Ibufen for children with strawberry flavor

Package leaflet: Information for the patient

Ibufen Dla Dzieci o smaku truskawkowym, 100 mg/5 ml, oral suspension
Ibuprofenum
Please read this leaflet carefully before taking this medicine because it contains important information for you.
This medicine should always be used exactly as described in this patient leaflet or as directed by your 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 you experience any adverse reactions, including any not listed in this leaflet, tell 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 aged 6 months and older, or if the patient feels worse, contact your doctor.

Leaflet contents

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

1. What Ibufen Dla Dzieci o smaku truskawkowym 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). This medicine relieves symptoms such as fever, pain and swelling by acting at the site where these symptoms arise.
This medicine is intended for use in infants and children in the following conditions:

• Fever of various causes (including viral infections and post-vaccination reactions).
• Mild to moderate pain of various origins:
  • 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 dental extraction, teething pain;
  • Headache;
  • Ear pain associated with middle ear inflammation.

2. Important information before using Ibufen Dla Dzieci o smaku truskawkowym

When not to use Ibufen Dla Dzieci o smaku truskawkowym:

• 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 reactions such as rhinitis (nasal congestion), 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 gastrointestinal ulceration or bleeding (two or more separate episodes of confirmed ulceration or bleeding);
• if the patient has experienced gastrointestinal bleeding from the upper gastrointestinal tract or perforation following the use of 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 truskawkowym, 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 truskawkowym and contact a doctor or emergency services.
Inform your pharmacist or doctor if the patient has an infection – see the section titled “Infections” below.
Consult your 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,
• active or past bronchial asthma or previous allergic reactions, as bronchospasm may occur after taking the medicine,
• chickenpox – see the section below titled “Infections”.

You should also consult a doctor if the patient is taking other medicines, especially anticoagulants, diuretics, cardiac medications, or corticosteroids (see section “Ibufen Dla Dzieci o smaku truskawkowym and other medicines”).
Avoid using ibuprofen together with other non-steroidal anti-inflammatory drugs, including drugs known as COX-2 inhibitors.
There is a risk of gastrointestinal bleeding, ulceration, or perforation, which may be life-threatening 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 truskawkowym may also be used by adults), should inform their doctor of any unusual gastrointestinal symptoms (especially bleeding), particularly 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, simultaneous use of various painkillers may lead to kidney damage with a risk of kidney failure (analgesic nephropathy). This risk may increase with physical exertion leading to salt loss and dehydration. Therefore, avoid long-term, simultaneous use of multiple painkillers.
There is a risk of kidney function impairment in dehydrated children.
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 truskawkowym, the patient should discuss treatment with a doctor or pharmacist if:

• the patient has heart diseases such as heart failure, angina (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, high 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 truskawkowym and seek immediate medical help if any symptoms related to severe skin reactions described in section 4 occur.

Infections
Ibufen Dla Dzieci o smaku truskawkowym may mask symptoms of infection such as fever and pain. Therefore, Ibufen Dla Dzieci o smaku truskawkowym 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, seek immediate medical advice.
Cases of toxic amblyopia (reduced visual acuity) have been reported during ibuprofen treatment; 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 truskawkowym and other medicines
Tell your doctor about all medicines currently or recently taken, as well as any medicines the patient plans to take.
Ibufen Dla Dzieci o smaku truskawkowym may affect the action of other medicines, or other medicines may affect the action of Ibufen Dla Dzieci o smaku truskawkowym. For example:

• anticoagulant medicines (i.e., blood thinners or those preventing clot formation, such as aspirin - acetylsalicylic acid, warfarin, ticlopidine);
• blood pressure-lowering medicines (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 cancer or rheumatoid arthritis treatment);
• corticosteroids (such as prednisolone);
• phenytoin (an anticonvulsant);
• cyclosporine, tacrolimus (immunosuppressive medicines);
• mifepristone (a medicine used in gynecology);
• quinolone antibiotics (such as ciprofloxacin);
• aminoglycoside antibiotics (such as streptomycin);
• cardiac glycosides, including digoxin (used in heart disease treatment);
• probenecid, sulfinpyrazone (medicines used in gout treatment);
• oral antidiabetic medicines (such as glimepiride);
• voriconazole, fluconazole (antifungal medicines);
• cholestyramine (used in patients with high cholesterol levels).

Other medicines may also interact with or be affected by treatment with Ibufen Dla Dzieci o smaku truskawkowym. Therefore, always consult a doctor or pharmacist before using Ibufen Dla Dzieci o smaku truskawkowym 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 truskawkowym 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 problems in the unborn child. It may affect bleeding tendency in the patient and her child and may delay or prolong labor.
Do not take Ibufen Dla Dzieci o smaku truskawkowym during the first 6 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 truskawkowym taken for longer than a few days starting from the 20th week of pregnancy may cause kidney problems in the unborn child, leading to low levels of amniotic fluid surrounding the baby (oligohydramnios), or narrowing of a blood vessel (ductus arteriosus) in the baby’s heart. If prolonged treatment is necessary, the doctor may recommend additional monitoring.

Breastfeeding
Ibuprofen passes into breast milk in small amounts but is very unlikely to adversely affect a breastfed infant.

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

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

Ibufen Dla Dzieci o smaku truskawkowym 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 certain sugars, they should contact their doctor before taking this 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 (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 truskawkowym

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

The dose may be repeated every 6-8 hours, ensuring at least a 4-hour interval between doses.
Do not use a higher dose than recommended.
This medicinal product is intended for short-term use only.
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, this medicinal product should only be administered after consultation with a doctor and on medical advice.
In children over 6 months of age, consult a doctor if treatment is required for more than 3 days or if symptoms worsen.
Once opened, the container should be used within 6 months.
A dosing syringe is supplied with the container.

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 slowly pull the syringe plunger down to draw the suspension up to the desired 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.

Overdose of Ibufen Dla Dzieci o smaku truskawkowym
If a patient has taken more than the recommended dose of Ibufen Dla Dzieci o smaku truskawkowym or if a child has accidentally ingested the medicinal product, seek immediate medical advice from a doctor or go to the nearest hospital to assess potential health risks and receive guidance on appropriate actions.
Cases of overdose are rare.
Symptoms of overdose may include nausea, epigastric pain, vomiting (possibly with blood), gastrointestinal bleeding (see also section 4 below), diarrhoea, headache, tinnitus, confusion, and nystagmus. Restlessness, drowsiness, confusion, or coma may also occur. Seizures have been reported occasionally in patients. After ingestion of large doses, somnolence, chest pain, palpitations, loss of consciousness, seizures (particularly in children), weakness, and dizziness have been reported, as well as haematuria, hypokalaemia, feeling cold, and breathing difficulties. 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 truskawkowym
Do not administer a double dose to make up for a missed dose.
If you have any further questions about the use of this medicinal product, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, 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-shaped skin lesions on the trunk, often with blisters in the centre, skin peeling, and ulcers in the mouth, throat, nose, genital area or 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 fever and swollen lymph nodes (DRESS syndrome) – frequency unknown.
• Red, peeling widespread rash with subcutaneous nodules and blisters, accompanied by fever. Symptoms usually appear at the beginning of treatment (acute generalized exanthematous pustulosis) – frequency unknown.

The medicine is generally well tolerated. The following adverse reactions have been observed during short-term use of ibuprofen at over-the-counter doses.

Common (occurring in less than 1 in 10 patients):

• Diarrhoea.

Uncommon (occurring in less than 1 in 100 patients):

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

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

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

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

• Aseptic meningitis, presenting as neck stiffness, headache, nausea, vomiting, fever and confusion – 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 with 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 facial, tongue and laryngeal swelling; 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 ulceration, gastrointestinal perforation or bleeding, tarry stools, vomiting blood, sometimes with fatal outcome, particularly in elderly patients; ulcerative stomatitis, gastric mucosal inflammation, oral mucosal ulceration;
• Exacerbation of colitis and Crohn's disease;
• Liver function disorders, particularly during prolonged use of ibuprofen; 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;
• Reduced haematocrit and haemoglobin levels in laboratory tests.

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 serious allergic reaction called Kounis syndrome.

Depression and psychotic reactions have been reported in isolated cases.
Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor, pharmacist or nurse. Adverse reactions 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 reactions can also be reported to the marketing authorisation holder.
Reporting adverse reactions helps provide more information on the safety of the medicine.

5. How to store Ibufen Dla Dzieci o smaku truskawkowym

Store in the original packaging, at a temperature below 25 °C.
Keep the medicine out of the 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 required. Such practices help protect the environment.

6. Contents of the pack and other information

What Ibufen for Children Strawberry-flavoured 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, strawberry flavour (flavouring substances, propylene glycol (E 1520), water), purified water.

What Ibufen for Children Strawberry-flavoured looks like and contents of the pack
Ibufen for Children Strawberry-flavoured is a white or almost white suspension with a strawberry odour.
Packaging – PET bottles containing 100 ml or 120 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 dosing syringe, in a cardboard box.
Not all pack sizes may be marketed.
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