IBUM

Poland

The medicine is used to relieve feverish states (e.g., in case of influenza, common cold, or after vaccination) and in cases of mild to moderate pain, such as headache, sore throat, muscle, tooth, joint, or bone pain, earache, as well as postoperative pain and soft tissue injuries.

Brand name IBUM

Dosage form suspension, oral

Active substance / Dosage

ibuprofen · 100 mg

Prescription type Over-the-counter

ATC code

M01AE01

Registration number 100109395

Manufacturer HASCO-LEK S.A. Pharmaceutical Production Enterprise

Frequently asked questions

How to dose IBUM?

The dose depends on body weight and is 20-30 mg/kg of body weight per day, in divided doses. The medicine should be administered at intervals of at least six hours. In infants under 6 months of age, use requires consultation with a doctor. Do not use a higher dose than recommended and do not use the medicine for longer than 3 days without consulting a doctor.

When should this medicine not be used?

It must not be taken if there is an allergy to ibuprofen or other NSAIDs, if the patient has or has had gastric or duodenal ulcers, has blood clotting problems, severe liver, kidney, or heart failure, or has cerebral bleeding. It should not be used in the last 3 months of pregnancy.

What are the possible side effects of IBUM?

It may cause, among others, headache, nausea, abdominal pain, diarrhea, dizziness, or rash. Discontinue use immediately and seek medical help if severe skin reactions occur (e.g., blisters, skin peeling), facial swelling, or difficulty breathing.

Can this medicine be combined with other medicines?

The doctor must be informed about the intake of other medicines, especially anticoagulants, NSAID painkillers, blood pressure-lowering drugs, corticosteroids, anticancer drugs, lithium, or zidovudine, as they may affect the action of the preparation.

What to do in case of overdose?

If a child or adult takes a higher dose than recommended, always consult a doctor or report to the nearest hospital. Symptoms of overdose may include nausea, vomiting, abdominal pain, drowsiness, convulsions, or breathing problems.

Instructions for use

Table of contents

1. What Ibum is and what it is used for
2. Important information before using Ibum
3. How to use Ibum
4. Possible adverse reactions
5. How to store medicine I
6. Contents of the packaging and other information
Package leaflet: information for the patient
1. What IBUM is and what it is used for
2. Important information before taking IBUM
3. How to take IBUM
4. Possible side effects
5. How to store medicine I
6. Contents of the pack and other information

Package leaflet: Information for the patient

IBUM
100 mg/5 ml, oral suspension
Ibuprofenum
Raspberry-flavoured oral suspension
Please read this leaflet carefully before using 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, pharmacist, or nurse.

Keep this leaflet, so 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 is and what it is used for
Important information before taking Ibum
How to take Ibum
Possible side effects
How to store Ibum
Contents of the pack and other information

1. What Ibum is and what it is used for

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

Fever of various origins, including fever associated with 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 occurring in middle ear inflammation (otitis media).

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

2. Important information before using Ibum

When not to use Ibum:

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),
in patients with active or a history of peptic ulceration or perforation (gastric or duodenal), gastrointestinal bleeding, or a history of such events occurring during treatment with NSAIDs,
in patients who previously experienced allergic symptoms such as rhinitis, urticaria, bronchospasm, or asthma during treatment with acetylsalicylic acid or other NSAIDs,
when taking other medicines from the NSAID group (including COX-2 inhibitors such as celecoxib or etoricoxib),
in cases of severe liver, kidney, or heart failure,
in cases of cerebral haemorrhage (bleeding from brain vessels) or other bleeding,
in cases of blood coagulation disorders, haemorrhagic diathesis (tendency to bleed), or blood cell production disorders of unknown origin.

Women should not take this medicine during the last three months of pregnancy.
Warnings and precautions
Before starting treatment with Ibum, discuss it with your doctor, pharmacist, or nurse.
Exercise particular caution when using Ibum:

if the patient has systemic lupus erythematosus or mixed connective tissue disease,
if allergic reactions occurred after taking acetylsalicylic acid,
if the patient has gastrointestinal disorders or chronic inflammatory bowel diseases (ulcerative colitis, Crohn's disease),
if the patient has hypertension and/or heart function disorders,
if the patient has kidney function disorders,
if the patient has liver function disorders,
if the patient has blood coagulation disorders (ibuprofen may prolong bleeding time),
in patients taking other medicines (especially anticoagulants, diuretics, cardiac glycosides, corticosteroids),
in patients with hereditary fructose intolerance (due to the potential conversion of maltitol, one of the excipients, into fructose).

There is a risk of gastrointestinal haemorrhage, ulceration, or perforation, which may be fatal and may occur without warning symptoms or in patients with a history of such symptoms. If gastrointestinal bleeding or ulceration occurs, discontinue Ibum immediately. Patients with a history of gastrointestinal disorders, especially elderly patients (Ibum may also be used by adults), should inform their doctor of any unusual gastrointestinal symptoms (especially bleeding), particularly during the initial treatment period.
Prolonged, concomitant use of painkillers may lead to kidney damage with a risk of renal failure (analgesic nephropathy).
Taking anti-inflammatory/analgesic medicines such as ibuprofen may be associated with a small increased risk of myocardial infarction or stroke, particularly when used at high doses. Do not exceed the recommended dose or duration of treatment.
Before using Ibum, 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 myocardial infarction, coronary artery bypass surgery, peripheral arterial disease (poor blood circulation in legs due to narrowed or blocked arteries), or history of stroke (including mini-stroke or transient ischaemic attack - TIA),
the patient has hypertension, diabetes, high cholesterol levels, a family history of heart disease or stroke, or is a smoker,
the patient has an infection – see below, section titled "Infections".

While taking ibuprofen, symptoms of allergic reactions to this medicine have occurred, including difficulty breathing, facial and neck swelling (angioedema), and chest pain. If any of these symptoms occur, discontinue Ibum immediately and contact a doctor or emergency medical services without delay.
Skin reactions
Severe skin reactions associated with the use of Ibum have been reported. If any skin rash, mucosal lesions, blisters, or other signs of hypersensitivity appear, stop taking Ibum immediately and seek medical help promptly, as these may be early 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 severe skin reactions described in section 4, Ibum should be stopped immediately and medical help sought.
Infections
Ibum may mask symptoms of infection such as fever and pain. Therefore, Ibum 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 symptoms persist or worsen, immediate medical consultation is required.
Ibum with other medicines
Inform your doctor or pharmacist about all medicines currently used, recently used, or planned for use.
Ibum may affect the action of other medicines, or other medicines may affect the action of Ibum. In particular, before taking ibuprofen, inform your doctor or pharmacist if you are taking any of the following medicines:

other NSAIDs (including COX-2 inhibitors such as celecoxib or etoricoxib),
anticoagulant medicines (i.e. blood thinners/preventing clot formation, such as aspirin/acetylsalicylic acid, warfarin, ticlopidine),
blood pressure-lowering medicines (ACE inhibitors such as captopril, beta-blockers such as atenolol-containing medicines, angiotensin II receptor antagonists such as losartan),
medicines that reduce blood coagulability (anticoagulants, e.g. acenocoumarol, or antiplatelet agents),
corticosteroids (such as prednisolone or dexamethasone),
methotrexate (anticancer medicines),
lithium (antidepressant medicine),
zidovudine (antiviral medicine).

Some other medicines may also influence or be influenced by treatment with Ibum. Therefore, always consult a doctor or pharmacist before using Ibum 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 become pregnant, she should consult a doctor or pharmacist before using this medicine.
Pregnancy
Do not take Ibum 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 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, Ibum should not be used unless absolutely necessary and prescribed 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 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 (oligohydramnios) or narrowing of the blood vessel (ductus arteriosus) in the baby's heart. If treatment is required for longer than a few days, the doctor may recommend additional monitoring.
Breastfeeding
Ibuprofen may pass into breast milk in small amounts.
As there have been no reports of harmful effects of ibuprofen on infants, discontinuation of breastfeeding is not necessary for short-term use of ibuprofen at low doses.
Effect on fertility
This medicine belongs to a group of medicines (non-steroidal anti-inflammatory drugs) which may reversibly impair fertility in women. This effect reverses upon discontinuation of treatment.
Driving and using machines
There are no data available on the effect of Ibum on the ability to drive vehicles, operate machinery, or psychomotor performance.
Ibum contains liquid maltitol, sodium benzoate (E 211), propylene glycol (E 1520), and sodium
Liquid maltitol
The medicine contains 1.087 g of liquid maltitol in each 5 ml of suspension. If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult a doctor before taking this medicine. The medicine may have a mild laxative effect. Calorific value: 2.3 kcal/g of maltitol.
Sodium benzoate (E 211)
The medicine contains 5.45 mg of sodium benzoate in each 5 ml of suspension.
Propylene glycol (E 1520)
The medicine contains 13.547 mg of propylene glycol in each 5 ml of suspension.
Sodium
The medicine contains 12.81 mg of sodium (main component of table salt) in each 5 ml of suspension.
This corresponds to 0.64% of the maximum recommended daily intake of sodium in the diet for adults.

3. How to use Ibum

This medicine should always be used exactly as described in this patient information leaflet or as directed by your doctor, pharmacist, or nurse. If in doubt, consult your doctor, pharmacist, or nurse.
Ibum is for oral use. Shake the bottle well before use.
The daily dose of Ibum is strictly dependent on body weight and amounts to 20–30 mg/kg body weight, given in divided doses, according to the following table:
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Child's age
(child's body weight)

For infants under 6 months of age, administer the medicine only after consulting a doctor.
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 more than 3 days without consulting a doctor.
The package includes a measuring cup or measuring spoon, or a stopper and an oral syringe.
Dosing instructions using the oral syringe:

Before first use, the syringe and stopper must be thoroughly washed in warm (not boiling) water with a cleaning agent,
firmly press the stopper into the neck of the bottle using the syringe,
to fill the syringe, shake the bottle vigorously, turn it upside down, then carefully pull the plunger down to draw in the required amount of suspension as indicated on the scale,
to measure the dose accurately, align the flange of the syringe barrel with the scale line on the plunger,
return the bottle to its original upright position and carefully remove the syringe from the stopper (Figure 1),

Figure 1

Diagram of medication instructions showing hands drawing liquid into a syringe from a bottle, turning the bottle, and slowly pulling the syringe upward

place the tip of the syringe into the child's mouth, then slowly press the plunger to gently empty the syringe contents,
after use, close the bottle, leaving the stopper in the neck of the bottle, and wash the oral syringe in warm (not boiling) water with a cleaning agent, then dry it.

The medicine is intended for immediate use; therefore, if symptoms persist or worsen, or if new symptoms occur, consult a doctor.
The medicine does not contain sugar or alcohol. It may be used by diabetic patients (5 ml of suspension I contains 1.087 g of liquid maltitol, equivalent to approximately 0.07 carbohydrate exchange unit).
Use of a higher than recommended dose of medicine I
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If a patient has taken a higher than recommended dose of medicine I, or if a child has accidentally ingested the medicine, always contact a doctor or go to the nearest hospital to assess potential health risks and receive advice on necessary actions.
In children, a single dose exceeding 400 mg may cause symptoms of overdose.
In adults, the dose that may cause such symptoms has not been precisely established. The half-life during overdose ranges from 1.5 to 3 hours.
Symptoms of overdose
Symptoms may include nausea, stomach pain (epigastric pain), less commonly diarrhea, vomiting (possibly with blood traces), headache, ringing in the ears (tinnitus), disorientation, and nystagmus. After ingestion of a large dose, drowsiness, chest pain, palpitations, loss of consciousness, seizures (mainly in children), weakness, dizziness, blood in urine, cold sensation, breathing difficulties, and gastrointestinal bleeding may occur.
Severe poisoning may cause central nervous system disturbances manifesting as drowsiness, and very rarely excitement, disorientation, or coma. Seizures may very rarely occur.
During severe poisoning, metabolic acidosis may develop, and prothrombin time (INR) may be prolonged. Acute kidney failure or liver damage may occur. In patients with asthma, worsening of asthma symptoms may occur.
Treatment of overdose
There is no specific antidote. Symptomatic and supportive treatment should be administered, aimed at clearing the body. The doctor should monitor vital signs and consider administering activated charcoal orally within 1 hour of overdose. In case of frequent or prolonged seizures, intravenous diazepam or lorazepam should be administered. In patients with asthma, bronchodilators should be given.
Missed dose of medicine I
Do not take a double dose to make up for a missed dose.
If you have any further doubts regarding the use of this medicine, consult your doctor, pharmacist, or nurse.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
If any of the following symptoms occur in a patient, ibuprofen must be discontinued immediately and medical help should be sought:

Red, flat, target-like or circular rash on the trunk, often with blisters in the center, peeling skin, mouth ulcers in the mouth, throat, nose, genital organs 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 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 reactions include:
Adverse reactions occurring not frequently (in 1 to 10 out of 1,000 patients):

Headache, dyspepsia, abdominal pain, nausea, urticaria, itching.

Adverse reactions occurring rarely (in 1 to 10 out of 10,000 patients):
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Diarrhea, flatulence, constipation, vomiting, gastritis, dizziness, insomnia, restlessness, irritability and feeling of fatigue,
Edema due to kidney and urinary tract disorders.

Adverse reactions occurring very rarely (less than 1 in 10,000 patients):

Black, tarry stools, vomiting blood, ulcerative stomatitis, exacerbation of colitis and Crohn's disease,
Gastric and (or) duodenal ulcer, gastrointestinal bleeding and perforation, sometimes with fatal outcome, particularly in elderly patients,
In isolated cases: depression, psychotic reactions and tinnitus, aseptic meningitis,
Decreased urine output, edema, acute renal failure, renal papillary necrosis, increased serum sodium concentration (sodium retention),
Liver function disorders, particularly during prolonged use,
Blood morphology abnormalities (anemia, leukopenia - decreased white blood cell count, thrombocytopenia - decreased platelet count, pancytopenia - hematological disorder with deficiency of all normal blood cells: erythrocytes and platelets, agranulocytosis - reduced granulocyte count). Initial symptoms include: fever, sore throat, superficial oral mucosal ulcers, flu-like symptoms, fatigue, hemorrhagic purpura (e.g. bruises, petechiae, purpura, nosebleeds),
Erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis,
Severe hypersensitivity reactions such as: facial, tongue and laryngeal swelling, dyspnea, tachycardia - heart rhythm disturbances, hypotension - sudden drop in blood pressure, shock, worsening of asthma and bronchospasm,
In patients with existing autoimmune diseases (systemic lupus erythematosus, mixed connective tissue disease), isolated cases of symptoms associated with aseptic meningitis have been reported during ibuprofen treatment, such as neck stiffness, headache, nausea, vomiting, fever, and disorientation.

Frequency unknown (frequency cannot be determined 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. 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, on the trunk and upper limbs, with fever occurring at the beginning of treatment (acute generalized exanthematous pustulosis). If such symptoms occur, the medication must be discontinued immediately and medical help sought without delay. See also section 2,
Skin becomes sensitive to light.

Edema, hypertension and heart failure have been reported in association with NSAID therapy.
Use of drugs such as I may be associated with a small increased risk of heart attack (myocardial infarction) or stroke.
Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform a doctor, pharmacist or nurse. Adverse reactions 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:
Jerozolimskie Avenue 181C, 02-222 Warsaw, phone: 22 49 21 301, fax: 22 49 21 309,
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
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Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store medicine I

Keep this medicine out of sight and reach of children.
Store below 25 °C. Keep in the original packaging.
Do not use this medicine after the expiry date stated on the carton. 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. Such measures help protect the environment.

6. Contents of the packaging and other information

What the medicine contains

The active substance is ibuprofen. 5 ml of suspension contains 100 mg of ibuprofen.
Other ingredients: liquid maltitol, glycerol, xanthan gum, sodium saccharin, sodium benzoate (E 211), fumaric acid, disodium phosphate dodecahydrate, raspberry flavour (containing propylene glycol E 1520), purified water.

What the medicine looks like and contents of the pack
The medicine is a white suspension with a raspberry odour.
Brown glass bottle with an aluminium cap, containing a liner and a tamper-evident ring, and
a measuring cup or measuring spoon, or a cap and oral syringe, in a cardboard box.
One pack contains 130 g of oral suspension.
Marketing Authorisation Holder and Manufacturer
„PRZEDSIĘBIORSTWO PRODUKCJI FARMACEUTYCZNEJ HASCO-LEK” S.A.
51-131 Wrocław, ul. Żmigrodzka 242 E
Medicine Information
tel.: 22 742 00 22
e-mail: [email protected]
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Package leaflet: information for the patient

IBUM
100 mg/5 ml, oral suspension
Ibuprofenum
Raspberry-flavoured oral suspension
Please read all of this leaflet carefully before taking this medicine because it contains
important information for you.
This medicine should always be taken exactly as described in this patient leaflet, or as directed
by your doctor, pharmacist or nurse.

Keep this leaflet, as you may need to read it again.
If you need advice or further information, consult your pharmacist.
If you experience any side effects, including any not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.
If there is no improvement after 3 days or if you feel worse, contact your doctor.

Contents of the leaflet

What IBUM is and what it is used for
Important information before taking IBUM
How to take IBUM
Possible side effects
How to store IBUM
Contents of the packaging and other information

1. What IBUM is and what it is used for

IBUM contains ibuprofen – a substance belonging to the group of non-steroidal anti-inflammatory drugs (NSAIDs),
which have analgesic, antipyretic and anti-inflammatory properties.
The indications for use are:

fever of various origins, including in the course of 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 after 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 occurring in middle ear inflammatory conditions.

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

2. Important information before taking IBUM

When not to take IBUM:

if you are allergic to ibuprofen, other non-steroidal anti-inflammatory drugs (NSAIDs), or any of the other ingredients of this medicine (listed in section 6),
in patients with active or previous gastric or duodenal ulcer, perforation (gastrointestinal perforation), or bleeding, including cases occurring after use of NSAIDs,
in patients who previously experienced allergic reactions (such as rhinitis, urticaria, dyspnoea or bronchial asthma) during treatment with acetylsalicylic acid or other NSAIDs,
when taking other NSAIDs (including COX-2 inhibitors such as celecoxib or etoricoxib),
in case of severe liver, kidney or heart failure,
in case of intracranial bleeding (cerebral haemorrhage) or other bleeding,
in case of blood coagulation disorders, haemorrhagic diathesis (tendency to bleed), or unexplained blood cell production disorders.

Women should not take this medicine during the last 3 months of pregnancy.
Warnings and precautions
Before starting treatment with IBUM, discuss it with your doctor, pharmacist or nurse.
Exercise particular caution when using IBUM:

if you have systemic lupus erythematosus or mixed connective tissue disease,
if you experienced allergic reactions after taking acetylsalicylic acid,
if you have gastrointestinal disorders or chronic inflammatory bowel diseases (ulcerative colitis, Crohn's disease),
if you have hypertension and/or heart function disorders,
if you have kidney function disorders,
if you have liver function disorders,
if you have blood coagulation disorders (ibuprofen may prolong bleeding time),
in patients taking other medicines (especially anticoagulants, diuretics, cardiac medications, corticosteroids),
in patients with hereditary fructose intolerance (due to possible conversion of maltitol, one of the excipients, into fructose).

There is a risk of gastrointestinal bleeding, ulceration or perforation, which may be fatal and which may occur without warning symptoms or in patients with previous warning signs. If gastrointestinal bleeding or ulceration occurs, discontinue the medicine immediately. Patients with a history of gastrointestinal disorders, especially elderly patients (IBUM may also be used by adults), should inform their doctor of any unusual gastrointestinal symptoms (especially bleeding), particularly during the initial treatment period.
Long-term, concomitant use of analgesics may lead to kidney damage with risk of kidney failure (analgesic nephropathy).
Taking anti-inflammatory/analgesic medicines such as ibuprofen may be associated with a small increased risk of heart attack or stroke, particularly when used in high doses. Do not exceed the recommended dose or duration of treatment.
Before taking IBUM, discuss treatment with your doctor or pharmacist if:

you have 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 legs due to narrowed or blocked arteries), or if you have had any stroke (including mini-stroke or transient ischaemic attack - TIA),
you have hypertension, diabetes, high cholesterol levels, a family history of heart disease or stroke, or if you smoke,
you have an infection – see below, section titled “Infections”.

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During treatment with ibuprofen, symptoms of allergic reaction to this medicine have occurred, including difficulty breathing, facial and neck swelling (angioedema), chest pain.
If any of these symptoms occur, discontinue IBUM immediately and contact your doctor or emergency medical services without delay.
Skin reactions
Severe skin reactions associated with the use of IBUM have been reported. If you develop: any skin rash, mucosal lesions, blisters or other allergic symptoms, stop taking IBUM immediately and seek medical help promptly, as these may be early 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 generalised exanthematous pustulosis (AGEP) have been reported with ibuprofen use. If you experience any of the symptoms related to these serious skin reactions described in section 4, discontinue IBUM immediately and seek medical help.
Infections
IBUM may mask symptoms of infection such as fever and pain. Therefore, IBUM 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 you are taking this medicine during an infection and infection symptoms persist or worsen, consult your doctor immediately.
IBUM and other medicines
Tell your doctor or pharmacist about all medicines you are currently taking, have recently taken, or plan to take.
IBUM may affect the action of other medicines or other medicines may affect the action of IBUM. In particular, before taking ibuprofen, inform your doctor or pharmacist if you are taking any of the following medicines:

other NSAIDs (including COX-2 inhibitors such as celecoxib or etoricoxib),
anticoagulant medicines (i.e. blood thinners/preventing clot formation, such as aspirin/acetylsalicylic acid, warfarin, ticlopidine),
blood pressure-lowering medicines (ACE inhibitors such as captopril, beta-blockers such as atenolol, angiotensin II receptor antagonists such as losartan),
medicines reducing blood coagulation (anticoagulants, e.g. acenocoumarol or antiplatelet agents),
corticosteroids (such as prednisolone or dexamethasone),
methotrexate (anticancer medicines),
lithium (antidepressant medicine),
zidovudine (antiviral medicine).

Some other medicines may also interact with or be affected by treatment with IBUM. Therefore, always consult your doctor or pharmacist before taking IBUM with other medicines.
Pregnancy, breastfeeding and fertility
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, you should consult your doctor or pharmacist before using this medicine.
Pregnancy
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Do not take IBUM during 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 the tendency to bleeding in both you and your child and may delay or prolong labour. During the first 6 months of pregnancy, do not use IBUM unless absolutely necessary and prescribed 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 week 20 of pregnancy, IBUM 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 (oligohydramnios) or narrowing of a blood vessel (ductus arteriosus) in the child's heart. If treatment is required for longer than a few days, your doctor may recommend additional monitoring.
Breastfeeding
Ibuprofen may pass into breast milk in small amounts.
As there are no reports of harmful effects of ibuprofen on infants, discontinuation of breastfeeding is not necessary during short-term use of ibuprofen in low doses.
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 using machines
There are no data on the effect of IBUM on the ability to drive or operate machinery and psycho-motor performance.
IBUM contains liquid maltitol, sodium benzoate (E 211), propylene glycol (E 1520) and sodium
Liquid maltitol
The medicine contains 1.087 g of liquid maltitol in each 5 ml of suspension. If you have previously been diagnosed with intolerance to certain sugars, consult your doctor before taking this medicine. The medicine may have a mild laxative effect. Calorific value: 2.3 kcal/g of maltitol.
Sodium benzoate (E 211)
The medicine contains 5.45 mg of sodium benzoate in each 5 ml of suspension.
Propylene glycol (E 1520)
The medicine contains 13.547 mg of propylene glycol in each 5 ml of suspension.
Sodium
The medicine contains 12.81 mg of sodium (main component of table salt) in each 5 ml of suspension.
This corresponds to 0.64% of the maximum recommended daily dietary sodium intake for adults.

3. How to take IBUM

This medicine should always be taken exactly as described in this patient leaflet or as directed by your doctor, pharmacist or nurse. If in doubt, consult your doctor, pharmacist or nurse.
This medicine is for oral use. Shake the bottle well before use.
The daily dose of IBUM is strictly dependent on body weight and amounts to 20–30 mg/kg body weight, divided into doses according to the table below:
4/8

Child's age
(child's body weight)

In infants under 6 months of age, the medicine should only be administered after consultation with a physician.
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 physician immediately (see section 2).
Do not use for longer than 3 days without consulting a physician.
A measuring cup, measuring spoon, or oral syringe is included with the packaging.
Dosing instructions using the oral syringe:

Before first use, the syringe must be washed thoroughly in warm (not boiling) water with detergent,
After removing the cap, attach the syringe to the stopper located in the neck of the bottle,
To fill the syringe, shake the bottle vigorously, turn it upside down, and then slowly push the plunger down, drawing the suspension into the syringe to the desired volume indicated on the scale,
To accurately measure the dose, align the flange of the syringe barrel with the mark on the plunger,
Return the bottle to its upright position and carefully remove the syringe from the stopper (Figure 1),

Figure 1

Instruction diagram: a hand holds the syringe above the bottle, turns it over, draws up the liquid, showing an enlarged view of the scale, then pulls the syringe upward

Place the tip of the syringe into the child's mouth and slowly depress the plunger to gently empty the syringe contents,
After use, close the bottle and wash the oral syringe in warm (not boiling) water with detergent, then dry it.

This medicine is intended for short-term use. If symptoms persist or worsen, or if new symptoms appear, consult a physician.
The medicine does not contain sugar or alcohol. It may be used by diabetic patients (5 ml of suspension I contains 1.087 g of liquid maltitol, equivalent to approximately 0.07 carbohydrate exchange unit).
Use of a higher than recommended dose of medicine I
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If a patient has taken a higher than recommended dose of medicine I, or if a child has accidentally ingested the medicine, always contact a physician or go to the nearest hospital to assess potential health risks and receive advice on appropriate actions.
In children, a single dose exceeding 400 mg may cause symptoms of overdose.
In adults, the dose that may cause such symptoms has not been precisely established. The half-life during overdose ranges from 1.5 to 3 hours.
Symptoms of overdose
Symptoms may include nausea, stomach pain (epigastric pain), less commonly diarrhea, vomiting (possibly with blood), headache, tinnitus (ringing in the ears), disorientation, and nystagmus. After ingestion of a large dose, drowsiness, chest pain, palpitations, loss of consciousness, seizures (mainly in children), weakness, dizziness, blood in urine, cold sensation, breathing difficulties, and gastrointestinal bleeding may occur.
Severe poisoning may cause central nervous system disturbances, manifesting as drowsiness, and very rarely excitement, disorientation, or coma. Seizures may very rarely occur.
During severe poisoning, metabolic acidosis may develop, and prothrombin time (INR) may be prolonged. Acute renal failure or liver damage may occur. In patients with asthma, worsening of asthma symptoms may occur.
Treatment of overdose
There is no specific antidote. Symptomatic and supportive treatment should be administered, including decontamination of the body. The physician should monitor vital signs and consider administering activated charcoal orally within 1 hour of overdose. In case of frequent or prolonged seizures, intravenous diazepam or lorazepam should be administered. In patients with asthma, bronchodilators should be administered.
Missed dose of medicine I
Do not administer a double dose to make up for a missed dose.
If you have any further doubts regarding the use of this medicine, consult your physician, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
If any of the following symptoms occur in the patient, ibuprofen use should be stopped immediately and medical help sought:

Red, flat, target-like or circular skin lesions, often with blisters in the center, skin peeling, and mucosal ulcers in the mouth, throat, nose, genital organs, and eyes. These severe skin reactions 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 side effects include:
Side effects occurring not very often (in 1 to 10 out of 1,000 patients):

Headache, dyspepsia, abdominal pain, nausea, urticaria, itching.

Side effects occurring rarely (in 1 to 10 out of 10,000 patients):
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Diarrhea, bloating, constipation, vomiting, gastric mucositis, dizziness, insomnia, agitation, irritability, and fatigue,
Edema due to kidney and urinary tract disorders.

Side effects occurring very rarely (less than 1 in 10,000 patients):

Tarry stools, bloody vomiting, ulcerative stomatitis, exacerbation of colitis and Crohn's disease,
Gastric and/or duodenal ulceration, gastrointestinal bleeding and perforation, sometimes fatal, particularly in elderly patients,
In isolated cases: depression, psychotic reactions, tinnitus, aseptic meningitis,
Reduced urine output, edema, acute renal failure, renal papillary necrosis, increased serum sodium concentration (sodium retention),
Liver function abnormalities, especially during prolonged use,
Blood morphology disorders (anemia, leukopenia - reduced white blood cell count, thrombocytopenia - reduced platelet count, pancytopenia - hematological disorder involving deficiency of all normal blood cells: erythrocytes and platelets, agranulocytosis - reduced granulocyte count). Initial symptoms include: fever, sore throat, superficial oral mucosal ulcers, flu-like symptoms, fatigue, hemorrhagic diathesis (e.g., bruising, petechiae, purpura, nosebleeds),
Erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis,
Severe hypersensitivity reactions such as: facial, tongue, and laryngeal swelling, dyspnea, tachycardia - heart rhythm disturbances, hypotension - sudden drop in blood pressure, shock, asthma exacerbation, and bronchospasm,
In patients with pre-existing autoimmune diseases (systemic lupus erythematosus, mixed connective tissue disease), isolated cases of symptoms of aseptic meningitis have been reported during ibuprofen treatment, such as neck stiffness, headache, nausea, vomiting, fever, and disorientation.

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

Chest pain, which may indicate a potentially severe allergic reaction called Kounis syndrome,
Severe skin reactions known as DRESS syndrome. DRESS syndrome symptoms 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, with fever occurring at the beginning of treatment (acute generalized exanthematous pustulosis). If such symptoms occur, discontinue medicine I immediately and seek medical help without delay. See also section 2,
Skin becomes photosensitive.

Edema, hypertension, and heart failure have been reported during treatment with NSAIDs.
Taking medicines such as I may be associated with a small increased risk of heart attack (myocardial infarction) or stroke.
Reporting of side effects
If any adverse reactions occur, including any not listed in this leaflet, inform your physician, pharmacist, or nurse. Adverse reactions can be reported directly to the Department of Monitoring of Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
Aleje Jerozolimskie 181C, 02-222 Warsaw, tel.: 22 49 21 301, fax: 22 49 21 309,
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
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Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store medicine I

Keep the medicine out of sight and reach of children.
Store below 25 °C. Keep in the original packaging.
Do not use this medicine after the expiry date stated on the carton. The expiry date refers to the last day of the stated month.
Medicines should 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 medicine I contains

The active substance is ibuprofen. 5 ml of suspension contains 100 mg of ibuprofen.
Other ingredients are: liquid maltitol, glycerol, xanthan gum, sodium saccharin, sodium benzoate (E 211), fumaric acid, disodium phosphate dodecahydrate, raspberry flavor (containing propylene glycol E 1520), purified water.

What medicine I looks like and contents of the pack
The medicine is a white suspension with a raspberry odor.
Brown glass bottle with a polyethylene cap with tamper-evident ring and stopper, and a measuring cup, measuring spoon, or oral syringe, in a cardboard box.
One pack contains 130 g of oral suspension.
Marketing authorization holder and manufacturer
"PRZEDSIĘBIORSTWO PRODUKCJI FARMACEUTYCZNEJ HASCO-LEK" S.A.
51-131 Wrocław, ul. Żmigrodzka 242 E
Medicine information
tel.: 22 742 00 22
e-mail: [email protected]
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The original data is available in the language of the country of manufacture.

Data source: Register of Medicinal Products of Poland (URPL)

Data last verified: September 01, 2026