Ibufen dla dzieci Forte o smaku truskavkovim

Leaflet attached to the packaging: information for the user

Ibufen for children FORTE with strawberry flavor, 200 mg/5 ml, oral suspension

Ibuprofen

Read the 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.

• Keep this leaflet, so you can read it again if you need to.
• If you need advice or additional information, you should consult a pharmacist.
• If the patient experiences any side effects, including those 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, they should contact a doctor.

Table of contents of the leaflet

• 1. What is Ibufen for children FORTE with strawberry flavor and what is it used for
• 2. Important information before taking Ibufen for children FORTE with strawberry flavor
• 3. How to take Ibufen for children FORTE with strawberry flavor
• 4. Possible side effects
• 5. How to store Ibufen for children FORTE with strawberry flavor
• 6. Contents of the packaging and other information

1. What is Ibufen for children FORTE with strawberry flavor and what is it used for

used for

How the medicine works

Ibufen for children FORTE with strawberry 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 with strawberry flavor is used for

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

• fever of various origins (also in the course of viral infections);
• pains of various origins of mild to moderate severity (also ear pains occurring in inflammatory conditions of the middle ear).

2. Important information before taking Ibufen for children FORTE with strawberry flavor

strawberry flavor

When not to take Ibufen for children FORTE with strawberry 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 bleeding or other active bleeding,
• if the patient has a bleeding disorder,
• 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, section "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 with strawberry 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 with strawberry flavor and contact their doctor or emergency services immediately.
The patient should inform their pharmacist or doctor if they have an infection - see below, section "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 taken in high doses. Do not exceed the recommended dose and duration of treatment.
Before taking Ibufen for children FORTE with strawberry flavor, the patient should discuss treatment with their doctor or pharmacist if:

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

The patient should also consult their doctor if they are taking other medicines, especially blood-thinning medicines, diuretics, cardiac glycosides, corticosteroids (see section "Ibufen for children FORTE with strawberry flavor and other medicines").
The patient should avoid taking ibuprofen with other NSAIDs, including selective cyclooxygenase-2 inhibitors, due to the increased risk of adverse reactions (see section "Ibufen for children FORTE with strawberry 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 likely to experience 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 stopped 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 in the case of 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 with strawberry 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 with strawberry flavor may mask the symptoms of infection, such as fever and pain. As a result, Ibufen for children FORTE with strawberry 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 with strawberry 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 with strawberry flavor may affect the action of other medicines or other medicines may affect the action of Ibufen for children FORTE with strawberry flavor. For example:

• blood-thinning medicines (e.g., anticoagulants, such as aspirin/acetylsalicylic acid, warfarin, ticlopidine);
• blood pressure-lowering medicines (e.g., ACE inhibitors, such as captopril, beta-blockers, such as atenolol, angiotensin II receptor antagonists, such as losartan);
• pain-relieving medicines;
• 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 body's immune 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 medicines (e.g., glimepiride);
• voriconazole, fluconazole (antifungal medicines);
• cholestyramine (used in people with high cholesterol levels);
• baclofen (a medicine used to reduce and alleviate excessive muscle tension in the muscles that occurs in certain diseases, e.g., multiple sclerosis).

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

Ibufen for children FORTE with strawberry 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 with strawberry 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 with strawberry flavor should not be taken during the first six months of pregnancy, unless it is absolutely necessary and prescribed by a doctor. If treatment is necessary 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 with strawberry 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 a low level of amniotic fluid surrounding the child (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, but it is very unlikely to have a negative effect on the breastfed infant.
Fertility
This medicine belongs to a group of medicines (nonsteroidal anti-inflammatory drugs) that may have a negative effect on female fertility. This effect is temporary and disappears after the end of treatment.

Driving and using machines

As large doses of Ibufen for children FORTE with strawberry flavor may cause adverse reactions related to the central nervous system, such as fatigue and dizziness, it may impair the ability to drive vehicles and operate machinery. This warning is particularly relevant when the medicine is taken with alcohol.

Ibufen for children FORTE with strawberry 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 with strawberry flavor

This medicine should always be taken exactly as described in this patient leaflet or as directed by a doctor or pharmacist. In case of doubt, the patient should consult their doctor or pharmacist.
The medicine should be taken orally.
A dosing device in the form of a syringe is included with the packaging for accurate dosing.
Before use, the bottle should be shaken.

• 1. Unscrew the bottle cap (press down and turn counterclockwise).
• 2. Firmly press the dosing device into the opening in the bottle neck.
• 3. Shake the bottle vigorously.
• 4. To fill the dosing device, turn the bottle upside down and then carefully move the plunger down to the desired mark on the scale.
• 5. Turn the bottle back to its original position and, carefully unscrewing the dosing device, remove it from the bottle.
• 6. Place the tip of the dosing device in the child's mouth and, slowly pressing the plunger, carefully empty the contents of the dosing device.
• 7. After administration, the bottle should be closed by screwing the cap, and the dosing device 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).
Do not exceed the maximum daily dose.
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 and moderate kidney and/or liver function disorders, there is no need to reduce the dose of Ibufen for children FORTE with strawberry flavor.
In elderly patients, dose adjustment is not required.

Taking a higher dose of Ibufen for children FORTE with strawberry flavor than recommended

If the patient has taken a higher dose of Ibufen for children FORTE with strawberry 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 possible health risks 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, dizziness, and disorientation. They may also include agitation, drowsiness, disorientation, or coma. In rare cases, seizures may occur. 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, 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 it has been less than one hour since the overdose.

Missing a dose of Ibufen for children FORTE with strawberry flavor

Do not take a double dose 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, this medicine 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 rashes can 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 with strawberry flavor is generally well-tolerated.
During short-term use of ibuprofen in doses available without a prescription, the following adverse reactions have been observed.
Adverse reactions are ranked according to frequency of occurrence.
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 (SLE) or 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 blood: red blood cells, white blood cells, and platelets; agranulocytosis - decreased granulocyte count). The first symptoms are fever, sore throat, superficial mouth ulcers, flu-like symptoms, fatigue, nosebleeds, and skin bruising.
• 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;
• ringing in the ears, dizziness;
• edema, high blood pressure, heart failure (reported in connection with the use of NSAIDs in high doses);
• stomach and duodenal ulcers, perforation, or gastrointestinal bleeding, black stools, bloody vomiting, sometimes with a fatal outcome, especially in the elderly; ulcerative stomatitis, 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 urea levels in the blood 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 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 described.

Reporting side effects

If side effects occur, including those 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 Adverse Reaction Monitoring 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 gather more information on the safety of the medicine.

5. How to store Ibufen for children FORTE with strawberry flavor

Store at a temperature below 25°C.
Store in the original packaging.
Store the bottle tightly closed.
The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiration date stated on the bottle and carton after:
EXP. The expiration date refers to the last day of the specified 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 that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Ibufen for children FORTE with strawberry flavor contains

• The active substance of the medicine is ibuprofen. 5 ml of oral suspension contains 200 mg of ibuprofen.
• 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, strawberry flavor, purified water.

What Ibufen for children FORTE with strawberry flavor looks like and what the packaging contains

The medicine is a white or almost white oral suspension with a strawberry flavor and smell.
Available packaging:
100 ml or 40 ml of oral suspension in a white PET bottle with an adapter inserted, closed with a polyethylene cap with a tamper-evident ring and a child-resistant closure system.
The bottle, together with the patient leaflet and a dosing device in the form of a syringe, is placed in a cardboard box. The dosing device in the form of a syringe has a volume of 5 ml and a scale every 0.25 ml.

Marketing authorization holder

Zakłady Farmaceutyczne POLPHARMA S.A.
ul. Pelplińska 19, 83-200 Starogard Gdański
phone: +48 22 364 61 01

Manufacturer

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

Date of last revision of the leaflet: