Ibufen dla dzieci Forte o smaku malinovim

Package Leaflet: Information for the User

Ibufen for Children FORTE Raspberry Flavor, 200 mg/5 ml, Oral Suspension

Ibuprofen

Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.

This medicine should always be taken exactly as described in this patient leaflet or as directed by a doctor or pharmacist.

• The leaflet should be kept in case it needs to be read again.
• If advice or additional information is needed, a pharmacist should be consulted.
• If the patient experiences any side effects, including any not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.
• If after 24 hours in children aged 3-5 months or after 3 days in children over 6 months there is no improvement or the patient feels worse, a doctor should be consulted.

Table of Contents of the Leaflet

• 1. What Ibufen for Children FORTE Raspberry Flavor is and what it is used for
• 2. Important information before taking Ibufen for Children FORTE Raspberry Flavor
• 3. How to take Ibufen for Children FORTE Raspberry Flavor
• 4. Possible side effects
• 5. How to store Ibufen for Children FORTE Raspberry Flavor
• 6. Contents of the pack and other information

1. What Ibufen for Children FORTE Raspberry Flavor is and what it is used for

How the medicine works

Ibufen for Children FORTE Raspberry Flavor belongs to a group of nonsteroidal anti-inflammatory drugs (NSAIDs). The medicine has analgesic, antipyretic, and anti-inflammatory effects.

What Ibufen for Children FORTE Raspberry Flavor is used for

The medicine is intended for use in children, adolescents, and adults in the following cases:

• fever of various origins (including viral infections);
• pain of various origins of mild to moderate severity (including ear pain occurring in middle ear infections).

2. Important information before taking Ibufen for Children FORTE Raspberry Flavor

Raspberry Flavor

When not to take Ibufen for Children FORTE Raspberry Flavor

• if the patient is allergic to ibuprofen, other nonsteroidal anti-inflammatory drugs (NSAIDs), or any of the other ingredients of this medicine (listed in section 6),
• if the patient has had symptoms of allergy in the form of rhinitis (allergic rhinitis), angioedema, urticaria, bronchospasm, or asthma after taking acetylsalicylic acid or other nonsteroidal anti-inflammatory drugs (NSAIDs),
• if the patient has or has had stomach or duodenal ulcers, or has had gastrointestinal bleeding,
• if the patient has had bleeding or perforation of the gastrointestinal tract associated with previous NSAID treatment,
• if the patient has severe liver, kidney, or heart failure,
• if the patient has had cerebral hemorrhage or other active bleeding,
• if the patient has hemophilia,
• if the patient has unexplained blood disorders, such as thrombocytopenia,
• if the patient has severe dehydration (caused by vomiting, diarrhea, or insufficient fluid intake),
• during the last three months of pregnancy (see below, "Pregnancy, breastfeeding, and fertility"),
• do not give to infants with a body weight below 5 kg.

Warnings and precautions

Before starting treatment with Ibufen for Children FORTE Raspberry Flavor, the patient should discuss it with their doctor or pharmacist.
During treatment with ibuprofen, symptoms of allergic reactions to this medicine have been reported, including difficulty breathing, facial and neck edema (angioedema), and chest pain. If the patient notices any of these symptoms, they should stop taking Ibufen for Children FORTE Raspberry Flavor and contact their doctor or emergency services immediately.
The patient should inform their pharmacist or doctor if they have an infection - see below, "Infections".
Taking anti-inflammatory/pain-relieving medications, such as ibuprofen, may be associated with a small increased risk of heart attack or stroke, especially when used in high doses. The recommended dose should not be exceeded, and the duration of treatment should be as short as possible.
Before taking Ibufen for Children FORTE Raspberry Flavor, the patient should discuss their treatment with their doctor or pharmacist if:

• they have heart disease, such as heart failure, angina pectoris (chest pain), have had a heart attack, coronary artery bypass grafting, or have peripheral arterial disease (poor blood circulation in the legs due to narrowing or blockage of arteries) or have had any stroke (including mini-stroke or transient ischemic attack - TIA),
• they have high blood pressure, diabetes, high cholesterol levels, or have a family history of heart disease or stroke, or if they smoke,
• they have certain skin diseases (systemic lupus erythematosus (SLE) or mixed connective tissue disease),
• they have or have had gastrointestinal disease, chronic inflammatory bowel disease (ulcerative colitis or Crohn's disease), as these conditions may worsen,
• they have kidney function disorders,
• they have liver function disorders,
• they have recently undergone major surgery,
• they have blood coagulation disorders,
• they have active or have had asthma or have had allergic reactions in the past, as bronchospasm may occur after taking the medicine,
• they have chickenpox - see below, "Infections".

The patient should also consult their doctor if they are taking other medicines, especially blood-thinning medications, diuretics, cardiac glycosides, corticosteroids (see "Ibufen for Children FORTE Raspberry Flavor and other medicines").
It is recommended to avoid concurrent use of ibuprofen with other NSAIDs, including selective cyclooxygenase-2 inhibitors, due to the increased risk of adverse reactions (see "Ibufen for Children FORTE Raspberry Flavor and other medicines").
Taking the medicine in the smallest effective dose for the shortest duration necessary to relieve symptoms reduces the risk of adverse reactions. Elderly patients are more prone to adverse reactions.
There is a risk of gastrointestinal bleeding, ulceration, or perforation, which can be fatal and does not necessarily have to be preceded by warning signs or may occur in patients who have had such warning signs. If gastrointestinal bleeding or ulceration occurs, the medicine should be discontinued immediately. Patients with a history of gastrointestinal disease, especially the elderly, should inform their doctor about any unusual gastrointestinal symptoms (especially bleeding), especially during the initial treatment period.
Concomitant, long-term use of different pain-relieving medications may lead to kidney damage with a risk of kidney failure (analgesic nephropathy). This risk may increase with physical exertion resulting in salt loss and dehydration.
Therefore, concomitant, long-term use of different pain-relieving medications should be avoided.
There is a risk of kidney function disorders in dehydrated children and adolescents.
Severe skin reactions
In connection with ibuprofen treatment, severe skin reactions have been reported, 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). The patient should stop taking Ibufen for Children FORTE Raspberry Flavor and seek medical attention immediately if they experience any symptoms associated with severe skin reactions described in section 4.
Infections
Ibufen for Children FORTE Raspberry Flavor may mask the symptoms of infection, such as fever and pain.
As a result, Ibufen for Children FORTE Raspberry Flavor may delay the use of appropriate infection treatment 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 infection and the symptoms of the infection persist or worsen, they should consult their doctor immediately.
During ibuprofen treatment, single cases of toxic amblyopia (visual impairment) have been reported, so any vision disturbances should be reported to the doctor.

Ibufen for Children FORTE Raspberry Flavor and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.
Ibufen for Children FORTE Raspberry Flavor may affect the action of other medicines or other medicines may affect the action of Ibufen for Children FORTE Raspberry Flavor.
For example:

• blood-thinning medications (e.g., anticoagulants, such as aspirin/acetylsalicylic acid, warfarin, ticlopidine);
• blood pressure-lowering medications (e.g., ACE inhibitors, such as captopril, beta-blockers, such as atenolol, angiotensin II receptor antagonists, such as losartan);
• pain-relieving medications;
• other nonsteroidal anti-inflammatory drugs;
• medicines used in depression (selective serotonin reuptake inhibitors (SSRIs)), lithium;
• diuretics;
• zydovudine, ritonavir (medicines used in HIV infection treatment);
• methotrexate (a medicine used in cancer or rheumatoid arthritis treatment);
• corticosteroids (e.g., prednisolone);
• cardiac glycosides, including digoxin (used in heart disease treatment);
• phenytoin (an antiepileptic medicine);
• cyclosporine, tacrolimus (medicines that reduce the immune system's response);
• quinolone antibiotics (e.g., ciprofloxacin);
• aminoglycoside antibiotics (e.g., streptomycin);
• mifepristone (a medicine used in gynecology);
• probenecid and sulfinpyrazone (medicines used in gout treatment);
• oral antidiabetic medications (e.g., glimepiride);
• voriconazole, fluconazole (antifungal medications);
• cholestyramine (used in high cholesterol treatment);
• baclofen (a medicine used to reduce muscle spasticity in certain diseases, e.g., multiple sclerosis).

Also, some other medicines may be affected or have an effect on the treatment with Ibufen for Children FORTE Raspberry Flavor. Therefore, before taking Ibufen for Children FORTE Raspberry Flavor with other medicines, the patient should always consult their doctor or pharmacist.

Taking Ibufen for Children FORTE Raspberry Flavor with food and drink

The medicine should be taken after meals, with a large amount of fluid.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before taking this medicine.
Pregnancy
Ibufen for Children FORTE Raspberry Flavor should not be taken 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 disorders in the unborn child. It may affect the patient's and their child's tendency to bleed and may cause delayed or prolonged labor.
Ibufen for Children FORTE Raspberry Flavor should not be taken during the first six months of pregnancy, unless it is absolutely necessary and recommended by a doctor. If the patient needs treatment during this period or when trying to conceive, the smallest effective dose of the medicine should be used for the shortest possible time. Ibufen for Children FORTE Raspberry Flavor taken for a period longer than a few days, starting from the 20th week of pregnancy, may cause kidney disorders in the unborn child, leading to low amniotic fluid levels (oligohydramnios) or narrowing of the arterial duct (ductus arteriosus) in the child's heart. If longer treatment is necessary, the doctor may recommend additional monitoring.
Breastfeeding
Ibuprofen passes into breast milk in small amounts and is unlikely to affect the breastfed infant adversely.
Fertility
This medicine belongs to a group of medicines (nonsteroidal anti-inflammatory drugs) that may adversely affect female fertility. This effect is temporary and reverses after the treatment is stopped.

Driving and using machines

As Ibufen for Children FORTE Raspberry Flavor may cause central nervous system side effects, such as fatigue and dizziness, especially when taken in high doses, it may impair the ability to drive or operate machinery. This warning is particularly relevant when the medicine is taken with alcohol.

Ibufen for Children FORTE Raspberry Flavor 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 some sugars, they should consult their 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, which means the medicine is considered "sodium-free".

3. How to take Ibufen for Children FORTE Raspberry Flavor

This medicine should always be taken exactly as described in this patient leaflet or as directed by a doctor or pharmacist. If in doubt, the patient should consult their doctor or pharmacist.
The medicine should be taken orally.
A dosing syringe is included in the package to ensure accurate dosing.
Before use, the bottle should be shaken.

• 1. Open the bottle cap (press down and turn in the opposite direction to the arrow).
• 2. Firmly press the dosing syringe into the opening in the bottle neck.
• 3. Shake the bottle vigorously.
• 4. To fill the dosing syringe, turn the bottle upside down and then carefully move the syringe plunger down to the desired mark on the scale.
• 5. Turn the bottle back to its original position and, carefully unscrewing the dosing syringe, remove it from the bottle.
• 6. Place the tip of the dosing syringe in the child's mouth and, slowly pressing the plunger, carefully empty the contents of the syringe.
• 7. After use, the bottle should be closed by screwing the cap back on, and the dosing syringe should be washed and dried.

When determining the dose of ibuprofen, the patient's body weight and age should be taken into account. The usual single dose of ibuprofen is 7-10 mg per kilogram of body weight, up to a maximum daily dose of 30 mg per kilogram of body weight, divided into 3-4 single doses.
The minimum interval between consecutive doses is 6 hours.
The patient should take the smallest effective dose for the shortest duration necessary to relieve symptoms and minimize the risk of adverse reactions. If the symptoms of the infection (such as fever and pain) persist or worsen, the patient should consult their doctor immediately (see section 2).
The maximum daily dose should not be exceeded.
Recommended dose

In the case of children aged 3-5 months, the patient should consult their doctor if the symptoms worsen or do not improve after 24 hours.
In the case of children over 6 months, the patient should consult their doctor if the medicine needs to be given for more than 3 days or if the symptoms worsen.
The medicine is intended for short-term use.
The medicine should not be given to infants with a body weight below 5 kg.
In patients with mild or moderate kidney or liver function disorders, there is no need to reduce the dose of Ibufen for Children FORTE Raspberry Flavor.
In elderly patients, dose adjustment is not required.

Taking a higher dose of Ibufen for Children FORTE Raspberry Flavor than recommended

If the patient has taken a higher dose of Ibufen for Children FORTE Raspberry Flavor than recommended or if a child has accidentally taken the medicine, they should always consult their doctor or go to the nearest hospital to get an opinion on the possible risk to their health and advice on what to do.
Symptoms of overdose may include nausea, abdominal pain, vomiting (which may contain blood), gastrointestinal bleeding (see also section 4 below), diarrhea, headache, ringing in the ears, disorientation, and nystagmus. They may also include agitation, drowsiness, disorientation, or coma. Rarely, patients may experience seizures. After taking large doses, drowsiness, chest pain, palpitations, loss of consciousness, seizures (mainly in children), weakness, and dizziness have been reported. Additionally, the prothrombin time (INR) may be prolonged, probably due to the disruption of blood clotting factors. Acute kidney failure and liver damage may occur. In patients with asthma, worsening of asthma symptoms may occur. Furthermore, hypotension and breathing difficulties may occur.

Missing a dose of Ibufen for Children FORTE Raspberry Flavor

A double dose should not be taken to make up for a missed dose.
If the patient has any further doubts about taking this medicine, they should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Ibufen for Children FORTE Raspberry Flavor can cause side effects, although not everybody gets them.
The patient should stop taking ibuprofen and seek medical attention immediately if they experience any of the following symptoms:

• red, non-raised, plate-like or round patches on the torso, often with blisters in the center, peeling of the skin, ulcers of the mouth, throat, nose, genitals, and eyes. These severe skin reactions 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 not known.
• red, peeling, widespread rash with nodules under the skin and blisters, accompanied by fever. Symptoms usually appear at the beginning of treatment (acute generalized exanthematous pustulosis) - frequency not known.

Ibufen for Children FORTE Raspberry Flavor is generally well-tolerated.
During short-term use of ibuprofen in doses available without a prescription, the following side effects have been observed.
Side effects are listed in order of frequency.
Common (occurring in less than 1 in 10 patients)

• diarrhea.

Uncommon (occurring in less than 1 in 100 patients)

• indigestion, abdominal pain, nausea, bloating;
• headache;
• skin rashes of various types, urticaria, and itching.

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

• flatulence, constipation, and vomiting;
• dizziness, insomnia, agitation, and fatigue.

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

• aseptic meningitis characterized by neck stiffness, headache, nausea, vomiting, fever, disorientation - reported in patients with existing autoimmune diseases such as systemic lupus erythematosus, mixed connective tissue disease;
• blood disorders (anemia - anemia; leukopenia - decreased white blood cell count; thrombocytopenia - decreased platelet count; pancytopenia - a hematological disorder characterized by a deficiency of all normal morphological elements of the blood: erythrocytes, leukocytes, and platelets; agranulocytosis - decreased granulocyte count). The first symptoms are fever, sore throat, superficial ulcers of the oral mucosa, flu-like symptoms, fatigue, nosebleeds, and petechiae on the skin.
• severe allergic reactions characterized by facial and neck edema (angioedema); difficulty breathing; rapid heart rate; significant decrease in blood pressure; anaphylaxis; angioedema; or shock;
• asthma, worsening of asthma, bronchospasm, difficulty breathing, and wheezing;
• nervousness;
• vision disturbances;
• tinnitus, dizziness;
• edema, hypertension, heart failure (reported in connection with the use of NSAIDs in high doses);
• gastric and duodenal ulcer disease, perforation, or gastrointestinal bleeding, melena, hematemesis, sometimes with a fatal outcome, especially in the elderly; oral mucosa ulcers, gastritis;
• worsening of colitis and Crohn's disease;
• liver function disorders, especially during long-term ibuprofen use; hepatitis and jaundice;
• acute kidney failure; renal papillary necrosis, especially after long-term ibuprofen use, associated with increased serum urea levels and edema, including peripheral edema; presence of blood and/or protein in the urine, interstitial nephritis, nephrotic syndrome;
• decreased hematocrit and hemoglobin levels in laboratory test results.

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

• skin becomes sensitive to light;
• chest pain, which may be a symptom of a potentially severe allergic reaction called Kounis syndrome.

In individual cases, depression and psychotic reactions have been reported.

Reporting side effects

If side effects occur, including any not listed in this leaflet, the patient should tell their doctor or pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of the medicine.

5. How to store Ibufen for Children FORTE Raspberry Flavor

Do not store above 25°C.
The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry date stated on the label and carton after EXP.
The expiry date refers to the last day of the month.
The medicine is suitable for use for 6 months after the first opening of the bottle.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines they no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Ibufen for Children FORTE Raspberry Flavor contains

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

What Ibufen for Children FORTE Raspberry Flavor looks like and what the pack contains

The medicine is a white or almost white oral suspension with a raspberry flavor and smell.
Available packs:
A 40 ml or 100 ml PET bottle with an LDPE connector, closed with an HDPE cap with a child-resistant closure and a guarantee ring, together with a 5 ml oral syringe (an LDPE cylinder and a PS plunger) in a cardboard box.

Marketing authorization holder

Polpharma S.A.
Pelplińska 19, 83-200 Starogard Gdański
phone: +48 22 364 61 01

Manufacturer

Polpharma S.A.
Medana Division in Sieradz
Władysława Łokietka 10, 98-200 Sieradz

Date of the last revision of the leaflet: