Nurofen for children forte orange

Package leaflet: Information for the user

Nurofen for Children Forte Orange
40 mg/ml, oral suspension
Ibuprofen
For children weighing from 5 kg (from 3 months of age) to 40 kg (12 years)
Please read all of this leaflet carefully before using this medicine because it contains
important information for you.

• This medicine should always be used exactly as described in this patient leaflet or as directed by your doctor or pharmacist.
• Keep this leaflet so that you can read it again if needed.
• If you need advice or further information, please consult your pharmacist.
• If you experience any adverse reactions, including any possible adverse reactions not listed in this leaflet, inform your doctor or pharmacist. See section 4.
• If there is no improvement after 24 hours (infants aged 3–5 months, body weight greater than 5 kg) or after 3 days (children over 6 months of age), or if the patient feels worse, consult a doctor.

Leaflet contents:

1. What Nurofen for Children Forte Orange is and what it is used for
2. Important information before taking Nurofen for Children Forte Orange
3. How to take Nurofen for Children Forte Orange
4. Possible side effects
5. How to store Nurofen for Children Forte Orange
6. Contents of the pack and other information

1. What Nurofen for Children Forte Orange 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 for Children Forte Orange 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 greater than 5 kg) or after 3 days (children over 6 months of age), or if the patient feels worse, consult a 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 any of the other ingredients of this medicine (listed in section 6).
• If breathlessness, asthma, rhinitis, facial and (or) hand swelling or urticaria 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 peptic ulceration and (or) duodenal ulceration (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 bleeding (cerebral haemorrhage) or any other active bleeding.
• If blood clotting disorders are present, as ibuprofen may prolong bleeding time.
• If there are blood cell production disorders of unknown origin.
• In children with severe dehydration (caused by vomiting, diarrhoea or insufficient fluid intake).

Do not take the 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 cell production 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. With long-term use of Nurofen for Children Forte Orange, 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), anticoagulant medicines (e.g. warfarin), selective serotonin reuptake inhibitors (antidepressants), and antiplatelet medicines (e.g. acetylsalicylic acid).
• If the child is taking other NSAIDs simultaneously (including COX-2 inhibitors such as celecoxib or etoricoxib), as concurrent 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 (multiple 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. This should therefore be avoided.
• Headaches may occur with long-term 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 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 for Children Forte Orange 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 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, consequently increasing the 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, medical advice should be sought immediately.
Skin reactions
Severe skin reactions such as exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), and acute generalised exanthematous pustulosis (AGEP) have occurred with the use of ibuprofen. If any of the symptoms associated with these severe skin reactions described in section 4 occur in the patient, Nurofen for Children Forte Orange should be discontinued 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 signs, or in patients who have previously experienced serious gastrointestinal disorders. If gastrointestinal bleeding or ulceration occurs, treatment should be stopped immediately. The risk of gastrointestinal bleeding, ulceration, or perforation increases with higher doses of NSAIDs, in patients who have previously experienced ulceration, 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, combination therapy with protective medicines (e.g. misoprostol or proton pump inhibitors) should be considered.
Use of anti-inflammatory and pain-relieving medicines such as ibuprofen may be associated with a small increased risk of myocardial infarction 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, bypass surgery, has peripheral arterial disease (poor blood circulation in 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. During ibuprofen use, symptoms of allergic reaction to this medicine have been reported, including breathing difficulties, facial and neck swelling (angioedema), chest pain. If the patient notices any of these symptoms, they should immediately stop using Nurofen for Children Forte Orange and contact a doctor or emergency services.

If any of the above-mentioned conditions apply to the child, consult a doctor before using Nurofen for Children Forte Orange.
Elderly patients
Elderly patients have an increased risk of adverse effects during treatment with NSAIDs, particularly those 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 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 clot formation, such as acetylsalicylic acid, warfarin, ticlopidine)
• Medicines lowering blood pressure (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 may 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 because the risk of adverse effects may increase
Digoxin (a medicine used in heart failure) because digoxin's action may be enhanced
Glucocorticoids (medicines containing cortisone or substances similar to cortisone) because the risk of gastrointestinal ulceration and bleeding may increase
Antiplatelet medicines because the risk of bleeding may increase
Acetylsalicylic acid (low doses) because the blood-thinning effect may be weakened
Anticoagulant medicines (e.g. warfarin) because ibuprofen may enhance the effect of these medicines
Phenytoin (a medicine used in epilepsy treatment) because phenytoin's action may be enhanced
Selective serotonin reuptake inhibitors (medicines used in depression treatment) because they may increase the risk of gastrointestinal bleeding
Lithium (a medicine used in bipolar disorder and depression treatment) because lithium's action may be enhanced
Probenecid and sulfinpyrazone (a medicine used in gout treatment) because ibuprofen excretion may be delayed
Antihypertensive medicines and diuretics because ibuprofen may weaken the effect of these medicines and the risk of worsening kidney function may increase
Potassium-sparing diuretics, e.g. amiloride, potassium canrenoate, spironolactone, triamterene because hyperkalaemia may occur
Methotrexate (a medicine used in cancer and rheumatoid arthritis treatment) because methotrexate's action may be enhanced
Tacrolimus and cyclosporine (immunosuppressive medicines) because kidney damage may occur
Zidovudine (in HIV/AIDS treatment) because use of Nurofen may increase the risk of intrastate or bleeding leading to swelling in HIV(+) patients with haemophilia
Sulfonylurea derivatives (antidiabetic medicines) because they may affect blood sugar levels
Antibiotics from the quinolone group because the risk of seizures may increase
Voriconazole and fluconazole (CYP2C9 inhibitors), used in fungal infections – ibuprofen's action may be enhanced; dose reduction of ibuprofen should be considered, especially during use of high ibuprofen doses together with voriconazole or fluconazole
Baclofen – after ibuprofen use, baclofen toxicity may develop
Ritonavir – ritonavir may increase NSAID plasma concentration
Aminoglycosides – NSAIDs may increase aminoglycoside excretion
Nurofen for Children Forte Orange and alcohol
Do not consume alcohol while taking 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 is taken together with Nurofen for Children Forte Orange.
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 function disorders in the unborn child. It may also affect bleeding tendency in the patient 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 the blood vessel (ductus arteriosus) in the child's heart. If longer-term treatment is necessary, the doctor may recommend additional control examinations.
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 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
During short-term use, the medicine does not affect or has a negligible effect on the ability to drive and operate machinery.

• 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.
• Calorific value for maltitol: 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 (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 an 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.
Do not 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 bottle neck.
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. Wash the syringe with warm water and leave it to dry. Store out of reach and 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 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 the patient has taken more than the recommended dose of Nurofen dla dzieci Forte pomarańczowy or if a child has accidentally ingested the medicine, seek immediate advice from a doctor or go to the nearest hospital to assess potential health risks and receive guidance on necessary actions.
Symptoms of overdose may include nausea, stomach pain, vomiting (possibly with blood), gastrointestinal bleeding, headache, tinnitus, confusion, and nystagmus, or less commonly, diarrhea. After ingestion of a large dose, disturbances in balance, visual disturbances, low blood pressure, agitation, confusion, 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, seizures (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 pomarańczowy:
Do not take a double dose to make up for a missed dose. If the patient forgets to take or administer a dose, it should be taken or administered as soon as remembered, then the next dose should be taken or administered according to the dosing interval described above.
If you have any further questions regarding the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, Nurofen dla dzieci Forte pomarańczowy may cause adverse effects, although not
everyone will experience them. The risk of adverse effects can be reduced by using the lowest dose for
the shortest duration necessary to relieve symptoms. In children, one of the known adverse effects of
NSAIDs may occur. If any adverse effects occur or if there is any uncertainty, administration of the
medicine should be discontinued and medical advice should be sought as soon as possible. Elderly
individuals using this medicine belong to a group at increased risk of adverse effects.
DISCONTINUE USE of the medicine and seek immediate medical help if the child
experiences:

• symptoms of intestinal 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 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, non-raised, target-like or circular skin rashes, often with blisters in the center, skin peeling, mouth ulcers, or lesions in the throat, nose, genital organs and eyes. 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 subcutaneous nodules and blisters, mainly located in skin folds, trunk, and upper limbs, accompanied by fever. Symptoms usually appear at the beginning of treatment (acute generalized exanthematous pustulosis) [Frequency unknown – cannot be estimated from available data]. If any of the adverse effects worsen or if any adverse effects not listed in this leaflet occur, inform a doctor immediately. 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)

• 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 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 levels, flank 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 in 10,000 people)

• Oesophagitis, pancreatitis, formation of membrane-like intestinal strictures
• Heart failure, myocardial infarction, 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, discontinue use of Nurofen dla dzieci Forte pomarańczowy 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 (first signs may include skin discoloration), particularly during prolonged treatment, liver failure, acute hepatitis
• Blood cell production disorders – first signs include: fever, sore throat, superficial oral mucosal ulcers, flu-like symptoms, severe fatigue, nosebleeds and skin bleeding, unexplained bruising. In such cases, treatment should be stopped immediately and medical advice sought. Do not self-medicate with painkillers or antipyretics (fever-reducing medicines)
• Severe skin infections and soft tissue complications during chickenpox infection
• Worsening of inflammatory conditions related to infection (e.g. necrotizing fasciitis) has been reported following use of certain painkillers (NSAIDs). If signs of infection appear or worsen, the patient should seek medical attention immediately. The need for anti-infective treatment (antibiotic therapy) should be evaluated
• Aseptic meningitis symptoms, including 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
• Hair loss (alopecia).

Frequency unknown (cannot be estimated from available data)

• Chest pain, which may be a symptom of a potentially serious allergic reaction known as 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 be reported directly to the Department of Monitoring Adverse Drug Reactions 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.pl
Adverse effects can also be reported to the marketing authorization holder.
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 cardboard box and bottle. 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 the sewage system or household waste. Ask your pharmacist
what to do with 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 30 ml, 50 ml, 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.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Importer
Marketing Authorisation 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,
The Netherlands

For further information, please contact the local representative of the Marketing Authorisation Holder:
Reckitt Benckiser (Poland) S.A.
ul. Okunin 1
05-100 Nowy Dwór Mazowiecki
Tel.: (22) 211 26 92

This medicinal product is authorised in the Member States of the European Economic Area under the following names: