Ibufen for children with raspberry flavor

Package leaflet: Information for the user

Ibufen dla dzieci o smaku malinowym, 100 mg/5 ml, oral suspension
Ibuprofenum
Please read this 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.

• Keep this leaflet, so that you can read it again if necessary.
• If you need advice or further information, please consult your pharmacist.
• If any adverse reactions occur, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.
• If there is no improvement within 24 hours in children aged 3–5 months, or within 3 days in children over 6 months of age, or if the patient feels worse, consult a doctor.

Table of contents

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

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

The active substance in this medicine is ibuprofen, which belongs to a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs). The medicine relieves symptoms such as fever, pain and swelling by acting at the site where they occur.
This medicine is intended for use in infants and children in the following cases:

• fever of various origins (including viral infections and post-vaccination reactions);
• mild to moderate pain of various causes:
  • headache, sore throat and muscle pain, e.g. during viral infections;
  • muscle, joint and bone pain due to musculoskeletal injuries (strains, sprains);
  • soft tissue injuries, postoperative pain;
  • toothache, pain after tooth extraction, teething pain;
  • headache;
  • ear pain associated with middle ear inflammation.

2. Important information before using Ibufen dla dzieci o smaku malinowym

When not to use Ibufen dla dzieci o smaku malinowym:

• if the patient is allergic to ibuprofen, other non-steroidal anti-inflammatory drugs (NSAIDs), or any of the other ingredients of this medicine (listed in section 6);
• if the patient has previously experienced allergic symptoms such as nasal congestion (rhinitis), angioedema, urticaria, bronchospasm, or bronchial asthma after taking acetylsalicylic acid or other non-steroidal anti-inflammatory drugs (NSAIDs);
• if the patient has active or past peptic ulcer disease of the stomach and/or duodenum, or recurrent ulceration or gastrointestinal bleeding (two or more separate episodes of confirmed ulceration or bleeding);
• if the patient has experienced bleeding from the upper gastrointestinal tract or perforation after using 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 dla dzieci o smaku malinowym, discuss this with your doctor or pharmacist.
Allergic reactions to ibuprofen, including breathing difficulties, facial and neck swelling (angioedema), and chest pain, have been reported during treatment. If the patient experiences any of these symptoms, they should immediately stop taking Ibufen dla dzieci o smaku malinowym and contact a doctor or emergency services.
Inform your pharmacist or doctor if the patient has an infection – see below, section titled "Infections".
Consult a doctor if the patient has been diagnosed with:

• systemic lupus erythematosus or mixed connective tissue disease,
• allergic reactions after taking acetylsalicylic acid,
• gastrointestinal disorders or chronic inflammatory bowel diseases (ulcerative colitis, Crohn's disease),
• hypertension and/or heart function disorders,
• kidney function disorders,
• liver function disorders,
• blood clotting disorders,
• current or past bronchial asthma or history of allergic reactions, as bronchospasm may occur after taking the medicine,
• chickenpox – see below, section titled "Infections".

Also consult a doctor if the patient is taking other medicines, especially anticoagulants, diuretics, cardiac glycosides, corticosteroids (see section "Ibufen dla dzieci o smaku malinowym and other medicines").
Avoid concomitant use of ibuprofen with other non-steroidal anti-inflammatory drugs, including COX-2 inhibitors.
There is a risk of gastrointestinal bleeding, ulceration, or perforation, which may be fatal and may occur without warning symptoms or in patients who previously experienced such warning signs. If gastrointestinal bleeding or ulceration occurs, discontinue the medicine immediately. Patients with a history of gastrointestinal disorders, especially elderly patients (Ibufen dla dzieci o smaku malinowym oral suspension may also be used by adults), should inform their doctor about any unusual gastrointestinal symptoms (particularly bleeding), especially during the initial treatment period.
The risk of adverse effects from using the medicine is higher in elderly patients than in younger patients.
Long-term, concomitant use of various painkillers may lead to kidney damage with risk of renal failure (analgesic nephropathy). This risk may increase with physical exertion leading to salt loss and dehydration. Therefore, avoid long-term, concomitant use of multiple painkillers.
There is a risk of kidney function impairment 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, particularly when used at high doses. Do not exceed the recommended dose or duration of treatment.
Before using Ibufen dla dzieci o smaku malinowym, the patient should discuss treatment with a doctor or pharmacist if:

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

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

Infections
Ibufen dla dzieci o smaku malinowym may mask symptoms of infection such as fever and pain. Therefore, Ibufen dla dzieci o smaku malinowym may delay appropriate treatment of infection and consequently increase the risk of complications. This has been observed in bacterial pneumonia and bacterial skin infections associated with chickenpox. If the patient takes this medicine during an ongoing infection and symptoms persist or worsen, consult a doctor immediately.
Cases of toxic amblyopia (reduced visual acuity) have been reported during ibuprofen use; therefore, any visual disturbances should be reported to a doctor.
Taking the medicine for the shortest duration necessary to relieve symptoms reduces the risk of adverse effects.

Ibufen dla dzieci o smaku malinowym and other medicines
Inform your doctor about all medicines currently or recently taken, as well as any medicines the patient plans to take.
Ibufen dla dzieci o smaku malinowym may affect the action of other medicines or other medicines may affect the action of Ibufen dla dzieci o smaku malinowym. For example:

• anticoagulant medicines (i.e., blood thinners or those preventing blood clots, such as aspirin - acetylsalicylic acid, warfarin, ticlopidine);
• medicines that lower blood pressure (ACE inhibitors such as captopril, beta-blockers such as those containing atenolol, angiotensin II receptor antagonists such as losartan);
• painkillers;
• other non-steroidal anti-inflammatory drugs;
• medicines used for depression (selective serotonin reuptake inhibitors (SSRIs)), lithium;
• diuretics;
• zidovudine, ritonavir (medicines used in 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 suppress 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 in the treatment of heart diseases);
• aminoglycosides (such as streptomycin);
• probenecid, sulfinpyrazone (medicines used in the treatment of gout);
• oral antidiabetic medicines (such as glimepiride);
• voriconazole, fluconazole (antifungal medicines);
• cholestyramine (used in patients with high cholesterol levels).

Also, some other medicines may be affected by or may affect treatment with Ibufen dla dzieci o smaku malinowym. Therefore, always consult a doctor or pharmacist before using Ibufen dla dzieci o smaku malinowym with other medicines.

Pregnancy, breastfeeding, and effects on fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult a doctor or pharmacist before using this medicine.

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

Breastfeeding
Ibuprofen may pass into breast milk in small amounts, but it is very unlikely to have a negative effect on the breastfed infant.

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

Driving and operating machinery
No effect of the medicine on the ability to drive or operate machinery is expected when used at recommended doses and treatment duration.

Ibufen dla dzieci o smaku malinowym 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 certain sugars, the patient should consult a doctor before taking the medicine.
The medicine contains 9.67 mg of sodium (main component of table salt) in each 5 ml of oral suspension. This corresponds to 0.48% of the maximum recommended daily sodium intake in the diet for adults.

3. How to use Ibufen dla dzieci o smaku malinowym

This medicine should always be taken exactly as described in this patient leaflet or as directed by a doctor or pharmacist. If in doubt, consult a doctor or pharmacist.
Oral use.
The lowest effective dose for the shortest possible duration necessary to relieve symptoms should be used in order to reduce the risk of adverse effects. If symptoms of infection (such as fever and pain) persist or worsen, consult a doctor immediately (see section 2).
The recommended daily dose is 20 to 30 mg per kg of body weight, administered in divided doses according to the table below.

The dose may be repeated every 6-8 hours, maintaining at least a 4-hour interval between doses.
Do not use a higher dose than recommended.
The medicine is intended for short-term use.
In children aged 3-5 months, consult a doctor if symptoms worsen or do not improve within 24 hours.
In children under 6 months of age, the medicine should be given only after consultation with a doctor and on medical advice.
In children over 6 months of age, consult a doctor if the medicine needs to be used for more than 3 days or if symptoms worsen.
An opened container should be used within 6 months.
A dosing syringe is attached to the package.
Instructions for using the dosing syringe

1. Unscrew the bottle cap (press down and turn counterclockwise).
2. Firmly insert the dosing syringe into the neck of the bottle.
3. Shake the bottle vigorously.
4. To fill the syringe, invert the bottle, then carefully pull the plunger down until the desired amount of suspension reaches the appropriate mark on the scale.
5. Return the bottle to upright position and carefully remove the syringe by twisting it out.
6. Place the tip of the syringe into the child's mouth, then slowly press the plunger to gently empty the syringe contents.
7. After use, close the bottle by replacing the cap, and wash and dry the dosing syringe. Use of a higher than recommended dose of Ibufen dla dzieci o smaku malinowym If a patient has taken more than the recommended dose of Ibufen dla dzieci o smaku malinowym or if a child has accidentally ingested the medicine, always consult a doctor or go to the nearest hospital to assess possible health risks and receive advice on necessary actions. Cases of overdose are rare. Symptoms of overdose may include nausea, abdominal pain, vomiting (possibly with blood), gastrointestinal bleeding (see also section 4 below), diarrhea, headache, tinnitus, confusion, and nystagmus. Excitement, drowsiness, confusion, or coma may also occur. Seizures have been reported occasionally in patients. After large doses, drowsiness, chest pain, palpitations, loss of consciousness, seizures (especially in children), weakness, dizziness, hematuria, hypokalemia, feeling cold, and breathing difficulties have been reported. Additionally, prothrombin time (INR) may be prolonged, likely due to impaired blood clotting factor function. Acute renal failure and liver damage may occur. In patients with asthma, worsening of asthma symptoms may occur. Additionally, hypotension and breathing difficulties may occur.

There is no specific antidote. Treatment is symptomatic and supportive. The doctor may consider administering activated charcoal if less than one hour has passed since the overdose.
Missed dose of Ibufen dla dzieci o smaku malinowym
Do not take a double dose to make up for a missed dose.
If you have any further doubts concerning the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
You should stop taking ibuprofen and seek immediate medical help if any of the following symptoms occur:

• Red, flat, circular or target-like skin lesions on the trunk, often with blisters in the centre, skin peeling, mouth, throat, nose, genital or eye ulcers. These severe skin rashes may be preceded by fever and flu-like symptoms [exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis] – very rare.
• Widespread rash, high fever, and swollen lymph nodes (DRESS syndrome) – frequency unknown.
• Red, scaly widespread rash with subcutaneous nodules and blisters, accompanied by fever. Symptoms usually appear at the beginning of treatment (acute generalized exanthematous pustulosis) – frequency unknown.

Ibufen dla dzieci o smaku malinowym is generally well tolerated. During short-term use of ibuprofen at over-the-counter doses, the following adverse effects have been observed:

Frequent (affects less than 1 in 10 people)

• Diarrhoea.

Uncommon (affects less than 1 in 100 people)

• Indigestion, abdominal pain, nausea, bloating;
• Headache;
• Various types of skin rash, urticaria, and itching.

Rare (affects less than 1 in 1,000 people)

• Bloating with gas release, constipation, and vomiting;
• Dizziness, insomnia, restlessness, and feeling tired.

Very rare (affects less than 1 in 10,000 people)

• Aseptic meningitis, presenting with neck stiffness, headache, nausea, vomiting, fever, and disorientation – reported in patients with pre-existing autoimmune diseases such as systemic lupus erythematosus or mixed connective tissue disease;
• Blood disorders (anaemia; leukopenia – reduced white blood cell count; thrombocytopenia – reduced platelet count; pancytopenia – haematological disorder characterised by deficiency of all normal blood cells: erythrocytes, leukocytes, and thrombocytes; agranulocytosis – reduced granulocyte count). Initial symptoms include fever, sore throat, superficial oral mucosal ulcers, flu-like symptoms, fatigue, nosebleeds, and skin petechiae;
• Severe hypersensitivity reactions presenting as swelling of the face, tongue, and larynx; shortness of breath; rapid heartbeat; significant drop in blood pressure, anaphylaxis, angioedema, or shock;
• Asthma, worsening of asthma, bronchospasm, dyspnoea, and wheezing;
• Nervousness;
• Visual disturbances;
• Tinnitus, dizziness;
• Oedema, hypertension, heart failure (reported with high-dose use of NSAIDs);
• Gastric and duodenal ulcer disease, gastrointestinal perforation or bleeding, melaena, haematemesis, sometimes fatal, particularly in elderly patients; ulcerative stomatitis, gastritis, oral ulcers;
• Exacerbation of colitis and Crohn's disease;
• Liver function disorders, particularly during long-term ibuprofen use; hepatitis and jaundice;
• Acute renal failure; renal papillary necrosis, particularly after prolonged ibuprofen use, associated with increased serum urea levels and oedema, including peripheral oedema; presence of blood and/or protein in urine; interstitial nephritis, nephrotic syndrome;
• Decreased haematocrit and haemoglobin levels in laboratory tests.

Frequency unknown (frequency cannot be estimated from available data):

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

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

5. How to store the medicine Ibufen dla dzieci o smaku malinowym

Store below 25 °C. Do not store in the refrigerator. Keep in the original packaging to protect from light.
Keep the medicine 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 stated month.
Once opened, the container should be used within 6 months.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the pack and other information

What Ibufen dla dzieci o smaku malinowym contains

• The active substance is ibuprofen. 5 ml of suspension contains 100 mg of ibuprofen.
• The other ingredients are: hypromellose, xanthan gum, glycerol (E 422), sodium benzoate (E 211), maltitol liquid (E 965), sodium citrate, citric acid monohydrate, sodium saccharin (E 954), sodium chloride, raspberry flavour, purified water.

What Ibufen dla dzieci o smaku malinowym looks like and contents of the pack
Ibufen dla dzieci o smaku malinowym is a white or almost white suspension with a raspberry odour.
Pack: a PET bottle containing 100 ml of suspension, fitted with an adapter, closed with a polyethylene cap with a tamper-evident ring and child-resistant closure system, together with an oral syringe dosing device, in a cardboard box.
Marketing Authorisation Holder
Zakłady Farmaceutyczne POLPHARMA S.A.
ul. Pelplińska 19, 83-200 Starogard Gdański
tel. + 48 22 364 61 01
Manufacturer
Zakłady Farmaceutyczne POLPHARMA S.A.
Medana Branch in Sieradz
ul. Władysława Łokietka 10, 98-200 Sieradz