Nurofen for children forte strawberry

Patient Information Leaflet: Instructions for Use

Nurofen dla dzieci Forte truskawkowy
40 mg/ml, oral suspension
Ibuprofenum
For children weighing from 5 kg (from 3 months of age) to 40 kg (12 years)
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, please consult your pharmacist.
• If the patient experiences any adverse reactions, including any possible side effects not listed in this leaflet, inform a doctor or pharmacist. See section 4.
• If there is no improvement after 24 hours (infants aged 3–5 months with body weight above 5 kg) or after 3 days (children over 6 months of age), or if the patient feels worse, consult a doctor.

Table of Contents:

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

1. What Nurofen dla dzieci Forte truskawkowy 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 truskawkowy 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 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 strawberry

When not to use Nurofen for Children Forte strawberry

• 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 there has ever been breathlessness, asthma, rhinitis, facial and (or) hand swelling, or urticaria after taking acetylsalicylic acid or other similar pain-relieving medicines (NSAIDs).
• If gastrointestinal bleeding or perforation has ever occurred related to previous use of NSAIDs.
• If there is current or past 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 the medicine during the last 3 months of pregnancy.
Warnings and precautions
Before starting treatment with Nurofen for Children Forte strawberry, 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 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. With long-term use of Nurofen for Children Forte strawberry, 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). Avoid concomitant use of other NSAIDs (including COX-2 inhibitors such as celecoxib or etoricoxib).
• The risk of adverse effects may be reduced by using the lowest effective dose for the shortest possible duration.
• Generally, prolonged use of (multiple types of) painkillers may lead to persistent serious kidney diseases. This risk may increase during physical exertion associated with salt loss and dehydration. Avoid this.
• Headaches may occur with prolonged use of any type of painkillers, which should not be treated with increased doses of this medicine. In such cases, discontinue the medicine and consult a doctor. 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.
• Avoid using Nurofen for Children Forte strawberry in case of chickenpox.
• 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 strawberry may mask symptoms of infection such as fever and pain. Therefore, Nurofen for Children Forte strawberry may delay appropriate treatment of infection and consequently lead to an increased risk of complications. This has been observed in bacterial pneumonia and bacterial skin infections associated with chickenpox. If the patient takes this medicine during an infection and infection symptoms persist or worsen, seek immediate medical advice.
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 the patient develops any symptoms related to these serious skin reactions described in section 4, immediately discontinue Nurofen for Children Forte strawberry and seek medical help.
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, especially in patients with a history of ulceration, particularly with bleeding or perforation (see section 2 " When not to use Nurofen for Children Forte strawberry") and in elderly patients. These patients should start treatment with the lowest effective dose. In these patients and in patients requiring concomitant low-dose acetylsalicylic acid or medicines increasing gastrointestinal risk, 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, particularly when used at high doses. Do not exceed the recommended dose or duration of treatment.
Before using Nurofen for Children Forte strawberry, 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 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.

Allergic reactions to ibuprofen, including breathing difficulties, facial and neck swelling (angioedema), and chest pain, have been reported. If the patient experiences any of these symptoms, stop using Nurofen for Children Forte strawberry immediately and contact a doctor or emergency services.
If any of the above conditions apply to the child, consult a doctor before using Nurofen for Children Forte strawberry.
Elderly patients
Elderly patients have an increased risk of adverse effects during NSAID treatment, particularly gastrointestinal effects.
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 strawberry 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 strawberry may affect the action of other medicines or other medicines may affect the action of Nurofen for Children Forte strawberry. For example:

• Anticoagulant medicines (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 atenolol-containing medicines, angiotensin II receptor antagonists such as losartan)

Also, some other medicines may be affected by or affect treatment with Nurofen for Children Forte strawberry. Therefore, always consult a doctor or pharmacist before using Nurofen for Children Forte strawberry 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 (used in heart failure) because digoxin's effect may be enhanced
Glucocorticoids (medicines containing cortisone or cortisone-like substances) because the risk of gastrointestinal ulceration and bleeding may increase
Antiplatelet agents because the risk of bleeding may increase
Acetylsalicylic acid (low doses) because the blood-thinning effect may be reduced
Anticoagulants (e.g. warfarin) because ibuprofen may enhance the effect of these medicines
Phenytoin (used in epilepsy treatment) because phenytoin's effect may be enhanced
Selective serotonin reuptake inhibitors (medicines used in depression treatment) because they may increase the risk of gastrointestinal bleeding
Lithium (used in bipolar disorder and depression treatment) because lithium's effect may be enhanced
Probenecid and sulfinpyrazone (used in gout treatment) because ibuprofen excretion may be delayed
Antihypertensive medicines and diuretics because ibuprofen may reduce 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 (used in cancer and rheumatism treatment) because methotrexate's effect may be enhanced
Tacrolimus and cyclosporine (immunosuppressive medicines) because kidney damage may occur
Zidovudine (in HIV/AIDS treatment) because using 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
Quinolone antibiotics because the risk of seizures may increase
Voriconazole and fluconazole (CYP2C9 inhibitors), ibuprofen's effect may be enhanced; consider reducing the ibuprofen dose, especially when using high ibuprofen doses 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 strawberry and alcohol
Do not consume alcohol while taking Nurofen for Children Forte strawberry. Some adverse effects, such as those related to the gastrointestinal tract or central nervous system, may be more likely when alcohol is taken concurrently with Nurofen for Children Forte strawberry.
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 problems 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 advised otherwise by a doctor. Taking ibuprofen for longer than a few days after the start of the 20th week of pregnancy may cause kidney problems 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 for Children Forte strawberry may be used during breastfeeding if taken at recommended doses and for the shortest possible duration.
Fertility
Nurofen for Children Forte strawberry belongs to a group of medicines (NSAIDs) that may affect fertility in women. This effect is reversible after stopping 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 strawberry 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.
• Caloric value for maltitol: 2.3 kcal/g
• Nurofen for Children Forte strawberry contains less than 1 mmol sodium (23 mg) per dose, meaning the medicine is considered "sodium-free".
• Nurofen for Children Forte strawberry contains 16.45 mg of propylene glycol in each 5 ml of suspension.

3. How to take Nurofen dla dzieci Forte truskawkowy

Nurofen dla dzieci Forte truskawkowy should always be taken 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 for the shortest duration necessary to relieve symptoms should be used.
If symptoms of infection (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.
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 truskawkowy be
taken during a meal.
WARNING: Do not exceed the recommended dose.
For oral use
Administration method using the oral syringe

1. Shake the bottle well.
2. Remove the cap by pressing down and turning it to the left.
3. Firmly insert the 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 it out of sight and reach 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.
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.
Overdose of Nurofen dla dzieci Forte truskawkowy:
If a patient has taken more than the recommended dose of Nurofen dla dzieci Forte truskawkowy 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 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 exacerbation of asthma in asthmatic patients, drowsiness, chest pain, palpitations, loss of consciousness, seizures (especially 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 truskawkowy:
Do not take a double dose to make up for a missed dose. If a 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 truskawkowy may cause side effects, although not
everyone experiences them. The risk of side effects can be reduced by using the lowest effective dose for
the shortest duration necessary to relieve symptoms. A 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 doubts, stop giving the medicine and consult a doctor as soon as possible. Elderly people
taking this medicine belong to a group at increased risk of side effects.

STOP TAKING THE MEDICINE AND SEEK IMMEDIATE MEDICAL HELP IF THE CHILD HAS:

• 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, palpitations, 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, target-like or round skin lesions on the trunk, often with blisters in the center, peeling skin, mouth ulcers, and lesions in the throat, nose, genitals, and eyes. These severe skin rashes 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 cell) (DRESS syndrome) [Frequency unknown (cannot be estimated from available data)].
• red, scaly, widespread rash with nodules under the skin and blisters, mainly located in skin folds, 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 side effects worsen or if any side effects not listed in this leaflet occur, inform a 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)

• 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 diaphragm-like intestinal strictures
• Heart failure, myocardial infarction, facial or hand swelling
• Reduced urine output compared to normal, 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 taking Nurofen dla dzieci Forte truskawkowy 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 (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 with the use of certain painkillers (NSAIDs). If signs of infection appear or worsen, the patient should seek medical advice immediately. It should be assessed whether anti-infective treatment (antibiotic therapy) is indicated
• Aseptic meningitis with symptoms such as neck stiffness, headache, nausea, vomiting, fever, and altered consciousness has been observed during ibuprofen use, particularly in patients with autoimmune disorders (e.g. lupus, mixed connective tissue disease). These patients are at higher risk. Contact a doctor immediately if such symptoms occur
• Hair loss (alopecia).

Frequency unknown (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 those not listed in this leaflet, inform your doctor, pharmacist, or nurse. Side effects can 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.

Reporting side effects helps provide more information on the safety of this medicine.

5. How to store Nurofen dla dzieci Forte truskawkowy

Keep the medicine out of sight and reach of children.
Do not use Nurofen dla dzieci Forte truskawkowy after the expiry date stated on the
carton 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 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 truskawkowy 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, strawberry flavour 500244E
(propylene glycol, ascorbic acid (E 300), natural and nature-identical flavouring substances), and purified water.
What Nurofen dla dzieci Forte truskawkowy looks like and contents of the pack
Nurofen dla dzieci Forte truskawkowy is a white, syrup-like oral suspension with a characteristic
strawberry odour.
Each bottle contains 100 ml, 150 ml or 200 ml.
The pack contains an oral syringe (5 ml syringe with scale: 1.25 ml, 2.5 ml, 3.75 ml and 5 ml).
Outer packaging: cardboard box.
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 European Economic Area countries under the following names: