Ibuprofen Kabi

Package Leaflet: Information for the Patient

Ibuprofen Kabi, 4 mg/ml, Solution for Infusion

Ibuprofen

Read the Package Leaflet Carefully Before Using the Medication, as it Contains Important Information for the Patient.

• Keep this package leaflet, as you may need to read it again.
• In case of any doubts, consult a doctor, pharmacist, or nurse.
• If the patient experiences any side effects, including those not listed in this package leaflet, they should inform their doctor, pharmacist, or nurse. See section 4.

Table of Contents of the Package Leaflet

• 1. What is Ibuprofen Kabi and What is it Used For
• 2. Important Information Before Using Ibuprofen Kabi
• 3. How to Use Ibuprofen Kabi
• 4. Possible Side Effects
• 5. How to Store Ibuprofen Kabi
• 6. Contents of the Package and Other Information

1. What is Ibuprofen Kabi and What is it Used For

Ibuprofen belongs to a group of medications known as nonsteroidal anti-inflammatory drugs (NSAIDs).
This medication is indicated for short-term symptomatic treatment of moderate pain and fever in adults, where intravenous administration is clinically justified and other routes of administration are not possible.

2. Important Information Before Using Ibuprofen Kabi

When Not to Use Ibuprofen Kabi:

• if the patient is hypersensitive to ibuprofen or any of the other ingredients of this medication (listed in section 6);
• if the patient has experienced dyspnea, asthma, skin rash, nasal congestion, or facial swelling after using ibuprofen, acetylsalicylic acid, or other similar pain-relieving medications (NSAIDs);
• if the patient has a condition that causes a tendency to bleed or active bleeding;
• if the patient currently has (or has had more than twice in the past) stomach or duodenal ulcers;
• if the patient has experienced gastrointestinal bleeding or perforation while using NSAIDs;
• if the patient has intracranial bleeding or other active bleeding;
• if the patient has severe kidney, liver, or heart disease;
• if the patient is severely dehydrated (due to vomiting, diarrhea, or inadequate fluid intake);
• if the patient is in the third trimester of pregnancy.

Warnings and Precautions

Before starting treatment with Ibuprofen Kabi, the patient should discuss it with their doctor, pharmacist, or nurse.
The use of anti-inflammatory and pain-relieving medications, such as ibuprofen, may be associated with a slightly increased risk of heart attack or stroke, especially when used in high doses. Do not exceed the recommended dose and duration of treatment.
During treatment with ibuprofen, allergic reactions to this medication have occurred, including difficulty breathing, facial swelling, and chest pain.
If any of these symptoms are observed, the patient should immediately discontinue Ibuprofen Kabi and seek medical attention or emergency care.

• if the patient has heart disease, such as heart failure, angina pectoris (chest pain), has had a heart attack, coronary artery bypass grafting, or has peripheral arterial disease (poor blood circulation in the legs due to narrowing or blockage of arteries) or has had a stroke (including mini-stroke or transient ischemic attack - TIA);
• if the patient has high blood pressure, diabetes, high cholesterol, or a family history of heart disease or stroke, or if the patient smokes;
• if the patient has recently undergone major surgery;
• if the patient has had stomach or duodenal ulcers, gastrointestinal bleeding, or perforation; in these cases, the doctor may consider prescribing a medication to protect the stomach;
• if the patient has asthma or other respiratory diseases;
• if the patient has an infection - see below, section entitled "Infections";
• if the patient has kidney or liver disease, is over 60 years old, or uses ibuprofen for a long time, the doctor may regularly monitor the patient. The doctor will inform the patient about the frequency of these tests;
• if the patient is dehydrated, e.g., due to diarrhea, they should drink plenty of fluids and contact their doctor immediately, as ibuprofen may cause kidney failure due to dehydration;
• there have been reports of severe skin reactions during treatment with ibuprofen, such as exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), drug reaction with eosinophilia and systemic symptoms (DRESS), and acute generalized exanthematous pustulosis (AGEP). The patient should immediately discontinue Ibuprofen Kabi and seek medical attention if they experience any symptoms related to these severe skin reactions described in section 4;
• if the patient has Crohn's disease or ulcerative colitis, as ibuprofen may worsen the course of these diseases;
• if the patient notices any injuries, swelling, or redness of the skin, difficulty breathing (dyspnea), they should immediately discontinue the medication and consult their doctor or nurse;
• if the patient has chickenpox, as complications may occur;
• if the patient has been diagnosed with congenital disorders of porphyrin metabolism (e.g., acute intermittent porphyria);
• if the patient has hay fever, nasal polyps, or chronic respiratory diseases with obstructive breathing disorders, as they are at increased risk of allergic reactions. Allergic reactions may manifest as asthma attacks (so-called analgesic asthma), sudden swelling (angioedema), or rash;
• it is very important that the patient receives the smallest effective dose that provides relief and controls pain, and that they do not receive this medication for longer than necessary to control symptoms;
• during treatment with this medication, especially at the beginning, allergic reactions may occur, in which case the medication should be discontinued;
• there have been reports of aseptic meningitis during treatment with ibuprofen. The risk of this complication is higher in patients with systemic lupus erythematosus and similar connective tissue diseases;
• the patient should avoid concomitant use of this medication and other NSAIDs, including selective cyclooxygenase-2 (COX-2) inhibitors.

Infections
Ibuprofen Kabi may mask the symptoms of infection, such as fever and pain. Therefore, Ibuprofen Kabi may delay the use of appropriate infection treatment, which may lead to increased risk of complications. This has been observed in bacterial pneumonia and bacterial skin infections associated with chickenpox. If the patient is taking this medication during an infection, and the infection symptoms persist or worsen, they should immediately consult their doctor.
Generally, habitual use (of several types) of pain-relieving medications may lead to permanent, severe kidney damage.
Long-term use of pain-relieving medications may cause headaches, which should not be treated with increased doses of ibuprofen.
Ibuprofen may affect the results of the following laboratory tests:

• bleeding time (may be prolonged for up to 24 hours after treatment is stopped);
• blood glucose levels (may decrease);
• creatinine clearance (may decrease);
• hematocrit or hemoglobin levels (may decrease);
• blood urea nitrogen and serum creatinine and potassium levels (may increase);
• liver function tests: increased transaminase activity.

Children and Adolescents

The safety and efficacy of Ibuprofen Kabi in children and adolescents have not been established.
This medication should not be used in children and adolescents (under 18 years of age).

Ibuprofen Kabi and Other Medications

The patient should inform their doctor or pharmacist about all medications they are currently taking or have recently taken, as well as any medications they plan to take.
Ibuprofen may interact with other medications or they may interact with its effects. For example:

• other NSAIDs, including COX-2 inhibitors (e.g., celecoxib), may increase the risk of gastrointestinal ulcers and bleeding due to additive effects;
• anticoagulant medications (blood thinners and medications that prevent blood clots, such as acetylsalicylic acid, warfarin, ticlopidine);
• digoxin (used to treat heart failure), phenytoin (used to treat epilepsy), and lithium salts (used to treat depression) may increase their blood levels if used concomitantly with ibuprofen;
• methotrexate (used to treat certain cancers and certain rheumatic diseases) used concomitantly with ibuprofen (within 24 hours) may increase its blood level and enhance the risk of toxic effects;
• mifepristone (a medication used to terminate pregnancy);
• selective serotonin reuptake inhibitors (SSRIs), such as fluoxetine, may also increase the risk of gastrointestinal bleeding;
• blood pressure-lowering medications (ACE inhibitors, such as captopril; beta-adrenergic blockers, such as atenolol; angiotensin II receptor antagonists, such as losartan);
• corticosteroids (e.g., hydrocortisone) (used in inflammatory diseases), as they increase the risk of stomach and intestinal ulcers and bleeding;
• diuretics (e.g., bendroflumethiazide), as NSAIDs may weaken their effect and increase the risk of kidney damage (concomitant use of potassium-sparing diuretics with ibuprofen may lead to increased potassium levels in the blood);
• medications containing probenecid or sulfinpyrazone may slow down the elimination of ibuprofen from the body;
• cyclosporine and tacrolimus (medications used to prevent transplant rejection) may increase the risk of kidney damage;
• sulfonylurea derivatives, such as glibenclamide (medications used to treat diabetes); when using these medications with ibuprofen, it is recommended to monitor blood glucose levels;
• quinolone antibiotics, such as ciprofloxacin, due to increased risk of seizures;
• voriconazole, fluconazole (CYP2C9 inhibitors) (medications used to treat fungal infections) may increase ibuprofen blood levels;
• zidovudine (used to treat HIV infection), due to increased risk of joint hemorrhages and bruising;
• aminoglycoside antibiotics (a type of antibiotic); NSAIDs may impair the elimination of aminoglycoside antibiotics;
• Ginkgo biloba extract (a herbal medication often used in dementia) may increase the risk of bleeding.

Other medications may also be affected or have an effect on ibuprofen treatment. Therefore, before using ibuprofen with other medications, the patient should always consult their doctor or pharmacist.

Ibuprofen Kabi and Alcohol

If the patient consumes alcohol around the same time as this medication is administered, it may increase the risk of side effects in the stomach, intestines, and nervous system.

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 using this medication.
Ibuprofen Kabi should not be administered to women in the third trimester (last three months) of pregnancy, as it may harm the unborn baby or cause problems during delivery. This medication may cause kidney and heart problems in the unborn baby. It may also increase the risk of bleeding in the mother and baby and prolong or delay labor.
In the first and second trimesters of pregnancy, Ibuprofen Kabi should only be used if absolutely necessary and under the guidance of a doctor. If treatment is necessary during this period or when trying to conceive, the smallest effective dose should be used for the shortest possible time.
If this medication is used for more than a few days after the 20th week of pregnancy, the unborn baby may experience kidney problems. This may lead to low levels of amniotic fluid surrounding the baby (oligohydramnios) or narrowing of the ductus arteriosus in the baby's heart. If treatment is required for a longer period, the doctor may recommend additional monitoring.
Ibuprofen and its metabolites pass into breast milk in small amounts. To date, no adverse effects on infants have been observed, and therefore, it is not necessary to discontinue breastfeeding during short-term use of ibuprofen at recommended doses.
Ibuprofen may make it more difficult to become pregnant. If the patient is planning to become pregnant or is having trouble becoming pregnant, they should inform their doctor.

Driving and Operating Machinery

In the case of single or short-term use of this medication, there is no need to take any precautions. However, in the case of longer treatment, the occurrence of side effects such as fatigue and balance disorders may impair the ability to drive vehicles and (or) operate machinery. This is especially important when consuming alcohol.

Ibuprofen Kabi Contains Sodium

The medication contains 371 mg of sodium (the main component of common salt) per bottle. This corresponds to 18.6% of the maximum recommended daily intake of sodium in the diet for adults.

3. How to Use Ibuprofen Kabi

This medication will be administered by a doctor or nurse.
The recommended dose for adults is 400 mg; a second dose of 400 mg can be administered after 6 to 8 hours, depending on the patient's condition and response to treatment. The maximum daily dose should not exceed 1200 mg.
To avoid side effects, the doctor will prescribe the smallest effective dose for the shortest possible time. Additionally, the doctor will ensure that the patient receives sufficient fluids to minimize the risk of side effects in the kidneys.
The patient should use the smallest effective dose for the shortest period necessary to relieve symptoms. If the patient has an infection and the infection symptoms persist or worsen, they should immediately consult their doctor (see section 2).
The use of this medication should be limited to situations where oral administration is not appropriate. Patients must switch to oral treatment as soon as possible.
This medication is indicated for short-term treatment of acute symptoms and should not be used for more than 3 days.

Method of Administration

Intravenous administration (iv infusion). The solution should be administered in an iv infusion lasting 30 minutes.
Ibuprofen Kabi is a medication for single use only. Before administration, a visual inspection of the solution should be performed. Do not use if particles or color changes are observed.

Overdose of Ibuprofen Kabi

If the patient believes they have received a higher dose of Ibuprofen Kabi than they should have, they should contact their doctor, pharmacist, or nurse.
Overdose symptoms may include nausea, stomach pain, vomiting (which may contain blood), headache, ringing in the ears, disorientation, and nystagmus. After taking a large dose, drowsiness, chest pain, rapid heartbeat, loss of consciousness, seizures (mainly in children), coordination disorders, weakness, and dizziness, blood in the urine, low potassium levels in the blood, feeling cold, and breathing difficulties may occur.
There may also be a drop in blood pressure, blue discoloration of the skin or mucous membranes (cyanosis), gastrointestinal bleeding, or liver and kidney dysfunction.
In case of any further doubts about the use of this medication, the patient should consult their doctor, pharmacist, or nurse.

4. Possible Side Effects

Like all medications, Ibuprofen Kabi can cause side effects, although not everybody gets them.
Side effects can be minimized by using the smallest effective dose for the shortest time necessary to relieve symptoms. The patient may experience one or more side effects typical of NSAIDs (see below). If any of the listed side effects occur, the patient should discontinue the medication and seek medical attention as soon as possible.
Patient's over 60 years of age who use this medication are at increased risk of experiencing these side effects.

• symptoms of gastrointestinal bleeding, which may occur frequently (in less than 1 in 10 patients), such as severe abdominal pain, vomiting blood or coffee grounds, sometimes fatal, especially in elderly patients;
• symptoms of very rare but severe allergic reactions (less than 1 in 10,000 patients), such as worsening of asthma, unexplained wheezing or shortness of breath, facial swelling, tongue or throat swelling, difficulty breathing, rapid heartbeat, blood pressure drop, leading to life-threatening shock; these may occur even after the first administration of the medication;
• worsening of inflammatory conditions caused by infections (e.g., development of necrotizing fasciitis), associated with the use of NSAIDs (less than 1 in 10,000 patients);
• red, non-raised, target-like or circular patches on the torso, often with blisters in the center, peeling of the skin, mouth ulcers, genital or eye lesions (may occur in up to 1 in 10,000 patients). 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) (may occur in less than 1 in 10,000 patients);
• red, peeling rash with bumps under the skin and blisters, accompanied by fever at the beginning of treatment (acute generalized exanthematous pustulosis) (frequency cannot be estimated from available data).

Very Common (may affect more than 1 in 10 patients):

• fatigue or insomnia, headache, and dizziness;
• heartburn, abdominal pain, nausea, vomiting, bloating, diarrhea, constipation, and minor gastrointestinal bleeding that may rarely lead to anemia.

Common (may affect less than 1 in 10 patients):

• vertigo of labyrinthine origin;
• skin rash;
• pain and burning sensation at the injection site;
• gastrointestinal ulcers, which may lead to bleeding and perforation; mouth ulcers, worsening of ulcerative colitis and Crohn's disease.

Uncommon (may affect less than 1 in 100 patients):

• insomnia, restlessness, irritability, or fatigue, anxiety, and agitation;
• vision disorders;
• tinnitus (ringing or buzzing in the ears);
• reduced urine production and swelling, especially in patients with high blood pressure or kidney disease, nephrotic syndrome, interstitial nephritis, which may be accompanied by acute kidney failure;
• hives, itching, urticaria (including allergic urticaria), skin rash;
• allergic reactions with skin and itching, as well as asthma attacks (which may be accompanied by blood pressure drops);
• gastritis.

Rare (may affect less than 1 in 1,000 patients):

• reversible toxic amblyopia (double vision);
• hearing impairment;
• esophageal stricture (narrowing of the esophagus), diverticulitis complications, non-specific hemorrhagic colitis; in case of gastrointestinal bleeding, anemia may occur;
• kidney tissue damage (renal papillary necrosis), especially with long-term use, increased blood urea levels;
• jaundice or liver dysfunction, liver damage, especially with long-term use, acute hepatitis;
• psychotic reactions, nervousness, irritability, confusion, or disorientation and depression;
• stiffness of the neck.

Very Rare (may affect less than 1 in 10,000 patients):

• blood disorders (anemia, leukopenia, thrombocytopenia, pancytopenia, agranulocytosis); the first symptoms are: fever, sore throat, mouth ulcers, flu-like symptoms, increased fatigue, nosebleeds, and subcutaneous bleeding;
• rapid heartbeat (tachycardia), heart failure, myocardial infarction;
• high blood pressure;
• aseptic meningitis (stiffness of the neck, headache, nausea, vomiting, fever, or confusion); especially in patients with autoimmune diseases (SLE, mixed connective tissue disease);
• esophagitis or pancreatitis, intestinal stricture;
• asthma, difficulty breathing (bronchospasm), shortness of breath, and wheezing;
• systemic lupus erythematosus (an autoimmune disease);
• erythema multiforme, hair loss (alopecia);
• sensitivity to light and vasculitis;
• in rare cases, during chickenpox, severe skin infections and subcutaneous tissue complications may occur.

Frequency Not Known (cannot be estimated from available data):

• liver failure;
• reactions at the injection site, such as swelling, bruising, or bleeding;
• severe skin reactions known as DRESS syndrome (drug reaction with eosinophilia and systemic symptoms); DRESS syndrome symptoms include: skin rash, fever, swollen lymph nodes, and increased eosinophil count (a type of white blood cell);
• red, peeling rash with bumps under the skin and blisters, mainly on skin folds, torso, and upper limbs, accompanied by fever at the beginning of treatment (acute generalized exanthematous pustulosis); the patient should discontinue Ibuprofen Kabi if such symptoms occur. See also section 2;
• chest pain may be a symptom of a potentially severe allergic reaction called Kounis syndrome.

Reporting Side Effects

If side effects occur, including those not listed in this package leaflet, the patient should inform 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
Al. Jerozolimskie 181C
02-222 Warsaw
tel.: +48 22 49 21 301
fax: +48 22 49 21 309
website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of this medication.

5. How to Store Ibuprofen Kabi

Store the medication out of sight and reach of children.
Do not use this medication after the expiration date stated on the label after EXP.
The expiration date refers to the last day of the month stated.
There are no special storage temperature recommendations for this medication.
Do not freeze. Store the bottle in the outer packaging to protect it from light.
Use immediately after opening.
Do not use this medication if particles or color changes are observed.
For single use only. Dispose of any unused solution.
Medications should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medications they no longer use. This will help protect the environment.

6. Contents of the Package and Other Information

What Ibuprofen Kabi Contains

• The active substance of the medication is ibuprofen. Each ml of solution contains 4 mg of ibuprofen. Each 100 ml bottle contains 400 mg of ibuprofen.
• Other ingredients are: sodium chloride, sodium dihydrogen phosphate dihydrate, disodium phosphate dodecahydrate, sodium hydroxide (for pH adjustment), hydrochloric acid (for pH adjustment), and water for injections.

What Ibuprofen Kabi Looks Like and Contents of the Package

Ibuprofen Kabi is a clear and colorless solution for infusion.
The solution for infusion is available in LDPE (KabiPac) bottles of 100 ml, in packs of 10, 20, and 40 bottles.
Not all pack sizes may be marketed.

Marketing Authorization Holder

Fresenius Kabi Polska Sp. z o.o.
Al. Jerozolimskie 134
02-305 Warsaw

Manufacturer

Fresenius Kabi Polska Sp. z o.o.
ul. Sienkiewicza 25
99-300 Kutno
Poland

This Medication is Authorized in the Member States of the European Economic Area Under the Following Names:

Austria, Germany:Ibuprofen Kabi 400 mg Infusionslösung
Belgium:Ibuprofen Fresenius Kabi 400 mg oplossing voor infusie/ Ibuprofen Fresenius Kabi 400 mg solution pour perfusion/Ibuprofen Fresenius Kabi 400 mg Infusionslösung
Czech Republic, Poland, Slovakia:Ibuprofen Kabi
Hungary:Ibuprofen Kabi 400 mg oldatos infúzió
Netherlands:Ibuprofen Fresenius Kabi 400 mg oplossing voor infusie
Portugal:Ibuprofeno Kabi
Romania:Ibuprofen Kabi 400 mg soluţie perfuzabilă
Slovenia:Ibuprofen Kabi 400 mg raztopina za infundiranje
Spain:Ibuprofeno Kabi mg solución para perfusión
Date of Last Revision of the Package Leaflet:25.10.2024