Package leaflet: Information for the user

IBUM for children
60 mg, suppositories
Ibuprofenum
Please read the entire leaflet carefully before use, 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
physician, pharmacist, or nurse.

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 possible adverse reactions not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.
If there is no improvement after 3 days, or if you feel worse, consult your doctor.

Table of contents

What Ibum for children is and what it is used for
Important information before using Ibum for children
How to use Ibum for children
Possible side effects
How to store Ibum for children
Contents of the pack and other information

1. What Ibum for children is and what it is used for

Ibum for children contains ibuprofen – an active substance belonging to the group of non-steroidal anti-inflammatory drugs (NSAIDs), which have analgesic, antipyretic, and anti-inflammatory properties.
Indications

Fever states of various origins, including those associated with influenza, colds, and post-vaccination reactions.
Mild to moderate pain of various origins, such as:
- Headache, sore throat, and muscle pain (e.g. during viral infections),
- Toothache, pain following dental procedures, teething pain,
- Joint and bone pain due to musculoskeletal injuries (e.g. sprains),
- Soft tissue injury pain,
- Postoperative pain,
- Ear pain associated with middle ear inflammation.

If there is no improvement after 3 days, or if you feel worse, consult a doctor.

2. Important information before using Ibum dla dzieci

When not to use Ibum dla dzieci

if the patient is allergic to the active substance or to any of the other ingredients of this medicine (listed in section 6),
if the patient is allergic to other non-steroidal anti-inflammatory drugs (NSAIDs),
in patients with active or a history of peptic ulcer or (and) duodenal ulcer, gastrointestinal perforation or bleeding, including those occurring after use of NSAIDs,
in patients who have experienced allergic symptoms such as rhinitis, urticaria, shortness of breath or bronchial asthma during treatment with acetylsalicylic acid or other NSAIDs,
when taking other NSAIDs (including COX-2 inhibitors such as celecoxib or etoricoxib),
if the patient has severe liver, kidney or heart failure,
if the patient has brain hemorrhage (cerebral vascular bleeding) or other bleeding,
if the patient has blood clotting disorders, haemorrhagic diathesis (tendency to bleed) or blood formation disorders of unknown origin,
in dehydrated patients (dehydration caused by vomiting, diarrhea or insufficient fluid intake).

If adults use this medicine, it should not be used during the last 3 months of pregnancy.
Warnings and precautions
Before starting to use Ibum dla dzieci, discuss this with your doctor, pharmacist or
nurse.
Exercise particular caution when using Ibum dla dzieci:

if the patient is taking other pain-relieving NSAIDs or acetylsalicylic acid,
if the patient has been diagnosed with certain skin diseases (systemic lupus erythematosus, mixed connective tissue disease),
if the patient has gastrointestinal disorders or chronic inflammatory bowel diseases (ulcerative colitis, Crohn's disease),
if the patient has high blood pressure and (or) heart function disorders,
if the patient has kidney function disorders,
if the patient has liver diseases,
after a recent major surgery,
if dehydration is present due to increased risk of kidney failure,
if the patient has blood clotting disorders (ibuprofen may prolong bleeding time),
if asthma, chronic rhinitis, nasal polyps or allergic diseases are currently present or have occurred in the past, as shortness of breath may occur,
when taking other medicines that may increase the risk of ulceration or bleeding, such as oral corticosteroids (e.g. prednisolone), anticoagulants (e.g. acenocoumarol), selective serotonin reuptake inhibitors (antidepressants) and antiplatelet drugs (such as acetylsalicylic acid).

Allergic reactions to ibuprofen have occurred, including breathing difficulties, facial and neck swelling (angioedema), and chest pain.
If any of these symptoms occur, discontinue Ibum dla dzieci immediately and contact a doctor or emergency medical services without delay.
Inform your pharmacist or doctor if the patient has an infection — see below, the section titled "Infections".
Concurrent, long-term use of painkillers may lead to persistent serious kidney problems.
Infections
Ibum dla dzieci may mask symptoms of infection such as fever and pain. Therefore, Ibum dla dzieci 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 existing infection and infection symptoms persist or worsen, consult a doctor immediately.
Ibum dla dzieci may mask symptoms of an existing infection or fever.
The use of drugs such as ibuprofen may be associated with a small increased risk of heart attack (myocardial infarction) or stroke. This risk increases with prolonged use of high doses. Do not use higher doses or longer treatment duration than recommended (3 days).
If the patient has heart problems, a history of stroke, or suspicion of an increased risk of these conditions (high blood pressure, diabetes, elevated cholesterol, smoking), discuss the treatment approach with a doctor or pharmacist.
Avoid using Ibum dla dzieci during chickenpox.
Skin reactions
Severe skin reactions associated with the use of Ibum dla dzieci have been reported.
If any skin rash, mucosal changes, blisters or other signs of allergy appear, stop taking Ibum dla dzieci and seek immediate medical help, as these may be the first signs of a very serious skin reaction. See section 4.
Serious skin reactions such as exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), and acute generalized exanthematous pustulosis (AGEP) have occurred with ibuprofen use. If the patient develops any of the symptoms related to these serious skin reactions described in section 4, discontinue Ibum dla dzieci immediately and seek medical help.
Elderly patients have an increased risk of adverse effects during treatment with NSAIDs, particularly those affecting the stomach and intestines.
Patients who have previously experienced adverse effects in the gastrointestinal tract, especially elderly patients, should report any unusual abdominal symptoms (particularly gastrointestinal bleeding), especially at the beginning of treatment.
Ibum dla dzieci and other medicines
Tell your doctor or pharmacist about all medicines currently used or recently used, as well as any medicines the patient plans to use.
In particular, inform your doctor if you are taking:

corticosteroids (e.g. prednisolone), as they may increase the risk of gastrointestinal ulceration or bleeding,
other NSAIDs (including COX-2 inhibitors such as celecoxib or etoricoxib),
certain anticoagulants (e.g. acetylsalicylic acid/aspirin, acenocoumarol, ticlopidine), as NSAIDs may enhance the effect of anticoagulants,
certain antihypertensive drugs (ACE inhibitors, e.g. captopril), which may be affected by or may affect ibuprofen treatment,
antiplatelet drugs (such as acetylsalicylic acid) and selective serotonin reuptake inhibitors (antidepressants), as they increase the risk of gastrointestinal adverse effects,
antihypertensive drugs and diuretics, as NSAIDs may reduce the effectiveness of these drugs and increase the risk of kidney damage; in such cases, it is important that the child drinks plenty of water throughout the day,
lithium (a drug used in depression), as ibuprofen may increase lithium effects,
methotrexate (a drug used in cancer or rheumatic diseases), as ibuprofen may increase methotrexate effects,
tacrolimus (an immunosuppressant), as there is an increased risk of nephrotoxicity,
cyclosporine (an immunosuppressant), as limited data suggest an increased risk of nephrotoxicity,
zidovudine (a drug used in AIDS treatment), as ibuprofen use may increase the risk of joint bleeding or bleeding leading to swelling (in patients with hemophilia and positive HIV antibody test),
sulfonylurea derivatives (antidiabetic drugs): clinical interactions between these drugs and NSAIDs may occur; blood glucose monitoring is recommended,
probenecid and sulfinpyrazone (drugs used in gout treatment): may delay ibuprofen elimination,
digoxin, phenytoin and lithium: ibuprofen may increase plasma concentrations of these drugs,
quinolone antibiotics: may increase the risk of seizures,
cholestyramine: may delay and reduce absorption of NSAIDs,
mifepristone: do not use NSAIDs within 8–12 days after mifepristone administration, as they may reduce mifepristone's effectiveness,
voriconazole and fluconazole (antifungal drugs): may increase risks associated with NSAID use.

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 take Ibum dla dzieci if the patient is in the last 3 months of pregnancy, as it may harm the unborn child or cause delivery complications. It may cause kidney and heart problems in the unborn child. It may increase bleeding tendency in both the mother and the child and may delay or prolong labor. During the first 6 months of pregnancy, this medicine should not be used unless absolutely necessary and recommended by a doctor. If treatment is necessary during this period or when trying to conceive, use the lowest possible dose for the shortest possible time. From the 20th week of pregnancy, Ibum dla dzieci may cause kidney function disorders in the unborn child if taken for longer than a few days. This may lead to reduced amniotic fluid volume (oligohydramnios) or narrowing of a blood vessel (ductus arteriosus) in the child's heart. If treatment longer than a few days is necessary, the doctor may recommend additional monitoring.
Breastfeeding
Ibuprofen may pass into breast milk in small amounts. After short-term use at recommended doses, harmful effects on infants seem unlikely.
Fertility
Ibuprofen may impair fertility. If the patient is planning pregnancy or has difficulty conceiving, she should inform her doctor.
Driving and operating machinery
Short-term use of this medicine has no effect or only a negligible effect on the ability to drive and operate machinery.

3. How to use Ibum dla dzieci

The medicine is administered rectally.
Use in children
Ibum dla dzieci should be used in children aged over 3 months with body weight not less than 6 kg.
The maximum daily dose of ibuprofen is 20 to 30 mg/kg body weight, given in 3 to 4 individual doses according to the following scheme:
Children weighing 6 to 8 kg (age 3 to approximately 9 months): initial dose is 1 suppository (60 mg). If needed, another 1 suppository after 6 to 8 hours. Do not use more than 3 suppositories (180 mg) per day.
Children weighing 8 to 12.5 kg (age approximately 9 months to 2 years): initial dose is 1 suppository (60 mg). If needed, another 1 suppository after 6 hours. Do not use more than 4 suppositories (240 mg) per day.
The medicine should be administered at intervals of at least six hours.
Do not exceed the recommended dose.
Use the lowest effective dose for the shortest duration necessary to relieve symptoms. If symptoms of infection (such as fever and pain) persist or worsen, consult a doctor immediately (see section 2).
Do not use for longer than 3 days without consulting a doctor.
This medicine is intended for short-term use only; therefore, if symptoms persist or worsen, or if new symptoms occur, consult a doctor.
Patients with impaired kidney or liver function: consult a doctor before using this medicine.
Use of a higher than recommended dose of Ibum dla dzieci
If a patient has used a higher than recommended dose of Ibum dla dzieci or if a child has accidentally taken the medicine, always contact a doctor or go to the nearest hospital to obtain advice on possible health risks and actions to take.
Symptoms may include nausea, stomach ache (abdominal pain), vomiting (possibly with blood traces), headache, tinnitus (ringing in the ears), disorientation, and nystagmus. After ingestion of a large dose, drowsiness, chest pain, palpitations, loss of consciousness, convulsions (especially in children), weakness, dizziness, blood in urine, feeling cold, breathing difficulties, eyelid twitching, visual disturbances, rarely low blood pressure, changes in blood composition, and impaired kidney function have been reported.
Missed dose of Ibum dla dzieci
Do not use a double dose to make up for a missed dose.
If you have any further doubts about the use of this medicine, consult your doctor, pharmacist, or nurse.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
The risk of adverse effects can be reduced by using the lowest effective dose for the shortest duration necessary to relieve symptoms.
If any adverse effects occur or if you have any concerns, stop using the medicine and consult a doctor as soon as possible.
Elderly patients using this medicine belong to a group at increased risk of experiencing problems related to adverse effects.
Use of medicines such as Ibum dla dzieci may be associated with a small increased risk of heart attack (myocardial infarction) or stroke.

STOP USING THE MEDICINE AND CONTACT A DOCTOR IMMEDIATELY IF THE CHILD EXPERIENCES:

Symptoms of gastrointestinal bleeding, such as severe abdominal pain, black stools, bloody vomiting or dark particles resembling coffee grounds.
Symptoms of rare but serious allergic reactions, such as worsening asthma, unexplained wheezing or shortness of breath, swelling of the face, tongue or throat, difficulty breathing, palpitations, or a drop in blood pressure leading to shock. These symptoms may occur even after the first dose. If any of these symptoms occur, contact a doctor immediately.
Symptoms of severe skin reactions, such as:
- Red, flat, target-like or circular rash on the trunk, often with blisters in the center, skin peeling, and ulcers in the mouth, throat, nose, genitals, and eyes. These severe skin rashes may be preceded by fever and flu-like symptoms (exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis).
- Widespread rash, high fever, and swollen lymph nodes (DRESS syndrome).
- Red, scaly rash with subcutaneous nodules and blisters, accompanied by fever. Symptoms usually appear at the beginning of treatment (acute generalized exanthematous pustulosis).

Other possible adverse effects include:
Common (occur in 1 to 10 patients out of 100):

Heartburn, abdominal pain, nausea, vomiting, bloating with gas release, diarrhea, constipation.

Uncommon (occur in 1 to 10 patients out of 1,000):

Gastritis, colitis, and exacerbation of Crohn's disease (inflammatory bowel disease),
Headache, dizziness, insomnia, restlessness, irritability, or fatigue,
Visual disturbances,
Gastric ulcers, which may bleed or perforate,
Oral ulceration and (or) swelling and irritation of the mouth,
Hypersensitivity reactions with rash and itching, asthma attacks (with possible drop in blood pressure).

Rare (occur in 1 to 10 patients out of 10,000):

Tinnitus (ringing in the ears).

Very rare (occur in less than 1 patient out of 10,000):

Esophagitis or pancreatitis, intestinal obstruction,
Severe skin reactions, including rash with redness and blisters which may peel and are accompanied by fever, chills, muscle pain, malaise, Stevens-Johnson syndrome; in exceptional cases, severe skin infections during chickenpox (varicella),
Reduced urine output and swelling (possible acute kidney failure or inflammation); kidney damage or increased blood urea levels (early signs include reduced urination, cloudy urine, blood in urine, back pain, possible leg swelling and general malaise),
Problems with blood cell production (early symptoms include fever, sore throat, superficial oral ulceration, flu-like symptoms, severe fatigue, nosebleeds and skin bleeding, unexplained or unusual bruising),
Psychotic reactions and depression,
Worsening of inflammatory condition due to infection; if signs of infection occur or worsen during treatment with Ibum dla dzieci, consult a doctor,
Swelling, high blood pressure, palpitations, heart failure, myocardial infarction,
Liver function disorders or hepatitis; liver failure or damage, especially during long-term use, manifesting as yellowing of the skin and eyes, pale stools, or dark urine,
Very rarely, during ibuprofen use, symptoms of aseptic meningitis have been observed, including neck stiffness, headache, malaise, fever, or disturbances in consciousness; patients with autoimmune diseases (systemic lupus erythematosus, mixed connective tissue disease) are more susceptible to adverse effects; contact a doctor immediately if such symptoms occur.

Frequency not known (frequency cannot be estimated from available data):

Chest pain, which may be a symptom of a potentially serious allergic reaction known as Kounis syndrome.
Severe skin reactions known as DRESS syndrome may occur. Symptoms of DRESS syndrome include skin rash, fever, swollen lymph nodes, and increased eosinophil count (a type of white blood cell).
Red, scaly rash with subcutaneous nodules and blisters, mainly located in skin folds, trunk, and upper limbs, accompanied by fever at the beginning of treatment (acute generalized exanthematous pustulosis). If such symptoms occur, discontinue use of Ibum dla dzieci and seek immediate medical help. See also section 2.
Skin becomes sensitive to light.

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

5. How to store Ibum dla dzieci

Keep in the original packaging, at a temperature below 25 °C.
Keep the medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the package and other information

What Ibum dla dzieci contains

The active substance is ibuprofen. Each suppository contains 60 mg of ibuprofen.
The other ingredient (excipient) is: Witepsol S58.

What Ibum dla dzieci looks like and contents of the pack
One pack contains 10 suppositories.
Marketing authorisation holder and manufacturer
"PRZEDSIĘBIORSTWO PRODUKCJI FARMACEUTYCZNEJ HASCO-LEK" S.A.
51-131 Wrocław, ul. Żmigrodzka 242 E
Product information
tel.: 22 742 00 22
e-mail: [email protected]