IBUPROFEN 200 mg /50 Ml Solution

Contents of the leaflet

1. Leaflet accompanying the packaging: patient information
2. Ibuprofen B. Braun, 200 mg, solution for infusion
   1. Read the leaflet carefully before using the medicine, as it contains important information for the patient.
   2. Table of contents of the leaflet
3. What is Ibuprofen B. Braun and what is it used for
4. Important information before using Ibuprofen B. Braun
   1. When not to use Ibuprofen B. Braun:
   2. Warnings and precautions
   3. Ibuprofen B. Braun and other medicines
   4. Pregnancy, breastfeeding, and fertility
   5. Driving and using machines
5. How to use Ibuprofen B. Braun
   1. Method of administration
   2. Using a higher dose of Ibuprofen B. Braun than recommended
6. Possible side effects
   1. Reporting side effects
7. How to store Ibuprofen B. Braun
8. Contents of the packaging and other information
   1. What Ibuprofen B. Braun contains
   2. What Ibuprofen B. Braun looks like and contents of the pack
   3. Marketing authorization holder
   4. Manufacturer
   5. This medicine is authorized in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:
   6. Date of last revision of the leaflet: 11-10-2024

Leaflet accompanying the packaging: patient information

Ibuprofen B. Braun, 200 mg, solution for infusion

ibuprofen

Read the leaflet carefully before using the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or nurse.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or nurse. See section 4.

Table of contents of the leaflet

• 1. What is Ibuprofen B. Braun and what is it used for
• 2. Important information before using Ibuprofen B. Braun
• 3. How to use Ibuprofen B. Braun
• 4. Possible side effects
• 5. How to store Ibuprofen B. Braun
• 6. Contents of the packaging and other information

1. What is Ibuprofen B. Braun and what is it used for

Ibuprofen belongs to a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs).
This medicine is used in adolescents and children with a body weight of at least 20 kg and aged 6 years and older for the short-term symptomatic treatment of moderate pain and for the short-term symptomatic treatment of fever, in situations where intravenous administration is clinically justified due to the inability to use other routes of administration.

2. Important information before using Ibuprofen B. Braun

When not to use Ibuprofen B. Braun:

• if the patient is hypersensitive to ibuprofen or any of the other ingredients of this medicine (listed in section 6);
• if the patient has ever had dyspnea, asthma, skin rash, hay fever, or facial edema after taking ibuprofen, acetylsalicylic acid (aspirin), or other similar painkillers (NSAIDs);
• if the patient has a condition that causes a tendency to bleed or active bleeding;
• if the patient has currently or has had in the past twice or more gastric or duodenal ulcers or gastrointestinal bleeding;
• if the patient has ever had gastrointestinal bleeding or perforation while taking NSAIDs;
• if the patient has cerebral 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 (last three months).

Warnings and precautions

Before starting treatment with Ibuprofen B. Braun, discuss it with your doctor or nurse.
Taking 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.
Skin reactions
Severe skin reactions, including exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), and acute generalized exanthematous pustulosis (AGEP), have been reported with ibuprofen use. If the patient notices any symptoms related to these severe skin reactions described in section 4, they should stop taking Ibuprofen B. Braun and seek medical attention immediately.
Due to the use of ibuprofen, allergic reactions to this medicine have been reported, including breathing problems, facial and neck swelling (angioedema), and chest pain. If any of these symptoms are noticed, the patient should stop taking Ibuprofen B. Braun immediately and contact their doctor or emergency services.
Before using Ibuprofen B. Braun, the patient should discuss treatment with their doctor if:

• the patient has heart disease, such as heart failure, chest pain (angina pectoris), has had a heart attack, coronary artery bypass grafting, or has poor circulation in the legs due to narrowed or blocked arteries (peripheral arterial disease) or has had any stroke (including mini-stroke or transient ischemic attack - TIA);
• the patient has high blood pressure, diabetes, high cholesterol levels, has a family history of heart disease or stroke, or smokes;
• the patient has recently undergone major surgery;
• the patient has ever had stomach or duodenal ulcers, gastrointestinal bleeding, or perforation. In these cases, the doctor may consider prescribing a medicine to protect the stomach;
• the patient has asthma or other respiratory diseases;
• the patient is being treated for an infection - see "Procedure in case of infections";
• the patient has kidney or liver disease - in this case, the doctor may regularly perform control tests. The doctor will inform the patient about the frequency of these tests;
• the patient is dehydrated, e.g., due to diarrhea, and should drink plenty of fluids and contact their doctor immediately, as ibuprofen may cause kidney failure due to dehydration;
• the patient has Crohn's disease or ulcerative colitis - as ibuprofen may worsen the course of these diseases;
• the patient notices any injuries, swelling, or redness of the skin, starts having difficulty breathing (dyspnea), or should stop the infusion immediately and contact their doctor or nurse;
• the patient has chickenpox - as the use of this medicine may lead to complications;
• the patient has been diagnosed with congenital disorders of porphyrin metabolism (e.g., acute intermittent porphyria);
• the patient consumes alcohol roughly at the same time as this medicine is administered; this may increase the risk of adverse reactions in the stomach, intestines, and nervous system;
• the patient has hay fever, nasal polyps, or chronic respiratory diseases with breathing difficulties - as these patients are at increased risk of allergic reactions. Allergic reactions may manifest as asthma attacks (so-called analgesic asthma), sudden swelling (angioedema), or rash.

A few cases of aseptic meningitis have been reported during the use of this medicine. The risk of this complication is higher in patients with an autoimmune disease called systemic lupus erythematosus and similar connective tissue diseases.
With oral ibuprofen, blurred or impaired vision, visual field defects, and changes in color vision have been reported.
Avoid concomitant use of this medicine and other NSAIDs, including selective cyclooxygenase-2 inhibitors.
Procedure in case of infections
Ibuprofen may mask the symptoms of infection, such as fever and pain. Therefore, the use of this medicine may delay proper treatment of the infection, which may lead to increased risk of complications. This phenomenon has been observed in patients with pneumonia caused by bacteria and bacterial skin infections associated with chickenpox. If the patient is taking this medicine during an infection, and the symptoms of the infection persist or worsen, they should consult their doctor immediately.
Side effects can be minimized by using the smallest effective dose for the shortest possible time necessary to control the symptoms.
Generally, habitual use of several types of painkillers can lead to permanent severe kidney damage.
Long-term use of painkillers can cause headaches that should not be treated with increased doses of these medicines.
Ibuprofen may affect the following laboratory tests:

• bleeding time (may be prolonged for up to one day after stopping this medicine);
• blood glucose levels (may decrease);
• creatinine clearance (may decrease);
• hematocrit or hemoglobin levels (may decrease);
• blood urea nitrogen and creatinine and potassium levels in serum (may increase);
• increased liver aminotransferase activity. The patient should inform their doctor if they are going to have a laboratory test, and they are taking or have recently taken ibuprofen.

This medicine is not recommended for use in children with a body weight below 20 kg or under 6 years of age.
In dehydrated children and adolescents, there is a risk of impaired kidney function.

Ibuprofen B. Braun and other medicines

Tell your doctor or nurse about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.
Some medicines may affect the action of Ibuprofen B. Braun, and this medicine may affect the action of other medicines. For example:

• other NSAIDs, including COX-2 inhibitors (e.g., celecoxib), may increase the risk of gastrointestinal ulcers and bleeding due to additive effects;
• blood thinners and/or anticoagulants (e.g., acetylsalicylic acid, warfarin, ticlopidine);
• medicines used to treat heart failure (cardiac glycosides, e.g., digoxin), epilepsy (phenytoin), or depression (lithium salts) may have increased blood levels if taken with ibuprofen;
• a medicine used to treat certain types of cancer and rheumatic diseases (methotrexate) taken at the same time as ibuprofen (within 24 hours) may have increased blood levels and toxicity;
• a medicine used to terminate pregnancy (mifepristone);
• antidepressants from the SSRI group, e.g., fluoxetine, may also increase the risk of gastrointestinal bleeding;
• medicines that lower blood pressure (ACE inhibitors, e.g., captopril; beta-adrenergic blockers, e.g., atenolol; angiotensin II receptor antagonists, e.g., losartan);
• medicines used in inflammatory diseases (corticosteroids, e.g., hydrocortisone), as they increase the risk of ulcers and gastrointestinal bleeding;
• diuretics (e.g., bendroflumethiazide), as NSAIDs may weaken their effect and increase the risk of kidney damage (using potassium-sparing diuretics with ibuprofen may lead to increased potassium levels in the blood);
• medicines containing probenecid or sulfinpyrazone may slow down the elimination of ibuprofen from the body;
• medicines used to prevent transplant rejection (cyclosporine and tacrolimus) may increase the risk of kidney damage;
• medicines used to treat diabetes (sulfonylurea derivatives, e.g., glibenclamide). When using these medicines with ibuprofen, it is recommended to monitor blood glucose levels;
• quinolone antibiotics, e.g., ciprofloxacin - due to increased risk of seizures;
• medicines used to treat fungal infections (CYP2C9 inhibitors, such as voriconazole, fluconazole) may increase ibuprofen blood levels;
• medicines used in HIV infection (zydovudine) - due to increased risk of joint effusions and bruising;
• chronic alcohol consumption may increase the risk of significant gastrointestinal bleeding;
• aminoglycoside antibiotics (a type of antibiotic) - NSAIDs may impair the elimination of aminoglycoside antibiotics and increase their toxicity;
• Ginkgo biloba (a herbal medicine often used in dementia) may increase the risk of bleeding.

Also, some other medicines may be affected or have an effect on ibuprofen treatment. Therefore, before using ibuprofen with other medicines, the patient should always consult their doctor or nurse.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or nurse before using this medicine.
Pregnancy
If the patient is pregnant, they will only receive ibuprofen if their doctor considers it absolutely necessary. This medicine should not be given to women during the last three months of pregnancy.
It may cause kidney and heart problems in the unborn child. It may also increase the risk of bleeding in the mother and child and prolong or delay labor.
Ibuprofen should not be used during the first six months of pregnancy unless the doctor considers it essential. If ibuprofen is used during this period or when trying to conceive, the smallest possible dose should be used for the shortest possible time.
Intravenous treatment with ibuprofen should not last longer than three days. If ibuprofen is administered for more than a few days from the 20th week of pregnancy, it may cause kidney problems in the unborn child, leading to a decrease in the amount of amniotic fluid surrounding the child (oligohydramnios). It may also cause narrowing of the blood vessel (ductus arteriosus) in the child's heart. If ibuprofen treatment is required for a longer period, the doctor may recommend additional monitoring.
Breastfeeding
This medicine passes into breast milk, but it can be used during breastfeeding if the recommended dose is used and for the shortest possible time. However, if this medicine is used in higher doses or for a long time, the doctor may recommend stopping breastfeeding.
Fertility
Ibuprofen may make it harder to get pregnant. If the patient plans to get pregnant or is having trouble getting pregnant, they should tell their doctor.

Driving and using machines

In the case of single or short-term use of this medicine, 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 machines. This is especially important when consuming alcohol.
Ibuprofen B. Braun contains sodium.This medicine contains 179 mg of sodium (the main component of table salt) per 50 ml of solution. This corresponds to 9% of the maximum recommended daily intake of sodium in the diet for adults.

3. How to use Ibuprofen B. Braun

This medicine can only be prescribed by a doctor and can only be administered by a doctor or nurse in a place where proper equipment is available.
The dose will be individually determined by the doctor based on the patient's body weight and overall condition.
Dosing
In children and adolescents, ibuprofen is dosed based on body weight or age, 5 to 10 mg/kg body weight in a single dose, up to a maximum total daily dose of 30 mg/kg body weight:
Children with a body weight of 20 kg - 29 kg (6-9 years): 200 mg of ibuprofen up to 3 times a day; do not exceed the maximum daily dose of 600 mg.
Children with a body weight of 30 kg - 39 kg (10-11 years): 200 mg of ibuprofen up to 4 times a day; do not exceed the maximum daily dose of 800 mg.
Adolescents with a body weight of ≥ 40 kg (12-17 years): 200 mg to 400 mg of ibuprofen, up to 3 times a day; do not exceed the maximum daily dose of 1200 mg.
This medicine is not recommended for use in children with a body weight below 20 kg or under 6 years of age.
The interval between consecutive doses should be chosen based on symptoms and the maximum daily dose. The interval between doses should not be less than 6 hours. Do not exceed the recommended maximum daily dose.
The doctor will administer the smallest effective dose to the patient for the shortest possible time required to relieve symptoms. If the patient has a concurrent infection, they should consult their doctor immediately if the symptoms of the infection (such as fever and pain) persist or worsen. Additionally, the doctor will ensure that the patient receives sufficient fluids to minimize the risk of adverse reactions in the kidneys.
The use of this medicine should be limited to situations where oral administration is not possible.
Patients must switch to oral treatment as soon as possible.
This medicine will be administered to patients for the shortest possible period. Do not administer the medicine for more than 3 days.

Method of administration

Intravenous administration. The solution should be administered in a 30-minute intravenous infusion.
Inspect the solution before use. Do not use if particles are visible.

Using a higher dose of Ibuprofen B. Braun than recommended

Since dosing is under the control of a doctor or nurse, it is unlikely that the patient will receive too high a dose of this solution.
If the patient has received a higher dose of the medicine than they should have, or if this medicine has been administered to children by mistake, they should always contact their doctor or the nearest hospital to get an opinion on the risk and advice on what measures to take.
Symptoms of overdose may include nausea, stomach pain, vomiting (which may contain blood), headache, ringing in the ears, confusion, ataxia (coordination disorders), and nystagmus. After taking a large dose, drowsiness, chest pain, palpitations, loss of consciousness, seizures (mainly in children), weakness, and dizziness, blood in the urine, low potassium levels in the blood, feeling cold, and breathing difficulties may occur.
It may also lead to a drop in blood pressure, blue discoloration of the skin or mucous membranes (cyanosis), gastrointestinal bleeding, and liver and kidney dysfunction.
If you have any further questions about using this medicine, ask your doctor or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Side effects can be minimized by using the smallest effective dose for the shortest possible time necessary to treat the symptoms. The patient may experience one or more of the identified side effects typical of NSAIDs (see below). If any of the listed side effects occur, the patient should stop taking this medicine and contact their doctor as soon as possible.
The most commonly observed adverse events are related to the stomach and intestines. There may be a development of gastrointestinal ulcers (stomach or intestinal ulcers), perforation of the stomach or intestinal wall, or gastrointestinal bleeding, in some cases with a fatal outcome.
Gastrointestinal disorders, such as melena, hematemesis, ulcerative stomatitis, exacerbation of ulcerative colitis and Crohn's disease, have been reported. Gastritis has been reported less frequently.

• red, non-raised, plate-like or round patches on the torso, often with blisters in the center, peeling of the skin, ulcers of the mouth, throat, nose, genitals, and eyes. These serious skin rashes can 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, widespread rash with nodules under the skin and blisters, usually in skin folds, on the torso, and upper limbs, with fever occurring at the beginning of treatment (acute generalized exanthematous pustulosis).

With the use of NSAIDs, very rare cases of worsening of inflammatory conditions caused by infections (e.g., development of a connective tissue disease called necrotizing fasciitis) have been reported.
In exceptional cases, during chickenpox, severe skin infections and complications in the subcutaneous tissue may occur.
Very common side effects (may affect more than 1 in 10 people):

• fatigue or insomnia, headache, balance disorders
• heartburn, stomach pain, nausea, vomiting, bloating, diarrhea, constipation, and minor gastrointestinal bleeding that may rarely cause anemia

Common side effects (may affect up to 1 in 10 people):

• dizziness
• skin rash
• pain and burning sensation at the injection site
• gastrointestinal ulcers, which may lead to bleeding and perforation. Ulcerative stomatitis, exacerbation of ulcerative colitis and Crohn's disease

Uncommon side effects (may affect up to 1 in 100 people):

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

Rare side effects (may affect up to 1 in 1,000 people):

• reversible double vision (toxic amblyopia)
• hearing disorders
• esophageal stricture, complications of diverticulitis, non-specific hemorrhagic colitis, characterized by severe cramps and diarrhea. In case of gastrointestinal bleeding, anemia may develop
• kidney tissue damage (renal papillary necrosis), especially with long-term use, increased blood uric acid levels
• jaundice or discoloration of the skin and whites of the eyes, liver dysfunction, liver damage, especially with long-term use, acute liver inflammation
• psychotic reactions, nervousness, irritability or fatigue, anxiety and restlessness, depression
• stiffness of the neck

Very rare side effects (may affect up to 1 in 10,000 people):

• blood disorders (anemia, leukopenia, thrombocytopenia, pancytopenia, agranulocytosis). The first symptoms are: fever, sore throat, superficial mouth ulcers, flu-like symptoms, increased fatigue, nosebleeds, and subcutaneous bleeding
• rapid heartbeat (palpitations), heart failure, heart attack
• high blood pressure
• aseptic meningitis (stiffness of the neck, headache, nausea, vomiting, fever, or confusion). This is especially true for patients with autoimmune diseases (SLE, mixed connective tissue disease)
• esophageal or pancreatic inflammation, intestinal stricture
• asthma, difficulty breathing (bronchospasm), shortness of breath, and wheezing
• systemic lupus erythematosus, severe allergic reactions (facial swelling, tongue swelling, swelling of the inner part of the larynx, and accompanying airway narrowing, shortness of breath, rapid heartbeat, drop in blood pressure, and life-threatening shock)

Side effects with unknown frequency (frequency cannot be estimated from available data):

• chest pain, which may be a symptom of a potentially severe allergic reaction called Kounis syndrome
• liver failure
• reactions at the injection site, such as swelling, hematoma, or bleeding
• severe skin reactions known as DRESS syndrome. The symptoms of DRESS syndrome include: skin rash, fever, swollen lymph nodes, and an increased number of eosinophils (a type of white blood cell)
• red, scaly, widespread rash with nodules under the skin and blisters, usually in skin folds, on the torso, and upper limbs, with fever occurring at the beginning of treatment (acute generalized exanthematous pustulosis). If such symptoms occur, the patient should stop taking Ibuprofen B. Braun and seek medical attention immediately. See also section 2.

Reporting side effects

If side effects occur, including those not listed in this leaflet, the patient should tell their doctor. Side effects can be reported directly to the Department of Drug Safety of the Office for Registration 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 medicine.

5. How to store Ibuprofen B. Braun

Keep the medicine out of the sight and reach of children.
There are no special precautions for storing the medicine.
Use the medicine immediately after opening. Do not use this medicine if particles are visible.
Do not use this medicine after the expiry date stated on the inner and outer packaging after "EXP".
The batch number is stated on the inner and outer packaging after "Lot".
The expiry date refers to the last day of the stated month.

6. Contents of the packaging and other information

What Ibuprofen B. Braun contains

• The active substance of the medicine is ibuprofen. 1 ml of the medicine contains 4 mg of ibuprofen. Each 50 ml vial contains 200 mg of ibuprofen.
• The other ingredients are: arginine, sodium chloride, hydrochloric acid (to adjust pH), sodium hydroxide (to adjust pH), water for injections.

What Ibuprofen B. Braun looks like and contents of the pack

Clear, colorless to pale yellow solution for infusion without particles.
The solution is contained in LDPE vials with a capacity of 50 ml, with a Twincap closure, in packs of 10 and 20 vials.
Not all pack sizes may be marketed.

Marketing authorization holder

• B. Braun Melsungen AG Carl-Braun-Strasse 1 34212 Melsungen Germany

Manufacturer

• B. Braun Medical, S.A. Ctra. Terrasa, 121 Rubí 08191 Barcelona Spain

For more detailed information, please contact the local representative of the marketing authorization holder.

This medicine is authorized in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:

Date of last revision of the leaflet: 11-10-2024