Ibum

Leaflet accompanying the packaging: patient information

IBUM

100 mg/5 ml, oral suspension

Ibuprofen

Oral suspension with a raspberry flavor

Before using the medicine, carefully read the contents of this leaflet, 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, you may need to read it again.
• If you need advice or additional information, ask your pharmacist.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.
• If after 3 days there is no improvement or you feel worse, contact your doctor.

Table of contents of the leaflet

• 1. What is medicine I and what is it used for
• 2. Important information before using medicine I
• 3. How to use medicine I
• 4. Possible side effects
• 5. How to store medicine I
• 6. Package contents and other information

1. What is medicine I and what is it used for

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

Indications for use of the medicine are:

• 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., in viral infections),
• toothaches, pains after dental procedures, pains due to teething,
• joint and bone pains due to musculoskeletal injuries (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 you feel worse, contact your doctor.

2. Important information before using medicine I

When not to use medicine I:

• if you are allergic to ibuprofen, other nonsteroidal anti-inflammatory drugs (NSAIDs), or any of the other ingredients of this medicine (listed in section 6),
• in patients with active or past stomach and/or duodenal ulcers, perforation (hole) or bleeding, also occurring after NSAID use,
• in patients who have had allergic reactions in the past when taking acetylsalicylic acid or other nonsteroidal anti-inflammatory drugs, such as nasal congestion, hives, difficulty breathing, or asthma,
• when taking other NSAID medicines (including COX-2 inhibitors such as celecoxib or etoricoxib),
• if you have severe liver, kidney, or heart failure,
• if you have bleeding in the brain (cerebral hemorrhage) or other bleeding,
• if you have blood clotting disorders, bleeding tendency, or unexplained blood disorders.

Women should not take this medicine during the last 3 months of pregnancy.

Warnings and precautions

Before starting to use medicine I, discuss it with your doctor, pharmacist, or nurse.

Be particularly careful when using medicine I:

• if you have systemic lupus erythematosus and mixed connective tissue disease,
• if you have had allergic reactions after taking acetylsalicylic acid,
• if you have gastrointestinal diseases and chronic inflammatory bowel diseases (ulcerative colitis, Crohn's disease),
• if you have high blood pressure and/or heart function disorders,
• if you have kidney function disorders,
• if you have liver function disorders,
• if you have blood clotting disorders (ibuprofen may prolong bleeding time),
• if you are taking other medicines (especially anticoagulants, diuretics, cardiac glycosides, corticosteroids),
• if you have a congenital fructose intolerance (due to the possibility of maltitol, one of the excipients, being converted to fructose).

There is a risk of gastrointestinal bleeding, ulceration, or perforation, which can be fatal and may not be preceded by warning signs or may occur in patients with such warning signs.

Concomitant long-term use of painkillers may lead to kidney damage with a risk of kidney failure (analgesic nephropathy).

Taking anti-inflammatory/pain-relieving medicines like ibuprofen may be associated with a small increased risk of heart attack (myocardial infarction) or stroke, especially when used in high doses.

Do not exceed the recommended dose and duration of treatment.

Before using medicine I, the patient should discuss the treatment with a doctor or pharmacist if:

• you have heart diseases, such as heart failure, angina pectoris (chest pain), you have had a heart attack, bypass surgery, you have peripheral arterial disease (poor blood circulation in the legs due to narrowing or blockage of arteries) or if you have had any stroke (including mini-stroke or transient ischemic attack - TIA),
• you have high blood pressure, diabetes, you have high cholesterol levels, there is a history of heart disease or stroke in your family, or if you smoke,
• you have an infection - see below, section "Infections".

During ibuprofen use, allergic reaction symptoms to this medicine have occurred, including difficulty breathing, facial and neck swelling (angioedema), and chest pain.

If you notice any of these symptoms, stop using medicine I immediately and contact your doctor or emergency medical services.

Skin reactions

Severe skin reactions associated with the use of medicine I have been reported.

If you experience any skin rash, mucosal lesions, blisters, or other signs of hypersensitivity, stop using medicine I and seek medical attention immediately, as these may be the first signs of a severe skin reaction.

See section 4.

Severe skin reactions such as exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, and drug reaction with eosinophilia and systemic symptoms (DRESS) have occurred with ibuprofen use.

If you experience any symptoms related to these severe skin reactions described in section 4, stop using medicine I and seek medical attention immediately.

Infections

Medicine I may mask infection symptoms such as fever and pain.

This may lead to delayed use of appropriate infection treatment and consequently increase the risk of complications.

This has been observed in bacterial pneumonia and bacterial skin infections related to chickenpox.

If you are taking this medicine during an infection and the infection symptoms persist or worsen, consult your doctor immediately.

Medicine I and other medicines

Tell your doctor or pharmacist about all the medicines you are taking or have recently taken, as well as any medicines you plan to take.

Medicine I may affect the action of other medicines, or other medicines may affect the action of medicine I.

In particular, before taking ibuprofen, inform your doctor or pharmacist if you are taking any of the following medicines:

• other NSAID medicines (including COX-2 inhibitors such as celecoxib or etoricoxib),
• anticoagulant medicines (e.g., acetylsalicylic acid, warfarin, ticlopidine),
• blood pressure-lowering medicines (e.g., ACE inhibitors such as captopril, beta-blockers such as atenolol, angiotensin II receptor antagonists such as losartan),
• medicines that reduce blood clotting (e.g., anticoagulants such as acenocoumarol or antiplatelet agents),
• corticosteroids (e.g., prednisolone or dexamethasone),
• methotrexate (anticancer medicines),
• lithium (antidepressant),
• zydovudine (antiviral medicine).

Some other medicines may also be affected or have an effect on the treatment with medicine I.

Therefore, before using medicine I with other medicines, always consult your doctor or pharmacist.

Pregnancy, breastfeeding, and fertility

If you are pregnant, breastfeeding, think you may be pregnant, or plan to have a child, consult your doctor or pharmacist before using this medicine.

Pregnancy

Do not take medicine I if you are 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 risk of bleeding in you and your child and cause prolongation or delay of labor.

During the first 6 months of pregnancy, do not use the medicine unless it is 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 the 20th week of pregnancy, medicine I may cause kidney function disorders in the unborn child.

If used for more than a few days, it may lead to a decrease in the amount of amniotic fluid surrounding the baby (oligohydramnios) or narrowing of the blood vessel (ductus arteriosus) in the baby's heart.

If treatment is necessary for a longer period, your doctor may recommend additional monitoring.

Breastfeeding

Ibuprofen may pass into breast milk in small amounts.

Since there are no reports of harmful effects of ibuprofen on infants, breastfeeding can be continued during short-term use of ibuprofen in small doses.

Fertility

This medicine belongs to a group of medicines (nonsteroidal anti-inflammatory drugs) that may adversely affect female fertility.

This effect is reversible and disappears after treatment is stopped.

Driving and using machines

No data are available on the effects of medicine I on the ability to drive and use machines.

3. How to use medicine I

Always use this medicine exactly as described in this patient leaflet or as directed by your doctor, pharmacist, or nurse.

If you are unsure, consult your doctor, pharmacist, or nurse.

This medicine is for oral use.

Before use, shake the bottle well.

The daily dose of medicine I depends strictly on body weight and is 20-30 mg/kg, in divided doses, according to the following table:

For infants under 6 months, administer the medicine only after consulting a doctor.

Administer the medicine at intervals of at least 6 hours.

Do not use a higher dose of the medicine than recommended.

Use the smallest effective dose for the shortest possible time to relieve symptoms.

If the infection symptoms (such as fever and pain) persist or worsen, consult your doctor immediately (see section 2).

Do not use the medicine for more than 3 days without consulting a doctor.

A measuring cup or measuring spoon, or a plug and oral syringe, is attached to the packaging.

Instructions for dosing with an oral syringe:

• before first use, wash the syringe with warm (not boiling) water with a detergent,
• press the plug firmly into the neck of the bottle using the syringe,
• to fill the syringe, shake the bottle vigorously, turn it upside down, and then carefully push the syringe plunger down, drawing the suspension in the desired amount indicated on the scale,
• to measure the dose accurately, set the collar of the syringe body to the mark on the plunger,
• turn the bottle back to its original position and carefully remove the syringe from the plug (Figure 1),

Figure 1

• place the tip of the syringe in the child's mouth and, slowly pressing the plunger, carefully empty the syringe,
• after use, close the bottle, leaving the plug in the neck, and wash the oral syringe with warm (not boiling) water with a detergent and dry it.

This medicine is intended for occasional use, so if symptoms persist or worsen, or if new symptoms occur, consult your doctor.

The medicine does not contain sugar or alcohol and can be used by diabetic patients (5 ml of medicine I suspension contains 1.087 g of liquid maltitol, equivalent to approximately 0.07 carbohydrate exchange units).

Using a higher dose of medicine I than recommended

If you have used a higher dose of medicine I than recommended or if a child has accidentally taken the medicine, always consult your doctor or go to the nearest hospital for an opinion on possible health risks and advice on what to do.

In children, taking a single dose above 400 mg may cause overdose symptoms.

In adults, the dose that may cause such symptoms has not been precisely determined.

The half-life during overdose is between 1.5 and 3 hours.

Overdose symptoms may include nausea, stomach pain (abdominal pain), diarrhea, vomiting (may contain blood), headaches, ringing in the ears (tinnitus), disorientation, and nystagmus.

After taking a large dose, drowsiness, chest pain, palpitations, loss of consciousness, seizures (mainly in children), weakness, and dizziness have occurred.

Severe poisoning can cause central nervous system disorders, manifested by drowsiness, and very rarely also agitation and disorientation or coma.

Very rarely, seizures may occur.

During severe poisonings, metabolic acidosis may occur, and the prothrombin time (INR) may be increased.

Acute kidney failure or liver damage may occur.

In patients with asthma, asthma symptoms may worsen.

Treatment of overdose

There is no specific antidote.

Symptomatic and supportive treatment is used, consisting of cleansing the body.

Your doctor should monitor vital signs and consider oral administration of activated charcoal 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.

Missing a dose of medicine I

Do not use a double dose to make up for a missed dose.

If you have any further questions about using this medicine, consult your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

If you experience any of the following symptoms, stop using ibuprofen and seek medical attention immediately:

• 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.
• widespread rash, high fever, and swollen lymph nodes (DRESS syndrome),
• red, scaly rash with nodules under the skin and blisters, usually occurring at the beginning of treatment, accompanied by fever (acute generalized exanthematous pustulosis).

Other possible side effects include:

Uncommon side effects (occurring in 1 to 10 in 1000 patients):

• headache, nausea, abdominal pain, rash, itching.

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

• diarrhea, bloating, constipation, vomiting, gastritis, dizziness, insomnia, agitation, irritability, and fatigue,
• edema due to kidney and urinary disorders.

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

• tarry stools, bloody vomiting, ulcerative stomatitis, exacerbation of colitis and Crohn's disease,
• peptic ulcer disease and/or duodenal ulcer, gastrointestinal bleeding, and perforation, sometimes fatal, especially in the elderly,
• in individual cases, the following have been reported: depression, psychotic reactions, and tinnitus, aseptic meningitis,
• reduced urine output, edema, acute kidney failure, renal papillary necrosis, increased sodium levels in the blood (sodium retention),
• liver function disorders, especially during long-term use,
• blood count abnormalities (anemia, leukopenia, thrombocytopenia, pancytopenia, agranulocytosis).

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

• chest pain, which may be a sign of a potentially serious allergic reaction known as Kounis syndrome,
• severe skin reactions known as DRESS syndrome.

With NSAID use, reports of edema, hypertension, and heart failure have been made.

Taking medicines like I may be associated with a small increased risk of heart attack (myocardial infarction) or stroke.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, tell your doctor, pharmacist, or nurse.

Side effects can be reported directly to the Department of Adverse Reaction Monitoring 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

Side effects can also be reported to the marketing authorization holder.

By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store medicine I

Keep the medicine out of sight and reach of children.

Store at a temperature below 25°C.

Store 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 month stated.

Medicines should not be disposed of via wastewater or household waste.

Ask your pharmacist how to dispose of medicines that are no longer needed.

This will help protect the environment.

6. Package contents and other information

What medicine I contains

• The active substance of the medicine is ibuprofen.
• 5 ml of the suspension contains 100 mg of ibuprofen.
• The other ingredients are liquid maltitol, glycerol, xanthan gum, sodium saccharin, sodium benzoate (E 211), fumaric acid, disodium phosphate dodecahydrate, raspberry flavor (contains 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 flavor.

The bottle is made of brown glass with an aluminum cap and a guarantee ring, and a measuring cup or measuring spoon, or a plug and oral syringe, in a cardboard box.

One package contains 130 g of oral suspension.

Marketing authorization holder and manufacturer

"HASCO-LEK" S.A.

51-131 Wrocław, ul. Żmigrodzka 242 E

Medicine information

tel.: 22 742 00 22

e-mail: informacjaoleku@hasco-lek.pl

Date of last revision of the leaflet:

8/8

3. How to use medicine I

This medicine should always be used exactly as described in this patient information leaflet or as directed by a doctor, pharmacist, or nurse. In case of doubt, consult a doctor, pharmacist, or nurse.
The medicine is intended for oral use. Before use, the bottle should be shaken.
The daily dose of medicine I is strictly dependent on body weight and is 20-30 mg/kg of body weight, in divided doses, as follows:
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In infants under 6 months, the medicine can only be given after consulting a doctor.
The medicine should be given at intervals of at least 6 hours.
A higher dose of the medicine should not be used than recommended.
The smallest effective dose should be used for the shortest period necessary to relieve symptoms. If the symptoms of the infection (such as fever and pain) persist or worsen, consult a doctor immediately (see section 2).
Without consulting a doctor, do not use for more than 3 days.
A measuring cup or measuring spoon, or an oral syringe, is attached to the packaging.
Instructions for dosing with an oral syringe:

• before first use, the syringe must be washed in warm (not boiling) water with a detergent,
• after unscrewing the cap, put the syringe on the cork in the neck of the bottle,
• to fill the syringe, shake the bottle vigorously, turn it upside down, and then carefully push the syringe plunger down, drawing in the suspension in the desired amount indicated on the scale,
• to accurately measure the dose, the collar of the syringe body should be set to the scale mark on the plunger,
• turn the bottle back to its original position and carefully remove the syringe from the cork (Figure 1),

Figure 1

• the tip of the syringe should be placed in the child's mouth, and then, slowly pressing the plunger, carefully empty the contents of the syringe,
• after use, close the bottle, and wash the oral syringe in warm (not boiling) water with a detergent and dry.

The medicine is intended for temporary use, so if the symptoms persist or worsen, or if new symptoms appear, consult a doctor.
The medicine does not contain sugar or alcohol. It can be used by people with diabetes (5 ml of suspension I contains 1.087 g of liquid maltitol, which corresponds to approximately 0.07 carbohydrate exchange units).

Using a higher dose of medicine I than recommended

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If the patient has used a higher dose of medicine I than recommended or if a child has accidentally taken the medicine, always consult a doctor or go to the nearest hospital to get an opinion on possible health risks and advice on what actions to take.
In children, taking a single dose above 400 mg may cause overdose symptoms.
In adults, the dose that may cause such symptoms has not been precisely determined. The half-life during overdose is from 1.5 to 3 hours.
Overdose symptoms
Symptoms may include nausea, stomach pain (abdominal pain), less frequently diarrhea, vomiting (may contain blood), headaches, ringing in the ears (tinnitus), disorientation, and nystagmus. After taking a large dose, drowsiness, chest pain, palpitations, loss of consciousness, seizures (mainly in children), weakness, and dizziness, blood in urine, feeling cold, breathing problems, and gastrointestinal bleeding have occurred.
Severe poisoning can cause central nervous system disorders, manifested by drowsiness, and very rarely also excitement and disorientation or coma. Seizures can occur very rarely.
During severe poisonings, metabolic acidosis may occur, and the prothrombin time (INR) may be increased. 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 is used, consisting of cleansing the body. The doctor should monitor vital signs and consider oral administration of activated charcoal 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.

Missing a dose of medicine I

A double dose should not be used to make up for a missed dose.
In case of any further doubts about the use of this medicine, consult a doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

If the patient experiences any of the following symptoms, stop using ibuprofen and seek medical help immediately:

• red, flat, 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 body temperature, 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, stop taking medicine I and seek medical help immediately. See also section 2,

Other possible side effects include:
Uncommon side effects (in 1 to 10 out of 1000 patients):

• headache, indigestion, stomach pain, nausea, hives, itching.

Rare side effects (in 1 to 10 out of 10,000 patients):
6/8

• diarrhea, bloating, constipation, vomiting, gastritis, dizziness, insomnia, agitation, irritability, and fatigue,
• edema resulting from renal and urinary disorders.

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

• tarry stools, bloody vomiting, ulcerative stomatitis, worsening of ulcerative colitis and Crohn's disease,
• gastric and duodenal ulcer, gastrointestinal bleeding and perforation, sometimes with fatal outcome, especially in the elderly,
• in individual cases, depression, psychotic reactions, and tinnitus, aseptic meningitis,
• decreased urine output, edema, acute renal failure, renal papillary necrosis, increased sodium levels in serum (sodium retention),
• liver function disorders, especially during long-term use,
• blood disorders (anemia, leukopenia, thrombocytopenia, pancytopenia, agranulocytosis). The first symptoms are: fever, sore throat, superficial ulcers of the oral mucosa, flu-like symptoms, fatigue, bleeding tendency (e.g., bruising, petechiae, purpura, nosebleeds),
• erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis,
• severe hypersensitivity reactions, such as: facial edema, tongue and laryngeal edema, dyspnea, tachycardia, hypotension, shock, worsening of asthma and bronchospasm,
• in patients with existing autoimmune diseases (systemic lupus erythematosus, mixed connective tissue disease) during ibuprofen treatment, individual cases of symptoms of aseptic meningitis have been reported, such as stiff neck, headache, nausea, vomiting, fever, disorientation.

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

• chest pain, which may be a symptom of a potentially severe allergic reaction called Kounis syndrome,
• severe skin reactions known as DRESS syndrome. The symptoms of DRESS syndrome include: skin rash, fever, lymph node swelling, 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, stop taking medicine I and seek medical help immediately. See also section 2,
• skin becomes sensitive to light.

With NSAID treatment, edema, hypertension, and heart failure have been reported.
Taking medicines like I may be associated with a small increased risk of heart attack (myocardial infarction) or stroke.
Reporting side effects
If any side effects occur, including any not listed in this leaflet, tell your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety Monitoring 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
Side effects can also be reported to the marketing authorization holder.
7/8
By reporting side effects, more information can be collected on the safety of the medicine.

5. How to store medicine I

Store the medicine out of sight and reach of children.
Store at a temperature below 25°C. Store 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 month.
Medicines should 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 pack and other information

What medicine I contains

• The active substance of the medicine 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 (contains propylene glycol E 1520), purified water.

What medicine I looks like and what the pack contains

The medicine is a white suspension with a raspberry flavor.
A brown glass bottle with a polyethylene cap with a guarantee ring and a cork, and a measuring cup or measuring spoon, or an 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: informacjaoleku@hasco-lek.pl

Date of last revision of the leaflet:

8/8