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 Junior Forte Orange (Nurofen Junior Fieber- und Schmerzsaft Orange)
40 mg/ml, oral suspension
Ibuprofen
Nurofen Junior Forte Orange 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, because
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, please consult a pharmacist.
• If the patient experiences any side effects, including any possible side effects not listed in this leaflet, inform a doctor, pharmacist, or nurse. See section 4.
• If there is no improvement within 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 Junior Forte Orange is and what it is used for
2. Important information before taking Nurofen Junior Forte Orange
3. How to take Nurofen Junior Forte Orange
4. Possible side effects
5. How to store Nurofen Junior Forte Orange
6. Contents of the pack and other information

1. What Nurofen Junior 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 Junior Forte Orange 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 above 5 kg) or 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 to any of the other ingredients of this medicine (listed in section 6).
• If asthma, wheezing, runny nose, swelling of the face and (or) hands or hives have ever occurred after taking acetylsalicylic acid or other similar pain-relieving medicines (NSAIDs).
• If gastrointestinal bleeding or perforation related to previous use of NSAIDs has ever occurred.
• If there is currently or has previously been a stomach or duodenal ulcer (peptic ulcer disease) or bleeding (two or more confirmed cases of ulcers 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 cell production 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 your 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 or has ever had 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 for Children Forte Orange, regular monitoring of liver and kidney function tests 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 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 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 currently has asthma or allergic diseases 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 manifest as asthma attacks (so-called drug-induced asthma), Quincke's oedema, or urticaria.
• The use of Nurofen for Children Forte Orange 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 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 and consequently increase 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 existing infection and symptoms persist or worsen, immediate consultation with a doctor is necessary.
Skin reactions
Serious 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 serious skin reactions described in section 4 occur in the patient, Nurofen for Children Forte Orange should be discontinued immediately and medical help sought.
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 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 previous 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, concomitant treatment with protective agents (e.g. misoprostol or proton pump inhibitors) should be considered.
The use of 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 in high doses. The recommended dose and duration of treatment should not be exceeded.
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 (chest pain), has had a heart attack, coronary 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, has high cholesterol levels, has a 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 any of these symptoms occur, the patient 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 NSAID use, particularly those affecting the stomach and intestines.
Patients with a history of gastrointestinal disorders, especially in old age, should report any unusual abdominal symptoms (particularly gastrointestinal bleeding), especially at the beginning of treatment.
Nurofen for Children Forte Orange and other medicines
Inform your 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 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 as the risk of adverse effects may increase
Digoxin (a medicine used in heart failure) as the action of digoxin may be enhanced
Glucocorticoids (medicines containing cortisone or substances similar to cortisone) 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 action 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 action of lithium may be enhanced
Probenecid and sulfinpyrazone (a medicine 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
Potassium-sparing diuretics such as amiloride, potassium canrenoate, spironolactone, triamterene as hyperkalaemia may occur
Methotrexate (a medicine used in cancer and rheumatism treatment) as the action of methotrexate may be enhanced
Tacrolimus and cyclosporine (immunosuppressive medicines) as kidney damage may occur
Zidovudine (in HIV/AIDS treatment) as the use of Nurofen may increase the 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 the risk of seizures may increase
Voriconazole and fluconazole (CYP2C9 inhibitors), used in fungal infections, the action of ibuprofen may be enhanced; dose reduction of ibuprofen should be considered, especially during high-dose ibuprofen use with voriconazole or fluconazole
Baclofen as baclofen toxicity may develop after ibuprofen use
Ritonavir as ritonavir may increase NSAID plasma concentrations
Aminoglycosides as 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 and Nurofen for Children Forte Orange are taken together.
Pregnancy, breastfeeding and fertility
If the patient is pregnant, breastfeeding, suspects she may be pregnant, or plans 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 the bleeding tendency of 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 levels of amniotic fluid 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 for Children Forte Orange may be used during breastfeeding if administered in 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, this medicine has no effect or 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 consult a doctor before taking the medicine.
• The medicine may have a mild laxative effect.
• The caloric value of maltitol is: 2.3 kcal/g
• Nurofen for Children Forte Orange 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 (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.
The lowest effective dose for the shortest duration necessary to relieve symptoms should be used.
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 given approximately every 6 to 8 hours.
Not recommended for 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 well.
2. Remove the cap from the bottle by pressing it 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 downward 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 push the plunger to administer the suspension. After use, replace the cap. Rinse the syringe with warm water and leave it to dry. Store out of the 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 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 the patient has taken more than the recommended dose of Nurofen dla dzieci Forte pomarańczowy or
if a child has accidentally taken the medicine, always contact a doctor or go to the
nearest hospital to obtain advice regarding possible health risks and guidance on actions to be taken.
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, 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 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 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 duration necessary to relieve symptoms.
Your child may experience one of the known side effects associated with NSAID medicines.
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 taking this medicine belong to a group at increased risk of
experiencing side effects.
STOP USING the medicine and seek immediate medical help if your child experiences:

• symptoms of gastrointestinal bleeding, such as: severe stomach 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, rapid heartbeat, or drop in blood pressure leading to shock. These symptoms may occur even after the first dose. If any of these symptoms occur, contact a doctor immediately.
• red, flat, non-elevated, target-like or circular skin lesions on the trunk, 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 out of 10,000 people].
• widespread rash, high fever, swollen lymph nodes, and increased eosinophil count (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 listed side effects worsen, or if any unlisted side effects occur, inform your doctor.
Common (may occur in 1 out of 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 out of 100 people)

• Peptic 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 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 diaphragm-like intestinal strictures
• Heart failure, heart attack, 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 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 (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, stop treatment immediately and consult a doctor. Do not self-medicate with painkillers or antipyretics
• 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 pain medicines (NSAIDs). If signs of infection appear or worsen, the patient should seek medical advice immediately. Consideration should be given to whether antimicrobial treatment (antibiotic therapy) is indicated
• 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 not known (cannot be estimated from available data)

• Chest pain, which may indicate 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 side effects
If any side effects occur, including any 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
Side effects can also be reported to the marketing authorisation holder or parallel importer.
Reporting side effects helps provide more information on the safety of this medicine.

5. How to store Nurofen dla dzieci Forte orange

Keep the medicine out of sight and reach of children.
Do not use Nurofen dla dzieci Forte orange 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.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist
how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the pack and other information

What Nurofen dla dzieci Forte pomaranczowy 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 pomaranczowy looks like and contents of the pack
Nurofen dla dzieci Forte pomaranczowy is a white, syrup-like oral suspension with a characteristic orange odour.
Each bottle contains 100 or 150 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 responsible party or the parallel importer.
Responsible party in Germany, the country of export:
Reckitt Benckiser Deutschland GmbH
Darwinstrasse 2-4
69115 Heidelberg
Germany
Manufacturer:
RB NL Brands B.V.
Schipol Boulevard 207
1118 BH Schipol
The Netherlands
Parallel importer:
Allpharm Sp. z o.o. sp.k.
ul. M. Zdziechowskiego 11/4
02-659 Warsaw
Repackaged in:
CEFEA Sp. z o.o. Sp. Synoptis Industrial Sp. z o.o. Shiraz Productions Sp. z o.o.
spółka komandytowa ul. Forteczna 35-37 ul. Tymiankowa 24/28
ul. Działkowa 56 87-100 Toruń 95-054 Ksawerów
02-234 Warsaw
Authorisation number in Germany, the country of export: 76553.00.00
Parallel import authorisation number: 356/25
This medicinal product is authorised for sale in the European Economic Area countries under the following names: