Nurofen for children forte strawberry flavored

Package leaflet: Information for the user

Warning! Keep the leaflet. Information on the immediate packaging in a foreign language.
Nurofen dla dzieci Forte truskawkowy (Nurofen pediátrico)
40 mg/ml, oral suspension
Ibuprofenum
Nurofen dla dzieci Forte truskawkowy and Nurofen pediátrico are different brand names of the
same medicine.
For children weighing from 5 kg (from 3 months of age) to 40 kg (12 years of age)
Please read the leaflet carefully before use, 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 advice or further information is needed, consult a pharmacist.
• If any adverse reactions occur, including any possible adverse reactions 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 greater than 5 kg) or 3 days (children aged over 6 months), or if the patient feels worse, contact a doctor.

Table of contents of the leaflet:

1. What Nurofen dla dzieci Forte truskawkowy is and what it is used for
2. Important information before taking Nurofen dla dzieci Forte truskawkowy
3. How to take 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 fever. 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 greater than 5 kg) or 3 days (children aged over 6 months), or if the patient feels worse, contact a doctor.

2. Important information before using Nurofen dla dzieci Forte truskawkowy

When not to use Nurofen dla dzieci Forte truskawkowy

• 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, rhinitis, facial swelling and (or) hand swelling, or hives 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 there is currently or has previously been peptic ulceration of the stomach and (or) duodenum (peptic ulcer disease) or gastrointestinal bleeding (two or more confirmed episodes 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 other active bleeding.
• If there are blood clotting disorders, as ibuprofen may prolong bleeding time.
• If there are blood formation disorders of unknown origin.
• In children with severe dehydration (caused by vomiting, diarrhoea or insufficient fluid intake).

Do not take this medicine during the last 3 months of pregnancy.
Warnings and precautions
Before starting treatment with Nurofen dla dzieci Forte truskawkowy, discuss this with your
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 or has ever had high blood pressure and (or) heart failure.
• If the child has kidney function disorders.
• If the child has liver diseases. With prolonged use of Nurofen dla dzieci Forte truskawkowy, 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 medicines (e.g. acetylsalicylic acid).
• If the child is taking other NSAIDs (including COX-2 inhibitors such as celecoxib or etoricoxib), as concurrent 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, long-term use of (multiple types of) pain-relieving medicines may lead to persistent serious kidney disease. This risk may increase during physical exertion associated with salt loss and dehydration. This should therefore be avoided.
• Prolonged use of any type of pain-relieving medicine may lead to headaches that 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 pain-relieving medicines.
• If the child has had or has asthma or allergic conditions that may cause breathlessness.
• If the child has hay fever, nasal polyps, or chronic obstructive respiratory disease, 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 truskawkowy if chickenpox occurs.
• If the child has recently undergone major surgery (medical supervision is required).
• If the child is dehydrated, due to increased risk of kidney failure in dehydrated children.

Infections
Nurofen dla dzieci Forte truskawkowy may mask symptoms of infection such as fever and pain.
Therefore, Nurofen dla dzieci Forte truskawkowy 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
ongoing infection and symptoms persist or worsen, immediate medical advice should be sought.
Skin reactions
Severe skin reactions associated with the use of Nurofen dla dzieci Forte truskawkowy have been
reported. If any rash, mucosal changes, blisters or other allergic symptoms appear, discontinue
Nurofen dla dzieci Forte truskawkowy immediately and seek medical help promptly, as these may be
early signs of a very serious skin reaction. See section 4.
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 had serious
gastrointestinal disorders. If gastrointestinal bleeding or ulceration occurs, treatment must be
stopped immediately.
The risk of gastrointestinal bleeding, ulceration or perforation increases with higher doses of
NSAIDs, in patients with a history of ulceration, especially with bleeding or perforation (see section
2 “When not to use Nurofen dla dzieci Forte truskawkowy”) 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 the risk of gastrointestinal reactions, concomitant treatment with protective agents (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 heart attack or stroke, particularly when used at high doses. Do not exceed the
recommended dose or duration of treatment.
Before using Nurofen dla dzieci Forte truskawkowy, 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 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 if the patient smokes.

If any of the above conditions apply to the child, contact a
doctor before using Nurofen dla dzieci Forte truskawkowy.
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), particularly at the beginning of treatment.
Nurofen dla dzieci Forte truskawkowy and other medicines
Tell your 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 truskawkowy may affect the action of other medicines or other medicines may affect the action of Nurofen dla dzieci Forte truskawkowy. For example:

• anticoagulant medicines (i.e. blood thinners/preventing blood clots, such as acetylsalicylic acid, warfarin, ticlopidine)
• medicines lowering blood pressure (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 dla dzieci Forte truskawkowy. Therefore, always consult a doctor or pharmacist before using Nurofen dla dzieci Forte truskawkowy with other medicines.
In particular, inform your doctor if the patient is taking the following medicines:
Other NSAIDs including COX-2 inhibitors as the risk of adverse effects may increase
Digoxin (a medicine used in heart failure) as the effect of digoxin may be enhanced
Glucocorticoids (medicines containing cortisone or cortisone-like substances) as the risk of gastrointestinal ulceration and bleeding may increase
Antiplatelet medicines as the risk of bleeding may increase
Acetylsalicylic acid (low doses) as the blood-thinning effect may be weakened
Anticoagulant medicines (e.g. warfarin) as ibuprofen may enhance the effect of these medicines
Phenytoin (a medicine used in epilepsy) as the effect of phenytoin may be enhanced
Selective serotonin reuptake inhibitors (medicines used in depression treatment) as they may increase the risk of gastrointestinal bleeding
Lithium (a medicine used in bipolar disorder and depression) as the effect of lithium may be enhanced
Probenecid and sulfinpyrazone (medicines used in gout treatment) as the excretion of ibuprofen may be delayed
Antihypertensive medicines and diuretics as ibuprofen may weaken the effect of these medicines and the risk of worsening kidney function may increase
Potassium-sparing diuretics e.g. amiloride, potassium canrenoate, spironolactone, triamterene as hyperkalaemia may occur
Methotrexate (a medicine used in cancer and rheumatism treatment) as the effect of methotrexate may be enhanced
Tacrolimus and cyclosporine (immunosuppressive medicines) as kidney damage may occur
Zidovudine (in HIV/AIDS treatment) as use of Nurofen dla dzieci Forte truskawkowy may increase the risk of intrastromal bleeding or bleeding leading to swelling in HIV(+) patients with haemophilia
Sulfonylurea derivatives (antidiabetic medicines) as they may affect blood glucose levels
Quinolone antibiotics as the risk of seizures may increase
Voriconazole and fluconazole (CYP2C9 inhibitors), used in fungal infections, may enhance the effect of ibuprofen;
consider reducing the dose of
ibuprofen, especially when using
high doses of ibuprofen together with
voriconazole or fluconazole
Baclofen as baclofen toxicity may develop after ibuprofen use
Ritonavir ritonavir may increase NSAID plasma concentrations
Aminoglycosides NSAIDs may increase aminoglycoside excretion
Nurofen dla dzieci Forte truskawkowy and alcohol
Do not consume alcohol while taking Nurofen dla dzieci Forte truskawkowy.
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 dla dzieci Forte truskawkowy.
Pregnancy, breastfeeding and effects on fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult a doctor or pharmacist before using this medicine.
Pregnancy
Do not use this medicine during the last 3 months of pregnancy. Avoid using this medicine during the first 6 months of pregnancy unless otherwise directed by a doctor.
Breastfeeding
Only small amounts of ibuprofen and its metabolites pass into breast milk. Nurofen dla dzieci Forte truskawkowy may be used during breastfeeding if administered at recommended doses and for the shortest possible duration.
Fertility
Nurofen dla dzieci Forte truskawkowy belongs to a group of medicines (NSAIDs) that may affect fertility in women. This effect is reversible upon discontinuation of the medicine.
Driving and operating machinery
During short-term use, this medicine does not affect or has a negligible effect on the ability to drive and operate machinery.
Important information about certain ingredients of Nurofen dla dzieci Forte truskawkowy

• Nurofen dla dzieci Forte truskawkowy contains liquid maltitol (E 965). If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult a doctor before taking this medicine.
• The medicine may have a mild laxative effect.
• Calorific value of maltitol: 2.3 kcal/g
• Nurofen dla dzieci Forte truskawkowy contains less than 1 mmol of sodium (23 mg) per dose, meaning the medicine is considered “sodium-free”.
• Nurofen dla dzieci Forte truskawkowy contains 16.45 mg of propylene glycol (E 1520) in each 5 ml of suspension.

3. How to use Nurofen dla dzieci Forte truskawkowy

Nurofen dla dzieci Forte truskawkowy should always be used exactly as described
in the patient leaflet or as advised 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, during an infection, its symptoms (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 with body weight below 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 vigorously.
2. Remove the cap 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 sy游戏副本

4. Possible adverse reactions

Like all medicines, Nurofen dla dzieci Forte truskawkowy may cause adverse reactions,
although not everyone experiences them. The risk of adverse reactions can be reduced by
using the lowest effective dose for the shortest duration necessary to relieve symptoms.
Children may experience any of the known adverse reactions associated with NSAIDs. If
adverse reactions occur or if there is any doubt, administration of the medicine should be
discontinued and medical advice should be sought as soon as possible. Elderly individuals
taking this medicine belong to a group at increased risk of adverse reactions.
DISCONTINUE USE of the medicine and seek immediate medical help if the 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 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.
• Severe skin reactions, such as rash spreading over the entire body, skin peeling, blister formation, and shedding of skin in sheets.

If any of the adverse symptoms worsen or if any adverse symptoms not listed in this
leaflet occur, inform a doctor.
Common (may occur in 1 out of 10 people)

• Gastrointestinal discomfort such as heartburn, abdominal pain, nausea, indigestion, diarrhoea, vomiting, bloating (gas), constipation, minor gastrointestinal bleeding 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 pre-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, 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, treatment with Nurofen dla dzieci Forte truskawkowy should be discontinued immediately and medical advice sought without delay, 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 discolouration), particularly during prolonged treatment, liver failure, acute hepatitis

• Blood cell production disorders – early symptoms include: fever, sore throat, superficial ulceration of the oral mucosa, flu-like symptoms, severe fatigue, nosebleeds and skin bleeding, unexplained bruising. In such cases, treatment must be stopped immediately and medical advice sought. Self-treatment with painkillers or antipyretics (fever-reducing medicines) must not be continued

• Severe skin infections and soft tissue complications during chickenpox infection

• Worsening of inflammatory conditions related to infection (e.g. necrotising fasciitis) has been reported with certain painkillers (NSAIDs). If signs of infection appear or worsen, the patient should seek immediate medical attention. The need for anti-infective treatment (antibiotic therapy) should be evaluated

• Symptoms of aseptic meningitis, 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 such symptoms occur, contact a doctor immediately

• Severe skin reactions, such as rash with redness and blister formation (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, predominantly located in skin folds, on the trunk and upper limbs, accompanied by fever at the beginning of treatment (acute generalised exanthematous pustulosis). If such symptoms occur, discontinue taking Nurofen dla dzieci Forte truskawkowy and seek immediate medical help. See also section 2.
• Skin becomes sensitive to light.

Medicines such as this one may be associated with a small increased risk of heart attack (myocardial infarction) or stroke.
Reporting of adverse reactions
If any adverse reactions occur, including those not listed in this leaflet, inform a doctor, pharmacist or nurse. Adverse reactions can also be reported directly to the Department of Monitoring Adverse Reactions of Medicinal Products, 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 adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Nurofen dla dzieci Forte truskawkowy

Keep the medicine out of the sight and reach of children.
Do not use this medicine 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 opening the bottle, the medicine should be used within 6 months.
Medicines must not be disposed of via wastewater or household waste. Please ask your pharmacist how to dispose of medicines no longer required. Proper disposal helps protect the environment.

6. Package contents 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.
Other ingredients are: citric acid monohydrate, sodium citrate, sodium chloride, sodium saccharin,
polysorbate 80, domiphen bromide, maltitol liquid (E 965), glycerol, xanthan gum, strawberry flavour
(containing propylene glycol (E 1520)) 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 150 ml.
The pack contains an oral syringe (5 ml syringe with scale: 1.25 ml, 2.5 ml, 3.75 ml and 5.0 ml).
Outer packaging: cardboard box.
For further information, please contact the Marketing Authorisation Holder or the Parallel Importer.
Marketing Authorisation Holder in Spain, the country of export:
Reckitt Benckiser Healthcare S.A., C/Mataró, 28, 08403 Granollers (Barcelona), Spain
Manufacturer:
RB NL Brands B.V., Schiphol Blvd 207, 1118 BH Schiphol, Netherlands
Parallel Importer:
Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź
Repackaged in:
Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź
Marketing Authorisation Number in Spain, the country of export: 701428.7
Parallel Import Licence Number: 417/22
This medicinal product is authorised for sale in the European Economic Area under the following names: