Nurofen for children forte strawberry

Patient Information Leaflet

Warning! Keep this leaflet! The information on the immediate packaging is in a foreign language.
Nurofen dla dzieci Forte truskawkowy (Nurofen Junior Fieber- und Schmerzsaft Erdbeer)
40 mg/ml, oral suspension
Ibuprofenum
For children weighing from 5 kg (from 3 months of age) up to 40 kg (12 years)
Nurofen dla dzieci Forte truskawkowy and Nurofen Junior Fieber- und Schmerzsaft Erdbeer are different
brand names for the same medicine.
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 so that you can read it again if necessary.
• 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 your 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 after 3 days (children aged over 6 months), contact your doctor.

Leaflet 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 greater than 5 kg) or after 3 days (children aged over 6 months), contact your 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 the child has ever experienced breathlessness, asthma, rhinitis, facial swelling and (or) swelling of the hands or hives after taking acetylsalicylic acid or other similar pain-relieving medicines (from the group of NSAIDs).
• If the child has ever had gastrointestinal bleeding or perforation related to previous use of NSAID medicines.
• If the child currently has or has previously had peptic ulceration of the stomach and (or) duodenum (peptic ulcer disease) or bleeding (two or more confirmed cases of ulcers or bleeding).
• If the child has severe liver or kidney failure.
• If the child has severe heart failure.
• If the child has brain haemorrhage (cerebral haemorrhage) or any other active bleeding.
• If the child has blood clotting disorders, because ibuprofen may prolong bleeding time.
• If the child has 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 previously had intestinal diseases (ulcerative colitis or Crohn’s disease), as symptoms may worsen.
• If the child has or has previously had high blood pressure and (or) heart failure.
• If the child has kidney function disorders.
• If the child has liver diseases. In case of prolonged 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 medicines (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 time.
• Generally, prolonged use of (several types of) pain-relieving medicines may lead to persistent serious kidney diseases. This risk may increase during physical exertion associated with loss of salts and dehydration. Therefore, this should 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 pain-relieving medicines.
• If the child has asthma or allergic diseases that may cause breathlessness.
• If the child has hay fever, nasal polyps, 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 has occurred.
• If the child has recently undergone a serious surgical procedure (medical supervision is required).
• If the child is dehydrated, due to an 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 is taking this medicine during an ongoing infection and symptoms of infection persist or worsen, medical advice should be sought immediately.
Skin reactions
Severe skin reactions such as exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS) and acute generalised exanthematous pustulosis (AGEP) have occurred with the use of ibuprofen. If the patient develops any of the symptoms related to these severe skin reactions described in section 4, Nurofen for Children Forte Strawberry 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 signs, or in patients who have previously had serious gastrointestinal diseases. If gastrointestinal bleeding or ulceration occurs, treatment should be discontinued immediately. The risk of gastrointestinal bleeding, ulceration or perforation increases with higher doses of NSAIDs, in patients who have previously 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 administration of low-dose acetylsalicylic acid or medicines increasing the risk of gastrointestinal reactions, concomitant treatment with protective medicines (e.g. misoprostol or proton pump inhibitors) should be considered.
Use of anti-inflammatory and pain-relieving medicines such as ibuprofen may be associated with a small increased risk of heart attack or stroke, especially 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 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 hypertension, diabetes, has increased 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 the patient notices any of these symptoms, they should immediately stop using Nurofen for Children Forte Strawberry 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 Strawberry.
Elderly patients
Elderly patients have an increased risk of adverse effects during treatment with NSAIDs, particularly those affecting the stomach and intestines.
Patients with a history of gastrointestinal disorders, especially elderly patients, should report any unusual abdominal symptoms (particularly gastrointestinal bleeding), especially at the beginning of treatment.
Nurofen for Children Forte 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 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 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 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 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 manic-depressive disorders and depression) as the effect of lithium may be enhanced
Probenecid and sulfinpyrazone (a medicine used in gout treatment) as excretion of ibuprofen may be delayed
Antihypertensive and diuretic medicines 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 may increase the risk of intra-articular or bleeding leading to swelling in HIV(+) patients with haemophilia
Sulfonylurea derivatives (antidiabetic medicines) as they may affect blood sugar levels
Antibiotics from the quinolone group as the risk of seizures may increase
Voriconazole and fluconazole (CYP2C9 inhibitors), used in fungal infections, may enhance the effect of ibuprofen; dose reduction of ibuprofen should be considered, especially when using high doses of ibuprofen together with voriconazole or fluconazole
Baclofen as baclofen toxicity may develop after administration of ibuprofen
Ritonavir as ritonavir may increase NSAID plasma concentration
Aminoglycosides as 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 together 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 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. Use of ibuprofen for longer than a few days after the 20th week of pregnancy may cause kidney function disorders in the unborn child and lead to reduced amniotic fluid levels surrounding the child (oligohydramnios) or narrowing of 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
For short-term use, this medicine has no effect or 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.
• 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 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.
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 during treatment, 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 well.
2. Remove the cap by pressing 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 down to draw the suspension up to the correct 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 protective cap. Wash 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 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 obtain advice on possible health risks and on what actions should be taken.
Symptoms of overdose may include nausea, stomach pain, vomiting (possibly with blood), gastrointestinal bleeding, headache, tinnitus, dizziness, 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, 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 truskawkowy:
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, and then the next dose should be taken or administered according to the dosing interval described above.
If you have any further questions concerning 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 will experience 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 uncertainty, 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
experiences:

• symptoms of gastrointestinal bleeding, such as severe abdominal pain, black tarry stools, vomiting blood, or vomiting material that looks 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, 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 skin lesions resembling targets or round spots, often with blisters in the center, skin peeling, mouth ulcers, or ulcers in the throat, nose, genital organs and eyes. These severe skin reactions may be preceded by fever and flu-like symptoms (toxic epidermal necrolysis, erythema multiforme, Stevens-Johnson syndrome). [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 papules 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 adverse effects worsen or if any adverse effects not listed in this leaflet occur,
inform a doctor immediately.
Common (may occur in 1 out of 10 people)

• Gastrointestinal discomfort such as heartburn, abdominal pain, nausea, indigestion, diarrhoea, vomiting, bloating (gas), constipation, minor bleeding 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, worsening 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 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 and immediate medical advice should be sought, 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 discoloration), particularly during long-term treatment, liver failure, acute hepatitis

• Blood cell production disorders – early 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, treatment should be immediately discontinued and medical advice sought. Self-treatment with analgesics or antipyretics should not be continued.

• Severe skin infections and soft tissue complications during chickenpox infection

• Worsening of inflammatory conditions related to infection (e.g. necrotizing fasciitis) has been reported following use of certain painkillers (NSAIDs). If signs of infection appear or worsen, the patient should seek immediate medical attention. It should be assessed whether antimicrobial treatment (antibiotic therapy) is indicated.

• Aseptic meningitis symptoms such as 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, immediate medical consultation is required.

• Hair loss (alopecia).

Frequency unknown (cannot be estimated from available data)

• Chest pain, which may indicate a potentially serious allergic reaction known as Kounis syndrome.
• Respiratory tract reactivity, including asthma, bronchospasm, shortness of breath.
• Skin becomes sensitive to light.

Medicines such as this one may be associated with a small increased risk of heart attack (myocardial infarction) or stroke.
Reporting of adverse effects
If any adverse effects occur, including those not listed in this leaflet, inform a doctor, pharmacist or nurse. Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions 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
Adverse effects can also be reported to the responsible party or parallel importer.
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.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist
how to dispose of medicines no longer required. Such measures will 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: citric acid monohydrate, sodium citrate, sodium chloride, sodium saccharin,
polysorbate 80, domiphen bromide, liquid maltitol, glycerol, xanthan gum, strawberry flavour
(containing propylene glycol), 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 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 more detailed information, please contact the marketing authorisation holder or the parallel importer.
Marketing Authorisation Holder in Germany, 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
Poland
Repackaged in:
CEFEA Sp. z o.o. Sp. Synoptis Industrial Sp. z o.o. Shiraz Productions Sp. z o.o.
sp. k. ul. Forteczna 35-37 ul. Tymiankowa 24/28
ul. Działkowa 56 87-100 Toruń 95-054 Ksawerów
02-234 Warsaw
German Marketing Authorisation Number, country of export: 76554.00.00
Parallel Import Authorisation Number: 369/25
This medicinal product is authorised for sale in the European Economic Area countries under the following names: