Nurofen for children forte strawberry flavored

Patient Information Leaflet

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 for the
same medicine.
For children weighing from 5 kg (from 3 months of age) to 40 kg (12 years)
Please read the entire leaflet carefully before using this medicine, as it contains
important information for the patient.

• This medicine should always be used exactly as described in this patient leaflet or as directed by a doctor or pharmacist.
• Keep this leaflet for future reference.
• If you need advice or further information, consult your pharmacist.
• If any adverse reactions occur, including any possible adverse reactions not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.
• If there is no improvement after 24 hours (infants aged 3–5 months weighing more than 5 kg) or 3 days (children aged over 6 months), or if the patient feels worse, consult a doctor.

Leaflet Contents:

1. What Nurofen dla dzieci Forte truskawkowy is and what it is used for
2. What you need to know 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 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 weighing more than 5 kg) or 3 days (children aged over 6 months), 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 to any of the other ingredients of this medicine (listed in section 6).
• If asthma, breathlessness, nasal congestion, facial and (or) hand swelling, or hives have ever 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 or bleeding of the stomach and (or) duodenum (peptic ulcer disease) 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 (bleeding from cerebral blood vessels) or any other active bleeding.
• If blood clotting disorders are present, as ibuprofen may prolong bleeding time.
• If there are blood formation disorders of unknown origin.
• In children with severe dehydration (caused by vomiting, diarrhoea, or insufficient fluid intake).

Do not take this medicine during the last 3 months of pregnancy.
Warnings and precautions
Before starting treatment with Nurofen 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 their 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 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 simultaneously taking other NSAIDs (including COX-2 inhibitors such as celecoxib or etoricoxib), simultaneous 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.
• With prolonged use of any type of pain-relieving medicine, headaches may occur, 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 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 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 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 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 a patient takes this medicine during an existing infection and infection symptoms
persist or worsen, immediate medical advice should be sought.
Skin reactions
Severe skin reactions associated with the use of Nurofen for Children Forte Strawberry have
been reported. If any skin rash, mucosal changes, blisters, or other allergic symptoms appear,
administration of Nurofen for Children Forte Strawberry should be stopped immediately and
medical help should be sought without delay, as these may be the first signs of a very serious
skin reaction. See section 4.
Bleeding, ulceration, or perforation of the gastrointestinal tract, which may be fatal, have been
reported during treatment with all NSAIDs, with or without warning signs, or in patients who
have had 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 NSAID doses, in patients who have had ulcers, especially 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 the risk of gastrointestinal reactions, co-therapy with protective agents (e.g. misoprostol or proton pump inhibitors) should be considered.
Taking 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 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 (chest pain), has had a heart attack, coronary artery bypass surgery, has peripheral arterial disease (poor blood circulation in the legs due to narrowed or blocked arteries), or has had any stroke (including mini-stroke or transient ischaemic attack - TIA).
• the patient has high blood pressure, 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 for Children Forte Strawberry.
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 elderly patients, should report
any unusual abdominal symptoms (particularly gastrointestinal bleeding), especially during the
initial phase of treatment.
Nurofen for Children Forte Strawberry and other medicines
Tell 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 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).

Some other medicines may also 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 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 substances similar to cortisone) as the risk of gastrointestinal ulceration and bleeding may increase
Antiplatelet agents 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 intensify the effect of these medicines
Phenytoin (a medicine used to treat epilepsy) as the effect of phenytoin may be enhanced
Selective serotonin reuptake inhibitors (medicines used to treat depression) as they may increase the risk of gastrointestinal bleeding
Lithium (a medicine used to treat manic-depressive and depressive disorders) as the effect of lithium may be enhanced
Probenecid and sulfinpyrazone (a medicine used to treat gout) as the excretion of ibuprofen may be delayed
Antihypertensive and diuretic medicines as ibuprofen may weaken the effect of these medicines and kidney function may worsen
Potassium-sparing diuretics as hyperkalaemia may occur
e.g. amiloride, potassium canrenoate, spironolactone, triamterene
Methotrexate (a medicine used to treat cancer and rheumatism) as the effect of methotrexate may be enhanced
Tacrolimus and cyclosporine (immunosuppressive medicines) as kidney damage may occur
Zidovudine (in the treatment of HIV/AIDS) as use of Nurofen may increase the risk of
intra-articular 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, 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 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 and Nurofen for Children Forte Strawberry are taken together.
Pregnancy, breastfeeding and effect 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 dysfunction in the unborn child. It may also affect bleeding tendency in the mother and her child and delay or prolong labour. Avoid using this medicine during the first 6 months of pregnancy unless otherwise advised by a doctor. Taking ibuprofen for longer than a few days after the start of the 20th week of pregnancy may cause kidney dysfunction 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 administered at the 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 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 Strawberry contains liquid maltitol. If the patient has previously been diagnosed with intolerance to certain sugars, the patient should contact a doctor before taking this medicine.
• The medicine may have a mild laxative effect.
• Calorific 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 recommended by a doctor or pharmacist. If in doubt, consult a
doctor or pharmacist.
The lowest effective dose for the shortest necessary duration 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 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 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 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 rotating 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 in a place inaccessible and out of sight of children.

Duration of treatment
This medicine is intended for short-term use only. If symptoms in children over 6 months of age persist for more than 3 days or if the patient feels worse, consult a doctor.
For infants aged 3–5 months (weighing 5 kg or more), consult a doctor if symptoms do not improve within 24 hours.
If symptoms worsen, consult a doctor.
Accidental overdose of Nurofen dla dzieci Forte truskawkowy:
If the 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 to assess potential health risks and receive advice on appropriate actions.
Symptoms may include nausea, stomach pain, vomiting (possibly with blood), gastrointestinal bleeding, headache, tinnitus, disorientation, and nystagmus, or less commonly, diarrhea. After ingestion of a large dose, disturbances in balance, visual disturbances, low blood pressure, agitation, disorientation, coma, hyperkalemia, metabolic acidosis, prolonged prothrombin time/INR, acute kidney failure, liver damage, respiratory depression, cyanosis, and exacerbation of asthma in asthmatic patients, drowsiness, chest pain, palpitations, loss of consciousness, seizures (especially in children), weakness, and dizziness, blood in urine, 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 dose has been forgotten or not administered, administer it as soon as remembered, then continue with the next dose according to the dosing interval described above.
If you have any further doubts regarding the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, Nurofen dla dzieci Forte truskawkowy may cause adverse effects, although not everyone experiences them. The risk of adverse effects 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 effects associated with NSAIDs. If any adverse effects 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 effects.

DISCONTINUE USE of the medicine and seek immediate medical help if the child develops:

• Symptoms of gastrointestinal bleeding, such as severe abdominal pain, black tarry stools, blood in 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, 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 affecting the entire body, skin peeling, blistering, or shedding of skin sheets.

If any adverse effect worsens or if any adverse effect not listed in this leaflet occurs, 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 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 1000 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 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, 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 must not be undertaken
• Severe skin infections and soft tissue complications during chickenpox infection
• Worsening of inflammatory conditions associated with 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. The need for anti-infective treatment (antibiotic therapy) should be assessed
• 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 (lupus, mixed connective tissue disease). The risk of such symptoms is higher in these patients. If such symptoms occur, contact a doctor immediately
• Severe skin reactions such as rash with redness and blistering (e.g. Stevens-Johnson syndrome, erythema multiforme, and toxic epidermal necrolysis/Lyell's syndrome), hair loss (alopecia).

Frequency not known (cannot be estimated from available data)

• Respiratory tract reactivity, including asthma, bronchospasm, dyspnoea.
• Severe skin reactions known as DRESS syndrome may occur. Symptoms of DRESS syndrome include: skin rash, fever, lymphadenopathy, and increased eosinophil count (a type of white blood cell).
• Red, scaly rash with subcutaneous nodules and blisters, predominantly located in skin folds, 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 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

Reporting adverse effects 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 Nurofen dla dzieci Forte truskawkowy 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. Such measures help protect the environment.

6. Contents of the packaging 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: maltitol liquid (E 965), propylene glycol (E 1520), sodium citrate, sodium chloride, sodium saccharin, citric acid monohydrate, polysorbate 80, domiphen bromide, glycerol, xanthan gum, strawberry flavour (contains propylene glycol (E 1520)), 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.
The pack contains a brown PET bottle with an HDPE child-resistant closure, with an LDPE adapter for the syringe, together with an oral syringe with a capacity of 5 ml and graduations at 1.25 ml, 2.5 ml, 3.75 ml and 5 ml (cylinder made of PP, plunger made of PE), all contained in a cardboard box.

For more detailed information, please contact the marketing authorisation holder or the parallel importer.

Marketing Authorisation Holder in Spain, 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
The Netherlands

Parallel Importer:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Poland

Repackaged in:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Poland

Marketing Authorisation Number in Spain, country of export: 701428.7
Parallel Import Licence Number: 286/24

This medicinal product is authorised for marketing in the European Economic Area countries under the following names: