Ibum dla dzieci

Leaflet attached to the packaging: patient information

IBUM for children

60 mg, suppositories

Ibuprofen

Read the leaflet carefully before taking the medicine, as it contains

important information for the patient.
The medicine should always be taken exactly as described in this patient leaflet or as advised by
the doctor, pharmacist, or nurse.

• The leaflet should be kept in case it needs to be read again.
• If advice or additional information is needed, the pharmacist should be consulted.
• If the patient experiences any side effects, including any possible side effects not listed in this leaflet, they should tell their doctor, pharmacist, or nurse. See section 4.
• If there is no improvement or the patient feels worse after 3 days, they should contact their doctor.

Table of contents of the leaflet

• 1. What is IBUM for children and what is it used for
• 2. Important information before taking IBUM for children
• 3. How to take IBUM for children
• 4. Possible side effects
• 5. How to store IBUM for children
• 6. Contents of the pack and other information

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

IBUM for children contains ibuprofen, a substance from the group of nonsteroidal anti-inflammatory drugs (NSAIDs), with analgesic, antipyretic, and anti-inflammatory effects.

Indications for use

• feverish conditions of various origins, including flu, colds, and post-vaccination reactions,
• pains of various origins with mild to moderate intensity, such as:
• headaches, throat, and muscle pains (e.g., with viral infections),
• toothaches, pains after dental procedures, teething pains,
• joint and bone pains due to injuries to the musculoskeletal system (e.g., sprains),
• pains due to soft tissue injuries,
• post-operative pains,
• ear pains occurring in middle ear inflammatory conditions.

If after 3 days there is no improvement or the patient feels worse, they should consult their doctor.

2. Important information before taking IBUM for children

When not to take IBUM for children

• if the patient is allergic to the active substance or any of the other ingredients of this medicine (listed in section 6),
• if the patient is allergic to other nonsteroidal anti-inflammatory drugs (NSAIDs),
• in patients with active or past stomach and (or) duodenal ulcer, perforation (hole) or bleeding, also occurring after taking NSAIDs,
• in patients who have experienced any symptoms of allergy while taking acetylsalicylic acid or other nonsteroidal anti-inflammatory drugs, such as rhinitis, urticaria, dyspnea, or bronchial asthma,
• in case of taking other NSAID medicines (including COX-2 inhibitors such as celecoxib or etoricoxib),
• if the patient has severe liver, kidney, or heart failure,
• if the patient has bleeding in the brain (cerebral hemorrhage) or other bleeding,
• if the patient has blood coagulation disorders, hemophilia (bleeding tendency), or blood production disorders of unknown origin,
• in dehydrated patients (dehydration caused by vomiting, diarrhea, or insufficient fluid intake).

If adults take this medicine, it should not be taken in the last 3 months of pregnancy.

Warnings and precautions

Before starting to take IBUM for children, the patient should discuss it with their doctor, pharmacist, or
nurse.
Special caution is required when taking IBUM for children:

• if the patient is taking other pain-relieving medicines from the NSAID group or acetylsalicylic acid,
• if the patient has certain skin diseases (systemic lupus erythematosus, mixed connective tissue disease),
• if the patient has gastrointestinal diseases and 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 recent major surgery,
• if there is dehydration 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 dyspnea may occur,
• when taking other medicines that may increase the risk of ulcers or bleeding, such as oral corticosteroids (e.g., prednisolone), blood thinners (e.g., acenocoumarol), selective serotonin reuptake inhibitors (antidepressants), and antiplatelet agents (like acetylsalicylic acid).

During ibuprofen treatment, allergic reactions to this medicine have occurred, including difficulty breathing, facial and neck swelling (angioedema), chest pain.
If any of these symptoms are observed, the patient should immediately stop taking IBUM for children and urgently contact their doctor or medical emergency services.
The patient should inform their pharmacist or doctor if they have an infection — see below, the section titled "Infections".
Concomitant, long-term use of pain-relieving medicines may lead to persistent serious kidney problems.
Infections
IBUM for children may mask the symptoms of an infection, such as fever and pain. Therefore, IBUM for children may delay the application of appropriate infection treatment and consequently lead to increased risk of complications. This has been observed in bacterial pneumonia and bacterial skin infections related to chickenpox. If the patient takes this medicine while an infection is present and the infection symptoms persist or worsen, they should immediately consult their doctor.
IBUM for children may mask the symptoms of an existing infection or fever.
Taking such medicines as ibuprofen may be associated with a small increased risk of heart attack (myocardial infarction) or stroke. This risk increases with long-term use of high doses of the medicine. The patient should not take higher doses or longer treatment than recommended (3 days).
In case of heart problems, a history of stroke, or suspected risk of these disorders (high blood pressure, diabetes, high cholesterol, smoking), the patient should discuss their treatment with their doctor or pharmacist.
During chickenpox, the patient should avoid taking IBUM for children.
Skin reactions
Severe skin reactions have been reported with the use of IBUM for children.
If the patient experiences: any skin rash, changes in the mucous membranes, blisters, or other signs of allergy, they should stop taking IBUM for children and seek medical help immediately, as these may be the first signs of a very severe skin reaction. See section 4.

• 4.

Severe 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 been reported with ibuprofen use. If the patient experiences any symptoms related to these severe skin reactions described in section 4, they should immediately stop taking IBUM for children and seek medical help.
Elderly patients are at increased risk of adverse reactions when taking NSAID medicines, particularly those affecting the stomach and intestines.
Patients who have previously experienced adverse reactions in the gastrointestinal tract, especially elderly patients, should report any unusual abdominal symptoms (especially gastrointestinal bleeding), especially during the initial treatment phase.

IBUM for children and other medicines

The patient should tell their doctor or pharmacist about all medicines they are taking, have recently taken, or might take.
In particular, they should tell their doctor if they are taking:

• corticosteroids (e.g., prednisolone), as they may increase the risk of stomach ulcers or bleeding,
• other NSAID medicines (including COX-2 inhibitors, such as celecoxib or etoricoxib),
• certain anticoagulant medicines (e.g., acetylsalicylic acid/aspirin, acenocoumarol, ticlopidine), as NSAID medicines may enhance the effects of anticoagulant medicines,
• certain antihypertensive medicines (e.g., ACE inhibitors, such as captopril), which may be affected by or affect ibuprofen treatment,
• antiplatelet agents (such as acetylsalicylic acid) and selective serotonin reuptake inhibitors (antidepressants), as they increase the risk of adverse reactions in the gastrointestinal tract,
• antihypertensive and diuretic medicines, as NSAID medicines may weaken their effects and increase the risk of kidney damage; in such cases, it is essential for the child to drink plenty of water throughout the day,
• lithium (a medicine used in depression), as its effects may increase,
• methotrexate (a medicine used in cancer or rheumatic diseases), as its effects may increase,
• tacrolimus (an immunosuppressive medicine), as the risk of toxic effects on the kidneys may increase,
• cyclosporin (an immunosuppressive medicine), as there is limited data on increased risk of toxic effects on the kidneys,
• zydovudine (a medicine used in AIDS treatment), as ibuprofen may increase the risk of bleeding into the joints or bleeding leading to swelling (in patients with hemophilia and positive HIV antibody test),
• sulfonylurea derivatives (oral antidiabetic medicines): clinical interactions may occur between these medicines and NSAID medicines; blood glucose monitoring is recommended,
• probenecid and sulfinpyrazone (medicines used in gout treatment): they may delay ibuprofen elimination,
• digitalis glycosides, phenytoin, and lithium: ibuprofen may increase their plasma concentrations,
• quinolone antibiotics: they may increase the risk of seizures,
• cholestyramine: it may delay and reduce the absorption of NSAID medicines,
• mifepristone: NSAID medicines should not be taken during the 8-12 days after mifepristone administration, as they may weaken its effects,
• voriconazole and fluconazole (antifungal medicines): they may increase the risk associated with NSAID medicine use.

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 their doctor or pharmacist before taking this medicine.
Pregnancy
IBUM for children should not be taken if the patient is in the last 3 months of pregnancy, as it may harm the unborn baby or cause complications during delivery. It may cause kidney and heart problems in the unborn baby.
It may increase the risk of bleeding in the patient and their baby and cause delayed or prolonged labor. During the first 6 months of pregnancy, the medicine should not be taken unless absolutely necessary and advised by a doctor. If treatment is necessary during this period or when trying to conceive, the lowest possible dose should be used for the shortest possible time. From the 20th week of pregnancy, IBUM for children may cause kidney problems in the unborn baby if taken for more than a few days. This may lead to reduced amniotic fluid around the baby (oligohydramnios) or narrowing of the arterial duct in the baby's heart. If treatment is necessary for a longer period, the doctor may recommend additional monitoring.
Breastfeeding
Ibuprofen may pass into breast milk in small amounts. With short-term use of ibuprofen in recommended doses, harmful effects on breastfed babies seem unlikely.
Fertility
Ibuprofen may make it harder to get pregnant. If the patient is planning to get pregnant or is having trouble getting pregnant, they should tell their doctor.

Driving and using machines

Short-term use of the medicine has no influence or negligible influence on the ability to drive and use machines.

3. How to take IBUM for children

The medicine is administered rectally.

Use in children

IBUM for children should be used in children over 3 months old with a body weight of at least 6 kg.
The maximum daily dose of ibuprofen is 20-30 mg/kg body weight, given in 3-4 single doses according to the following scheme:
Children with a body weight of 6-8 kg (age 3 to approximately 9 months): the initial dose is 1 suppository (60 mg). If necessary, 1 suppository can be given after 6-8 hours. No more than 3 suppositories (180 mg) should be taken per day.
Children with a body weight of 8-12.5 kg (age approximately 9 months to 2 years): the initial dose is 1 suppository (60 mg). If necessary, 1 suppository can be given after 6 hours. No more than 4 suppositories (240 mg) should be taken per day.
The medicine should be administered at intervals of at least 6 hours.
A higher dose of the medicine than recommended should not be taken.
The smallest effective dose should be used for the shortest period necessary to relieve symptoms. If the symptoms of an infection (such as fever and pain) persist or worsen, the patient should immediately consult their doctor (see section 2).
Without consulting a doctor, the medicine should not be taken for more than 3 days.
The medicine is intended for occasional use, so if symptoms persist or worsen, or if new symptoms occur, the patient should consult their doctor.
Patients with kidney or liver function disorders: before taking the medicine, they should consult their doctor.

Taking a higher dose of IBUM for children than recommended

If the patient has taken a higher dose of IBUM for children than recommended or if a child has accidentally taken the medicine, they should always consult their doctor or go to the nearest hospital to get an opinion on possible health risks and advice on what to do.
Symptoms may include nausea, stomach pain (abdominal pain), vomiting (which may contain blood), headaches, ringing in the ears (tinnitus), dizziness, and nystagmus. After taking a large dose, drowsiness, chest pain, palpitations, loss of consciousness, seizures (mainly in children), weakness, and dizziness have occurred, as well as blood in the urine, feeling cold, breathing problems, eyelid twitching, vision disturbances, and rare cases of low blood pressure and changes in blood composition and kidney function disorders.

Missing a dose of IBUM for children

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 their doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, IBUM for children can cause side effects, although not everybody gets them.
The risk of side effects can be minimized by using the smallest effective dose for the shortest time necessary to relieve symptoms.
If side effects occur or in case of doubts, the patient should stop taking the medicine and talk to their doctor as soon as possible.
Elderly patients taking this medicine are at increased risk of adverse reactions.
Taking such medicines as IBUM for children may be associated with a small increased risk of heart attack (myocardial infarction) or stroke.

STOP TAKING THE MEDICINE and immediately consult a doctor if the child experiences:

• symptoms of gastrointestinal bleeding, such as severe abdominal pain, black stools, bloody vomiting, or dark particles that resemble coffee grounds.
• symptoms of rare but serious allergic reactions, such as worsening of asthma, unexplained wheezing or shortness of breath, swelling of the face, tongue, or throat, difficulty breathing, rapid heartbeat, decreased blood pressure leading to shock. Symptoms may occur even after the first use of the medicine. If any of these symptoms occur, the patient should immediately contact their doctor.
• symptoms of severe skin reactions, such as:
• red, non-raised, target-like, or circular patches on the torso, often with blisters in the center, peeling skin, 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 nodules under the skin and blisters, usually located in skin folds, on the torso, and upper limbs, with fever occurring at the beginning of treatment (acute generalized exanthematous pustulosis). If such symptoms occur, the patient should stop taking IBUM for children and seek medical help immediately. See also section 2.

Other possible side effects include:
Frequent(occurring in 1 to 10 patients in 100):

• heartburn, abdominal pain, nausea, vomiting, bloating with gas, diarrhea, constipation.

Uncommon(occurring in 1 to 10 patients in 1,000):

• gastritis, colitis, and exacerbation of Crohn's disease (inflammatory bowel disease),
• headaches, dizziness, insomnia, agitation, irritability, or fatigue,
• vision disturbances,
• stomach ulcers, which may bleed or perforate,
• mouth ulcers and (or) swelling and irritation of the mouth,
• allergic reactions with rash and itching, asthma attacks (with possible decreased blood pressure).

Rare(occurring in 1 to 10 patients in 10,000):

• tinnitus (ringing in the ears).

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

• esophagitis or pancreatitis, intestinal obstruction,
• severe skin reactions, including rash with redness and blisters, which may peel and be accompanied by fever, chills, and muscle pain, malaise, and aseptic meningitis; patients with autoimmune diseases (systemic lupus erythematosus, mixed connective tissue disease) are more prone to adverse reactions; the patient should immediately consult their doctor if these occur.

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

• Chest pain, which may be a sign of a potentially serious allergic reaction called Kounis syndrome.
• Severe skin reactions known as DRESS syndrome may occur. The 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 nodules under the skin and blisters, usually located in skin folds, on the torso, and upper limbs, with fever occurring at the beginning of treatment (acute generalized exanthematous pustulosis). If such symptoms occur, the patient should stop taking IBUM for children and seek medical help immediately. See also section 2.
• The skin becomes sensitive to light.

Reporting side effects

If the patient experiences any side effects, including any possible side effects not listed in this leaflet, they should tell their doctor, pharmacist, or nurse.
Side effects can be reported directly to the Department of Post-Marketing Surveillance of Medicinal Products, Medical Devices, and Biocidal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Jerozolimskie Avenue 181C, 02-222 Warsaw
phone: 22 49 21 301, fax: 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 IBUM for children

Store in the original packaging, at a temperature below 25°C.
The medicine should be kept out of sight and reach of children.
The medicine should not be taken after the expiry date stated on the packaging. The expiry date refers to the last day of the month stated.
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. Contents of the pack and other information

What IBUM for children contains

• The active substance of the medicine is ibuprofen. One suppository contains 60 mg of ibuprofen.
• The other ingredient (excipient) is Witepsol S58.

What IBUM for children looks like and contents of the pack

One pack of the medicine contains 10 suppositories.

Marketing authorization holder and manufacturer

“PRZEDSIĘBIORSTWO PRODUKCJI FARMACEUTYCZNEJ HASCO-LEK” S.A.
51-131 Wrocław, Żmigrodzka 242E

Medicine information

phone: 22 742 00 22
e-mail: informacjaoleku@hasco-lek.pl

Date of last revision of the leaflet: