Ibufen Dla Dzieci o smaku truskavkovim

Leaflet attached to the packaging: patient information

Ibufen for children with strawberry flavor, 100 mg/5 ml, oral suspension

Ibuprofen

You should carefully read the contents of the leaflet before taking the medicine, as it contains important information for the patient.

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

• You should 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 any side effects 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 their doctor.

Table of contents of the leaflet

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

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

The active substance of the medicine is ibuprofen, which belongs to the group of non-steroidal anti-inflammatory drugs (NSAIDs). The medicine relieves symptoms such as fever, pain, and swelling by acting at the site of their occurrence.

The medicine is intended for use in infants and children in the following cases:

• fever of various origins (also in the course of viral infections, in the course of post-vaccination reaction).
• pains of various origins of mild to moderate severity:
• headaches, throat and muscle pains, e.g. in the course of viral infections;
• muscle, joint and bone pains, as a result of injuries to the musculoskeletal system (sprains, twists);
• pains due to injuries to soft tissues, post-operative pains;
• toothaches, pains after tooth extraction, pains due to teething;
• headaches;
• ear pains occurring in inflammatory conditions of the middle ear.

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

When not to take Ibufen for children with strawberry flavor:

• 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 had symptoms of an allergic reaction in the form of rhinitis (allergic rhinitis), angioedema, urticaria, bronchospasm or asthma after taking acetylsalicylic acid or other non-steroidal anti-inflammatory drugs (NSAIDs);
• if the patient has active or recurrent gastric and/or duodenal ulcer, or recurrent ulceration or bleeding from the gastrointestinal tract (two or more separate episodes of confirmed ulceration or bleeding);
• if the patient has had bleeding from the upper gastrointestinal tract or perforation after taking NSAIDs;
• if the patient has severe liver, kidney or heart failure;
• if the patient is in the third trimester of pregnancy;
• if the patient has a bleeding disorder.

Warnings and precautions

Before starting to take Ibufen for children with strawberry flavor, you should discuss it with your doctor or pharmacist.

During the use of ibuprofen, symptoms of an allergic reaction to this medicine have been reported, including breathing problems, facial and neck swelling (angioedema), chest pain. If the patient notices any of these symptoms, they should stop taking Ibufen for children with strawberry flavor and contact their doctor or emergency services immediately.

You should inform your pharmacist or doctor if the patient has an infection - see below, section entitled "Infections".

You should consult a doctor if the patient has:

• lupus erythematosus and mixed connective tissue disease,
• symptoms of allergic reactions after taking acetylsalicylic acid,
• gastrointestinal diseases and chronic inflammatory bowel diseases (ulcerative colitis, Crohn's disease),
• hypertension and/or heart function disorders,
• kidney function disorders,
• liver function disorders,
• blood clotting disorders,
• active or recurrent asthma or symptoms of allergic reactions in the past, as taking the medicine may cause bronchospasm,
• chickenpox - see below, section entitled "Infections".

You should also consult a doctor if the patient is taking other medicines, especially anticoagulant medicines, diuretics, cardiac glycosides, corticosteroids (see section "Ibufen for children with strawberry flavor and other medicines").

You should avoid taking ibuprofen at the same time as other non-steroidal anti-inflammatory drugs, including medicines called COX-2 inhibitors.

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. In case of gastrointestinal bleeding or ulceration, the medicine should be discontinued immediately. Patients with a history of gastrointestinal diseases, especially the elderly (Ibufen for children with strawberry flavor can also be used by adults), should inform their doctor about any unusual gastrointestinal symptoms (especially bleeding), especially during the initial treatment period.

In elderly patients, the risk of adverse reactions due to the use of the medicine is higher than in younger patients.

Concomitant, prolonged use of different painkillers may lead to kidney damage with a risk of kidney failure (analgesic nephropathy). This risk may increase in case of physical exertion resulting in loss of salts and dehydration.

Therefore, concomitant, prolonged use of different painkillers should be avoided.

There is a risk of kidney function disorder in dehydrated children.

Taking anti-inflammatory and pain-relieving medicines, such as ibuprofen, may be associated with a small increase in the risk of heart attack or stroke, especially when used in high doses. You should not exceed the recommended dose and duration of treatment.

Before taking Ibufen for children with strawberry flavor, the patient should discuss the treatment with their doctor or pharmacist if:

• the patient has heart diseases, such as heart failure, angina pectoris (chest pain), the patient has had a heart attack, coronary artery bypass grafting, the patient has peripheral arterial disease (poor blood circulation in the legs due to narrowing or blockage of arteries) or if the patient has had any stroke (including mini-stroke or transient ischemic attack - TIA).
• the patient has hypertension, diabetes, increased cholesterol levels, there is a history of heart disease or stroke in the patient's family, or if the patient smokes.

Severe skin reactions

Severe skin reactions have been reported in connection 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). You should stop taking Ibufen for children with strawberry flavor and seek medical attention immediately if any of the symptoms associated with severe skin reactions described in section 4 occur.

Infections

Ibufen for children with strawberry flavor may mask the symptoms of an infection, such as fever and pain.

Therefore, Ibufen for children with strawberry flavor may delay the use of appropriate infection treatment, which can lead to an increased risk of complications.

This has been observed in the course of 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 the use of ibuprofen, single cases of toxic amblyopia (visual impairment) have been reported, so any vision disorders should be reported to the doctor.

Taking the medicine for the shortest period necessary to relieve symptoms reduces the risk of adverse reactions.

Ibufen for children with strawberry flavor and other medicines

You should tell your doctor about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.

Ibufen for children with strawberry flavor may affect the action of other medicines or other medicines may affect the action of Ibufen for children with strawberry flavor. For example:

• anticoagulant medicines (i.e. blood thinners or medicines that prevent blood clots, such as aspirin - acetylsalicylic acid, warfarin, ticlopidine);
• medicines that lower blood pressure (ACE inhibitors, such as captopril, beta-adrenergic blockers, such as atenolol, angiotensin II receptor antagonists, such as losartan);
• painkillers;
• other non-steroidal anti-inflammatory drugs;
• medicines used in depression (selective serotonin reuptake inhibitors (SSRIs)), lithium;
• diuretics;
• zydovudine, ritonavir (medicines used in the treatment of HIV infections);
• methotrexate (a medicine used in the treatment of cancer or rheumatoid arthritis);
• corticosteroids (such as prednisolone);
• phenytoin (an antiepileptic medicine);
• cyclosporine, tacrolimus (medicines that reduce the body's immune response);
• mifepristone (a medicine used in gynecology);
• quinolone antibiotics (such as ciprofloxacin);
• aminoglycoside antibiotics (such as streptomycin);
• cardiac glycosides, including digoxin (used in the treatment of heart diseases);
• probenecid, sulfinpyrazone (medicines used in the treatment of gout);
• oral anti-diabetic medicines (such as glimepiride);
• voriconazole, fluconazole (antifungal medicines);
• cholestyramine (used in people with high cholesterol levels). Also, some other medicines may be affected or have an effect on the treatment with Ibufen for children with strawberry flavor. Therefore, before taking Ibufen for children with strawberry flavor with other medicines, you should always consult a doctor or pharmacist.

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 a doctor or pharmacist before taking this medicine.

Pregnancy

Ibufen for children with strawberry flavor should not be used during the last 3 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 with strawberry flavor should not be taken during the first 6 months of pregnancy, unless it is absolutely necessary and recommended by a doctor. If treatment is necessary during this period or during an attempt to become pregnant, the smallest effective dose of the medicine should be used for the shortest possible time. Ibufen for children 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, which can lead 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 treatment for a longer period than a few days 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 (non-steroidal anti-inflammatory drugs) that may have a negative effect on fertility in women. This effect is temporary and disappears after the end of treatment.

Driving and using machines

You should not expect the medicine to affect the ability to drive and use machines if it is used in the recommended doses and treatment duration.

Ibufen for children with strawberry flavor contains sodium benzoate (E 211), liquid maltitol (E 965), propylene glycol (E 1520) and sodium

The medicine contains 5 mg of sodium benzoate in each 5 ml of oral suspension.

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 4.17 mg of propylene glycol in each 5 ml of oral suspension.

The medicine contains 9.67 mg of sodium (the main component of common salt) in each 5 ml of oral suspension.

This corresponds to 0.48% of the maximum recommended daily intake of sodium in the diet for adults.

3. How to take Ibufen for children with strawberry flavor

This medicine should always be taken exactly as described in this patient leaflet or as directed by your doctor or pharmacist. In case of doubt, you should consult a doctor or pharmacist.

Oral administration.

The smallest effective dose should be used for the shortest period necessary to relieve symptoms and reduce the risk of adverse reactions. If the symptoms of an infection (such as fever and pain) persist or worsen, you should consult a doctor immediately (see section 2).

The recommended daily dose of the medicine is 20 to 30 mg per kilogram of body weight, given in divided doses according to the following table.

The dose can be repeated every 6-8 hours, with a minimum of 4 hours between doses.

A higher dose of the medicine than recommended should not be used.

The medicine is intended for short-term use.

In the case of children aged 3-5 months, a doctor should be consulted if the symptoms worsen or if they do not improve after 24 hours.

Children under 6 months of age should only be given the medicine after consulting a doctor and on their recommendation.

In the case of children over 6 months of age, a doctor should be consulted if the medicine needs to be given for more than 3 days or if the symptoms worsen.

The opened package should be used within 6 months.

A dosing syringe is attached to the packaging.

Instructions for using the dosing syringe

• 1. The bottle cap should be unscrewed (pressed down and turned in the opposite direction to the arrow).
• 2. The dosing syringe should be firmly inserted into the opening in the bottle neck.
• 3. The bottle should be shaken vigorously.
• 4. To fill the dosing syringe, the bottle should be turned upside down and then the plunger of the dosing syringe should be carefully pushed down to the desired mark on the scale.
• 5. The bottle should be turned back to its original position and the dosing syringe should be carefully removed from the bottle by twisting it.
• 6. The tip of the dosing syringe should be placed in the child's mouth and then, slowly pressing the plunger, the contents of the dosing syringe should be carefully emptied.
• 7. After use, the bottle should be closed by screwing the cap on, and the dosing syringe should be washed and dried.

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

If the patient has taken a higher dose of Ibufen for children with strawberry flavor than recommended or if a child has accidentally taken the medicine, they should always consult a doctor or go to the nearest hospital to get an opinion on the possible risk to their health and advice on what actions to take in such a case.

Overdose cases are rare.

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. Seizures have also been reported in some cases. After taking high 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. Additionally, low blood pressure and breathing difficulties may occur.

There is no specific antidote. Treatment is symptomatic and supportive. The doctor will consider administering activated charcoal if it has been no more than one hour since the overdose.

Missing a dose of Ibufen for children with strawberry flavor

A double dose should not be taken to make up for a missed dose.

In case of any further doubts about the use of this medicine, you should consult a doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

You should stop taking ibuprofen and seek medical attention immediately if you 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 enlarged 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.

The medicine is generally well tolerated. During short-term use of ibuprofen in doses available without a prescription, the following adverse reactions have been observed.

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)

• bloatedness with gas, constipation, and vomiting;
• dizziness, insomnia, agitation, and fatigue.

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

• aseptic meningitis characterized by stiffness of the neck, 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: red blood cells, white blood cells, and platelets; agranulocytosis - decreased granulocyte count). The first symptoms are fever, sore throat, superficial ulcers of the oral mucosa, flu-like symptoms, fatigue, nosebleeds, skin bruising.
• severe hypersensitivity reactions characterized by facial and neck swelling (angioedema); shortness of breath; rapid heartbeat; significantly lowered blood pressure; anaphylaxis; angioedema or shock;
• asthma, worsening of asthma, bronchospasm, shortness of breath, and wheezing;
• nervousness;
• visual 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 bleeding from the gastrointestinal tract, 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 use of ibuprofen; hepatitis and jaundice;
• acute kidney failure; necrosis of the renal papillae, especially after long-term use of ibuprofen, associated with an increased level of urea in the serum 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 determined based on 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 you experience any side effects, including any side effects not listed in this leaflet, you should tell your 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

Tel.: +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.

By reporting side effects, you can help gather more information on the safety of the medicine.

5. How to store Ibufen for children with strawberry flavor

Store in the original packaging, at a temperature below 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 specified month.

The opened package should be used within 6 months.

Medicines should not be disposed of via wastewater or household waste. You should ask your 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 with strawberry flavor contains

• The active substance of the medicine is ibuprofen. 5 ml of oral suspension contains 100 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, strawberry flavor (flavoring ingredients, propylene glycol (E 1520), purified water), purified water.

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

Ibufen for children with strawberry flavor is a white or almost white oral suspension with a strawberry flavor.

The packaging is a PET bottle containing 100 or 120 ml of oral suspension, with an adapter inserted, closed with a polyethylene cap with a tamper-evident ring and a child-resistant closure system, together with a dosing syringe, in a cardboard box.

Not all pack sizes may be marketed.

Marketing authorization 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 Division in Sieradz

ul. Władysława Łokietka 10, 98-200 Sieradz

Date of last revision of the leaflet: