Ibufen dla dzieci o smaku malinovim

Leaflet accompanying the packaging: patient information

Ibufen for children with raspberry flavor, 100 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 used 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 is Ibufen for children with raspberry flavor and what is it used for
• 2. Important information before taking Ibufen for children with raspberry flavor
• 3. How to take Ibufen for children with raspberry flavor
• 4. Possible side effects
• 5. How to store Ibufen for children with raspberry flavor
• 6. Package contents and other information

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

The active substance of the medicine is ibuprofen, which belongs to the group of nonsteroidal 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 (including viral infections, post-vaccination reactions).
• pain of various origins of mild to moderate severity:
• headaches, throat and muscle pain, e.g. with viral infections;
• muscle, joint and bone pain due to injuries to the musculoskeletal system (sprains, strains);
• pain due to soft tissue injuries, post-operative pain;
• toothaches, pain after tooth extraction, pain due to teething;
• headaches;
• ear pain occurring in middle ear infections.

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

When not to take Ibufen for children with 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 an allergic reaction in the form of a runny nose (rhinitis), angioedema, urticaria, bronchospasm, or asthma after taking acetylsalicylic acid or other nonsteroidal anti-inflammatory drugs (NSAIDs);
• if the patient has active or recurrent peptic ulcer disease of the stomach and/or duodenum, or recurrent ulceration or bleeding from the gastrointestinal tract (two or more separate episodes of confirmed ulceration or bleeding);
• if the patient has had gastrointestinal bleeding 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 treatment with Ibufen for children with raspberry flavor, the patient should discuss it with a doctor or pharmacist.

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

The patient should inform the pharmacist or doctor if they have an infection - see below, section "Infections".

The patient should consult a doctor if they have:

• systemic 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 a history of allergic reactions, as ibuprofen may cause bronchospasm,
• chickenpox - see below, section "Infections".

The patient should also consult a doctor if they are taking other medicines, especially anticoagulants, diuretics, cardiac glycosides, corticosteroids (see section "Ibufen for children with raspberry flavor and other medicines").

The patient should avoid taking ibuprofen with other nonsteroidal anti-inflammatory drugs, including those called COX-2 inhibitors.

There is a risk of gastrointestinal bleeding, ulceration, or perforation, which can be fatal and may not 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 diseases, especially the elderly (Ibufen for children with raspberry flavor oral suspension may 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 the case of physical exertion resulting in salt loss and dehydration.

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

There is a risk of kidney function disorders in dehydrated children and adolescents.

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

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

• the patient has heart diseases, such as heart failure, angina pectoris (chest pain), has had a heart attack, coronary artery bypass grafting, or has peripheral arterial disease (poor blood 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 hypertension, diabetes, high cholesterol levels, has a family history of heart disease or stroke, or smokes.

Severe skin reactions

Severe skin reactions have been reported with ibuprofen, 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 with raspberry flavor and seek medical help immediately if they experience any symptoms associated with severe skin reactions described in section 4.

Infections

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

Therefore, Ibufen for children with raspberry flavor may delay the use of appropriate infection treatment, which can 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 a doctor immediately.

During treatment with ibuprofen, single cases of toxic amblyopia (visual impairment) have been reported, so any vision disturbances should be reported to a doctor.

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

Ibufen for children with raspberry flavor and other medicines

The patient should tell their doctor about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.

Ibufen for children with raspberry flavor may affect the action of other medicines or other medicines may affect the action of Ibufen for children with raspberry 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-blockers, such as atenolol, angiotensin II receptor antagonists, such as losartan);
• painkillers;
• other nonsteroidal anti-inflammatory drugs;
• medicines used in depression (selective serotonin reuptake inhibitors - SSRIs), lithium;
• diuretics;
• zydovudine, ritonavir (medicines used to treat HIV infections);
• methotrexate (a medicine used to treat 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 (medicines used to treat heart diseases);
• aminoglycosides (such as streptomycin);
• probenecid, sulfinpyrazone (medicines used to treat gout);
• oral antidiabetic medicines (such as glimepiride);
• voriconazole, fluconazole (antifungal medicines);
• cholestyramine (used in people with high cholesterol levels).

Also, some other medicines may be affected by or have an effect on the treatment with Ibufen for children with raspberry flavor. Therefore, before taking Ibufen for children with raspberry flavor with other medicines, the patient 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 baby, they should consult a doctor or pharmacist before taking this medicine.

Pregnancy

Ibufen for children with raspberry flavor should not be used during the last 3 months of pregnancy, as it may harm the unborn baby or cause complications during delivery.

It may cause kidney and heart disorders in the unborn baby. It may affect the patient's and their baby's tendency to bleed and may cause delayed or prolonged labor.

Ibufen for children with raspberry 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 when trying to conceive, the smallest effective dose of the medicine should be used for the shortest possible time. Ibufen for children with 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 baby, leading to a low level of amniotic fluid surrounding the baby (oligohydramnios) or narrowing of the arterial duct (ductus arteriosus) in the baby's heart. If longer treatment is necessary, the doctor may recommend additional monitoring.

Breastfeeding

Ibuprofen may pass into breast milk in small amounts, but it is unlikely to affect breastfed babies negatively.

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

No effect on the ability to drive and use machines is expected if the medicine is used as recommended and for the recommended duration.

Ibufen for children with raspberry flavor contains sodium benzoate (E 211), liquid maltitol (E 965), 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 a doctor before taking the medicine.

The medicine contains 9.67 mg of sodium (a major 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 raspberry 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 doubts, the patient 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, the patient 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 at least a 4-hour interval between doses.

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

The medicine is intended for short-term use.

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

In children under 6 months of age, the medicine can only be given after consulting a doctor and on their recommendation.

In 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 included with the package.

Instructions for using the dosing syringe

• 1. The bottle cap should be unscrewed (press down and turn counterclockwise).
• 2. The dosing syringe should be firmly pressed 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 the plunger of the dosing syringe slowly pushed down to the desired mark on the scale.
• 5. The bottle should be turned back to its original position and the dosing syringe carefully unscrewed and removed from the bottle.
• 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, and the dosing syringe should be washed and dried.

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

If the patient has taken a higher dose of Ibufen for children with raspberry 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 possible health risks and advice on what to do.

Overdose cases are rare.

Overdose symptoms 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 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, asthma symptoms may worsen. Additionally, low blood pressure and breathing difficulties may occur.

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 with 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 a 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 help 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 in 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 bumps 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 with 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.

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 neck stiffness, headache, nausea, vomiting, fever, disorientation - reported in patients with existing autoimmune diseases such as systemic lupus erythematosus;
• 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: 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, petechiae on the skin;
• severe allergic reactions characterized by face and neck swelling (angioedema); difficulty breathing; rapid heartbeat; significantly low 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 association with the use of NSAIDs in high doses);
• peptic ulcer disease of the stomach and duodenum, perforation, or gastrointestinal bleeding, black stools, bloody vomiting, sometimes with a fatal outcome, especially in the elderly; ulcerative stomatitis, gastritis, oral ulcers;
• 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 estimated from the available data):

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

In single cases, depression and psychotic reactions have been described.

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.

By reporting side effects, more information can be collected on the safety of the medicine.

5. How to store Ibufen for children with raspberry flavor

Store at a temperature below 25°C. Do not store in the refrigerator. Store in the original packaging to protect from light.

The medicine should be kept out of sight and reach of children.

The medicine should not be used after the expiration date stated on the label and carton after EXP. The expiration 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. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Package contents and other information

What Ibufen for children with raspberry 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, raspberry flavor, purified water.

What Ibufen for children with raspberry flavor looks like and what the package contains

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

The package is a 100 ml PET bottle with an adapter, closed with a polyethylene cap with a tamper-evident ring and a child-resistant closure system, along with a dosing syringe, in a cardboard box.

Marketing authorization holder

Polpharma S.A.

ul. Pelplińska 19, 83-200 Starogard Gdański

phone: +48 22 364 61 01

Manufacturer

Polpharma S.A.

Medana Division in Sieradz

ul. Władysława Łokietka 10, 98-200 Sieradz

Date of the last revision of the leaflet: