Package leaflet: Information for the user

IBUM for children
125 mg, suppositories
Ibuprofenum
Please read the entire leaflet carefully before using this medicine, as it contains
important information for the patient.
This medicine should always be used exactly as described in this patient leaflet or as
advised by the doctor, 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 the patient experiences any adverse reactions, including any possible adverse reactions not listed in this leaflet, inform the doctor, pharmacist, or nurse. See section 4.
If there is no improvement after 3 days, or if the patient feels worse, consult a doctor.

Contents of the leaflet

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

Feverish conditions of various origins, including influenza, common cold, and post-vaccination reactions,
Mild to moderate pain of various origins, such as:
- Headaches, 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),
- Pain due to soft tissue injuries,
- Postoperative pain,
- Ear pain associated with middle ear inflammation.

If there is no improvement after 3 days, or if the patient feels 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 previous peptic ulcer or duodenal ulcer, perforation (gastrointestinal perforation), or bleeding, including cases occurring after use of NSAIDs,
in patients who during treatment with acetylsalicylic acid or other non-steroidal anti-inflammatory drugs have experienced any allergic symptoms such as rhinitis, urticaria, dyspnoea, or bronchial asthma,
when taking other medicines from the NSAID group (including COX-2 inhibitors such as celecoxib or etoricoxib),
if the patient has severe liver, kidney, or heart failure,
if the patient has cerebral haemorrhage (bleeding from cerebral vessels) or other bleeding,
if the patient has blood coagulation disorders, haemorrhagic diathesis (tendency to bleed), or blood cell production disorders of unknown origin,
in dehydrated patients (dehydration caused by vomiting, diarrhoea, 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 medicines from the NSAID group 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 been diagnosed with 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 coagulation disorders (ibuprofen may prolong bleeding time),
in case of current or past asthma, chronic rhinitis, nasal polyps, or allergic diseases, as dyspnoea 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 medicines (such as acetylsalicylic acid).

Allergic reactions to ibuprofen, including breathing difficulties, facial and neck swelling (angioedema), and chest pain, have been reported during treatment.
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, 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 ongoing infection and infection symptoms persist or worsen, consult a doctor immediately.
Ibum dla dzieci may mask symptoms of existing infection or fever.
The use of medicines 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 suspected 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 allergic symptoms appear, discontinue taking Ibum dla dzieci immediately and seek medical help promptly, as these may be the first signs of a very serious skin reaction. See section 4.
Serious skin reactions associated with ibuprofen use include exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), and acute generalised exanthematous pustulosis (AGEP). 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 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 the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.
In particular, inform the doctor if the patient is 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 anticoagulant medicines,
certain antihypertensive medicines (ACE inhibitors, e.g. captopril), which may be affected by or affect ibuprofen treatment,
antiplatelet medicines (such as acetylsalicylic acid) and selective serotonin reuptake inhibitors (antidepressants), as they increase the risk of gastrointestinal adverse effects,
antihypertensive medicines and diuretics, as NSAIDs may reduce the effectiveness of these medicines and increase the risk of kidney damage; in such cases, it is important that the child drinks plenty of fluids throughout the day,
lithium (a medicine used in depression), as the effect of lithium may increase,
methotrexate (a medicine used in cancer or rheumatic diseases), as the effect of methotrexate may increase,
tacrolimus (an immunosuppressive medicine), as there is an increased risk of nephrotoxicity,
cyclosporine (an immunosuppressive medicine), as limited data suggest an increased risk of nephrotoxicity,
zidovudine (a medicine used in the treatment of AIDS), as ibuprofen use may increase the risk of joint bleeding or bleeding leading to swelling (in patients with haemophilia and a positive HIV antibody test),
sulfonylurea derivatives (antidiabetic medicines): clinical interactions between these medicines and NSAIDs may occur; blood glucose levels should be monitored,
probenecid and sulfinpyrazone (medicines used in the treatment of gout): may delay ibuprofen excretion,
digoxin, phenytoin, and lithium: ibuprofen may increase plasma levels of these medicines,
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 the effectiveness of mifepristone,
voriconazole and fluconazole (antifungal medicines): may increase the risk 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 her 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 complications during delivery. It may cause kidney and heart problems in the unborn child. It may increase the tendency to bleeding in both the mother and the child and may delay or prolong labour. During the first 6 months of pregnancy, do not use this medicine unless absolutely necessary and prescribed by a doctor. If treatment is required during this period or during attempts to conceive, use the lowest possible dose for the shortest possible time. From week 20 of pregnancy, Ibum dla dzieci may cause kidney function disorders in the unborn child; if taken for longer than a few days, it may lead to reduced amniotic fluid volume surrounding the baby (oligohydramnios) or narrowing of a blood vessel (ductus arteriosus) in the baby's heart. If treatment longer than a few days is required, the doctor may recommend additional monitoring.
Breastfeeding
Ibuprofen may pass into breast milk in small amounts. With short-term use of ibuprofen 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 has negligible effect on the ability to drive and operate machinery.

3. How to use Ibum dla dzieci

The medicine is for rectal use only.
Use in children
Ibum dla dzieci, 125 mg, suppositories, should not be used in children weighing less than 12.5 kg, as Ibum dla dzieci, 60 mg, suppositories are intended for these children.
The maximum daily dose of ibuprofen is 20 to 30 mg/kg body weight, administered in 3 to 4 divided doses according to the following schedule:
Children weighing from 12.5 kg to 17 kg (aged 2 to 4 years): initial dose is 1 suppository (125 mg).
If necessary, subsequently 1 suppository every 6 to 8 hours. Do not use more than 3 suppositories (375 mg) per day.
Children weighing from 17 kg to 20.5 kg (aged 4 to 6 years): initial dose is 1 suppository (125 mg).
If necessary, subsequently 1 suppository every 6 hours. Do not use more than 4 suppositories (500 mg) per day.
The medicine should be administered at intervals of at least six hours.
Do not use a higher dose than recommended.
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; 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 the medicine.
Overdose of Ibum dla dzieci
If a patient has used more than the recommended dose of Ibum dla dzieci or if a child has accidentally ingested the medicine, always contact a doctor or go to the nearest hospital to assess possible health risks and receive advice on 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, seizures (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 occurred.
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 concerning 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 adverse effects occur or if you have any doubts, stop giving the medicine and consult a doctor as soon as possible.
Elderly individuals using this medicine belong to a group at increased risk of 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 immediately contact a doctor if the child experiences:

symptoms of gastrointestinal bleeding, such as severe abdominal pain, black stools, vomiting blood 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, drop in blood pressure leading to shock. Symptoms may occur even after the first dose of the medicine. If any of these symptoms occur, contact a doctor immediately.
symptoms of severe skin reactions, such as:
- red, flat, target-like or circular spots on the trunk, often with blisters in the center, peeling skin, mouth ulcers, ulcers in the 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 body temperature and enlarged lymph nodes (DRESS syndrome).
- red, peeling 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, diarrhea, constipation.

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

inflammation of the stomach, large intestine and exacerbation of Crohn's disease (inflammatory bowel disease),
headache, dizziness, insomnia, restlessness, irritability or fatigue,
visual disturbances,
stomach 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):

inflammation of the esophagus or pancreas, intestinal obstruction,
severe skin reactions, including rash with redness and blisters which may peel, 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 concentration (early signs include reduced urine output, 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, heart attack,
liver function disorders or hepatitis; liver failure or damage, especially during prolonged use, manifesting as yellowing of the skin and eyes, pale stools and 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 these 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 called 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, predominantly located in skin folds, trunk and upper limbs, with fever occurring at the beginning of treatment (acute generalized exanthematous pustulosis). If such symptoms occur, stop taking Ibum dla dzieci and seek medical help immediately. 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 Adverse Drug Reactions of 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 in use. 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 125 mg of ibuprofen.
The other component (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
Medicinal product information
tel.: 22 742 00 22
e-mail: [email protected]