Ibufen for children forte strawberry flavored

Package leaflet: Information for the user

Ibufen dla dzieci FORTE o smaku truskawkowym, 200 mg/5 ml, oral suspension
Ibuprofenum
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for you.
This medicine should always be taken exactly as described in this patient leaflet or as directed by
your 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 you experience any adverse effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.
• If there is no improvement after 24 hours in children aged 3–5 months, or after 3 days in children over 6 months of age, or if the patient feels worse, consult a doctor.

Contents of the leaflet

1. What Ibufen dla dzieci FORTE o smaku truskawkowym is and what it is used for
2. Important information before taking Ibufen dla dzieci FORTE o smaku truskawkowym
3. How to take Ibufen dla dzieci FORTE o smaku truskawkowym
4. Possible side effects
5. How to store Ibufen dla dzieci FORTE o smaku truskawkowym
6. Contents of the pack and other information

1. What Ibufen dla dzieci FORTE o smaku truskawkowym is and what it is used for

How the medicine works
Ibufen dla dzieci FORTE o smaku truskawkowym belongs to a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs). The medicine has analgesic, antipyretic, and anti-inflammatory properties.

What Ibufen dla dzieci FORTE o smaku truskawkowym is used for
This medicine is intended for use in children, adolescents, and adults in the following conditions:

• fever of various origins (including fever associated with viral infections);
• mild to moderate pain of various causes (including ear pain associated with middle ear inflammation).

2. Important information before using Ibufen dla dzieci FORTE with strawberry flavour

When not to use Ibufen dla dzieci FORTE with strawberry flavour

• if the patient is allergic to ibuprofen, other non-steroidal anti-inflammatory drugs (NSAIDs), or any of the other ingredients of this medicine (listed in section 6),
• if the patient has previously experienced allergic reactions such as rhinitis (nasal mucosa irritation), angioedema, urticaria, bronchospasm, or bronchial asthma after taking acetylsalicylic acid or other non-steroidal anti-inflammatory drugs (NSAIDs),
• if the patient currently has or has previously had gastric or duodenal ulcers, or gastrointestinal bleeding,
• if the patient has experienced gastrointestinal bleeding or perforation related to previous treatment with NSAIDs,
• if the patient has been diagnosed with severe liver, kidney, or heart failure,
• if the patient has cerebral haemorrhage or any other active bleeding,
• if the patient has a haemorrhagic diathesis,
• if the patient has unexplained blood disorders, such as thrombocytopenia,
• if the patient has severe dehydration (caused by vomiting, diarrhoea, or insufficient fluid intake),
• during the last three months of pregnancy (see section below titled "Pregnancy, breastfeeding and fertility"),
• do not administer to infants with body weight below 5 kg.

Warnings and precautions
Before starting treatment with Ibufen dla dzieci FORTE with strawberry flavour, discuss this with a doctor or pharmacist.
Allergic reactions to ibuprofen, including difficulty breathing, facial and neck swelling (angioedema), and chest pain, have been reported during treatment. If the patient experiences any of these symptoms, they should immediately discontinue use of Ibufen dla dzieci FORTE with strawberry flavour and contact a doctor or emergency services.
Inform the pharmacist or doctor if the patient has an infection – see the section below titled "Infections".
Taking anti-inflammatory/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 Ibufen dla dzieci FORTE with strawberry flavour, the patient should discuss treatment with a doctor or pharmacist if:

• the patient has heart conditions such as heart failure, angina pectoris (chest pain), history of myocardial infarction, coronary artery bypass surgery, peripheral arterial disease (poor blood circulation in the legs due to narrowed or blocked arteries), or has previously experienced any stroke (including mini-stroke or transient ischaemic attack - TIA),
• the patient has hypertension, diabetes, elevated cholesterol levels, a family history of heart disease or stroke, or is a smoker,
• certain skin diseases are present (systemic lupus erythematosus (SLE) or mixed connective tissue disease),
• there is current or past gastrointestinal disease, inflammatory bowel diseases (ulcerative colitis or Crohn's disease), as these conditions may worsen,
• impaired kidney function has been diagnosed,
• impaired liver function has been diagnosed,
• the patient has recently undergone major surgery,
• blood clotting disorders are present,
• active or past bronchial asthma or allergic reactions have been diagnosed, as bronchospasm may occur after taking the medicine,
• chickenpox has been diagnosed – see the section below titled "Infections".

Consult a doctor if the patient is taking other medicines, especially anticoagulants, diuretics, cardiac glycosides, or corticosteroids (see section "Ibufen dla dzieci FORTE with strawberry flavour and other medicines").
Avoid concomitant use of ibuprofen with other NSAIDs, including selective cyclooxygenase-2 inhibitors, due to increased risk of adverse effects (see section "Ibufen dla dzieci FORTE with strawberry flavour and other medicines").
Using the medicine at the lowest effective dose for the shortest necessary duration to relieve symptoms reduces the risk of adverse effects. Elderly patients are more susceptible to adverse effects.
There is a risk of gastrointestinal bleeding, ulceration, or perforation, which may be fatal and may occur without warning symptoms or in patients who previously experienced such warning signs. If gastrointestinal bleeding or ulceration occurs, discontinue the medicine immediately. Patients with a history of gastrointestinal disorders, especially elderly individuals, should inform their doctor of any unusual gastrointestinal symptoms (particularly bleeding), especially during initial treatment.
Long-term, concomitant use of various painkillers may lead to kidney damage with risk of renal failure (analgesic nephropathy). This risk may increase with physical exertion leading to salt loss and dehydration. Therefore, avoid long-term, concomitant use of multiple painkillers.
There is a risk of impaired kidney function in dehydrated children and adolescents.

Severe skin reactions
Severe skin reactions have been reported with ibuprofen treatment, including exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), drug reaction with eosinophilia and systemic symptoms (DRESS), and acute generalized exanthematous pustulosis (AGEP). Discontinue use of Ibufen dla dzieci FORTE with strawberry flavour and seek immediate medical help if any symptoms related to severe skin reactions described in section 4 occur.

Infections
Ibufen dla dzieci FORTE with strawberry flavour may mask symptoms of infection such as fever and pain. Therefore, Ibufen dla dzieci FORTE with strawberry flavour 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 the patient takes this medicine during an ongoing infection and symptoms persist or worsen, consult a doctor immediately.
Isolated cases of toxic amblyopia (reduced visual acuity) have been reported during ibuprofen use; therefore, any visual disturbances should be reported to a doctor.

Ibufen dla dzieci FORTE with strawberry flavour and other medicines
Inform the doctor or pharmacist about all medicines currently or recently taken, as well as any medicines the patient plans to take.
Ibufen dla dzieci FORTE with strawberry flavour may affect the action of other medicines, and other medicines may affect the action of Ibufen dla dzieci FORTE with strawberry flavour. For example:

• anticoagulant medicines (i.e., blood thinners/preventing clot formation), such as aspirin/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);
• painkillers;
• other non-steroidal anti-inflammatory drugs;
• medicines used for depression (selective serotonin reuptake inhibitors (SSRIs)), lithium;
• diuretics;
• zidovudine, ritonavir (medicines used in HIV treatment);
• methotrexate (a medicine used in cancer or rheumatoid arthritis treatment);
• corticosteroids (such as prednisolone);
• cardiac glycosides, including digoxin (used in heart disease treatment);
• phenytoin (an anticonvulsant);
• cyclosporine, tacrolimus (immunosuppressive medicines);
• quinolone antibiotics (such as ciprofloxacin);
• aminoglycoside antibiotics (such as streptomycin);
• mifepristone (a medicine used in gynaecology);
• probenecid and sulfinpyrazone (medicines used in gout treatment);
• oral antidiabetic medicines (such as glimepiride);
• voriconazole, fluconazole (antifungal medicines);
• cholestyramine (used in patients with high cholesterol levels);
• baclofen (a medicine used to reduce and relieve excessive skeletal muscle tension occurring in certain diseases, e.g., multiple sclerosis).

Other medicines may also interact with or be affected by treatment with Ibufen dla dzieci FORTE with strawberry flavour. Therefore, always consult a doctor or pharmacist before using Ibufen dla dzieci FORTE with strawberry flavour with other medicines.

Ibufen dla dzieci FORTE with strawberry flavour with food and drink
Administer the medicine after meals, with plenty of fluids.

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 Ibufen dla dzieci FORTE with strawberry flavour during the last three months of pregnancy, as it may harm the unborn child or cause complications during delivery. It may cause kidney and heart problems in the unborn child. It may affect bleeding tendency in both the patient and her child and may delay or prolong labour.
Do not take Ibufen dla dzieci FORTE with strawberry flavour during the first six months of pregnancy unless absolutely necessary and recommended by a doctor. If treatment is necessary during this period or when trying to conceive, use the lowest effective dose for the shortest possible time. Ibufen dla dzieci FORTE with strawberry flavour taken for longer than a few days starting from the 20th week of pregnancy may cause kidney problems in the unborn child, which may lead to low levels of amniotic fluid surrounding the baby (oligohydramnios), or narrowing of a blood vessel (ductus arteriosus) in the baby's heart. If prolonged treatment is necessary, the doctor may recommend additional monitoring.

Breastfeeding
Ibuprofen passes into breast milk in small amounts, but it is very unlikely to negatively affect the breastfed infant.

Fertility
This medicine belongs to a group of medicines (non-steroidal anti-inflammatory drugs) that may adversely affect fertility in women. This effect is reversible and resolves after discontinuation of treatment.

Driving and operating machinery
Since undesirable effects on the central nervous system, such as fatigue and dizziness, may occur when using Ibufen dla dzieci FORTE with strawberry flavour at high doses, ability to drive or operate machinery may be impaired in isolated cases. This warning is particularly relevant when taking the medicine with alcohol.

Ibufen dla dzieci FORTE with strawberry flavour contains liquid maltitol (E 965), sodium benzoate (E 211) and sodium
The medicine contains 2.4 g of liquid maltitol in each 5 ml of oral suspension. If the patient has previously been diagnosed with intolerance to certain sugars, they should consult a doctor before taking the medicine.
The medicine contains 5 mg of sodium benzoate in each 5 ml of oral suspension.
The medicine contains less than 1 mmol (23 mg) of sodium in each 5 ml of oral suspension, meaning the medicine is considered "sodium-free".

3. How to use Ibufen dla dzieci FORTE strawberry-flavoured oral suspension

This medicine should always be used exactly as described in this Patient Information Leaflet or as directed by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
This medicine is for oral use.
For accurate dosing, an oral syringe dispenser is provided with the packaging.
Shake the bottle well before use.

1. Unscrew the bottle cap (press down and turn counterclockwise).
2. Firmly insert the syringe dispenser into the neck of the bottle.
3. Shake the bottle vigorously.
4. To fill the syringe, invert the bottle, then slowly pull down the plunger of the syringe to draw the suspension up to the required mark on the syringe scale.
5. Return the bottle to upright position and carefully remove the syringe by twisting it out.
6. Place the tip of the syringe into the child’s mouth, then slowly and gently press the plunger to empty the syringe contents.
7. After use, close the bottle tightly by replacing the cap, then wash and dry the syringe.

The dose of ibuprofen should be based on the patient’s body weight and age. The usual single dose of ibuprofen is 7 to 10 mg per kg of body weight, up to a maximum daily dose of 30 mg per kg of body weight, divided into 3 to 4 doses.
The minimum interval between doses should be 6 hours.
Use the lowest effective dose for the shortest duration necessary to relieve symptoms and minimize the risk of adverse effects. If symptoms of infection (such as fever and pain) persist or worsen, consult a doctor immediately (see section 2).
Do not exceed the maximum daily dose.
Recommended dose

In the case of children aged 3–5 months, consult a doctor if symptoms worsen or do not improve within 24 hours.
In the case of children over 6 months of age, consult a doctor if the medicine needs to be administered for more than 3 days or if symptoms worsen.
The medicine is intended for short-term use only.
This medicine should not be used in infants with body weight below 5 kg.
In patients with mild to moderate renal and/or hepatic impairment, there is no need to reduce the dose of Ibufen dla dzieci FORTE o smaku truskawkowym.
Dose adjustment is not required in elderly patients.
Use of a higher than recommended dose of Ibufen dla dzieci FORTE o smaku truskawkowym
If a patient has used a higher than recommended dose of Ibufen dla dzieci FORTE o smaku truskawkowym or if a child has accidentally taken the medicine, always contact a doctor or go to the nearest hospital to obtain advice regarding possible health risks and what actions should be taken in such a case.
Symptoms of overdose may include nausea, epigastric pain, vomiting (possibly with blood traces), gastrointestinal bleeding (see also point 4 below), diarrhoea, headache, tinnitus, confusion, and nystagmus. Stimulation, drowsiness, confusion, or coma may also occur. Seizures may occur rarely in patients. After ingestion of large doses, drowsiness, chest pain, palpitations, loss of consciousness, seizures (mainly in children), weakness, and dizziness have been reported, as well as blood in urine, low blood potassium levels, feeling cold, and breathing difficulties. Additionally, prothrombin time (INR) may be prolonged, probably due to impaired blood coagulation factors. Acute renal failure and liver damage may occur. In patients with asthma, worsening of asthma symptoms may occur.
Additionally, low blood pressure and breathing difficulties may occur.
Overdose cases are rare. There is no specific antidote. Treatment is symptomatic and supportive. The doctor may consider administering activated charcoal if less than one hour has passed since the overdose.
Missed dose of Ibufen dla dzieci FORTE o smaku truskawkowym
Do not use a double dose to make up for a missed dose.
If you have any further doubts concerning the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
Ibuprofen should be discontinued and immediate medical help sought if any of the following symptoms occur:

• Red, flat, round or target-like skin lesions, often with blisters in the center, peeling skin, and ulcers of the mouth, throat, nose, genital organs, 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 symptoms.
• Widespread rash, high body temperature, and swollen lymph nodes (DRESS syndrome) – frequency unknown.
• Red, peeling widespread rash with subcutaneous nodules and blisters, accompanied by fever. Symptoms usually appear at the beginning of treatment (acute generalized exanthematous pustulosis) – frequency unknown.

Ibufen dla dzieci FORTE o smaku truskawkowym is generally well tolerated.
Adverse reactions observed during short-term use of ibuprofen at over-the-counter doses are listed below.
Adverse reactions are categorized according to their frequency of occurrence.

Frequent (occurring in fewer than 1 in 10 patients)

• Diarrhea.

Uncommon (occurring in fewer than 1 in 100 patients)

• Indigestion, abdominal pain, nausea, bloating;
• Headache;
• Skin rashes of various types, urticaria, and itching.

Rare (occurring in fewer than 1 in 1,000 patients)

• Flatulence with gas release, constipation, and vomiting;
• Dizziness, insomnia, restlessness, and feeling of fatigue.

Very rare (occurring in fewer than 1 in 10,000 patients)

• Aseptic meningitis, characterized by neck stiffness, headache, nausea, vomiting, fever, and confusion – reported in patients with pre-existing autoimmune diseases such as systemic lupus erythematosus and mixed connective tissue disease;
• Blood dyscrasias (anemia; leukopenia – reduced white blood cell count; thrombocytopenia – reduced platelet count; pancytopenia – hematological disorder with deficiency of all major blood cell types: erythrocytes, leukocytes, and platelets; agranulocytosis – reduced granulocyte count). Initial symptoms include fever, sore throat, superficial oral mucosal ulcers, flu-like symptoms, fatigue, nosebleeds, and skin petechiae;
• Severe hypersensitivity reactions presenting as facial, tongue, and laryngeal swelling; dyspnea; tachycardia; significant drop in blood pressure; anaphylaxis; angioedema; or shock;
• Asthma, worsening of asthma, bronchospasm, dyspnea, and wheezing;
• Nervousness;
• Visual disturbances;
• Tinnitus, dizziness;
• Edema, hypertension, heart failure (reported with high-dose NSAID use);
• Gastric and duodenal ulcer disease, gastrointestinal perforation or bleeding, tarry stools, bloody vomiting, sometimes fatal, particularly in elderly patients; ulcerative stomatitis, gastric mucosal inflammation, oral mucosal ulceration;
• Exacerbation of colitis and Crohn's disease;
• Liver function disorders, particularly during prolonged ibuprofen use; hepatitis and jaundice;
• Acute renal failure; renal papillary necrosis, particularly after prolonged ibuprofen use, associated with increased serum urea levels and edema, including peripheral edema; presence of blood and/or protein in urine, interstitial nephritis, nephrotic syndrome;
• Decreased hematocrit and hemoglobin levels in laboratory tests.

Frequency not known (frequency cannot be estimated from available data):

• Skin becomes photosensitive;
• Chest pain, which may indicate a potentially serious allergic reaction known as Kounis syndrome.

Depression and psychotic reactions have been reported in isolated cases.

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Tel.: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps increase knowledge about the safety of the medicine.

5. How to store Ibufen dla dzieci FORTE o smaku truskawkowym

Store below 25°C.
Store in the original packaging.
Keep the bottle tightly closed.
Keep the medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the bottle and carton after:
EXP. The expiry date refers to the last day of the stated month.
The medicine is suitable for use within 6 months after first opening the bottle.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. Such practices help protect the environment.

6. Contents of the pack and other information

What Ibufen dla dzieci FORTE o smaku truskawkowym contains

• The active substance is ibuprofen. 5 ml of suspension contains 200 mg of ibuprofen.
• The other ingredients are: hypromellose, xanthan gum, glycerol (E 422), sodium benzoate (E 211), maltitol liquid (E 965), sodium citrate, citric acid monohydrate, sodium saccharin (E 954), sodium chloride, strawberry flavour, purified water.

What Ibufen dla dzieci FORTE o smaku truskawkowym looks like and contents of the pack
The medicine is a white or almost white suspension with a strawberry odour and taste.
Available pack sizes:
100 ml or 40 ml of suspension in a white PET bottle with an adapter inside, closed with a polyethylene cap with a tamper-evident ring and child-resistant closure system.
The bottle, together with the patient leaflet and an oral syringe dosing device, is placed in a cardboard box. The oral syringe dosing device has a capacity of 5 ml and is graduated in 0.25 ml increments.

Marketing Authorisation Holder
Zakłady Farmaceutyczne POLPHARMA S.A.
ul. Pelplińska 19, 83-200 Starogard Gdański
tel. + 48 22 364 61 01

Manufacturer
Zakłady Farmaceutyczne POLPHARMA S.A.
Medana Plant in Sieradz
ul. Władysława Łokietka 10, 98-200 Sieradz