants (i.e. blood thinners/preventing clot formation, such as acetylsalicylic acid, warfarin, ticlopidine)
• blood pressure-lowering medicines (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 influence 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 the doctor if the patient is taking the following medicines:
Other NSAIDs including COX-2 inhibitors as risk of adverse effects may increase
Digoxin (a medicine used in heart failure) as digoxin action may be enhanced
Glucocorticoids (medicines containing cortisone or substances similar to cortisone) as risk of gastrointestinal ulceration and bleeding may increase
Antiplatelet agents as risk of bleeding may increase
Acetylsalicylic acid (low doses) as blood-thinning effect may be weakened
Anticoagulants (e.g. warfarin) as ibuprofen may enhance the effect of these medicines
Phenytoin (a medicine used in epilepsy treatment) as phenytoin action may be enhanced
Selective serotonin reuptake inhibitors (medicines used in depression treatment) as risk of gastrointestinal bleeding may increase
Lithium (a medicine used in bipolar disorder and depression treatment) as lithium action may be enhanced
Probenecid and sulfinpyrazone (a medicine used in gout treatment) as ibuprofen excretion may be delayed
Antihypertensive medicines and diuretics as ibuprofen may weaken the effect of these medicines and risk of worsening kidney function may increase
Potassium-sparing diuretics e.g. amiloride, potassium canrenoate, spironolactone, triamterene as hyperkalaemia may occur
Methotrexate (a medicine used in cancer and rheumatism treatment) as methotrexate action may be enhanced
Tacrolimus and cyclosporine (immunosuppressive medicines) as kidney damage may occur
Zidovudine (in HIV/AIDS treatment) as use of Nurofen may cause increased risk of intrasternal 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 risk of seizures may increase
Voriconazole and fluconazole (CYP2C9 inhibitors), ibuprofen action may be enhanced;
used in fungal infections Consider reducing ibuprofen dose, especially during use of high-dose ibuprofen with voriconazole or fluconazole
Baclofen after ibuprofen administration, baclofen toxicity may develop
Ritonavir ritonavir may increase NSAID plasma concentration
Aminoglycosides NSAIDs may increase aminoglycoside excretion
Nurofen dla dzieci Forte pomarańczowy and alcohol
Do not consume alcohol while taking Nurofen dla dzieci Forte pomarańczowy. Some adverse effects, such as those related to the gastrointestinal tract or central nervous system, may be more likely when alcohol and Nurofen dla dzieci Forte pomarańczowy are taken together.
Pregnancy, breastfeeding and 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 function disorders in the unborn child. It may also affect bleeding tendency in the mother and her child and 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 function disorders 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.
Breastfeeding
Only small amounts of ibuprofen and its metabolites pass into breast milk. Nurofen dla dzieci Forte pomarańczowy may be used during breastfeeding if administered at recommended doses and for the shortest possible duration.
Fertility
Nurofen dla dzieci Forte pomarańczowy 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
During 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 dla dzieci Forte pomarańczowy

• Nurofen dla dzieci Forte pomarańczowy 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.
• Calorific value for maltitol: 2.3 kcal/g.
• Nurofen dla dzieci Forte pomarańczowy 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 pomaranczowy

Nurofen dla dzieci Forte pomaranczowy should always be used exactly as described in the
patient information leaflet or as directed 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 symptoms of infection (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 stomachs, 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 well.
2. Remove the cap by pressing it down and turning to the left.
3. Firmly insert the syringe into the opening in 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.
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 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 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 to assess possible health risks and receive advice on appropriate actions.
Symptoms may include nausea, stomach pain, vomiting (blood may be present), 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, seizures (mainly in children), weakness, dizziness, blood in urine, feeling cold, and breathing difficulties may occur.
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 according to the dosing interval described above.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, Nurofen dla dzieci Forte pomaranczowy may cause side effects, although not
everyone will experience them. The risk of side effects can be reduced by using the lowest effective
dose for the shortest necessary duration to relieve symptoms. Your child may experience one of the
known side effects associated with NSAIDs (non-steroidal anti-inflammatory drugs). If any side
effects occur or if you have any concerns, stop giving the medicine and consult a doctor as soon as
possible. Elderly patients taking this medicine are at increased risk of side 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, bloody 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, rapid heartbeat, or low blood pressure leading to shock. These symptoms may occur even after the first dose. If any of these symptoms occur, contact a doctor immediately.
• severe skin reactions, such as widespread rash, skin peeling, blistering, or shedding of skin in sheets.

If any of the side effects worsen or if any unlisted side effects occur, inform your doctor.

Common (may affect up to 1 in 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 affect up to 1 in 100 people)

• Peptic ulcers which may bleed or perforate, oral mucosal inflammation with ulceration, exacerbation of existing bowel disease (colitis or Crohn's disease), gastric mucosal inflammation
• Central nervous system disorders such as headache, dizziness, insomnia, restlessness, irritability, or fatigue
• Visual disturbances
• Various skin rashes
• Hypersensitivity reactions with urticaria (hives) and itching.

Rare (may affect up to 1 in 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 affect up to 1 in 10,000 people)

• Oesophagitis, pancreatitis, development of diaphragm-like intestinal strictures
• Heart failure, myocardial infarction, facial or hand swelling
• Reduced urine output compared to usual, 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 pomaranczowy and consult a doctor immediately, as these may be early signs of kidney damage or kidney 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 symptoms include: fever, sore throat, superficial oral mucosal ulcers, 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 used
• 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 assessed
• 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 of such symptoms. If these symptoms occur, contact a doctor immediately
• Severe skin reactions such as rash with redness and blistering (e.g. Stevens-Johnson syndrome, erythema multiforme, toxic epidermal necrolysis/Lyell's syndrome), hair loss (alopecia).

Frequency not known (cannot be estimated from available data)

• Respiratory tract reactivity, including asthma, bronchospasm, shortness of breath.
• 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, stop taking Nurofen dla dzieci Forte pomaranczowy and seek immediate medical help. See also section 2.
• Skin photosensitivity (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 this 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.
Do not store above 25°C.
After first opening the bottle, the medicine should be used within 6 months.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist
what to do with medicines no longer required. Such measures 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 scale: 1.25 ml, 2.5 ml, 3.75 ml and 5 ml).
Outer packaging: cardboard box.
For further 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:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Repackaged in:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Marketing authorisation number in Germany, the country of export: 76553.00.00
Parallel import authorisation number: 82/25
This medicinal product is authorised in the Member States of the European Economic Area
under the following names: